A Qualitative Study to Explore the Impact of Simulating Extreme Obesity on Health Care Professionals’ Attitudes and Perceptions

Volume 64 - Issue 1 - January 2018 ISSN 1943-2720

↧

A Retrospective, Cost-minimization Analysis of Disposable and Traditional Negative Pressure Wound Therapy Medicare Paid Claims

January 9, 2018, 8:31 am

≫ Next: Bariatric Care and Obesity: A Compendium of 20 Years of Articles From Ostomy Wound Management

≪ Previous: A Qualitative Study to Explore the Impact of Simulating Extreme Obesity on Health Care Professionals’ Attitudes and Perceptions

Issue Number:

Index:

Ostomy Wound Management 2018;64(1):26–33

Gary Delhougne, JD, MHA; Christopher Hogan, PhD; Kim Tarka, BA; and Sunitha Nair, MD, FACPWA

Topics:

cost-minimization analysis

negative pressure wound therapy

durable medical equipment

disposable equipment

Abstract

Traditional negative pressure wound therapy (NPWT) systems are considered durable. The pump is designed for use by numerous patients over a period of several years. Recently developed smaller, disposable devices are designed for single-patient use. A retrospective analysis of 2012–2014 national Medicare claims data was used to examine payments associated with the use of traditional and disposable NPWT systems.

Data extracted included NPWT episodes from the Limited Data Set Standard Analytic Files including the 5% sample for traditional NPWT and 100% sample for disposable NPWT. NPWT episodes were identified using claim service dates and billing codes. Mean costs per episode were compared and analyzed using chi-squared tests for comparisons between patients who received traditional and those who used disposable NPWT. For continuous variables, statistical significance was assessed using Mann-Whitney U tests. The data included traditional (n = 2938; mean age 66.6 years) and disposable (n = 3522; mean age 67.6 years) episodes for the 2 NPWT groups. Wound types differed for NPWT groups (P <.0001) and included surgical (1134 [39%] versus 764 [22%]), generic open (850 [29%] versus 342 [10%]), skin ulcers (561 [19%] versus 1301 [37%]), diabetic ulcers (240 [8%] versus 342 [10%]), and circulatory system wounds (105 [4%] versus 563 [16%]). Average payment amounts were $4650 ± $2782 for traditional and $1532 ± $1767 per disposable NPWT episode (P <.0001). Payment differences were not affected by wound or comorbidity characteristics. Using the 2016 rates, average payments were $3501 for traditional and $1564 for disposable NPWT. Considering the rate of NPWT use in the United States and the results of this study suggesting substantial potential cost savings, additional analyses and cost-effectiveness studies are warranted.

According to estimates, at least $33 billion is spent annually in the United States (US) on direct medical costs of chronic wounds, including pressure ulcers, diabetic foot ulcers, and venous leg ulcers.1-3 This estimate understates the total cost of wound care because it does not include the cost of surgical, traumatic, or other nonhealing open wounds; indirect costs; and lost productivity. Approximately 6.5 million Americans or 2% of the general population suffer from chronic wounds4; Medicare-covered older adults account for the majority. The cost to treat wounds will increase as the US population ages and chronic diseases such as diabetes become more prevalent. As a result, wound care imposes a significant cost and morbidity burden on patients, their families, and the health care system.

Negative pressure wound therapy (NPWT) is commonly used to treat a variety of chronic and acute wounds.5-7 Retrospective analyses of data obtained from clinical trials8,9 as well an outpatient wound care setting10 indicate NPWT is more cost-effective than non-NPWT care in treating chronic wounds of various etiologies, including diabetic foot ulcers, venous leg ulcers, pressure ulcers, arterial ulcers, and surgical wounds.8-10 In these studies, the cost savings for those receiving NPWT versus standard wound care was attributed to improved clinical outcomes (more patients achieving complete wound closure and shorter time to wound closure), which in turn resulted in shorter duration of treatment and fewer medical/surgical procedures and reduced the number of hospitalizations, days hospitalized, and clinic visits.

Traditional NPWT systems are considered durable medical equipment (DME) and consist of an electric suction pump to generate negative pressure, canisters to collect wound exudate, and wound dressing kits. Traditional systems are “durable” because the pump is designed for several years of use with numerous individual patients. A more recent innovation in NPWT is smaller, disposable devices designed for single-patient use. These single-use or disposable systems are predicated on the methods of action of traditional NPWT systems11-14 and designed to deliver equivalent outcomes. Furthermore, a case series14 (N = 326) conducted among patients in a community care setting showed disposable NPWT simplifies application and management for health care professionals and makes the therapy more accessible to patients, including more active and home-bound individuals. According to that study, more than 90% of patients who were treated with single-use, disposable devices were able to perform their daily activities unimpeded, and 97% were pleased or satisfied with the therapy.

The cost of NPWT use is a significant concern to the Medicare program. As a result, payment and coverage rules for NPWT continue to evolve. Historically, when a home health agency (HHA) provided a beneficiary traditional NPWT, Medicare made a payment to the HHA for the visit and a monthly payment to a DME supplier for the NPWT system. However, if a HHA used disposable NPWT (not provided during another facility visit such as a hospital-based outpatient department [HOPD]) or inpatient discharge) Medicare only made a visit payment to the HHA, which then absorbed the cost of the disposable NPWT.

One way to control the cost of NPWT was through the competitive bidding program implemented by the Centers for Medicare and Medicaid Services (CMS). The competitive bidding program is a process where DME providers submit bids for providing certain DME in bidding areas for Medicare beneficiaries. From these bids, Medicare sets the payment rates and secures savings for the program. In a recent development, Congress acted to encourage access to disposable NPWT and required Medicare to make a new, separate payment to HHAs for disposable NPWT systems in addition to the normal HHA visit payment starting January 1, 2017.15,16

With this in mind, the authors hypothesized that disposable NPWT systems might present a new option to control Medicare expenditures. To date, limited research has been published identifying the potential cost savings of disposable NPWT devices to payers.17,18 The objective of this retrospective cost-minimization analysis was to assess Medicare payments associated with traditional and disposable NPWT for Medicare beneficiaries from national Medicare claims data.

Methods

Data source. Medicare is the federal health insurance program for people 65 or older, certain younger people with disabilities, and people with end-stage renal disease. Medicare has 4 distinct parts (A, B, C, and D) to help beneficiaries cover certain health care services; Parts A and B are of consequence to this analysis. Medicare Part A covers inpatient hospital stays, skilled care in a skilled nursing facility up to 100 days, medically necessary hospice care, and some HHA care. Part B covers certain Qualified Health Plan services and procedures, HOPD care, some medical supplies, and preventive services.

This analysis used the 2012–2014 national Medicare Limited Data Set Standard Analytic Files, including Denominator (enrollment), hospital inpatient and outpatient, DME, carrier (physician), and HHA claims. The 5% sample data (nationally representative sample of beneficiaries) was used to study traditional NPWT episodes, while the 100% sample (all Medicare beneficiaries) was used for disposable NPWT episodes to increase the number of disposable episodes. These files are claims data sets that contain information on care provided to Medicare beneficiaries and on patient characteristics such as age, gender, enrollment history, medical diagnoses, dates and places of service, and payment amounts. Claims data are based on the bills submitted by providers to payers representing services provided, provider setting of care, and patient comorbidities. Although claims data often are utilized to approximate cost of service, the cost identified is not direct medical cost.

Construction of episodes of care. NPWT episodes were identified from the data using service dates on Medicare claims. Traditional NPWT patients were identified using the Current Procedural Terminology/Healthcare Common Procedure Coding System (CPT/HCPCS) codes A6550, A7000, E2402, 97605, and 97606; disposable NPWT patients were identified with the CPT/HCPCS codes A9272, G0456, G0457, 97607, and 97608 (see Table 1). Medicare-denied NPWT claims and home health claims not directly related to nursing care were excluded from analysis.

For traditional NPWT, episodes began with the first observed DME monthly pump rental claim (HCPCS E2402) and continued until a break of >31 days occurred between rentals. To ensure the episode of care was followed to its completion, a break of 31 days was used based on DME monthly pump rental policies. The episode end date was estimated beyond the last pump rental by assuming all supplies were used at the standard Medicare allowed use rates of 15 dressings (HCPCS A6550) and 10 canisters (HCPCS A7000) per month. For disposable NPWT, episodes began with the first observed HOPD NPWT claim (HCPCS G0456/G0457 during this period) and continued until a break of >31 days occurred between claims. The same 31 day cutoff as based on traditional NPWT monthly pump rental policies was used to maintain consistency in evaluating the end of disposable NPWT episodes. For this analysis, neither group episode payment analysis started in the acute inpatient setting.

The episode end date for paid claims (ie, nondenied) was estimated using 1 of 2 methods to ensure the full length of discrete episodes was captured. First, for episodes with more than 1 HOPD NPWT bill, the average interval between device changes (for that episode) was added to the last HOPD NPWT bill. Second, for episodes with just 1 HOPD NPWT bill, the average device change interval for all patients in the data file was added. Patients with disposable or traditional NPWT episodes were mutually exclusive.

Episode costs (total payments) were constructed from relevant wound diagnosis and treatment claims on the billing forms within the episode and included DME, physician, or HOPD paid claims lines with any relevant CPT/HCPCS codes (see Table 1). Cost was defined as total payment including both Medicare program payments and beneficiary coinsurance and deductible liabilities. To ensure a proportion of the HHA bill associated with NPWT was captured and arrived at a more accurate episode cost, the portion of HHA bills that overlapped the NPWT episode was prorated. Because HHA bills do not have line-item payment amounts, HHA claim total payments were prorated based on charges, excluded line items other than nursing visits (eg, physical therapy), and then selected all nursing visits falling within the NPWT episode. Using this method, some HHA cost not directly related to NPWT may have been captured, but the principal diagnoses on HHA claims overwhelmingly indicated wound care as the main reason for the HHA care.

Risk adjustment and sensitivity analyses. Several analyses were performed to test the robustness of the total mean payments results. First, the influence of wound type and comorbidities on episode cost was examined. Episodes of care were stratified by episode type (traditional versus disposable) and wound type (surgical wounds, generic open wounds, skin ulcers, diabetic ulcers, and circulatory disease wounds). Mean cost within strata were calculated, and the means were weighted by the all-episodes proportion of cases by wound type. Episode costs also were assessed for different wound types.

Second, ordinary-least-squares (OLS) regression was used to predict episode costs as a function of episode type, patient demographics, and diagnoses from the claims (diagnosis-based risk adjustment). Comorbidities were identified using diagnoses reported on 12 months of physician and hospital claims, aggregated into Clinical Classification System disease categories.19

Third, aspects of Medicare payment policy were handled. The presence of traditional NPWT qualifies any homebound patient for home health care; all HHA costs and recomputed episode costs were removed. Medicare updates its payment rates on an annual basis through a rulemaking process to reflect updated costs and evolving payment policies. Similarly, Medicare adjusts DME fee schedule rates through its competitive bidding process among DME providers. Therefore, because Medicare payment rates for DME items changed in response to its recent competitive bidding initiatives, all claims were priced using 2016 Medicare rates20,21 and recomputed episode costs.

Statistical analyses. For categorical variables, statistical significance was assessed using chi-squared for comparisons between patients who used traditional and patients who used disposable NPWT. For continuous variables, statistical significance was assessed using Mann-Whitney U tests. The claims data analyses were conducted using Statistical Analysis System (SAS) software, version 9.4 (SAS Institute, Cary, NC).

Results

The Medicare claims database included 2938 traditional NPWT episodes and 3522 disposable NPWT episodes (see Table 2). Differences in demographics between the cohorts were identified, including a difference in mean age of patients (66.6 versus 67.6, P = 0.001) and race (2350 [80%] versus 2923 [83%] Caucasian, P = 0.0021) for traditional and disposable NPWT, respectively. Differences in the mix of wounds were identified between the groups (P <.0001) and included surgical wounds (1134 [39%] versus 764 [22%]), generic open wounds (850 [29%] versus 342 [10%]), skin ulcers (561 [19%] versus 1301 [37%]), diabetic ulcers (240 [8%] versus 342 [10%]), circulatory system disease wounds (105 [4%] versus 210 [6%]), and all others (48 [2%] versus 563 [16%)], for traditional and disposable NPWT, respectively (see Table 2).

Total direct costs associated with each patient’s traditional NPWT episode were 3 times greater than total costs associated with each patient’s disposable NPWT episode ($4650 ± $2782 versus $1532 ± $1767, respectively, P = .0001; see Table 3). Device costs dominate both estimates; traditional NPWT pump rental, wound dressings, and exudate canisters represented mean costs of $2390 ± $1406, $499 ± $301, and $104 ± $61, respectively (see Table 3). Pump rental was the single highest cost item for traditional NPWT ($2390 ± $1406), while device replacement (including labor) in the HOPD was the largest single item for disposable NPWT ($1076 ± $1436; see Table 3). Necessarily, disposable NPWT does not have DME costs as outlined previously for traditional NPWT, but costs were identified and compared in the HHA ($1553 ± $1422 versus $456 ± $865; P = .0001) and HOPD ($104 ± $284 versus $1076 ± $1436; P = .0001) for traditional and disposable NPWT, respectively. Mean cost per day was estimated to be $142 ± $203 and $56 ± $33 for traditional NPWT and disposable NPWT, respectively (see Figure). A difference in the mean episode lengths of 43.3 days and 28.3 days was observed for traditional and disposable NPWT, respectively. Finally, as a result of dissimilar product treatment paths, additional differences were identified in days of service for HOPD and HHA services (1.5 versus 4.9 days, P = .0001) and (13.5 versus 3.9 days, P = .0001; see Table 4) for traditional and disposable NPWT, respectively. For traditional NPWT, dressing changes are frequently paid as HHA services while HOPD dressing changes are less common. By contrast, essentially all disposable device replacements occur in the HOPD.

owm_0118_delhougne_figure

Table 5 provides the results of the sensitivity analyses that assessed whether patient characteristics, Medicare HHA payment rules, or periodic Medicare payment rates changes can explain or eliminate the observed difference in cost. As estimated, the cost of traditional NPWT was 3 times that of disposable NPWT. The first 3 analyses show patient characteristics (2 on wound type and 1 on comorbidities plus demographics) do little to explain the cost difference between traditional and disposable NPWT. The weighted analysis holding the proportion of wound types constant showed the total mean payment per episode of care for traditional NPWT was 3.1 times more than disposable NPWT ($4837 versus $1567 for wound types; see Table 5). Similarly, when costs were assessed by wound type, the cost difference between traditional NPWT and disposable NPWT remained close to the ratio of 3 observed in the primary analysis, ranging from 2.4 for open wounds to 3.7 for skin ulcers (see Table 5). Even though OLS regression indicated 18% of episode cost variation (adjusted R-squared) and only 1 comorbidity (paralysis) had a statistically significant effect in excess of $1000 per episode, the cost of traditional NPWT remained approximately 3 times greater than disposable NPWT after adjusting for comorbidities plus demographics ($4670 versus $1511; see Table 5). The fourth sensitivity test removed HHA costs for homebound patients to determine if it affected the payment delta ($3097 versus $1076; see Table 5). Finally, Medicare’s substantial reductions in DME rates (mainly NPWT pump rental) and modest increases in HOPD rates reduced the initial 3 to 1 ratio to 2.2 to 1 (from $4837 versus $1567 to $3501 versus $1564; see Table 5).

Traditional NPWT episodes (N = 2938 based on the 5% LDS; see Table 2) were significantly more common than disposable NPWT episodes (N = 3522 based on the 100% sample; see Table 2). Given the current level of traditional NPWT use (N = 2938 multiplied by 20 equals approximately 60 000 episodes; see Table 2), and the cost savings identified after adjustment to 2016 rates ($1937; see Table 5), a potential estimated Medicare cost savings of more than $1 billion would be realized over the next decade if traditional NPWT was replaced by disposable NPWT.

Discussion

The purpose of this study was to examine the cost of NPWT use from a Medicare payment policy perspective. Although the authors are not aware of other research on cost from the Medicare payment perspective, previously published studies8-10 from the provider perspective report NPWT can reduce the cost of wound care. Two (2) of these studies8,9 assessed the cost of traditional NPWT versus standard moist wound therapy (not otherwise specified) using results obtained in randomized clinical trials. Apelqvist et al8 analyzed data from 162 patients with diabetes with postamputation wounds and found the average direct cost per patient was $27 270 versus $36 096 for the NPWT and standard therapy groups, respectively. Driver and Blume9 analyzed data from 324 patients with grade 2 or 3 diabetic foot ulcers and found mean cost per patient was $11 984 and $13 558 for NPWT and advanced moist wound therapy groups, respectively. A third study10 examined outpatient data from 304 patients with either diabetes or peripheral artery disease and multiple comorbidities likely to interfere with wound healing. The cost-effectiveness analysis showed an incremental net health benefit of $1371 per ulcer-free month and an incremental cost-effectiveness ratio of $366 682 per quality adjusted life year gained in the NPWT group.

A limited number of studies17,18 has examined costs associated with the use of disposable NPWT. One (1) was a case study17 of 21 patients with various postoperative or posttraumatic wounds of which 8 patients would have been hospitalized based on hospital surgery department treatment practice if disposable NPWT was not available. The cost savings for treating these patients with disposable NPWT was estimated to be £7800 per patient based on hospital costs averted. A decision analytic model study18 evaluated the cost-effectiveness of disposable NPWT in patients undergoing primary hip and knee replacement surgery. Data from 209 patients were analyzed and showed an estimated cost savings for health care payers in the United Kingdom of £1132 per patient for those treated with disposable NPWT compared with standard care.

Unlike the previously published studies described that focus on cost savings from the providers’ perspective, the current study examines costs from the payers’ perspective. Specifically, Medicare payments for traditional NPWT and disposable NPWT episodes of care were compared using data extracted from the national Medicare database. The analysis demonstrated a considerable opportunity for Medicare (and by extension, private payers) to substantially lower costs for NPWT episodes while embracing the use of more patient-friendly disposable technology. The analysis demonstrated the average risk-adjusted cost for Medicare to treat a post-acute patient with traditional NPWT was $3118 more than disposable NPWT ($4650 versus $1532); the cost of pump rental for traditional NPWT and the cost of the device for disposable NPWT dominate each group’s costs. It is important to note the large difference in cost is a result of Medicare payment policy for traditional versus disposable NPWT episodes. Medicare’s payment policy is a significant contributor to the cost difference identified in this research. Patients treated with traditional NPWT in the HOPD, clinic, or home by a HHA use electrical pumps and supplies and receive services from trained nurses, physical and occupational therapists, and physicians. For Medicare patients treated with traditional NPWT, Medicare reimburses the DME supplier for the pump, the HOPD for any services of qualified health care professionals (MD, DO, DPM, NP, PA, CNS) for care, and a HHA for their assessment of the wound, application of the NPWT, and education of the patient or caregiver. In addition, large differences in cost remain after accounting for patient characteristics, possible bias from HHA costs, and evolving DME and HOPD payment changes (since 2013). These results seem reasonable given that the episodes, by definition, are limited to ≤3 months and the disposable systems may be suitable for almost all of the wounds that can be treated with traditional NPWT systems. This analysis, based on similar ages and across various wound types, demonstrates that payers can capture significant savings by encouraging the use of disposable NPWT.

Because the claims data showed surgical wounds were more prevalent among traditional NPWT users and skin ulcers were more prevalent among disposable NPWT users, the authors performed a sensitivity analysis based on wound type. Results of the analysis indicated wound type had a negligible impact on the estimated payment difference between traditional and disposable NPWT therapy. To further test the impact of wound type on payment, the authors performed an analysis holding the proportion of wound types constant. Results of the weighted analysis also showed the observed differences in the types of wounds were unlikely to affect the payment difference between traditional and disposable NPWT technologies. However, it should be noted that the differences in wound types observed may be an artifact of coding practices because DME claims are more likely to report nonspecific (eg, not otherwise specified) diagnosis codes with traditional NPWT cases compared to specific codes for other wounds identified more frequently with disposable NPWT cases. Although the current analysis showed a difference in mean episode lengths for traditional and disposable NPWT, the authors are not aware of any literature demonstrating shorter treatment episodes for disposable cases, a finding that may be an artifact of their analysis.

Despite the substantial cost advantage of disposable NPWT devices, these devices are infrequently provided to Medicare beneficiaries (approximately 6% of all NPWT claims in this analysis were for disposable NPWT devices). A possible explanation for underutilization may be the silo nature of traditional Medicare payments. As such, traditional Medicare separate per-service payment to the prescribing physician, HOPD, and DME supplier may insulate each player from the other regarding the cost implications of their choice of NPWT modality. Another possible explanation for the limited use of these devices on Medicare beneficiaries is the relative newness of disposable NPWT as a treatment alternative to traditional NPWT. As awareness of this new option develops, evolving Medicare payment policy may have a tremendous impact on the adoption of disposable NPWT. Medicare’s new initiatives implementing value- and episode-based payments should destroy silos and motivate providers through payment tied to quality reporting, costs, outcomes, and patient satisfaction.

In 2015, the CMS set aggressive targets of having 90% of all Medicare fee-for-service payments tied to quality reporting; by 2018, 50% of all payments will be part of an “alternative” model (ie, bundled payments).22 The authors speculate that value- and episode-based payments will hasten the adoption of disposable NPWT over traditional NPWT. Additionally, Congress passed a consolidated appropriations act in 2015 that included a provision supporting the adoption of disposable NPWT technologies.15 Starting January 1, 2017, Medicare began making a new, separate payment to HHAs that furnish Medicare beneficiaries with disposable NPWT. Given the current level of traditional NPWT (DME) use (approximately 60 000 episodes per year as identified in the Medicare 5% sample) and the per episode cost savings of $1937 identified here after adjustment to 2016 rates, the estimated potential cost savings could be more than $1 billion over the next decade if traditional NPWT is replaced by disposable NPWT where clinically appropriate.

However, realizing those savings will likely require action by Medicare. Disposable NPWT systems offer policymakers a new option to reduce expenditures, limit waste (both bulk supply waste and unnecessary cost), and improve the quality of life for patients. In isolation, competitive bidding has generated some reductions in payment for traditional NPWT to date but not enough to bend the NPWT cost curve. The authors expect Medicare’s initiatives in value- and episode-based payment will spur adoption of the more cost-effective technology within those episodes. However, for the bulk of Medicare claims, current payment policies offer limited incentive for adoption of the lower cost technology.

Limitations

The current analysis was based on claims data and therefore subject to traditional limitations of claims data sets (ie, coding errors, absence of detailed wound etiology, and limited diagnostic information). Claims data do not reflect the direct cost of products and services and may not reflect provider cost; instead, the data reflect payments made to the provider(s) based on Medicare payment policy. All episodes start with a home health or hospital outpatient claim that may understate episode lengths for persons starting NPWT treatment before discharge from an acute inpatient facility. A further important limitation of claims data is accurately knowing when a patient completes his/her course of NPWT and whether NPWT was stopped because the goal of care was met. Clinical outcomes are not included in the claims data.

The overall purpose of the research was to compare Medicare payments and to do this the authors ended treatment episodes when patients had a 31-day break with no NPWT bills. The findings of this research are specific to Medicare patients, Medicare payment policy, and patients in postacute settings of care. The reader should decide the applicability of the findings to other settings of care or other payer groups. The statistical significance values presented may be affected by the sample sizes in the study and should be interpreted with caution. The authors acknowledge that disposable NPWT systems may not be appropriate for all wounds and that a clinician’s assessment of a particular wound should determine treatment choice. Although efforts were made to compare similar patients, the analysis did not attempt to match cohorts of patients. The analysis did not control for patients that may have had more than 1 treatment episode separated by 31 days of no bills. Instead, the authors relied on varying sensitivity analyses to determine conditions that may or may not impact the effect of Medicare payment policy. Confounding bias is a risk of this analysis, although the authors attempted to control for extraneous reasons for the ultimate result of significant cost difference. Despite the limitations and assumptions made, the strength of this analysis is the simplicity of using Medicare’s own data to approximate the average payment difference based on Medicare’s payment policies for patients prescribed traditional and disposable NPWT systems.

Conclusion

This retrospective cost-minimization analysis of 2938 traditional NPWT episodes and 3522 disposable NPWT episodes of use in the 2012–2014 national Medicare paid claims database demonstrated that using disposable NPWT resulted in much lower total episode payments than using traditional NPWT. On average, disposable NPWT costs were $1937 lower per episode of care. All else being equal (eg, if patient outcomes are similar), the lower payments represent a significant savings opportunity for Medicare and private payers. Considering the cost savings potential, additional cost and cost-effectiveness studies to validate these findings are warranted. n

Acknowledgment

The authors thank Joann Hettasch, Arbor Communications, Inc, a member of the Fishawack Group of Companies, Conshohocken, PA, who provided medical writing assistance on behalf of Smith & Nephew.

References

1. Russo CA, Steiner C, Spector W. Hospitalizations related to pressure ulcers. HCUP Statistical Brief #64. Rockville, MD. Agency for Healthcare Research and Quality. 2008. Available at: www.hcup-us.ahrq.gov/reports/statbriefs/sb64.pdf. Accessed October 10, 2016.

2. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons N. Burden of venous leg ulcers in the United States. J Med Econ. 2014;17(5):347–356. doi: 10.3111/13696998.2014.903258.

3. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for Medicare and private insurers. Diabetes Care. 2014;37(3):651–658. doi: 10.2337/dc13-2176.

4. Sen CK, Gordillo GM, Roy S, et al. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009;17(6):763–771. doi: 10.1111/j.1524-475X.2009.00543.x.

5. Krug E, Berg L, Lee C, et al. Evidence-based recommendations for the use of negative pressure wound therapy in traumatic wounds and reconstructive surgery: steps towards an international consensus. Injury. 2011;42(1 suppl):S1–S12. doi: 10.1016/S0020-1383(11)00041-6.

6. Birke-Sorensen H, Malmsjo M, Rome P, et al; International Expert Panel on Negative Pressure Wound Therapy. Evidence-based recommendations for negative pressure wound therapy: treatment variables (pressure levels, wound filler and contact layer)--steps towards an international consensus. J Plast Reconstr Aesthet Surg. 2011;64(suppl):S1–S16. doi: 10.1016/S0020-1383(11)00041-6.

7. Vig S, Dowsett C, Berg L, et al; International Expert Panel on Negative Pressure Wound Therapy. Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: steps towards an international consensus. J Tissue Viability. 2011;20 Suppl 1:S1–S18. doi: 10.1016/j.jtv.2011.07.002

8. Apelqvist J, Armstrong DG, Lavery LA, Boulton AJ. Resource utilization and economic costs of care based on a randomized trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds. Am J Surg. 2008;195(6):782–788. doi: 10.1016/j.amjsurg.2007.06.023.

9. Driver VR, Blume PA. Evaluation of wound care and health-care use costs in patients with diabetic foot ulcers treated with negative pressure wound therapy versus advanced moist wound therapy. J Am Podiatr Med Assoc. 2014;104(2):147–153. doi: 10.7547/0003-0538-104.2.147.

10. Driver VR, Eckert KA, Carter MJ, French MA. Cost-effectiveness of negative pressure wound therapy in patients with many comorbidities and severe wounds of various etiology. Wound Repair Regen. 2016;24(6):1041–1058. doi: 10.1111/wrr.12483

11. Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: a multicenter randomized controlled trial. Wound Repair Regen. 2012;20(3):332–341. doi: 10.1111/j.1524-475X.2012.00780.x.

12. Gabriel A, Thimmappa B, Rubano C, Storm-Dickerson T. Evaluation of an ultra-lightweight, single-patient-use negative pressure wound therapy system over dermal regeneration template and skin grafts. Int Wound J. 2013;10(4):418–424. doi: 10.1111/j.1742-481X.2012.00999.x.

13. Grauhan O, Navasardyan A, Hofmann M, Müller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013;145(5):1387–1392. doi: 10.1016/j.jtcvs.2012.09.040.

14. Hurd T, Trueman P, Rossington A. Use of a portable, single-use negative pressure wound therapy device in home care patients with low to moderately exuding wounds: a case series. Ostomy Wound Manage. 2014;60(3):30–36.

15. H.R.2029 - Consolidated Appropriations Act, No. 2016. Public Law 114–113—December 18, 2015. Available at: www.congress.gov/114/plaws/publ113/PLAW-114publ113.pdf. Accessed December 19, 2017.

16. Centers for Medicare amd Medicaid Services. CMS-1648-F. CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. Available at: www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home.... Accessed December 19, 2017.

17. Payne C, Edwards D. Application of the single use negative pressure wound therapy device (PICO) on a heterogeneous group of surgical and traumatic wounds. Eplasty. 2014;14:e20.

18. Nherera LM, Trueman P, Karlakki SL. Cost-effectiveness analysis of single-use negative pressure wound therapy dressings (sNPWT) to reduce surgical site complications (SSC) in routine primary hip and knee replacements. Wound Repair Regen. 2017;25(3):474–482. doi: 10.1111/wrr.12530.

19. Healthcare Cost and Utilization Project Clinical Classifications Software (CCS) for ICD-9-CM. Available at: www.hcup-us.ahrq.gov/toolssoftware/ccs/ccs.jsp. Accessed October 19, 2016.

20. Centers for Medicare amd Medicaid Services. CMS-1625-F. CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. Available at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home.... Accessed September 1, 2017.

21. Centers for Medicare amd Medicaid Services. CMS-1633-FC; CMS-1607-F2. Hospital Outpatient Prospective Payment- Final Rule with Comment Period and Final CY2016 Payment Rates. Available at: www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatient... . Accessed September 1, 2017.

22. Centers for Medicare amd Medicaid Services. Better Care. Smarter Spending. Healthier People: Paying Providers for Value, Not Volume. Available at: www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-i.... Accessed December 19, 2017.

Potential Conflicts of Interest: This study was funded by Smith & Nephew, Inc (Fort Worth, TX), which was involved in developing the study design, data collection, data analysis and interpretation, and the decision to publish these results. Dr. Hogan and Dr. Nair are paid consultants for Smith & Nephew. Mr. Delhougne and Ms. Tarka are employees of Smith & Nephew and may own shares of Smith & Nephew stock.

Mr. Delhougne is Senior Director of Health Economics, Smith & Nephew, Inc, Fort Worth, TX. Dr. Hogan is President, Direct Research LLC, Vienna, VA. Ms. Tarka is Vice President of Post-Acute Care, Smith & Nephew. Dr. Nair is Medical Director, Wound Healing Center at Presence St. Francis Hospital, Evanston, IL. Please address correspondence to: Gary Delhougne, Smith & Nephew Biotherapeutics, 5600 Clearfork Main Street, Suite 600, Fort Worth, TX 76109; email: Gary.Delhougne@Smith-Nephew.com.

Section:

Volume 64 - Issue 1 - January 2018 ISSN 1943-2720

↧

Bariatric Care and Obesity: A Compendium of 20 Years of Articles From Ostomy Wound Management

January 9, 2018, 8:33 am

≫ Next: Assessment of the Biomechanical Effects of Prophylactic Sacral Dressings on Tissue Loads: A Computational Modeling Analysis

≪ Previous: A Retrospective, Cost-minimization Analysis of Disposable and Traditional Negative Pressure Wound Therapy Medicare Paid Claims

Issue Number:

Barbara Zeiger

As far back as 1994, Ostomy Wound Management realized there was a crisis at hand. Obesity (body mass index [BMI] >30) and morbid obesity (BMI >40) were becoming increasingly prevalent, impacting all aspects of patient care and provider safety and underscoring the importance of understanding the implications of proper management of the bariatric patient. OWM has published at least 25 articles over the past 2 decades to enhance knowledge of this unique group of patients whose clinical, physical, and emotional needs sometimes remain unmet despite the fact that obesity is now recognized as a disease.

For this endeavor, the articles have been organized by the most obvious care theme (general obesity/bariatric management, relevant technology, skin and wound care, age and/or disease/condition, and surgical considerations), but many overarch several categories. Feature articles that have been indexed appear with their (in some cases, abbreviated) abstracts. Articles that OWM publishes as “Departments” have been edited for space. Articles published after 2000 are available in their entirety at www.o-wm.com; please contact the Editor for copies of older publications.

We are grateful to the authors and researchers for addressing the problems faced by obese persons and their families and care providers. We especially acknowledge the efforts of Dr. Susan Gallagher, who has been a prolific contributor and staunch patient advocate and professional champion in this arena. Our hope is that this compilation of articles will influence bariatric protocols and provider awareness of the many facets of caring for this challenging patient population.

Background

Emerging data on the state of obesity (Gallagher S). It is no surprise an obesity crisis is plaguing health care in general and wound/ostomy care specifically. Many researchers suggest the trend will continue because lifestyles and nutritional habits have changed drastically in the past 50 years. Obesity is one of the biggest drivers of preventable chronic diseases and health care costs in the US. Currently, this economic burden ranges from $147 billion to nearly $210 billion per year. From a wound or ostomy perspective, the literature explains the mechanisms by which obesity increases surgical and wound complications. Potential factors include the intrinsic anatomic properties of excess weight and poor vascularity of adipose tissue. Relative vascular insufficiency and subsequent decreased oxygen tension lead to decreased collagen synthesis, decreased capacity to fight infection, and decreased ability to support the necessary mechanisms of the healing cascade. These data have been available for at least the past 3 decades and are recognized as factors that delay healing. The literature suggests patients with a high degree of adiposity are at greater risk for a number of well-documented concerns than their leaner peers. Adipose tissue acts similar to an endocrine organ and influences hormone and cytokine production and secretion. Dysregulation of cytokines, often observed in the obese patient, facilitates an environment of chronic inflammation. This dysregulation affects every organ of the body, including the intestinal tract, the integumentary system, chronic wound healing, and response to an acute illness. As obesity continues to gain attention, wound and ostomy providers need to consider evidence-based strategies to manage the clinical, humanistic, and economic aspects of bariatric patient care. 2016;62(1):6–7.

General Obesity/Bariatric Management

Innovative methods to better manage the clinical, cost, and humanistic aspects of bariatric care (Gallagher S). Obesity has become a worldwide issue as evidenced by the emerging demographics of obesity among all categories of individuals: 71.4% of Americans are overweight or obese, more than one third of Americans are obese, and 3% to 10% (at least 8 million) people are morbidly obese. As the prevalence of obesity continues to rise across all categories of patients, health care providers and researchers continue to seek innovative and proven methods to better manage the clinical, cost, and humanistic concerns of bariatric patient care. 2015;61(1):6.

Clinician challenges in providing health care for a morbidly obese family member: a bariatric case study (Beitz JM). This case study describes the experiences of a morbidly obese woman in the final years of her life from the perspective of her health professional relative. The patient typifies many of the major risk factors for morbid obesity; her story reveals many of the issues faced as she revolved in and out of the critical care and acute care system. Her substantive health problems affected multiple body systems and included hypothyroidism, congestive heart failure, hyperlipidemia, and subclinical Cushing’s Syndrome, likely related to previous medical therapy (cortisone) for rheumatic fever in childhood. The case description addresses many integumentary system issues the patient experienced; skin injuries and infections that can pose serious life-threatening situations for the morbidly obese patient must be prevented or treated efficiently. Health professionals can learn a great deal and improve the care they provide by listening to morbidly obese patients. 2015;61(1):42–46.

The intersection of ostomy and wound management, obesity, and associated science (Gallagher S). The word obesity originates from the Latin language and refers to the state of becoming fattened by eating. Bariatrics is a term derived from the Greek word baros and refers to issues pertaining to weight. In some circles, the term bariatrics is associated with metabolic surgery. However, the word encompasses much broader meaning; currently, it refers to the practice of health care that relates to the treatment of weight and weight-related conditions. This includes bariatric surgery as well as bariatric gynecology, bariatric reconstruction after massive weight loss, bariatric pediatrics, bariatric wound care, and more. Care of larger, heavier patients has become important in the practice of ostomy and wound care.

Issues related to weight are of interest to the public for several reasons. Bariatrics as a specialty is becoming increasingly important in pace with the growing number of obese and overweight Americans. The problem is pandemic — overweight and obesity are not limited to the US. Worldwide, nearly 2 billion individuals are overweight, exceeding the number of individuals suffering from starvation.

Care challenges are substantial. Consider the effect of obesity-related consequences of care on patients and clinicians. Repositioning for pressure ulcer prevention, turning for examination or treatment of skin injury, or movement of the panniculus for ostomy care all may impact the outcome of patient care if the caregiver is physically unable to perform the task. Further, handling larger, heavier patients may put caregiver safety at risk if these tasks are performed manually.

Providing care for the larger, heavier individual who enters the health care facility for an unplanned event can be more complex and time-consuming than with normal-weight patients; seldom do staffing administrators or reimbursement plans accommodate this difference. Regardless of the practice setting, preplanning becomes an essential component of safe patient care. Therefore, hospitals across the country are creating bariatric teams in hopes of designing processes to control or prevent some of the untoward complications associated with caring for the obese patient. However, limited availability of resources with which to develop appropriate tools and plans presents numerous obstacles. Likewise, skin and wound considerations, adequate nutritional support, intravenous access, appropriately sized equipment, airway management, resuscitation, diagnostic testing, pain control, social and emotional concerns, and prevention of complications all present special and unique concerns. Practical resources such as longer gloves, wider commodes, specialized tracheostomy tubes, bariatric furniture, and mobility devices are important to consider.

With obesity on the rise, clinicians are increasingly responsible for managing the needs of this complex patient population. This is especially true in the case of the obese patient with a wound or ostomy. Caregivers provided the tools, resources, and knowledge to provide good patient care feel good about their efforts and their job satisfaction rises. Satisfaction scores reflect that the happier the caregiver, the happier the patient. Numerous resources are available to clinicians across practice settings, and use of resources in a timely and appropriate manner is thought to improve measurable therapeutic, satisfaction, and cost outcomes. Coordinating these resources in the form of a comprehensive bariatric care plan may ensure the most favorable outcome for the patient with a wound or ostomy.

The obese patient presents numerous care challenges. It is in the interest of health care organizations to meet these care challenges in a dignified and sensitive manner. 2014;60(1):6–7.

Criteria-based protocols and the obese patient: planning care for a high-risk population (Gallagher S, Arzouman J, Lacovara J, Blackett A, McDonald PK, Traver G, Bartholomeaux F). Well-recognized obesity-related health problems pose many challenges in the acute care facility. These challenges include not only physical barriers and complications, but also concern for the well-being of caregivers. Despite these problems, little preplanning of resources occurs. Barriers to bariatric protocol development are discussed and strategies for overcoming these barriers with attention to preventing caregiver injury, optimizing patient care, and limiting associated costs are reviewed. A description of an interdisciplinary, criteria-based bariatric protocol is included. With adequate and appropriate preplanning, the challenge of providing bariatric care can be met. 2004;50(5):32–38.

New and revised overweight and obesity ICD-9 codes (Schaum KD). 2006;52(6):63–64. We have included the original article; updated ICD-10 codes are available at: www. icd10data.com/ICD10CM/Codes/E00-E89/E65-E68/E66-.

Obesity-related Technology

A computer modeling study to evaluate the potential effect of air cell-based cushions on the tissues of bariatric and diabetic patients (Levy A, Kopplin K, Gefen A). Sitting-acquired pressure ulcers (PUs) are a potentially life-endangering complication for wheelchair users who are obese and have diabetes mellitus. The increased body weight and diabetes-related alterations in weight-bearing tissue properties have been identified in the literature to increase the risk for PUs and deep tissue injuries (DTIs). A computer modeling study was conducted to evaluate the biomechanical effect of an air cell-based (ACB) cushion on tissues with increased fat mass and diabetes, which causes altered stiffness properties in connective tissues with respect to healthy tissues. Specifically, 10 finite element (FE) computer simulations were developed with the strain and stress distributions and localized magnitudes considered as measures of the theoretical risk for PUs and DTIs to assess the effects of fat mass and pathological tissue properties on the effective strains and stresses in the soft tissues of buttocks during sitting on an ACB cushion. The FE modeling captured the anatomy of a seated buttocks acquired in an open magnetic resonance imaging examination of an individual with a spinal cord injury. The ACB cushion facilitated a moderate increase in muscle strains (up to 15%) and stresses (up to 30%) and likewise a moderate increase in size of the affected tissue areas with the increase in fat mass for both diabetic and nondiabetic conditions. These simulation results suggest wheelchair users who are obese and have diabetes may benefit from using an ACB to minimize the increased mechanical strains and stresses in the weight-bearing soft tissues in the buttocks that result from these conditions. Clinical studies to increase understanding about the risk factors of both obesity and diabetes mellitus for the development of PUs and DTIs, as well as robust preclinical comparative studies, may provide much-needed evidence to help clinicians make informed PU prevention and wheelchair cushion decisions for this patient population and other wheelchair-bound individuals. 2016;62(1):22–30.

A pictorial overview of technology-assisted care options for bariatric patients: one hospital’s experience (Arnold M, Roe E, Williams D). Best practice guidelines to avoid pressure ulcers and skin breakdown among obese patients include early and progressive mobility, rigorous turning schedules, and proper skin care. However, implementation of some these guidelines may increase the risk of patient and caregiver injury. An acute care hospital implemented safe patient handling protocols that involved equipment purchase and extensive training for all care staff. The new equipment facilitated repositioning, including boosting and turning, lateral transfers, vertical transfers and ambulation, and bathing and toileting. All health care facilities are expected to see an increase in the number of bariatric patients and the need for safe patient handling protocols and procedures. 2014;60(1):36–42.

The effect of using a low-air-loss surface on the skin integrity of obese patients: results of a pilot study (Pemberton V, Turner V, VanGilder C). Obese patients often are immobile, acutely ill, and at high risk for developing pressure ulcers when admitted to acute care facilities. Pressure-relieving mattresses are an integral part of a pressure ulcer prevention plan of care. Patients with a body mass index >35, weight between 250 lb and 500 lb, and a minimum 3-day length of stay were recruited to participate in a pilot study to evaluate the safety and use of a new low-air-loss, continuous lateral rotation bariatric bed. Skin inspection was performed at the beginning and end of the study (maximum 7 days). Participants included 21 consecutively admitted patients (10 men, 11 women, average age 51.7 years [range 32–76], average BMI = 51.4 [range 37–71]) with an average Braden pressure ulcer risk score of 14.7 (range 9–21). Most (n = 11) were receiving treatment in the intensive care unit. Six (6) patients had 10 pressure ulcers (6 Stage I, 4 Stage II). Average length of stay on the surface was 4.8 days (range 2–8 days); ulcers decreased from an average size of 5.2 cm² to 2.6 cm². No new pressure ulcers developed. 2009;55(2):44–48.

Skin and Wound Care

Providing quality skin and wound care for the bariatric patient: an overview of clinical challenges (Beitz JM). The purpose of this overview is to address some common skin and wound care issues faced by bariatric patients in order to inform clinicians, patients, and caregivers and enable them to optimize care. For bariatric patients, extra attention must be paid to skin care, cleanliness, skin fold management, perigenital care, odor management, and effective pressure redistribution. Despite these interventions, the multifactorial challenges presented by morbid obesity increase patient risk for serious skin diseases and wound conditions. Implications for practice include how best to educate patients and caregivers for optimal problem prevention. 2014;60(1):12–21.

Intertrigo in the obese patient: finding the silver lining (Muller N). The soaring prevalence of obesity in the past decade has forced health care providers to pay increasing attention to the unique needs of the obese patient. Not the least of these needs is skin care and the risk of moisture-associated skin damage, most often diagnosed as intertriginous dermatitis (intertrigo). Obese patients are particularly vulnerable because the natural cooling mechanisms of their bodies are compromised, making perspiration a virtual constant. In addition, their body mass can limit mobility. As moisture accumulates and remains trapped within skin folds, bacterial, fungal, and viral growth inevitably leads to intertrigo and even skin breakdown.

Intertrigo is first manifested by itching, burning, pain, odor, and erythema. If left undiagnosed or not addressed properly, the condition can progress to intense inflammation, erosion, and crusting. As skin becomes macerated with hyperhydration, skin-against-skin friction increases and weakens epidermal tissue, allowing invasion by external organisms. The ultimate insult of skin breakdown and secondary infection is similar to what occurs in the patient experiencing incontinence-associated dermatitis. Bariatric patients experiencing weight loss-redundant skin also are at risk.

Nurses and aides must routinely inspect the skin inside skin folds and pay particular attention to the axilla, pannus, area just below the breast, groin, gluteal folds and upper thighs, and back of the knee. The incontinent obese patient is even more likely to encounter such skin problems, given the likelihood of both urine and perspiration becoming trapped in skin folds. Whether these patients are in acute care, rehab, extended-care facilities, or home care or hospice, the nursing team responsible for hands-on care must inspect the skin down to the base of folds. Comprehensive nursing protocols for the bariatric patient should encompass bathing, toileting, skin fold management, odor, and genital care.

Over the years, many nurses assumed intertrigo inflammation is fungal in nature and best treated with antifungal or, in some cases, talcum powder. Increasingly, case studies are documenting a diverse number of organisms (eg, Escherichia coli, coagulase-negative Staphylococcus, Enterococcus faecalis, Proteus mirabilis, and Candida albicans) in skin folds. In a recent, hospital-based study, barely 1 in 10 infections (9.5%) was identified as a (frequently suspected) yeast-like fungus. Unfortunately, the costs of cultures can discourage clinicians to take the steps necessary to properly identify the organism at work. However, untimely and inappropriate treatment can lead to even greater expense, wasteful interventions, and more serious complications. Regardless of your practice setting, you are likely to encounter patients with skin fold complications. 2013;59(3):14.

An overview of dermatological conditions commonly associated with the obese patient (Hahler B). Obesity is a chronic disease that may lead to skin problems, including acanthosis nigricans, skin tags, hyperandrogenism, striae distensae, plantar hyperkeratosis, and candidal intertrigo. Although some conditions (eg, skin tags and striae distensae) may simply be annoying or present cosmetic issues, conditions such as acanthosis nigricans and hyperandrogenism may be indicative of systemic diseases. Obesity also may contribute to poor healing of acute and chronic wounds that develop in this population. Some of the most common obesity-related skin disorders and factors affecting wound healing are described with suggestions on how to address these issues. With the continuing increase in the incidence of obesity, investigation into the specific care needs of this population is needed. In clinical practice, measures to reduce friction and shear and improve devices to move the obese patient would enhance care provision. Studies of the incidence of dermatological problems and the best treatments for these conditions are warranted. 2006;52(6):34–40.

Morbid obesity: a chronic disease with an impact on wounds and related problems. (Gallagher SM). Morbid obesity is a chronic disease that manifests as a steady, slow, progressive increase in body weight. Because of both emotional and physical reasons, obese people resist pursuing health care and may be more difficult to care for. In taking a practical approach to skin and wound care, using an interdisciplinary team is valuable. Difficulty in assessment stems from problems such as equipment that is too small or patient uncooperativeness. Skin/wound problems which are common, yet more difficult to manage for these patients, include pressure ulcers, tracheostomy care (potentially resulting from ventilatory insufficiency), candidiasis, tape-related skin tears, incontinence, and lymphedema. In order to offer care and support to these patients and their families, clinicians must acknowledge and manage any personal prejudice they may have toward this patient population. A comprehensive patient-focused plan of care is the goal. Four (4) annotated suggested readings are included introducing topics such as the failure of behavioral and dietary treatments for obesity, theoretical and practical aspects of obesity assessment, current views on obesity (such as a move back to pharmacotherapeutic treatment), and the psychological aspects of severe obesity. 1997;43(5):18–27.

Special Populations and Conditions

The relationship between obesity and calciphylaxis: a review of the literature (Davis JM). Calciphylaxis is characterized by calcification in the medium and small vessel arterioles and can be a life-threatening complication often associated with chronic kidney disease (CKD). A review of the literature was conducted to explore existing evidence about the relationship between obesity and calciphylaxis. A total of 54 publications (published between 1962 and 2015) were identified. Most studies noted a variety of risk factors for calciphylaxis, including CKD, female gender, Caucasian race, liver disease, and lower serum albumin. Obesity was identified as a risk factor in 6 of the 8 studies reviewed. In one study, obesity was found to quadruple the risk of calciphylaxis. The majority of calciphylaxis lesions in obese persons were proximal in distribution; all studies reported proximal lesions are associated with a higher mortality rate than distal lesions. The mortality rate of persons with CKD and calciphylaxis is 8 times higher than that of persons with CKD without calciphylaxis. There is no definitive evidence to support the belief current epidemic rates of obesity, diabetes, (diabesity), and chronic renal disease will predispose more patients to the development of calciphylaxis. However, until more information from the calciphylaxis registries and other studies is available, clinicians should maintain a high index of suspicion when a patient presents with indurated, painful nodules or necrotic ulcers, especially if the patient also has CKD. 2016;62(1):12–18.

Massive localized lymphedema, a disease unique to the morbidly obese: a case study (Fife C). Massive localized lymphedema (MLL) is a unique presentation of lymphedema resulting in a large, benign, painless mass that develops in morbidly obese patients, most commonly on the medial thigh. Because nearly 6% of the United States adult population is morbidly obese, MLL is believed to be underdiagnosed. To better guide the clinician in identifying and treating MLL, a case study of a 44-year-old Caucasian woman with type 1 diabetes who presented to the study wound care clinic with MLL is reported, along with the experience of managing more than 70 patients with MLL. A diagnosis of MLL is usually made based on clinical history and presentation. Routine tissue biopsy is not advisable, and diagnostic tests such as magnetic resonance imaging (MRI) may be impossible due to the morbid obesity of most patients. Complete decongestive physiotherapy (CDP) is recommended. Although surgical removal of the MLL collection may be possible, it is technically difficult and not always advisable due to the risk of perioperative complications, including wound dehiscence. Furthermore, in the author’s experience, recurrence is possible even after surgical removal, particularly if conscientious adherence to compression and weight management do not continue. The advent of advanced pneumatic compression devices designed for the morbidly obese and the possibility of using near-infrared fluorescence imaging to guide treatment may transform the MLL management process. Considering the increasing number of MLL cases, the comorbidities and complexities of treating morbidly obese patients, and associated complications, clinicians caring for the morbidly obese need a heightened awareness of this condition. 2014;60(1):30–35.

Lymphedema in the morbidly obese patient: unique challenges in a unique population (Fife CE, Carter MJ). The population of morbidly obese patients, along with the incidence of lymphedema and massive localized lymphedema associated with this condition, is increasing. A 5-year retrospective review of data (2000–2005) shows that the percentage of patients >350 lb in the authors’ clinic population increased from approximately 7% to 11% and 75% of their morbidly obese patients (body mass index >40) had or have lymphedema. After a differential diagnosis between lipedema and lymphedema (primary or secondary) has been made, lymphedema management options include compression bandaging, manual lymphatic drainage, and localized surgeries. The treatment of morbidly obese lymphedema patients requires additional staff time and specialized equipment to move or position them and may be confounded by other conditions (eg, heart failure and venous insufficiency) that contribute to edema. Lymphedema treatments have been found to be useful, providing patients are able to follow treatment guidelines, especially with regard to weight control. In the authors’ experience, massive localized lymphedema will recur unless the primary issue of obesity is addressed. Establishing clear criteria and patient participation guidelines before initiating a comprehensive localized lymphedema program will improve outcomes. 2008;54(1):44–56.

A patient-centered approach to treatment of morbid obesity and lower extremity complications: an overview and case studies (Fife CE, Benavides S, Carter MJ). The purpose of this overview is to examine common concerns related to morbid obesity and interrelated lower extremity complications, including wound and skin infections, dermatologic conditions, lymphovenous obstruction syndromes, chronic venous insufficiency, and anatomical abnormalities such as massive localized lymphedema. Treatment may include surgery for massive lymphedema localizations, compression bandaging for chronic venous insufficiency as well as lymphedema, manual lymph drainage for lymphedema, and prompt and aggressive management of wound infection and bioburden. Case studies are presented to illustrate some lower extremity complications of morbid obesity and appropriate protocols of care. Although increasing evidence suggests that morbidly obese patients are predisposed to secondary lymphedema and that primary lymphedema can cause adult-onset obesity, the mechanisms by which these events occur remain unclear. However, unless the underlying problem of morbid obesity is addressed, the problems for which these patients seek care will continue to recur. 2008;54(1):20–32.

Managing complex, high-output, enterocutaneous fistulas: a case study (Hahler B, Schassberger D, Novakovic R, Lang S). Gastrointestinal (GI) fistulas are an uncommon but serious complication. Following diagnosis, management strategies may have to be adapted frequently to address changes in fistula output, surrounding skin or wound condition, overall patient clinical and nutritional status, mobility level, and body contours. Following a motor vehicle accident, a 49-year-old man with a body mass index of 36.8 and a history of multiple previous surgeries, including gastric bypass, experienced excessive output from a fistula within a large open abdominal wound measuring 45 cm x 40 cm x 5 cm. Abdominal creases and the need to protect a split-thickness skin graft of the wound surrounding his fistula complicated wound management. During his prolonged 4-month hospital stay, the patient underwent several surgical procedures, repeated wound debridement, and various nutritional support interventions; a wide variety of wound and fistula management systems were utilized. One (1) year after the initial trauma, the fistula was surgically closed. One (1) week later, the patient died from a cardiac event. This case study confirms that GI fistulas increase costs of care and hospital length of stay and require the experience and expertise of a wide array of patient support staff members and clinicians. 2009;55(10):30–42.

Obesity: changing the face of geriatric care (Gallagher Camden S, Gates J). Obesity, coupled with the challenges of aging, leads to an unfortunate burden of chronic disease, functional decline, poor quality of life, and an increased risk of being homebound. Physical assessment of the elderly obese patient should include measurement of height, weight (to determine body mass index), waist circumference (to address central obesity), and consideration of vascular, skin, and mobility issues. Weight management strategies such as diet and hydration should balance nutritional requirements with weight loss; particular attention to protein needs in chair- and bedbound patients is necessary. Additional approaches such as exercise, bariatric weight loss surgery, and weight loss medication should be considered on an individual basis related to their inherent risks in this population. Weight loss/management options framed from an interdisciplinary perspective can improve quality of life for these patients and their caregivers. 2006;52(10):36–44.

The battle of the bulge and ostomy care (Turnbull GB). A 2006 meeting in Florida included an exemplary presentation on diabetes mellitus. The speaker had a frightening set of chronological slides that illustrated the mounting overweight and obesity epidemic in the US over the past several years and its link to the increase in diabetes mellitus — even in children as young as 8 years old. This is not something new, yet we read more and more that this problem is taking an enormous toll — not only on our health, but also on the economy, our nation’s future, and the health care professionals who care for bariatric patients.

Although not a uniquely American phenomenon, Americans seem to be paving this downhill path. As an ex-patriot working in Canada, I see the American overweight trend creeping northward. Peoples with traditionally healthy Asian or Mediterranean diets are being enticed by high-fat, highly processed, high-sugar foods, increasing incidence of obesity, heart disease, vascular problems, and diabetes where these diseases previously had been nearly nonexistent.

The 25-year-long Canadian Health Survey (compiled 1997 to 2004) studied adults and children between the ages of 2 and 17 years. In 1979, 3% of Canadian children and 14% of Canadian adults were listed as obese. By 2004, nearly 30% of Canadian children and 60% of adults in Canada were considered either obese or overweight. It has been reported that the direct cost of obesity in Canada in 1997 (2 years before the Canadian Health Survey began) was more than $1.8 billion (CAD) or 2.9% of the total health expenditures for all diseases. The current nearly 3-fold increase in people who are overweight and obese is anticipated to grow costs exponentially.

The US conducted a similar study between 1985 and 2004 — the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System. The results mimic Canada’s data. In 1991, 4 states reported obesity prevalence between 15% and 19%; no state had a prevalence rate at or higher than 20%. In 2004, 7 states reported obesity rates between 15% and 19%, 33 states reported rate between 20% and 24%, and 9 states reported rates higher than 25% (1 state sent no data). The trend continues.

Susan Gallagher Camden illustrates the multifaceted problems relating to caring for the obese patient, subsequently generating questions regarding the impact of obesity on ostomy, wound, and continence care. Her book reaffirms the absolute imperative of preoperative stoma site marking to facilitate the ability of the overweight or obese patient to care for an ostomy after surgery and attain some level of normalcy and self-control. Ostomy care providers may have to revisit previous notions about when and how convex ostomy pouching systems should be used.

The obesity epidemic reminds us of the difficulty associated with healing in the overweight patient or the patient with diabetes. The emergence of bariatric medicine is a testament. Ostomy care is one of many specialties that require extra attention, expertise, and understanding in order to provide quality health care to an increasing number of patients. 2006;52(4):22, 24.

Challenges of ostomy care and obesity (Gallagher S, Gates J). In the United States, 13 to 16 million people are morbidly obese to the extent that medical intervention, simply based on obesity-related comorbidities, is needed. The challenge of ostomy care and the very obese patient lies in the skill and planning required for successful physical, emotional, and spiritual recovery. It is commonly believed that from the onset, the obese patient having surgery is at a significant disadvantage. Care of the obese patient requiring ostomy surgery includes considerable challenges — from preoperative preparation, including finding an optimal location for stoma placement, to the challenge of preventing complications during the intraoperative and postoperative phases of care. Concerns regarding pain management, immobility, skin injury, respiratory issues, embolic threats, and caregiver injury increase when treating the obese patient and must be addressed specifically. A case study approach is used as a framework to discuss the ostomy experience. 2004;50(9):38–46.

Needs of the homebound morbidly obese patient: a descriptive survey of home health nurses (Gallagher SM). The purpose of this descriptive survey was to identify challenges encountered by the home care provider when caring for a morbidly obese client in the home care setting and to provide recommendations to those involved in the transition of the patient from the acute care setting to the home. This descriptive study used a convenience sample of 25 RNs employed in 1 of the many referral home care agencies in the greater Los Angeles, California area. The referral home care agencies were selected randomly. Criterion for inclusion was that the nurse had cared for at least 3 patients in the past 12 months with a body mass index >40. A semi-structured interview was completed using a 10-item survey tool that included open-ended questions. One hundred percent (100%) of persons approached participated (N = 25). The home care setting was their primary place of employment for at least 2 years (mean 5 years), and each RN had cared for an average of 4 patients with a BMI >40 in the past years. Challenges expressed by the nurses in the home care setting included equipment (n = 25), reimbursement (n = 25), access to resources (n = 18), client motivation (n = 8), and family/significant other support (n = 10). 1998;44(4):32–38.

Surgery-related Issues

The role of obesity in the patient undergoing colorectal surgery and fecal diversion: a review of the literature (Colwell JC). The obese colorectal surgery patient may face several challenges, including a high risk for the development of colorectal cancer, an increased risk for complications with diverticular disease, and surgical risk factors including anastomotic leaks, inability to perform a low anastomosis, and septic complications. The purpose of this literature review was to examine available data on the implications of obesity on colorectal disease and colorectal surgery, particularly stoma surgery. Obesity has been documented as a risk factor for colorectal disease, but results of studies examining surgery-related problems secondary to obesity are inconsistent. However, clinicians generally believe obese patients undergoing colorectal surgery may be at higher risk of complications than their non-obese counterparts. The obese patient requiring the creation of a fecal diversion may encounter stoma-related issues such as stenosis, retraction, and inability to maintain a consistent pouching system seal. Stoma site marking can be challenging because of the large shifts in subcutaneous tissue and the inability for a person with a large abdomen to be able to visualize the stoma if the stoma is placed too low on the abdomen. Additional research to elucidate complication rates and risk factors is needed to help clinicians develop optimal plans of care. 2014;60(1):24–28.

Bariatric surgery: patient incision care and discharge concerns (Pieper B, Sieggreen M, Nordstrom C, Kulwicki P, Freeland B, Palleschi MT, Sidor D, Bednarski D, Burns J, Frattaroli M). Because they provide greater and more durable weight reduction than behavioral and pharmacological interventions for the morbidly obese, the number of bariatric surgeries is increasing. One such procedure is the Roux-en-Y gastric bypass. A cross-sectional study was conducted to examine incision care knowledge and discharge concerns of patients who had undergone this type of gastric bypass bariatric surgery. Participants (N = 31; 28 women, 3 men; mean age 45 years), recruited from a bariatric surgery center in a large, urban teaching hospital, had undergone a Roux-en-Y gastric bypass by either the open (n = 29) or laparoscopic (n = 2) method. Patients scheduled to be discharged home, 21 years of age or older, and able to understand and respond in English were eligible to participate. Participants completed questionnaires that included demographic information and rating scales regarding incision care knowledge, fears, and discharge concerns. Mean time from hospital admission to study participation was 1.1 ± 3 days. Knowledge of incision care and amount of information received about incision care were rated low. The 5 most frequently mentioned post-discharge concerns included bowel trouble at home, wound pain at home, looking for wound complications, watching for wound infection, and activity limitations. The higher the amount of information received about incision care, the higher the patient’s knowledge (r = .57, P<.001). Lower incision care knowledge scores correlated with a higher fear of incision care (r = .46, P = .008) and patients reporting greater pain had more concerns about discharge (r = .49, P<.005). Little is known about preparing the bariatric surgery patient for discharge home. To improve outcomes, research that examines issues including discharge teaching methods, patient concerns, and information for persons undergoing bariatric surgery is needed. 2006;52(6):48–56.

Obesity and the surgical patient: nursing alert (Jacobson TM). The risk for postoperative wound complications such as dehiscence and wound infection increases in the obese patient. Patients with postoperative wound complications may experience additional pain, prolonged hospitalization with its associated expenses, and emotional stress. When caring for the obese surgical patient, the nurse is challenged to anticipate potential postoperative complications and implement strategies to optimize the wound healing environment. In order to successfully meet this challenge, knowledge of the wound healing process (ie, 4 stages of healing), the core elements necessary for wound healing (oxygen, nutrients, blood cells), and the effects of obesity on wound healing (the role of adipose tissue, impaired perfusion, increased likelihood for infection) is needed. 1994;40(2):56–63.

Section:

Volume 63 - Issue 10 - October 2017 ISSN 1943-2720

↧

Assessment of the Biomechanical Effects of Prophylactic Sacral Dressings on Tissue Loads: A Computational Modeling Analysis

October 4, 2017, 10:10 am

≫ Next: A Randomized, Controlled Clinical Study to Assess the Effect of Anodal and Cathodal Electrical Stimulation on Periwound Skin Blood Flow and Pressure Ulcer Size Reduction in Persons with Neurological Injuries

≪ Previous: Bariatric Care and Obesity: A Compendium of 20 Years of Articles From Ostomy Wound Management

Issue Number:

Index:

Ostomy Wound Management 2017;63(10):48–55 doi: 10.25270/owm.10.4855

Ayelet Levy, MSc; and Amit Gefen, PhD

Topics:

laboratory research

Pressure Ulcer

Prevention

Dressings

Abstract

The sacrum is the most susceptible anatomical site for developing pressure injuries, including deep tissue injuries, during supine lying. Prophylactic dressings generally are designed to reduce friction, alleviate internal tissue shear, manage the microclimate, and overall cushion the soft tissues subjected to sustained deformations under the sacrum. Using computational modeling, the authors developed a set of 8 magnetic resonance imaging-based, 3-dimensional finite element models of the buttocks of a healthy 28-year-old woman for comparing the biomechanical effects of different prophylactic sacral dressing designs when used during supine lying on a standard hospital foam mattress.

Computer simulation data from model variants incorporating an isotropic (same stiffness in every direction) multilayer compliant dressing, an anisotropic (directionally dependent stiffness properties) multilayer compliant dressing, and a completely stiff dressing were compared to control (no dressing). Specific outcome measures that were compared across these simulation cases were strain energy density (SED) and maximal shear stresses in a volume of interest (VOI) of soft tissues surrounding the sacrum. The SED and shear stress measurements were obtained in pure compression loading of the buttocks (ie, simulating a horizontal supine bed rest) and in combined compression-and-shear loads applied to the buttocks (ie, 45˚ Fowler position causing frictional and shear forces) on a standard foam mattress. Compared to the isotropic dressing design, the anisotropic dressing facilitated more soft tissue protection through an additional 11% reduction in exposure to SED at the VOI. In this model, use of the anisotropic compliant dressing resulted in the lowest exposures to internal tissue SED and shear stresses. Research to examine the clinical inference of this modeling technique and studies to compare the effects of prophylactic dressings on healthy volunteers and patients in different positions are warranted.

A pressure ulcer (PU), now termed a pressure injury (PI) in the United States, is defined in the international guidelines¹ as a localized injury to the skin and/or underlying tissues, usually over a bony prominence, resulting from sustained pressure (including pressure associated with shear). The soft tissues around the sacrum are known to be the most common anatomical site for patients to develop a PU while in bed.² During prolonged supine bed rest, the weight of the lower trunk and pelvis is transferred through the pelvic bones to the mattress, subjecting subcutaneous fat and skin tissues under the sacrum to sustained intensified deformations. In cases where impaired mobility, sensitivity, or both are present, these sustained tissue deformations may exceed tissue tolerance levels, increasing the risk for PUs and particularly for a deep tissue injury (DTI), which is especially dangerous due to the potential extent of tissue damage.³ Because the sacrum is a major body weight-bearing site for a supine patient, and the sacral bone is not only rigid but also highly curved (almost “sharp”), the soft tissues in the sacral area are extremely susceptible to compressive tensional and shear loads. As shown by magnetic resonance imaging (MRI) and computer modeling studies, shear, which is naturally present in deformed soft tissues due to the complex curved anatomy and stiffness gradients between hard/soft and layered tissue structures, is substantially magnified when a patient is positioned in a Fowler position and starts sliding down in bed, during repositioning, or when spontaneous movements occur.⁴

Minimizing magnitudes and exposure durations of mechanical compression and shear loads in soft tissues during weight-bearing, as well as reducing friction, have long been the main goals in PU prevention and management.^1,4,5 According to clinical guidelines,¹ conventional sacral PU prevention strategies mainly include manual periodical repositioning and use of pressure-redistributing mattresses, either static or alternating air pressure-based, which are designed to cushion the body of the patient and thereby minimize localized increased contact pressures between the skin and the support surface. However, several critical concerns are relevant regarding this approach; for example, how can it be determined whether reduced focal contact pressures on the skin also improve the mechanical state of the deep soft tissues in the context of DTI prevention? In addition, the effects of shearing forces that act on the internal soft tissues under the sacrum have not been evaluated for different prophylactic dressing designs. This is specifically relevant during manual repositioning or when a patient slides down in bed when the head of the bed is elevated due to gravity.

The use of dressings as preventive (prophylactic) measures is a relatively new concept that is attracting attention in academia, medical settings, and the industry worldwide.⁶ Sacral prophylactic dressings generally are designed to reduce friction and shear with the mattress, manage the microclimate of the skin by maintaining an appropriate humidity level, and redistribute pressure by adding a layer of soft, cushioning materials between the skin and the mattress.⁶ In the past few years, several clinical studies^7,8 have demonstrated the efficacy of prophylactic dressings. For example, Santamaria et al⁷ showed significantly fewer patients developed PUs in the intensive care unit when prophylactic heel and sacral dressings were applied in the emergency department, compared to when dressings were not used prophylactically (5 versus 20 patients, P = .001). Other evidence regarding the biomechanical effects of prophylactic dressings has been generated based on laboratory testing of shear and frictional properties.^9-12 Ohura et al¹⁰ used an experimental model consisting of porcine skin embedded with a force/shear sensor that demonstrated shear forces in the subcutaneous layer were reduced to within 31% to 45% when dressings were used, compared to a no-dressing scenario. Previously published mechanical studies^13,14 from the current authors’ group have shown biomechanical efficacy of compliant multilayer heel dressings (the Mepilex® Border Heel dressing [Mölnlycke Health Care, Gothenberg, Sweden] design) by means of computational finite element (FE) modeling. Briefly, the FE method is a computational technique used to evaluate the mechanical deformations, strains, and stresses deep within complex structures of multiple materials and amorphous shapes. The complex structure is divided into thousands of small elements, each having a simple geometry, and then the differential governing equations that describe the mechanical interactions of the problem are solved numerically per each element with respect to its surrounding elements to form the solution of the entire structure. Apart from its ability to evaluate the mechanical states deep within the soft tissues in clinically realistic scenarios as opposed to superficial pressure mapping which merely captures pressure (but not shear) on the skin, flexibility and robustness are what make the FE method such an important approach in preclinical PI prevention research. However, it is important to recognize that the credibility of any model relies on the quality and realism of the input data, such as geometric factors, material properties, and boundary conditions.¹⁵ Biomechanical modeling should generally be developed based on relevant clinical observations and data in order to avoid threats to valid clinical inference. Hence, modeling work is complementary to clinical research, and, in the case of clinical studies of prophylactic dressings,^7,8 it is particularly useful for explaining and interpreting the published clinical evidence of efficacy. As shown in the present study, modeling is specifically able to identify preferred design features and mechanisms of action of a prophylactic dressing technology that facilitate the reported clinically evident efficacy.^7,8

In the authors’ published modeling studies, the aforementioned multilayer dressing was found to have a beneficial effect on the mechanical states of the soft tissues of the heel of a single healthy subject, which may reduce the corresponding risk for heel ulceration (heel DTI) during supine bedrest.^13,14 Specifically, the aforementioned computer simulation studies employed an MRI-based FE model of the heel resting on a hospital foam mattress and with either healthy or diabetic tissue properties to evaluate internal tissue deformations and mechanical stresses in the soft tissues that are distorted by the weight of the foot.^13,14 Tissue deformations and stresses were compared between cases of the heel protected by a dedicated prophylactic dressing versus no protection and for the protected heel between multilayered and single-layer dressing designs. A 25.5% reduction of peak effective stresses occurred in the soft tissues of the heel in the healthy subject with the use of the multilayered prophylactic dressing that was modeled.¹³ The protective performance of the tested dressing was consistent across different plantar flexion positions of the foot subjected to various shearing forces.¹⁴

In the current study, previous modeling techniques^13,14 were applied to the sacral model to determine the biomechanical effects of different (sacral) prophylactic dressing designs on the state of mechanical loads in the soft tissues surrounding the sacrum for supine/Fowler posture on a hospital foam mattress. Furthermore, the modeling was expanded to investigate a new research question — namely, are there benefits in anisotropy of the dressing with regard to alleviation of internal soft tissue loads? Anisotropy, the characteristic of having directionally dependent stiffness (ie, the ratio of the force deforming the dressing over the actual deformation of the dressing) properties, is a design feature of the modeled anisotropic-compliant dressing. This is in contrast to conventional isotropy (ie, same stiffness in every direction) of other currently available prophylactic dressings.

The aim of this study was to compare mechanical states of simulated soft tissues surrounding the sacral bone across scenarios involving an anisotropic-compliant dressing, an isotropic-compliant dressing, and a completely stiff dressing using a set of computational FE model variants of the 3-dimensional (3D) buttocks and prophylactic dressing structures during supine weight-bearing or a 45˚ Fowler position. Outcome measures assessed were strain energy density (SED) — an indicator of mechanical stress — and maximal shear stresses in a volume of interest (VOI) of soft tissues surrounding the sacrum.

Methods

Eight (8) FE model variants were developed to investigate the effects of the design (particularly, the stiffness anisotropy) of prophylactic dressings on the mechanical states of the soft tissues at the sacral region in a supine weight-bearing position (see Table 1). The following conditions were simulated: 1) without a dressing, 2) with an isotropic multilayer compliant dressing, 3) with an anisotropic multilayer compliant dressing, and 4) with a completely stiff isotropic dressing. These mechanical states in soft tissues were simulated in pure compression loading of the buttocks (ie, simulating a horizontal supine bed rest) and in combined compression and shear loads applied to the buttocks (ie, 45˚ Fowler position).

Geometry. In order to develop a 3D, anatomically realistic geometrical model of the buttocks of a supine subject, 76 T1-weighted axial MRI slices were used. A 28-year-old healthy woman was scanned in a supine position, fully weight-bearing, on a designated rigid platform. Imaging was performed in a 1.5 Tesla MR system (MAGNETOM Aera, SIEMENS AG, Munich, Germany) utilizing T1-weighted images (TR/TE=550/10, field of view 42 mm × 420 mm, slice thickness 3 mm), at the Assaf Harofeh Hospital (greater Tel Aviv area), Israel. The MRI study was approved by the Institutional Review Board (Helsinki Committee) of Assaf Harofeh Hospital (Approval no. 190/14). The above MRI scan captured the entire region of the pelvis from the iliac crest to the shaft of the femurs. The image set was imported from the MRI to the ScanIP 3D image module of Simpleware® (Exeter, UK), where semi-automatic segmentation was performed in order to distinguish between the pelvic bones and soft tissue regions¹⁶ (see Figure 1a).

Next, 3 of the 5 layers of the isotropic and anisotropic multilayer dressings were applied in the modeling — namely, the polyurethane foam (PUR), the nonwoven (NW), and the airlaid (AL) layers, using the 3D image module. The innermost Safetac® layer (Mölnlycke Health Care) then was added as a tied interface between the skin and the polyurethane foam, preventing these layers from penetrating or sliding across each other in the modeling, and the backing film layer also was represented to address frictional sliding with the elastic (foam) support (as reported in previous papers from the authors^13,14).

The present modeling challenge of representing the modes of action of the sacral prophylactic dressing involved allocating greater computational power than demonstrated in the authors’ previous work^13,14 involving heel dressings. This is primarily due to the complexity of this 3D FE problem that includes elements with dimensions that vary from fractions of mm for the dressing components and up to tens of cm for the bone and soft tissue structures of the 3D buttocks. Accordingly, several measures were taken to simplify this large deformation problem to the extent that adequate numerical solutions could be obtained, despite the considerable challenge regarding the multiscales as explained previously. First, for these modeling procedures, skin, muscle and fat components were considered together and grouped as “soft tissue” structures. Second, the model volume for the FE analyses was decreased to include the dressing, the sacrum, and the surrounding soft tissues contained in the 3D block shown in Figure 1b. Adequate margins of soft tissue structures were intentionally kept around the dressing to avoid any boundary or edge effects (see Figure 1b).

Next, a flat standard foam mattress was added under the modeled buttocks (and under the dressing, in cases where a dressing was applied). Final FE meshing also was performed in the 3D imaging module using 139 964 to 212 585 linear tetrahedral elements describing the bones and soft tissues as well as 1 636 013 linear tetrahedral elements describing the 3 physical layers of the multilayer dressings. Hence, the FE analyses, which are described here, were conducted using meshes that contained nearly 2 million elements, which was essential given the multiscale challenge, and specifically, for adequate numerical transition between the microscale of the layered structure of the dressing and the macroscale of the buttocks tissues.

Mechanical properties of the tissues and dressing. The constitutive laws and mechanical properties of all tissues were adopted from the literature based on empirical data.^13,14 Specifically, the pelvic bone and femurs were assumed to be linear-elastic isotropic materials with elastic moduli of 7 GPa and Poisson’s ratios of 0.3. All soft tissues were considered together as 1 effective material as previously noted¹⁷ and were assumed to be nearly incompressible nonlinear isotropic materials, with their large deformation behavior described by an uncoupled Neo-Hookean constitutive model.

The material constants reported by Oomens et al¹⁷ were used to represent the effective soft tissue stiffness, assuming that skin contributes 60% to the effective stiffness and the other 40% are attributed to fat. The PUR, NW, and AL layers of the isotropic multilayer dressing were considered isotropic linear-elastic materials with elastic moduli of 24 kPa, 150 kPa, and 30.6 kPa, respectively, based on measurements previously performed in the authors’ laboratory and recently reported.^13,14 The Poisson’s ratio assigned to these dressing layers was 0.258 based on published experiments.¹² In cases where the completely stiff isotropic dressing was used (variants 4 and 8), the PUR, NW, and AL layers of the stiff dressing were considered isotropic linear-elastic materials with elastic modulus of 1 MPa and a Poisson’s ratio of 0.258. The mattress was considered isotropic linear-elastic as well, with an elastic modulus of 50 kPa and Poisson’s ratio of 0.3, again based on literature.^13,14,18

The anisotropic multilayer compliant dressing design comprises anisotropy — directional stiffness properties that constitute a stiffer longitudinal behavior in the direction of the spine versus more compliant “wings” that facilitate lateral stretching of the dressing. To capture this anisotropy feature, the stiffness properties of the PUR, NW, and AL layers of model variants 3 and 7 of the isotropic dressing were increased by 45% only in the axial (Z) direction to replicate the longitudinal stiffness characteristic of the anisotropic dressing based on measurements preformed in the authors’ laboratory to quantify this anisotropy (see Table 1).

Body loads applied to the buttocks model, shear, and friction conditions. Boundary conditions were chosen to simulate the descent of the weight-bearing pelvic bones during supine lying or a 45˚ Fowler position. The response of soft tissues to this descent was tested without and with each of 3 test dressings of the same shape. In all simulation cases, dressings were attached to exactly the same sacral region, ideally aligned, and symmetrically placed according to manufacturer’s guidelines (as these dressings would have been in a real-world scenario), as detailed in Table 1.

In terms of other relevant constraints, the bottom surface of the mattress was fixed for all translations and rotations. Tied interfaces were defined between the bones and soft tissues as well as between the soft tissues and the PUR layer of the dressing to account for the full adherence properties of the Safetac layer of the dressings. Frictional sliding was defined between the AL layer of the dressings and the mattress, with the coefficient of friction set as 0.35 to simulate the low-friction effect provided by the backing film layer of the dressings.¹² In model variants 1 and 5 (ie, simulations of the weight-bearing buttocks without a dressing), the coefficient of friction between the soft tissues and the mattress was set to be higher (0.4) because of the absence of the backing film.¹³

To simulate loading conditions, downward displacements in the range of 5.3 mm to 6.45 mm in all model variants were applied on the top surface of the reduced model volume (marked in Figure 1b) until the total reaction force acting back from the mattress reached 40 Newtons (roughly 7% of the total bodyweight of the subject), which were assumed to be transferred through this reduced model volume for the purpose of comparison across model variants. In model variants 5, 6, 7, and 8, the same extent of displacement also was applied in the axial (Z) direction, accounting for the shearing forces that may act due to sliding down in the bed (eg, when seated in bed in a 45˚ Fowler position) or due to some spontaneous movements or repositioning of the patient in the bed. The FE simulations all were created using the PreView module of FEBio (version 1.18), analyzed using the Pardiso linear solver of FEBio (version 2.3.1), and post-processed using PostView of FEBio (version 1.919) (University of Utah, Salt Lake City, UT).

Biomechanical outcome measures. Volumetric exposures of the soft tissues adjacent to the sacral bone to sustained deformations were examined and quantified in terms of the strain energy density (SED) in these soft tissues within the reduced model volume (see Figure 1b). Briefly, SED is a scalar measure in units of mechanical stress (eg, kPa) that describes the spatial dispersion of the elastic energy that is stored in an object that undergoes deformation. It is a factor of the stiffness of the material and of the mechanical strains and stresses that develop in every point within the deformed object.

Data analysis. The SED data were pooled from the soft tissues for all the elements in a 67 mm x 55 mm x 20 mm soft tissue cube located immediately under the sacrum, which had been defined as the volume of interest (VOI) for the purpose of SED data comparisons across the model variants (see Table 1), as depicted in Figure 1d. Converging time steps were chosen for data collection, so the resulting reaction forces between the buttocks and the support were within less than a 2.4% difference from the aforementioned target reaction force. The SED in the VOI were analyzed across the model variants to determine whether additional biomechanical efficacy is present in the anisotropic multilayer dressing design in terms of alleviation of tissue loads with respect to a no-dressing situation, to an isotropic multilayer dressing case, or to a completely stiff dressing. These simulations were repeated in either pure compression or compression combined with shear loads (see Figure 1c) and compared quantitatively by calculating the volumetric exposures to SED in the soft tissues in the VOI per each simulation case (see Table 1). The details of the method of FE analysis are explained in the authors’ previous publication¹⁴ that includes explanations with regard to calculation and data processing techniques.

Results

Contact pressure distributions on the skin surface with and without the isotropic multilayered dressing are shown in Figure 2a. Similar to previously published results^13,14 regarding contact pressure distributions under the heel protected by a border dressing, the isotropic multilayer dressing was able to reduce peak (maximal) contact pressures under the weight-bearing buttocks from 6 kPa to 2.9 kPa (52%) when loaded in pure compression, resulting in a more uniform distribution of contact pressures between the skin and the mattress at the sacral region (see Figure 2a).

Furthermore, with respect to a bare skin condition, the isotropic multilayer dressing consistently reduced the volumetric exposures of the soft tissues under the sacrum to sustained deformations across the entire range of SEDs from 0.1 kPa to 1.9 kPa (see Figures 2b, 3b, 4) and when loaded in either pure compression or in combined compression and shear. However, the anisotropic design, which is stiffer in the axial (Z) direction of the dressing, further reduced the volumetric exposures of the soft tissues under the sacrum to sustained large deformations when external shear was introduced, by an additional 11% with respect to the isotropic case (model variant 7) (see Figures 3, 4, and 5). Specifically, while the isotropic multilayer dressing lowered the average volumetric exposure of the soft tissues under the sacrum by 54% and 50% in the low (<0.5 kPa) and high (>0.5 kPa) SED domains, respectively, (as defined by Sopher et al¹⁸), the corresponding value for the anisotropic dressing was 61% (for both domains) (see Figure 5). Hence, the anisotropy feature of the anisotropic dressing facilitated more soft tissue protection (additional 11% reduction) in exposure to large tissue deformations.

While in theory applying a completely stiff dressing on the sacral region may shield the underlying soft tissues in the sacral bone region from sustained deformations, in the cases where completely stiff dressings were tested (model variants 4 and 8), tissue deformations were found to have shifted laterally, resulting in increased stress concentrations in the soft tissues near the perimeter of the dressing rather than under the sacrum (see Figure 3d). For example, in the cases where combined compression and shear were applied, the maximal shear stress above the midpoint of the dressing and just below the sacral bone decreased from 0.2 kPa to 0.16 kPa (21.5%) when a completely stiff dressing was used (compared to the corresponding no-dressing case) but increased from 0.15 kPa to 0.5 kPa (as high as 70%) upon analysis of the soft tissue volume above the perimeter of the dressing (see Figure 3).

Discussion

In the present study, a set of MRI-based 3D FE model variants of the buttocks in a supine position was used to evaluate the design features and biomechanical effects of sacral dressings designed to prevent PIs and DTIs. Focusing specifically on stiffness and anisotropy of stiffness properties of these sacral dressings, volumetric exposures of soft tissues under the sacrum to tissue deformations and loads (quantified as elevated SED values) during supine lying when using dressings were determined. The biomechanical effects of an isotropic multilayer dressing, an anisotropic dressing, and a completely stiff dressing were compared when loaded in either pure compression or in combined compression and shear. The primary objective of the present study was to determine whether anisotropy of the prophylactic sacral dressing, which allows it to be more stretchable in the lateral (buttock cheeks) direction than along the direction of the spine, is beneficial in protecting the soft tissues from deformation-inflicted tissue damage.

Similar to the authors’ previous modeling work regarding the risk for heel ulcers and the potential mitigating role of prophylactic dressings,^13,14 prophylactic dressings were found effective in lowering exposure to sustained tissue deformations under the sacrum as well. Peak contact pressures and SED values decreased 50% to 61% compared to the no-dressing equivalent cases (see Figures 2 and 4). Multilayered sacral dressings not only provided extra cushioning and pressure redistribution under the weight-bearing buttocks, but they also deformed themselves (particularly in shear), given their compliant-stiff-compliant layered structure, which then diverted deformation and load from the tissues to the structure of the dressing itself. An additional advantage specific to the multilayer dressings that were modeled may be offered by the smooth backing film layer of the dressings, which facilitates decreased friction and hence, reduced shear loads in the underlying tissues.^12,13 In addition, completely stiff isotropic dressings, which in theory could be effective in minimizing tissue deformations at the center of the dressing, were found to show a tradeoff effect, inflicting increased deformations and loads (SED values), especially elevated shear stresses in the soft tissues along the perimeter of the dressing. This was thought to be due to the sharp gradients in stiffness between the dressing material and the soft tissues, which was promoting shear in tissues at the borders. Hence, the concept of completely stiff dressings is not recommended for tissue protection; while stiff dressings will maintain the shape of tissues at the center of the dressing (much like a plaster cast will do), they may cause tissues at the border of the dressing to stretch and shear (see Figure 3d).

The most important finding from this modeling study concerns the benefit of using anisotropy as a design feature in prophylactic sacral dressings. The anisotropic structure of the modeled anisotropic dressing resulted in the lowest exposures to tissue SED values, particularly when the buttocks model was loaded in combined compression and shear, a common scenario in patients who require head-of-bed elevation and frequent repositioning.¹⁴ The stiffness anisotropy of the anisotropic dressing (ie, modeled here using greater stiffness in the direction of the spine) was shown in this model to provide extra protection to soft tissues around the sacrum when shear loads are present. Specifically, in this model, the compliant stretch range in the lateral direction of the dressing (pointing toward the buttock cheeks) facilitated an extra 11% reduction in soft tissue exposure to SED at the VOI. The anisotropic dressing mitigated tissue deformations and loads under the perimeter of the dressing as well as directly under the sacrum (see Figure 3c) as opposed to the isotropic dressing, which did not allow tissues to expand laterally, leading to stress concentrations under the lateral borders of the isotropic dressing (see Figure 3d). The authors concluded the stiffness anisotropy may be a critically important design feature in multilayer dressings for prophylactic use.

In order to quantify the potential for tissue damage, the authors opted to use the SED measure, believing it is optimal for quantifying the exposure to sustained tissue loads as related to PI and in particular to DTI risks. In the literature, SED distributions have been experimentally correlated with the severity and extent of tissue damage in rodent model experiments.²⁰ These findings made this scalar measure the first choice for characterizing tissue loads in the context of PI risks.¹⁸ Moreover, SED data are a weighed measure of all tissue deformation modes (ie, a strain tensor that includes compression, shear, and tension distortion components) with added tissue stiffness properties (ie, the stiffness tensor). This helps resolve the debate regarding which engineering load measures — strain or stress measures — are preferable for evaluating the risk for PIs in tissues.²¹

Limitations

The clinical inference of this study design is unknown and any modeling inevitably includes assumptions and limitations, which should be discussed for completeness and interpretation of the findings. First, the authors chose to use the deformed (weight-bearing) anatomy of the buttocks to develop the initial geometric model, with the aim to focus on tissue deformations at the nearly weight-bearing configuration of the buttocks as relevant to a resting supine patient. If they had used a completely underformed (nonweight-bearing) anatomy, slightly greater exposures to SED (manifested as higher curves in the graphs in Figure 4) would have been expected. However, this additional tissue deformation would have been mostly due to the lateral tensile component (tissue stretching) from the spreading of the cheeks of the buttocks during the weight-bearing process rather than from the compression and shear components resulting from interactions between hard and soft tissues under the sacrum. That being said, for the purpose of comparison of cases with prophylactic dressings versus without them or for comparing isotropic to anisotropic dressing designs, a deformed anatomical buttocks model was believed to be reasonable and practical to use. Furthermore, to reduce the required computer power and simplify this extremely complex 3D large deformation FE problem, soft tissues were considered as 1 entity and used an effective soft tissue material. Using a distinct geometrical and mechanical representation of each tissue could have resulted in a more accurate resolution of tissue loads, and with the development of computational modeling technologies in this field, it will probably be attempted in the future. For example, with the soft tissues considered together into 1 “soft tissue” material as was done in this study, lower stresses were more likely to be noted in the “skin” region than had the skin (which is stiffer than the underlying fat and muscles) been represented as a separate tissue layer. In other words, the observed stresses at the skin surface are likely slightly less than they would be if tissue layers had been assessed separately, but subdermal tissue stresses, which were the focus of this work, are adequately evaluated. Hence, given that this study focused on the prevention of DTIs and the potential role of prophylactic sacral dressings in doing so, the resolution of superficial tissue loads (on the skin) could be reasonably compromised for the benefit of achieving the 3D representation of the large deformation of the entire buttocks.

Lastly, although the geometrical model is anatomically accurate, it is based on an MRI scan of a single (healthy) subject, which is not necessarily representative of a patient at a high risk for PIs and DTIs. Future work should include modeling of the variations and changes in tissue structures and mechanical properties as associated with known risk factors for PIs (eg, type 2 diabetes).¹⁴ Likewise, more research is needed with regard to the variations in the shear loading schemes associated with the patient’s position in bed and guidelines for repositioning and general care, as well as to the use of advanced, more sophisticated support surfaces, which are commonly provided for at-risk patients. Specifically, more information is needed with regard to the interactions of sophisticated support surfaces with prophylactic dressings.

Conclusion

The FE modeling results obtained in this study suggest prophylactic sacral dressings may minimize exposure to sustained tissue deformations and as such protect tissues from PIs and DTIs during supine lying or a 45˚ Fowler position on a standard hospital foam mattress. Further, the differences in mechanical behavior observed between the modeled anisotropic, isotropic, and stiff dressings suggests the former may provide enhanced protection against unavoidable shear loads under the sacrum as well as in adjacent soft tissues underlying the perimeter of the dressing. Additional clinical research should be conducted to examine the clinical inference of this modeling technique and investigate the effects of prophylactic dressings on healthy volunteers and patients in different positions in bed or on operation tables, perhaps using force/shear sensors over and under the dressings.

References

1. European Pressure Ulcer Advisory Panel (EPUAP), National Pressure Ulcer Advisory Panel (NPUAP), Pan-Pacific Pressure Injury Alliance (PPIAA). International Pressure Ulcer Guidelines, 2014. Available at: www.epuap.org/pu-guidelines/#2014guidelines&qrg. Accessed September 26, 2017.

2. Vangilder C, Macfarlane S, Meyer S. Results of nine international pressure ulcer prevalence surveys: 1989 to 2005. Ostomy Wound Manage. 2008;54(2):40–54.

3. Butcher M, Thompson G. Can the use of dressing materials actually prevent pressure ulcers: presenting the evidence. Wounds UK. 2010;6(1):119–125.

4. Shabshin N1, Zoizner G, Herman A, Ougortsin V, Gefen A. Use of weight-bearing MRI for evaluating wheelchair cushions based on internal soft-tissue deformations under ischial tuberosities. J Rehabil Res Dev. 2010;47(1):31–42.

5. Gefen A, van Nierop B, Bader DL, Oomens CW. Strain-time cell-death threshold for skeletal muscle in a tissue-engineered model system for deep tissue injury. J Biomech. 2008;41(9):2003-2012.

6. Gefen A, Kottner J, Santamaria N. Clinical and biomechanical perspectives on pressure injury prevention research: the case of prophylactic dressings. Clin Biomech (Bristol, Avon). 2016;38:29–34.

7. Santamaria N, Gerdtz M, Sage S, et al. A randomized controlled trial of the effectiveness of soft silicone foam multi-layered dressings in the prevention of sacral and heel pressure ulcers in trauma and critically ill patients: the border trial. Int Wound J. 2015;12(3):302–308.

8. Santamaria N, Gerdtz M, Liu W, et al. Clinical effectiveness of a silicone foam dressing for the prevention of heel pressure ulcers in critically ill patients: Border II Trial. J Wound Care. 2015;24(8):340–345.

9. Forni C, Loro L, Tremosini M, et al. Use of polyurethane foam inside plaster casts to prevent the onset of heel sores in the population at risk. A controlled clinical study. J Clin Nurs. 2011;20(5-6):675-680.

10. Ohura T, Takahashi M, Ohura N Jr. Influence of external forces (pressure and shear force) on superficial layer and subcutis of porcine skin and effects of dressing materials: are dressing materials beneficial for reducing pressure and shear force in tissues? Wound Repair Regen. 2008;16(1):102–107.

11. Nakagami G, Sanada H, Konya C, Kitagawa A, Tadaka E, Matsuyama Y. Evaluation of a new pressure ulcer preventive dressing containing ceramide 2 with low frictional outer layer. J Adv Nurs. 2007;59(5):520–529.

12. Call E, Pedersen J, Bill B, et al. Enhancing pressure ulcer prevention using wound dressings: what are the modes of action? Int Wound J. 2015;12(4):408-413.

13. Levy A, Frank MB, Gefen A. The biomechanical efficacy of dressings in preventing heel ulcers. J Tissue Viability. 2015;24(1):1–11.

14. Levy A, Gefen A. Computer modeling studies to assess whether a prophylactic dressing reduces the risk for deep tissue injury in the heels of supine patients with diabetes. Ostomy Wound Manage. 2016;62(4):42–52.

15. Bader DL. Editorial. J Tissue Viability. 2013;2(2):23–24.

16. Simpleware^® Ltd. ScanIP, +FE, +NURBS and +CAD Reference Guide ver. 5.1, 2012. Available at: www.simpleware.com/software. Accessed September 26, 2017.

17. Oomens CW, Zenhorst W, Broek M, et al. A numerical study to analyse the risk for pressure ulcer development on a spine board. Clin Biomech (Bristol, Avon). 2013;28(7):736–742.

18. Sopher R, Nixon J, McGinnis E, Gefen A. The influence of foot posture, support stiffness, heel pad loading and tissue mechanical properties on biomechanical factors associated with a risk of heel ulceration. J Mech Behav Biomed Mater. 2011;4(4):572–582.

19. Maas SA, Ellis BJ, Ateshian GA, Weiss JA. FEBio: finite elements for biomechanics. J Biomech Eng. 2012;134(1):011005.

20. Loerakker S, Manders E, Strijkers GJ, et al. The effects of deformation, ischemia, and reperfusion on the development of muscle damage during prolonged loading. J Appl Physiol (1985). 2011;111(4):1168–1177.

21. Linder-Ganz E, Shabshin N, Gefen A. Patient-specific modeling of deep tissue injury biomechanics in an unconscious patient who developed myonecrosis after prolonged lying. J Tissue Viability. 2009;18(3):62–71.

Potential Conflicts of Interest: Dr. Gefen is Chair of the Scientific Advisory Board, Mölnlycke Health Care, Gothenburg, Sweden; and is funded by Mölnlycke Health Care for investigating the effects of dressing materials and designs on soft tissues during weight-bearing.

Ms. Levy is a doctoral student; and Dr. Gefen is a Professor of Biomedical Engineering, Department of Biomedical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv, Israel. Please address correspondence to: Amit Gefen, PhD, Tel Aviv University, Tel Aviv 6997801 Israel; email: gefen@eng.tau.ac.il.

Section:

↧

A Randomized, Controlled Clinical Study to Assess the Effect of Anodal and Cathodal Electrical Stimulation on Periwound Skin Blood Flow and Pressure Ulcer Size Reduction in Persons with Neurological Injuries

February 1, 2018, 12:19 pm

≫ Next: Factors Affecting Wound Healing in Individuals With Pressure Ulcers: A Retrospective Study

≪ Previous: Assessment of the Biomechanical Effects of Prophylactic Sacral Dressings on Tissue Loads: A Computational Modeling Analysis

Issue Number:

Index:

Ostomy Wound Management 2018;64(2):10–29 doi: 10.25270/owm.2018.2.1029

Anna Polak, PT, PhD; Prof Cezary Kucio, MD, PhD; Prof Luther C. Kloth, MS, PT, FAPTA, FACCWS; Malgorzata Paczula, MD; Ewa Hordynska, MD; Tomasz Ickowicz, PT; Prof Edward Blaszczak, MSc, PhD; Ewa Kucio, MSP, PhD; Krystian Oleszczyk, MD, PhD; Prof Krzysztof Ficek, MD, PhD; and Prof Andrzej Franek, MSc, PhD

Topics:

randomized controlled trial

Pressure Ulcer

wound healing

Electrical Stimulation

skin blood flow

Abstract

The use of electrical stimulation (ES) should be considered for treating nonhealing pressure ulcers (PUs), but optimal ES wound treatment protocols have yet to be established. A randomized, controlled, double-blind clinical study was conducted to evaluate the effects of cathodal and anodal high-voltage monophasic pulsed current (HVMPC) on periwound skin blood flow (PSBF) and size reduction of Stage 2 to Stage 4 PUs of at least 4 weeks’ duration.

Persons >18 years of age, hospitalized with neurological injuries, at high risk for PU development (Norton scale <14 points; Waterlow scale >15 points), and with at least 1 Stage 2 to Stage 4 PU were eligible to participate in the study. Persons with necrotic wounds, osteomyelitis, electronic or metal implants in the PU area, PUs in need of surgical intervention, acute wound inflammation, diabetes (HBA1c >7%), diabetic neuropathy, cancer, and/or allergies to standard wound treatments were excluded. Patients were randomly assigned to 1 of 3 groups: anodal (AG), cathodal (CG), or placebo (PG) ES. All groups received individualized PU prevention and standard wound care. In the PG, sham ES was applied; the AG and CG were treated with anodal and cathodal HVMPC, respectively (154 μs 100 Hz; 360 µC/second; 1.08 C/day), 50 minutes per day, 5 days per week, for a maximum of 8 weeks. PSBF was measured using laser Doppler flowmetry at baseline, week 2, and week 4, and wound surface area measurements were obtained and analyzed using a digitizer connected to a personal computer. Data analysis utilized the maximum-likelihood chi-squared test, the analysis of variance Kruskal-Wallis test, the Kruskal-Wallis post-hoc test, and Spearman’s rank order correlation. Nonlinear approximation based on exponential function was used to calculate treatment time needed to reduce the wound area by 50%. In all tests, the level of significance was set at P≤.05. Of the 61 participating patients, 20 were in the AG (mean age 53.2 ± 13.82 years), 21 in the CG (mean age 55.67 ± 17.83 years), and 20 in the PG (mean age 52.5 ± 13.18 years). PUs (baseline size range 1.01 cm² to 59.57 cm²; duration 4 to 48 weeks) were most frequently located in the sacral region (73.77%) and classified as Stage 3 (62.29%). PSBF at week 2 was significantly higher in the AG and CG than in the PG (P<.05). Week 4 differences were not statistically significant. Wound percentage area reduction calculated at week 8 for the AG (64.10% ± 29.22%) and CG (74.06% ± 23.23%) were significantly different from PG ulcers (41.42% ± 27.88%; P = .0391 and P = .0024, respectively). In both ES groups, PSBF at week 4 and percent wound surface area reductions between weeks 4 and 8 were positively correlated, but only the AG correlation was statistically significant (P = .049). In this study, both ES modalities improved blood flow and wound area reduction rate. Studies examining optimal ES treatment times for healing to occur, the effect of comorbidities and baseline wound variables on ES outcomes, and the nature of the relationship between blood flow and healing are necessary.

Clinical practice guidelines^1,2 suggest electrical stimulation (ES) should be considered for treating recalcitrant Stage 2, Stage 3, and Stage 4 pressure ulcers (PUs). The recommendation is based on A-level strength of evidence from controlled trials on PUs in humans.¹

ES influence on blood flow. A common factor that may prevent or delay wound healing is compromised perfusion of the wound and periwound tissues. In a preclinical, experimental study with 10 healthy volunteers (age 20 to 40 years), Petrofsky et al³ investigated whether skin blood flow changes induced by ES could be attributed to the electrical current effect on nitric oxide (NO) that is known to dilate blood vessels. From the first part of the study,³ the authors concluded a 4-minute application of biphasic sine current in the thigh area significantly increased skin blood flow compared to its pre-ES level (P <.01). In the second part of the study, biphasic sine current and iontophoresis with a NO synthetase inhibitor (N-nitro-L-arginine methyl-ester) were applied simultaneously to the same part of the body in the same patients. A significant reduction in skin blood flow (P<.01) was observed. The authors concluded the increase in skin blood flow in the first part of the experiment was caused by the release of NO induced by ES.

A randomized, double-blind, controlled, placebo clinical study by Mohajeri-Tehrani et al⁴ (N = 20) investigated the effect of low-intensity direct current on the release of plasma vascular endothelial growth factor (VEGF) and NO in patients with diabetic foot ulcerations. After 12 ES sessions, a significantly higher level of NO was noted in blood plasma in the ES-treated patients compared to patients in the control (placebo) ES group (P = .04). A randomized, single-blind, controlled clinical trial by Asadi et al⁵ showed ES significantly increased wound-fluid levels of hypoxic inducible factor-1α and VEGF while decreasing wound surface area after 12 sessions of ES with low-intensity direct current applied at sensory level. In vitro studies by Zhao et al⁶ and Bai et al⁷ have shown that an electric field (75 to 200 mV/mm) induced by a direct current, comparable in amplitude to the measurable current of injury at a wound, caused a direct release of VEGF by vascular endothelial cells⁶ and induced directional migration, orientation, and elongation of endothelial cells, vascular fibroblasts, and smooth muscle cells.⁷ It also was shown that vascular endothelial cells migrate toward the cathode, as opposed to vascular fibroblasts and smooth muscle cells that migrate toward the anode.

The cited preclinical^3,6,7 and clinical^4,5 studies have demonstrated that direct^4-7 and biphasic pulsed³ currents increase the release of NO, dilating blood vessels,^3,4 stimulating the release of angiogenetic factors (VEGF^4-6 and of hypoxic inducible factor-1α⁵), and induce reorientation, elongation, and migration of endothelial cells as well as vascular fibroblasts and smooth muscle cells,⁷ all of which exert a positive influence on wound healing.

Clinical evidence supporting the use of high-voltage monophasic pulsed current (HVMPC) for wound treatment. Chronic wounds treated with ES utilize subsensory amplitudes of direct and pulsed currents with amperage below 1 mA (so-called microcurrents)^8,9 as well as sensory stimulation below the muscle contraction threshold. Sensory ES involves the application of HVMPC^10-18 and low-voltage monophasic^19-21 and biphasic^22-24 pulsed currents. The authors of critical and systematic reviews published in 2014²⁵ and 2017²⁶ concluded both high-voltage and low-voltage pulsed currents can produce consistently positive results in patients with chronic wounds.

Several clinical studies compared HVMPC to standard wound care (SWC) alone^12,15,16 or SWC + sham ES^{10,11,13,17,18} to treat PUs,^10,11,15-18 venous leg ulcers,^12,14 and diabetic foot ulcers.¹³ The main results and methodology of HVMPC in PU treatment studies are summarized in Table 1. The outcomes of the cited studies^10,11,15-18 indicated PU area decreased more in the SWC + ES groups than in controls treated with HVMPC.

In reviews of clinical^27,28 and epidemiological studies,²⁹ wound closure was the crucial endpoint in evaluating treatment efficacy. However, clinical studies utilizing ES rarely last long enough for closure to be achieved. Only 1 study¹⁰ involved treatment of PUs with HVMPC until full closure. In trials that terminated before wounds were closed, the percentage wound area reduction from baseline at weeks 4, 6, or 12 of treatment was a crucial indicator of treatment efficacy.^11-18 The time during which PU surface area decreases from baseline by at least 50% is also important.^27-29

Three (3) clinical studies evaluated changes in wound surface area (WSA) and periwound skin blood flow (PSBF) in ulcers that received 2 and 4 weeks of ES with sensory level low-voltage, biphasic, pulsed currents.^22-24 To address a gap in the research literature, this clinical study was designed assess the effect of cathodal and anodal high-voltage HVMPC on PSBF and WSA reduction in Stage 2 to Stage 4 PUs in adult persons with neurological injuries.

Methods

Study design. This prospective, randomized, blind, controlled, clinical trial was designed to compare PSBF around the PU area after 2 and 4 weeks of treatment as well as WSA reduction during 8 weeks of treatment between 3 groups of patients receiving SWC plus cathodal ES, anodal ES, or sham ES, respectively. Parallel treatment of patients in all 3 groups and equal numbers of patients in the groups were assumed.

Ethical approval. Ethical approval was granted by the Academy Bioethics Commission.

The trial was prospectively registered with the Australian-New Zealand Clinical Trials Registry (ANZCTR): ANZCTRN 12615001281583.

Study enrollment and criteria. Patients screened for the study were treated as inpatients at 1 rehabilitation center between December 1, 2015, and January, 30, 2017. Their eligibility to participate was assessed by their physician using the following criteria: neurological injuries (spinal cord injury, ischemic stroke, and/or blunt trauma to the head); age 18 years or older; high risk of PU development (<14 points on the Norton scale and >15 points on the Waterlow scale); and Stage 2, Stage 3, or Stage 4 PU of at least 0.5 cm² in size and at least 4 weeks’ duration located on the pelvic girdle or lower extremities.

Because it was initially planned that only patients with spinal cord injuries would be enrolled in the trial, this inclusion criterion was stated in the ANZCTR registration form. However, because the number of qualifying patients in the rehabilitation center turned out to be insufficient for statistical analysis, patients with brain injuries from a cerebral stroke or skull trauma also were included. These changes were reported to the ANZCTR. Patients who could not receive ES (ie, persons with cancer, electronic implants, metal implants, osteomyelitis in the PU area, tunneling, necrotic wounds, and PUs requiring surgical intervention), patients with acute inflammation in the wound area, and patients with conditions impeding wound healing such as diabetes (HbA1c >7%), critical wound infection, allergies to standard wound treatment, and/or alcoholism were excluded from the study.

Randomization. Patients were informed in writing by the research manager about the aim and course of the study and that they could withdraw from the study at any time without having to state a reason and without any consequences for their further treatment. Patients who consented to participate in the trial (or whose legal guardians gave consent for their inclusion) were randomly assigned to 3 groups.

The study was initially designed to involve 3 groups of 15 people. Accordingly, a person independent of the trial was given 3 sets of 15 slips of paper that were marked with letters A, B, and C denoting group assignment: A for the SWC + anodal HVMPC group, B for the SWC + cathodal HVMPC group, and C for the SWC + sham ES group. The person, who was not aware of what the letters meant, inserted the slips into 45 computer-generated, randomly drawn envelopes. Once sealed, the envelopes were delivered to the main investigator in charge of allocating patients to groups. Before the trial commenced, the envelopes were opened 1 at a time in the presence of a physiotherapist and the patient concerned was directed to the appropriate group. Because more persons volunteered to participate in the study than originally planned, 3 additional sets of 6 envelopes were prepared for each group and the randomization of patients proceeded as described. The final sample consisted of 61 patients. The increased number of participants diminished the risk of study bias.

Blinding. All patients, medical personnel, and researchers were blinded as to what type of ES was being applied to individual patients (anodal ES, cathodal ES, or sham ES). The exceptions were the main investigator and the principal physiotherapist who set the equipment to apply active or sham ES. The person responsible for statistical analysis also was blinded.

Study variables. Demographic information on the patients enrolled in the study was obtained from standardized participant interviews, physical examinations, the results of additional examinations, and the history of concomitant diseases. Study variables for assessing wounds, PU risk, and patients’ nutritional status were collected with paper-pencil instruments and transferred to a data sheet. Other data, such as patient case history, blood cell count results, and previous treatment results, were obtained from the electronic hospital database. The information then was entered to a computer database enabling data analysis.

Wound assessment. Before treatment, patients’ wounds were examined by a physician. Patients with PUs covered with eschar and with wounds showing signs of acute inflammation were excluded from the study. Patients with a PU covered with slough or with PUs in the granulation and epithelialization phases were included in the study. Wound depth was determined by a physician based on the criteria developed by the National Pressure Ulcer Advisory Panel¹ (Stage 2 PUs = partial-thickness loss of the dermis presenting as a shallow open ulcer with a red pink wound bed, no slough; Stage 3 PUs = full-thickness tissue loss and subcutaneous fat possibly visible but not the bone, tendon, or muscles; and Stage 4 PU = full-thickness tissue loss, muscle/bone exposed).

PU risk. Patients’ risk of PU development was assessed with the Norton scale³⁰ and the Waterlow scale³¹ with respect to factors such as patient gender and age, body composition and weight, mobility, concomitant diseases (primarily central nervous system injuries, diabetes, anemia), history of smoking, appetite and level of nourishment, and medications used (mainly anti-inflammatory drugs, cytostatics, and steroids).

Nutritional status. In assessing patients’ nutritional status, malnutrition was defined as a state resulting from lack of intake or uptake of nutrition that leads to altered body composition (decreased fat free mass) and body cell mass leading to diminished physical and mental function and impaired clinical outcome from disease.³² The primary diagnostic criteria of malnutrition included body mass index (BMI) <18.5 kg/m² as indicated by the underweight definition created by the World Health Organization or combined weight loss and reduced BMI.³³

To determine patients’ nutritional status, their blood samples also were tested for markers of metabolic disorders, anemia, thyroid dysfunction, impaired glycemic control, dehydration, protein deficit, hypoalbuminemia, vitamin level, indicators of inflammation (C-reactive protein), and nitrogen balance.^34,35 Diet was reviewed to assess intake of healthy and nonhealthy nutrients and fluid losses. Nutritional status was quantified by means of the Nutritional Risk Score (2002).³⁶

Anemia. Anemia was diagnosed as hemoglobin level <13.4 g/dL in men and <12 g/dL in women. In cases where mean corpuscular volume (MCV) erythrocyte was <80 fl, blood iron concentration was determined. When MCV erythrocyte was above 100 fl, blood B12 concentration was tested.

Interventions. All patients in the cathodal ES, anodal ES, and placebo groups received SWC (prevention measures, wound care, and physical treatment) under the supervision of the physician and the principle investigator following best practices.^1,2,37 Each patient was assessed by an interdisciplinary team consisting of a physician, a nurse, a physiotherapist, and a dietitian.

Individualization. The team developed individual wound prevention and treatment programs in consideration of patients’ needs regarding PU prevention and nutritional intervention, the optimization of the wound dressing protocol, and incontinence management. To protect the trial participants from developing more PUs, pressure-redistribution surfaces, foam devices, and pillows were used. Patients who were immobile were repositioned by a nurse or physiotherapist at least every 2 hours, and persons who could move were instructed to change position as often as they could. Malnourished patients received individual nutritional support. They were assisted during meals by a nurse or a medical assistant who made sure the quantity and quality of food and liquids they ingested followed the dietitian’s guidelines. Nutritional supplementation with proteins, vitamins, and minerals was administered when necessary. Patients who did not consume sufficient amounts of food received enteral or parental nutrition.¹

Wound care protocol. Wounds were regularly assessed by the physician throughout the period of the study with a view to selecting topical treatments to appropriately address moisture control, bacterial burden, and debridement needs. When wound infection was suspected, a swab was taken to identify the bacteria and prepare an antibiogram.

Before ES was applied, necrotic tissue was removed from PUs with surgical/sharp, conservative sharp, or enzymatic debridement.

A moist wound environment was maintained consistently with hydrogel, hydrocolloid, or alginate dressings. Dressing type depended on the PU stage, phase of healing, the amount of wound secretion, and pain severity. Wounds covered with slough and granulating wounds were covered between ES procedures with alginate dressings (high or moderate exudate levels; surface and deep wounds) and hydrocolloid dressings (moderate or low exudate levels; surface wounds). Granulating and epithelializing wounds with minimal exudate were covered between ES procedures with hydrocolloid or hydrogel dressings.

Infected wounds were washed with antiseptics that included Octenilin Wound Gel (Schülke, Norderstedt, Germany); Octenisept solution (Schülke); and/or Actolind W Solution/Gel (Polvet Healthcare Teodorowski SJ, Laziska, Gorne, Poland). PUs also were washed with Kodan Tinktur forte solution (Schülke) and Skinsept (Ecolab, Monheim am Rhein, Germany). According to the information provided by the manufacturers of these antiseptic agents, none of them is cytotoxic to healthy cells.

Patients with elevated leukocyte levels received antibiotics selected according to the results of microbiological culture and sensitivity tests. All immobile patients received low-molecular-weight heparin.

Anodal ES group (AG). Patients in the AG were administered SWC and anodal HVMPC energy. The device used to deliver HVMPC was the Intelect Advanced Combo unit, Model 2771 (Chattanooga Group, Vista, CA) with 2 independent electrical circuits, of which only 1 was active. The device generated a twin-peak monophasic pulse (154 µs) consisting of 2 77-µs exponential pulses in rapid succession. Pulse frequency was set at 100 pps and voltage above 100 V for amperage of 0.36 A that did not elicit motor reactions. The electrodes delivered a 360 µC per second charge (1.08 C per day). Patients participated in 5 50-minute, once-a-day sessions held weekdays (Monday through Friday). All patients had a personal set of conductive carbon-rubber electrodes. During the procedure, the treatment electrode (5.0 cm x 10.0 cm) was placed on the wound and the return electrode (10.0 cm x 10.0 cm) was attached to healthy periwound skin at least 20 cm from the PU. Both electrodes were separated from the tissue by aseptic gauze pads saturated with physiological saline.

Cathodal ES group (CG). HVMPC protocol in the CG was almost the same as the AG protocol; the only difference was cathodal (not anodal) stimulation was used. The protocol of HVMPC in both ES groups was based on methods used in earlier clinical trials using anodal¹⁰ and cathodal^11,14,17,18 ES in patients with PUs^10,11,17,18 and venous leg ulcers.¹⁴

Placebo ES group (PG). This group received SWC and sham ES. The arrangement of electrodes during the procedure was the same as in the ES groups. The monitor of the ES unit displayed all parameters, but because the electrodes were connected to the inactive electrical circuit current energy was not delivered to wounds.

The main physiotherapist connected the electrodes and selected the polarity of the treatment electrode. The procedure was performed in an inconspicuous manner so neither the patient nor the members of the medical team could see whether real or sham ES was applied. In the active ES groups, voltage was set above 100 V (the same value was displayed on the monitor for patients receiving sham ES), which did not cause muscle contractions, only weak tactile sensations. Because most patients in the groups had tactile sensory impairments and did not feel the current, patients in the sham ES group did not know they were not receiving treatment. All treatment sessions had the same duration and frequency (50-minute sessions, once a day, 5 times a week) and followed the same protocol whether sham or active ES was applied.

The electrodes were sterilized before and after each session in an approved disinfectant solution (Incidin Liquid and Sani-Cloth Active, Ecolab). As soon as the procedure ended, patients’ wounds were thoroughly washed with a 0.9% sodium chloride solution and covered with SWC dressings as described earlier.

The trial design assumed wounds would be monitored for 8 weeks in all groups, representing the average length of stay in the facility. Patients hospitalized longer than 8 weeks were to be treated and monitored for wound healing as before. In patients with more than 1 PU, all wounds were treated, but only the deepest PU (the most advanced stage) was included in the study analysis.

Measures/data collection.

PSBF. PSBF was measured using a laser Doppler imager (PERIFLUX 5000, Perimed, Järfälla, Sweden) linked to a personal computer with the PeriSoft software for Windows (version 25.5; Galen Ortopedia Sp z o.o., PL, Bierun, Poland) that also was used for making computations and storing the results. A single point, infrared (IR), laser blood flow probe was used; it was calibrated before each measurement. To ensure the stability of readings, the laser was warmed for 15 minutes before measurement commenced. The probe was attached to the skin using a small piece of adhesive tape. Over the 4 weeks of treatment, 3 blood flow tests were conducted: before the first treatment session, at week 2 (after 10 ES procedures), and at week 4 (after 20 ES procedures). All measurements were conducted in the patient’s room, usually in an ambient temperature of 21˚ C to 22˚ C. Patients could assume a position that was comfortable for them (supine or sidelying). In preparation for the measurement of skin blood flow, the skin around the wound first was washed with aseptic fluid. Using the patient’s head as the 12 o’clock reference point, the laser probe was attached to wound edges at 4 points (superior, inferior, right, and left side of the wound). At each point, blood flow was measured for 20 seconds. The temperature under the probe was maintained at all times at a constant level of 33˚ C. The authors of other clinical trials used a similar protocol to measure skin blood flow.³⁸

Wound measurements. Wound (cm²) measurements were taken and area calculated at baseline and after each week of therapy. If a PU closed before week 8 ended, the day it closed was recorded. The WSA was determined by tracing the wound shape onto acetate sheets and from the sheets onto rigid, transparent film for measurement with a planimeter. Measurements were processed by a digitizer (Mutoh Kurta XGT; ALTEK Information Technology Inc, (Spokane, WA) connected to a personal computer with the C-GEO software (version 4.0; Nadowski SoftLine, PL, Tychy, Poland) that also was used for making computations and storing the results. Measurement errors caused by irregular wound shapes ranged from 2.7% (for PUs of 70 cm² in size) to 37.9% (PUs <1 cm²). The method used to estimate wound size has been presented in an earlier study.¹⁶

Primary outcome. The primary outcome of the trial was PSBF at weeks 2 and 4 of treatment and between-group differences in the flow. To compare the study groups, percentage changes in PSBF at weeks 2 (PSBF 2-0) and 4 (PSBF 4-0) were calculated using equations 1 and 2 described in Table 2.

Secondary outcomes. The secondary outcome was the rate of change in wound area. It was estimated as the nonlinear approximation of the time during which PU area would decrease from baseline by 50% (T½). First, the nonlinear approximation of the relative wound area in each week of treatment (WSArel[t]) was calculated to ensure the comparability of WSA change rates regardless of treatment length (see equation 3 in Table 2). For the sake of illustration, the relative wound area of 20 cm² at week 0 (baseline) was calculated as WSArel(0) = WSA (0)/WSA (t=0) = 20 cm²/20 cm² = 1. For a wound area of 15 cm² at week 1, the relative area is given by WSArel(1) = WSA (1)/WSA (t=0) = 15 cm²/20 cm² = 0.75 cm². In the next step, the nonlinear approximation was performed using the exponential model presented as equation 4 in Table 2. Percentage wound area reduction at week 2 and 8 also was calculated (see Table 2). Finally, the number of PUs closed during the 8-week study and duration of time to closure for ulcers that healed were analyzed, and correlations between PSBF and changes in wound area were examined.

Statistical analysis. All statistical analyses were performed by a person blinded to the ES devices using Statistica software (version 13.0, StatSoft Polska Sp. z o.o, Krakow, Poland). In all tests, the level of significance was P≤.05.

Group sizes for the trial were determined through a pilot of this study during which 3 groups of 4 patients with PUs were treated with AG, CG, and PG. At week 2, percentage changes in PSBF from baseline were calculated and compared between pairs of groups: AG and PG and CG and PG. The greatest standard deviation of PSBF2 calculated for the groups (92.38%) and the smallest between-group difference for PSBF2 (75.00%) indicated that statistically significant between-group differences (at P<.05) in PSBF2 could be obtained with groups of at least 12 participants. Taking advantage of the fact that the number of patients willing to participate in the study was greater than originally planned, enrollment continued and the final sample was enlarged to 61 patients to reduce the risk of error if some of them dropped out before the end of treatment.

Because PSBF values obtained at the end of treatment were considerably different from those calculated with the pilot study data, the relative values of PSBF were subjected to statistical analysis to minimize the risk of baseline interpatient differences biasing the results of the main study. Relative values also were used to estimate changes in WSA at week 8 (PAR8) and the amount of time necessary for WSA to decrease by half (WSArel[t]) (nonlinear approximation) and to calculate correlations between PSBF and percentage reductions in wound area between weeks 0 and 2 (PAR 0-2), 2 and 4 (PAR 2-4), and 4 and 8 (PAR 4-8).

To retain data of all randomly allocated participants, an intent-to-treat analysis was performed. Data that were not available were approximated using an exponential regression function written as WSA = b exp(-at), where WSA is wound surface area; b and a are respectively, the regression constant and the exponential regression coefficient calculated for each patient using WSA (cm²) obtained over the period of treatment; exp is the exponential regression function with a base of e ≈ 2.718282 (the Euler’s number); and t is the week of treatment. The function allows WSA decreases³⁹ to be described and can be calculated with data from at least 3 weeks. The exponential correlation coefficient proved negative for each patient and higher than 0.9 for the absolute WSA.

Patient characteristics were tested for normal distribution using the Shapiro-Wilk W-test, which showed their distribution was not normal. The Levene test revealed heterogeneity of variance. Despite the absence of normal distribution and because of low absolute values of skewness and kurtosis (<2.5), a mean was used as the central value and standard deviation as a measure of dispersion.

The homogeneity of patients’ characteristics between groups was assessed using the maximum-likelihood chi-squared test, the analysis of variance (ANOVA) Kruskal-Wallis test, and the Kruskal-Wallis post-hoc test.

To compare test and control groups’ mean PSBF2, PSBF4, and PAR8, the ANOVA Kruskal-Wallis test and the Kruskal-Wallis post-hoc test were employed. The nonlinear approximation was calculated using the exponential function (equation 4, see Table 2).

PSBF and PAR were tested for correlation with Spearman’s rank order correlation.

The following correlations were calculated between:

1) skin blood flow at baseline (PSBF0) and the percentage change in wound surface area noted at week 2 of treatment (PAR 2; equation 6 in Table 2);

2) skin blood flow at week 2 (PSBF2) and a change in wound surface area from week 2 to week 4 (PAR 2-4; equation 7 in Table 2); and

3) skin blood flow at week 4 (PSBF4) and change in wound surface area from week 4 to week 8 (PAR 4-8; Equation 8 in Table 2).

Results

Of the 73 persons screened for the trial, 12 failed to meet the inclusion criteria. The other 61 persons were randomly assigned to groups AG (20), CG (21) and PG (20). Between 4 and 8 weeks of treatment, 19 individuals (31.15%) dropped out from the trial. A statistical analysis was applied to all data obtained, including data from patients who dropped out between weeks 4 and 8. The flow of participants through the trial is illustrated in Figure 1.

Baseline patient and wound characteristics.

Sample characteristics. Of the 61 patients enrolled in the trial, 27 were women (44.26%) and 34 were men (55.74%), age range 22–78 years. The risk of PU development, assessed with the Norton and Waterlow scales, was <14 points and >15 points, respectively, for all patients; 10 patients (16.39%) were obese (BMI >30) and 16 (26.23%) were considerably underweight (BMI <18.5); 45 patients (73.77%) were immobile and needed assistance to change positions; 23 (37.70%) smoked cigarettes before they became ill; and 35 (57.38%) were malnourished and administered nutrition therapy. Twenty-seven (27) patients (44.26%) had spinal cord injury, 32 (52.46%) had experienced a cerebral stroke, and 3 (4.92%) had a head injury. Tetra- or quadriplegia was diagnosed in 21 (34.43%) patients, 19 (31.15%) had paraplegia, and 20 (32.79%) had hemiparesis. Nineteen (19) patients (31.15%) had type 2 diabetes and 26 (42.62%) had anemia. The 61 PUs treated as part of the protocol ranged in size from 1.01 cm² to 59.57 cm²; 9 were Stage 2 (14.75%), 38 were Stage 3 (62.29%), and 14 were Stage 4 (22.95%). Most PUs were located in the sacral region (45; 73.77%); 7 (11.45%) were located on the ischial tuberosity or the trochanter and 9 (14.75%) on the lower extremities (lower leg and foot). Forty (40; 65.57%) patients had more than 1 PU. The duration of the study PUs varied from 4 to 48 weeks. At baseline, most PUs (41; 67.21%) had started to granulate, 16 (26.23%) wounds were covered with slough, and in 4 wounds (6.56%) reepithelialization occurred. Between ES treatments, hydrogel dressings were applied in 38 (62.3%) patients, hydrocolloid dressings in 16 (26.2%) patients, and alginate in 7 (11.5%) patients. PSBF measured at baseline ranged from 9.33 to 86.08 perfusion units, and blood flow in healthy skin approximately 20 cm to 30 cm from the wound edges was 4.3 to 34.92 perfusion units.

According to the baseline demographic and wound characteristics of the patients (see Table 3), the groups were not significantly different for any of the characteristics considered (P>.05).

Anodal ES group characteristics. The AG included 20 patients (8 women, 12 men, average age 53.2 ± 13.82 years). Mean PU risk on the Norton and Waterlow Scales was 10 ± 2.63 and 31.3 ± 6.96, respectively. Two (2; 10%) patients were obese (BMI >30), 6 (30%) were underweight (BMI <18.5), 15 (75%) were immobile and needed assistance to change position, 8 (40%) smoked cigarettes, and 11 (55%) were malnourished and were administered nutrition therapy. Nine (9) patients (45%) had spinal cord injury, 10 (50%) had experienced a cerebral stroke, and 1 (5%) had a head injury. Six (6; 30%) patients had tetra- or quadriplegia, 7 (35%) had paraplegia, and 6 (30%) had hemiparesis. Five (5) patients (25%) had type 2 diabetes and 9 (45%) had anemia. The patients had a total of 20 PUs, mean size 17.88 ± 16.68 cm²: 2 PUs were Stage 2 (10%), 13 Stage 3 (65%), and 5 Stage 4 (25%). Most PUs were located in the sacral region (15; 75%), 2 (10%) were located on the ischial tuberosity or the trochanter, and 3 (15%) on the lower extremities (lower leg and foot). The mean duration of the PUs was 13.9 ± 11.21 weeks. Twelve (12; 60%) patients had more than 1 PU. At baseline, most PUs (13; 65%) started to granulate, 6 (30%) were covered with slough, and reepithelialization occurred in 1 wound (5%). Between ES treatments, hydrogel dressings were applied in 13 (65%) patients, hydrocolloid dressings in 4 (20%), and alginate in 3 (15%). The mean PSBF was 46.42 ± 20.42 perfusion units, and blood flow in healthy skin approximately 20 cm to 30 cm from the edges of the wound was 12.53 ± 7.13 perfusion units.

Cathodal ES group characteristics. The CG included 21 patients (11 women, 10 men, average age 55.67 ± 17.83 years). The mean PU risk per the Norton and Waterlow Scales was 9.72 ± 2.31 and 30.5 ± 6.83, respectively. Six (6) patients (28.57%) were obese (BMI >30) and 5 (23.81%) were underweight (BMI <18.5). Eighteen (18) patients (85.71%) were immobile and needed assistance to change position, 6 (28.57%) smoked cigarettes, and 11 (52.38%) were malnourished and were administered nutrition therapy. Eight (8) patients (38.10%) had spinal cord injury, 13 (61.90%) had experienced a cerebral stroke, and 1 (4.76%) had a head injury. Six (6) patients (28.57%) had tetra- or quadriplegia, 7 (33.33%) had paraplegia, and 8 (38.10%) were diagnosed with hemiparesis. Eight (8) patients (38.10%) had type 2 diabetes and 11 (52.38%) had anemia.

The average size of the 21 PUs was 19.25 ± 16.47 cm²; 4 were Stage 2 (19.05%), 12 were Stage 3 (57.14%), and 5 were Stage 4 (23.81%). At baseline, most PUs were located in the sacral region (16; 76.19%), 2 (9.52%) were on the ischial tuberosity or the trochanter and 3 (14.29%) on the lower extremities (lower leg and foot). The mean duration of the PUs was 11.62 ± 8.98 weeks; 14 patients (66.67%) had more than 1 PU. Most PUs (16; 76.19%) started to granulate, 4 (19.05%) wounds were covered with slough, and in 1 PU (4.76%) reepithelialization occurred. Between ES treatments, hydrogel dressings were applied in 11 (52.38%) patients, hydrocolloid dressings in 7 (33.33%) patients, and alginate in 3 (14.29%) patients. The mean PSBF was 37.37 ± 21.50 perfusion units, and blood flow in healthy skin approximately 20 cm to 30 cm from the edges of the wound was 12.07 ± 7.52 perfusion units.

Placebo ES group characteristics. The PG included 20 patients (8 women and 12 men, average age 52.50 ± 13.18 years). Mean PU risk as per the Norton and Waterlow Scales was 10.05 ± 1.96 and 31.8 ± 8.13, respectively. Two (2, 10%) patients were obese (BMI >30) and 5 (25%) were underweight (BMI <18.5); 13 (65%) were immobile and needed assistance to change position, 9 (45%) smoked cigarettes, and 14 (70%) were malnourished and were administered nutrition therapy. Ten (10) patients (50%) had spinal cord injury, 9 (45%) had experienced a cerebral stroke, and 1 (5%) had a head injury. Nine (9; 45%) patients had tetra- or quadriplegia, 5 (25%) had paraplegia, and 6 (30%) had hemiparesis. Six (6) patients (30%) had type 2 diabetes and 6 (30%) had anemia.

The mean size of the 20 PUs was 25.12 ± 17.42 cm²; 3 were Stage 2 (15%), 13 Stage 3 (65%), and 4 Stage 4 (20%). Most were located in the sacral region (14; 70%), 3 (15%) on the ischial tuberosity or the trochanter, and 3 (15%) were on the lower extremities (lower leg and foot). The mean duration of the PUs was 10.85 ± 8.59 weeks; 14 patients (70%) had more than 1 PU. At baseline, more than half of the PUs in the study (12; 60%) started to granulate, 6 (30%) were covered with slough, and in 2 PUs (10%) reepithelialization occurred. Between ES treatments, 14 patients (70%) received hydrogel dressings, 5 (25%) received hydrocolloid dressings, and 1 (5%) received alginate. Mean PSBF was 45.61 ± 15.73 perfusion units, and blood flow in healthy skin approximately 20 cm to 30 cm from the edges of the wound was 13.76 ± 4.54 perfusion units.

Primary outcome. The cumulative change in PSBF flow after 2 weeks of treatment (PSBF2) was 109.52% (95% confidence interval [CI]: 44.59-174.45) for the AG, 131.54% (95% CI: 60.28-202.80) for the CG, and 35.83% (95% CI: 14.63-57.02) for the PG (see Table 4). The CIs of the mean PSBF2 values overlapped between AG:PG and CG:PG, but the mean PSBF2 calculated for the PG was smaller than the smallest CIs for the AG and the CG, showing that the results obtained for AG and CG groups were statistically more significant than those obtained for the PG. These results were supported by the ANOVA Kruskal-Wallis and post-hoc Kruskal-Wallis tests. The ANOVA Kruskal-Wallis test showed changes in PBSF were significantly different among the 3 groups (AG, CG, PG; P = .0129). The post-hoc Kruskal-Wallis test showed statistically significant differences between the AG and PG groups (P = .0470) and CG and PG groups (P = .0152). The AG and CG were not found to be significantly different from each other (P = .9999) (see Table 4).

The cumulative change in PSBF after 4 weeks of treatment (PSBF4) was 89.30% (95% CI: 21.79-156.81) for the AG, 88.25% (95% CI: 18.19-158.30) for the CG, and 34.53% (95% CI: 13.90-55.16) for the PG. Differences among AG, CG, and PG were not statistically significant: the ANOVA Kruskal-Wallis test showed P = .74, and the post-hoc Kruskal-Wallis tests showed that in AG versus CG P = .9999; in AG versus PG P = .9999; and in CG versus PG P = .9999 (see Table 4).

Secondary outcomes. The nonlinear approximation of treatment results showed that to decrease WSA from baseline by half (T½) would require 4.30 weeks of treatment (95% CI: 0.20-0.26) in the AG, 3.86 (95% CI: 0.23-0.28) in the CG, and 9.86 (95% CI: 0.09-0.12) in the PG. The analysis of CIs for T½ showed that the periods were statistically significant different between the AG and the PG and between the CG and the PG (P<.05) but not between the AG and the CG (see Table 5 and Figure 2). OWM_0218_Polak_Table5

The cumulative percentage area reduction after 8 weeks of treatment (PAR8) was 64.10% (95% CI: 50.42-77.78) for the AG, 74.06% (95% CI: 63.48-84.63) for the CG, and 41.42% (95% CI: 28.37-54.47) for the PG. The PAR8 for CG was significantly higher statistically than that obtained for the PG, as indicated by nonoverlapping CIs of the mean PAR8 values and results of the post-hoc Kruskal-Wallis test (P = .0024). The CIs for the mean PAR8 values overlapped between AG:PG, but the mean PAR8 for PG was smaller than the smallest confidence intervals for AG, meaning that results obtained for the AG were also statistically more significant than those obtained for the PG. The finding was supported by the post-hoc Kruskal-Wallis test (P = .0391). No statistically significant differences were noted between the AG and the CG (P = .9999) (see Table 6).

Over 8 weeks of treatment, 4 of the 20 (20%) PUs in the AG, 7 of 21 (33%) in the CG, and 2 of 20 (10%) in the PG closed. Differences among the groups were not statistically significant: for AG versus PG, P = .3721; for CG versus PG, P = .0645; and for AG versus CG, P =.3331. Average duration of treatment to wound closure was 6.7 weeks (95% CI: 5.04-8.36) in the AG, 7.38 weeks (95% CI: 5.72-9.04) in the CG, and 6.05 weeks (95% CI: 4.92-7.18) in the PG. Differences among the groups (AG:CG:PG) were not statistically significant (P = .5111).

In the AG, PSBF at baseline (PSBF0) was negatively correlated with percentage wound area reduction after 2 weeks of treatment (PAR 0-2; P = .0361), meaning that greater baseline PSBF was associated with smaller reduction in wound area over the first 2 weeks of therapy. A positive correlation between PSBF at week 2 (PSBF2) and week 4 (PSBF4) and percentage wound area reduction between weeks 2 and 4 (PAR 2-4), as well as between weeks 4–8 (PAR 4-8), was indicative of a positive relationship between greater PSBF and a smaller reduction in wound area. In the AG, positive correlation between PSBF4 and PAR 4 to 8 was statistically significant (P = .049; see Table 7). In the CG, positive correlation (although not statistically significant [P = .161]) was established between PSBF at week 4 and PAR 4–8. For PG, no positive correlations between blood flow at weeks 2 and 4 and PAR 2–4 and PAR 4–8 were determined (see Table 7).

No adverse effects of applying HVMPC were observed in this study.

Discussion

Statement and principal findings. The trial has shown that in patients with neurological injuries an 8-week treatment program consisting of SWC plus anodal HVMPC and/or SWC plus cathodal HVMPC can increase PSBF and reduce PU surface area more significantly than SWC alone. PUs treated with SWC plus anodal and cathodal ES decreased in size by half, significantly faster than when only SWC was provided.

In this trial, increases in PSBF measured at weeks 2 and 4 of treatment were not significantly different between groups receiving anodal and cathodal ES, nor was percentage wound area reduction significantly different between groups after 8 weeks of treatment. This implies anodal and cathodal HVMPC have a similar effect on PSBF and PU area reduction. In both groups receiving HVMPC, the amount of blood flow in wound edges and WSA decrease were positively correlated with each other. In the group treated with anodal HVMPC, a positive correlation between the amount of blood flow after 2 weeks of treatment and WSA decrease between weeks 2 and 4 was observed. In both ES groups, the amount of blood flow at week 4 of treatment positively correlated with WSA decrease between weeks 4 and 8. In the anodal ES group, the correlation was statistically significant. In the control group, positive correlations between the amount of blood flow after weeks 2 and 4 of treatment and WSA decrease between weeks 2 and 4 and 4 and 8 were not noted. More research is necessary to determine the exact role of wound blood flow changes observed with HVMPC and between anodal and cathodal HVMPC in PU wound healing.

The primary research outcome in this study was percentage change in PSBF after 2 and 4 weeks of treatment. After 2 weeks of applying HVMPC, PSBF increased in the AG by 109.52% and in the CG by 131.54%. Both rates were significantly higher than in the PG (35.83%). Between weeks 2 and 4 of treatment, PSBF slightly decreased in all groups studied, but after 4 weeks it was still higher than at baseline by 89.3% in the AG, 88.25% in the CG, and 34.53% in the PG. No clinical studies were found that compared how anodal and cathodal HVMPC influences PSBF and area reduction of PUs (or other chronic wounds).

Several clinical studies^22-24 on wounds of mixed etiology (including PUs and diabetic foot ulcers) showed biphasic currents increase PSBF and reduce wound area, results similar to those obtained in the present study. In these studies,^22-24 researchers applied biphasic charge-balanced sine wave current (30 Hz; 250 µs; 20 mA) for 30 minutes once a day, 3 times a week, for 4 weeks. Current was delivered via electrodes attached to the opposite wound edges. In these 3 studies,^22-24 as well as in the present study, current amplitude was set at sensory level without eliciting muscle contractions.

In the randomized clinical study by Lawson and Petrofsky,²² ES was applied to 2 groups of 10 patients with Stage 3 and Stage 4 chronic wounds of mixed etiology. The groups included patients with type 2 diabetes (mean age 64.7 years; mean ulcer duration 10.6 months) and nondiabetic patients (mean age 55.3 years; mean ulcer duration 12.7 months). Both groups received ES. After 2 weeks of treatment, PSBF measured before an ES procedure in patients with diabetes was 35% greater than at baseline and significantly greater than in nondiabetic patients whose PSBF did not change over that period (P<.003). At week 4 of treatment, PSBF before ES in patients with diabetes was 21% greater than at baseline and in nondiabetic patients an increase of 18% was noted (P >.05). PSBF in patients with diabetes measured during ES was significantly greater than in nondiabetic patients after both 2 and 4 weeks of treatment. At week 2, the PSBF in patients with diabetes increased by 215%, as opposed to nondiabetic patients’ whose PSBF did not change significantly (P<.003). PBSF measured at week 4 in patients with diabetes was 87% higher compared with only 6% in nondiabetic patients (P<.003). Lawson and Petrofsky²² also noted that the 4-week healing rate for patients with diabetes was 70.0%, while the healing rate for the other patients was 38.4%, a statistically significant difference (P<.01).

Suh et al²³ conducted a pilot study without a control group where 18 persons (10 men, 8 women, mean age 35.7 years) with chronic ulcers of mixed etiology (mainly Stage 3 and Stage 4 PUs and diabetic ulcers; mean area 10.7 cm²) unhealed after 26.1 months’ duration received ES. Twenty (20) minutes before each ES procedure, the wound and periwound skin were warmed to 37˚ C using thermal energy from an IR heat lamp. This temperature was maintained until the ES procedure ended. After 4 weeks of treatment, a mean increase in PSBF recorded 20 minutes after the lamp was switched on was 9.3% (P>.05); the application of ES resulted in a significant increase in PSBF by an average of 15.6% (P<.05) after 30 minutes. During the 4 weeks of treatment, wound measurements decreased by 43.4% (P<.05). The authors also observed that PSBF increased from the beginning and well past the middle of the study (2 weeks) (P<.05) but decreased toward the end of treatment (statistically, the changes were not significant;P>.05).

In a longitudinal, randomized, clinical study by Petrofsky et al,²⁴ 20 patients (mean age 48.4 years) with nonhealing diabetic foot ulcers (mean duration 38.9 months) were randomly divided into 2 groups. Groups were treated with local dry heat (heat group; n = 10; mean WSA was 28.2 cm²) or local dry heat + ES (heat + ES group; n = 10; mean WSA was 24.1 cm²). In both groups, local heating was provided by an IR lamp positioned 5 cm above the wound to warm the wound area to 37˚ C. Before treatment, the average blood flow was greatest in the center of the wounds. The average blood flow for all participants in both groups was 112.3 flux in the outside of the wound, 224.3 flux on the edge of the wound, and 385.7 flux in the center of the wound. On the first day of the study, the average blood flow from all 3 areas increased from baseline by 102.3% in the heat group and by 152.3% in the heat + ES group. By the last day of the study, the average blood flow in all 3 areas had decreased by 54.5% in both groups. Blood flow differences between the groups were not significant, but percentage wound area reduction in the heat + ES group at week 4 was significantly greater than in the heat group (68.4% and 30.1%, respectively; P<.05).

The authors of the cited studies^22-24 reported blood flow was greater after weeks 2 and 4 of treatment than at baseline. As in the current study, blood flow was at its highest at week 2 and then decreased. The authors also stated that after 4 weeks of treatment with biphasic current surface area of mixed etiology, wound size decreased from 38.4% to 70%. In the current study, 8 weeks of treatment with anodal and cathodal HVMPC reduced wound area by 64.10% and 74.06%, respectively.

In the cited studies,^22-24 blood flow was measured using laser Doppler imaging and computerized image analysis. A study on healthy people by Wikstrom et al⁴⁰ found both laser Doppler flowmetry and intravital video microscopy to be useful in studying the microcirculation in the healthy skin and in the skin around experimental blister wounds. In the present study, Doppler flowmetry was used; skin temperature under the probe head was 33˚ C. In the cited studies,^22-24skin temperature during ES procedures and PSBF measurements was 37˚ C. In the study by Petrofsky et al³⁸ among healthy men, biphasic square wave ES (30 Hz; 250 µs; 15 minutes; 15 mA) increased skin blood flow when skin temperature was maintained at 30˚ C and 40˚ C, but at 20˚ C no significant change in skin blood flow was observed.

The secondary research outcome in the current study was the healing rate and percentage decrease in PU surface area, which also was used by the authors of other clinical studies evaluating the efficacy of wound treatment.^10-18 The percentage reduction in wound area noted at week 8 was significantly greater in the AG and CG than in the PG (64.10% in the AG, 74.06% in the CG, and 41.42% in the PG). The authors found the approximate length of treatment necessary to decrease area in Stage 2 to Stage 4 PUs by 50% was 4.30 weeks in the AG and 3.86 weeks in the CG — in both scenarios, times significantly shorter statistically than in the PG (9.86 weeks).

Thus far, no clinical studies have compared the influence of anodal and cathodal HVMPC or other electrical currents on the healing of PUs or other types of wounds. However, the results of the existing clinical research show both anodal and cathodal HVMPC promote the healing of PUs, which supports present results.^10,11,17,18

In the study by Kloth and Feedar,¹⁰ anodal stimulation with HVMPC + SWC (9 patients) decreased the surface area of Stage 4 PUs by an average of 44.8% a week. Wounds closed completely over a period of 7.3 weeks. In the control group (7 patients) that received sham ES + SWC, wound area increased by 28.8% over a mean period of 7.4 weeks.

In Griffin et al,¹¹ HVMPC + SWC decreased the area of 8 Stage 2 to Stage 4 PUs by 80% after 3 weeks of cathodal ES, a result that was significantly greater than in the control group (sham ES + SWC; 9 patients), where PUs decreased by an average of 52% (P<.05).

In the study by Polak et al,¹⁷ 6 weeks of cathodal HVMPC + SWC (25 patients) decreased the area of Stage 2 to Stage 3 PUs by 88.31%, also significantly better than in the control group (sham HVMPC + SWC; 24 patients) where wound area decreased by an average of 54.65% (P = .046). The Polak et al¹⁷ study also showed that in the group treated with cathodal HVMPC + SWC, 45% of Stage 2 PUs and 17.65% of Stage 3 PUs closed after 6 weeks of treatment compared with 35.29% of Stage 2 PUs and 6.25% of Stage 3 PUs in the control group (sham HVMPC + SWC). The results were not significantly different between the groups (P = .74 and P = .60, respectively).

In an additional study by Polak et al,¹⁸ the surface area of 23 Stage 2 to Stage 4 PUs decreased after 6 weeks of cathodal HVMPC + SWC by an average of 82.34%. This result was significantly greater than in the control group (sham HVMPC + SWC), where average decrease in WSA was 40.53% (P = .0006). Cathodal HVMPC was therapeutically as effective as 1 week of anodal stimulation followed by 5 weeks of cathodal stimulation that reduced WSA by 70.77% (P = .9932). WSA decrease induced by anodal plus cathodal stimulation also was significantly greater than in the control group (P = .0124). In the group treated with cathodal HVMPC + SWC, 47.8% of Stage 2 to Stage 4 PUs closed over 6 weeks, compared with 45% of Stage 2 to Stage 4 PUs (P = .48) in the group receiving anodal plus cathodal HVMPC + SWC. In both ES groups, the percentage of PUs that closed was significantly greater than in the control group, where not a single PU closed (P = .013 and P = .045, respectively).

Implications for clinicians and policymakers. In designing the protocol for the application of HVMPC, the authors referred to solutions used by other authors.^10-18 After sterilizing, the treatment electrode was placed on the wound and the return electrode on intact periwound skin at least 15 cm from the wound edge. Both electrodes were separated from the tissue by sterile gauze pads, which were moistened with physiological saline to improve electrical conductivity and maintain a moist wound environment.

Previous and present research showed HVMPC with twin-peaked pulses (50-154 µs, 100 pps) used to treat PUs,^10,11,15-18 venous leg ulcers,^12,14 and diabetic foot ulcers¹³ is therapeutically efficient. In the study, 0.36 A and an electric charge of 360 µC/sec (1.08 C/day) in the voltage range from 100 to 150 V was applied; in other studies, the electrical charge ranged from 250 – 500 µC/sec (0.89 – 1.78 C/day).^{10,11,17-20,41} Following the protocols used by other researchers,^10-18 the amperage used in the present study could be detected only by cutaneous receptors.

Most authors^{10-12,14,16-18} applied HVMPC to wounds for 45 minutes to 60 minutes, once a day, 3 to 7 days a week, so treatment time ranged from 2.25 to 7 hours per week. The sessions in this study were similar in duration (50 minutes, 5 days/week; total treatment time of 4.16 hours of a week).

The results of preclinical ES reports^7,42-44 note the polarity of the treatment electrode is important in managing chronic wounds, but this clinical trial appears to be the first to compare PUs treated with anodal versus cathodal HVMPC. More clinical research is necessary to determine how the polarity of the treatment electrode influences wound healing. More research is also necessary to determine whether anodal or cathodal HVMPC accelerates wound healing by stimulating blood flow in the wound area. Future clinical trials also should investigate the influence of electrical currents on the concentrations of pro- and anti-inflammatory factors such as cytokines and growth factors in wounds.

Limitations

This study has several strengths. First, the research team (physicians, nurses, physiotherapists), the person in charge of measuring WSA, and the statistician were blinded as to treatment provided. Second, the participants were hospitalized at the same rehabilitation center, making it possible for the medical staff to supervise the uniform application of PU prevention measures and treatments and to ensure the ES protocol was observed at all times. Third, wound sizes were measured based on valid and reliable acetate tracings. Fourth, all patients completed at least 4 weeks of treatment, so PSBF4 and PAR4 could be calculated and compared for all of them. Finally, the intent-to-treat analysis employed the exponential regression function, which allows WSA decreases to be precisely represented, to approximate the likely treatment results between weeks 4 and 8.

However, the study was not without limitations. A major limitation of the study is that the period of treatment was insufficient for all PUs to close. Consequently, length of treatment (ie, optimal treatment time of anodal or cathodal HVMPC to facilitate complete closure of Stage 2 to Stage 4 PUs) could not be determined. The blinding rate of patients and assessors was not assessed. Another limitation is the relatively high dropout rate between weeks 4 and 8 (31.15%); some patients were discharged from the hospital to be treated at home and a number of others were moved to other wards for treatment for concomitant diseases. This thwarted the monitoring of the healing of their PUs. The PU prevention and treatment program for all 3 groups generally followed the same best practice recommendations,^1,2,37 but its specific solutions addressed the needs of individual patients. Finally, the sample size in each group was too small to control for the potential effect of baseline variables such as ulcer depth/stage and start of treatment wound characteristics on study outcomes.

Conclusion

This study demonstrated that anodal and cathodal HVMPC with double-peaked impulses (154 µs; 100 pps; above 100 V; 360 µC/sec; 1.08 C/day) administered 50 minutes a day, 5 times a week, can be used in clinical practice to improve PSBF and promote healing of Stage 2 to Stage 4 PUs in patients with neurological injuries. These results are consistent with those obtained by other researchers who also reported HVMPC can improve the healing of chronic wounds, including PUs. However, this is the first study to document that type of ES (anodal or cathodal) did not affect wound blood flow and wound size reduction in patients with PUs.

Future clinical trials are necessary to elucidate the nature of the relationship between the stimulation of wound blood flow following anodal and cathodal HVMPC and change in wound area. n

Acknowledgments

The authors are grateful to the physicians, physical therapists, and nurses who assisted in carrying out this study, particularly to Jaroslaw Szczygiel, MD, PhD; Prof Jakub Taradaj, PT, PhD; Ms. Krystyna Loda-Kurek; Ms. Zdzislawa Podles; Kamila Kasprzyk, PT; Aleksandra Chlebek, PT; and Jolanta Filipek, MsC. The authors also thank Mr. E. Janikowski for his assistance in the statistical analysis of the data.

References

1. National Pressure Ulcer Advisory Panel, European Pressure Advisory Panel, Pan Pacific Pressure Injury Alliance. In: Haesler E, ed. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Perth, Australia; Cambridge Media;2014.

2. Keast DH, Parslow N, Houghton PE, Norton L, Fraser C. Best practice recommendations for prevention and treatment of pressure ulcers: update 2006. Wound Care Canada. 2006;4(1):31–43.

3. Petrofsky J, Hinds CM, Batt J, Prowse M, Suh HJ. The interrelationships between electrical stimulation, the environment surrounding the vascular endothelial cells of the skin, and the role of nitric oxide in mediating the blood flow response to electrical stimulation. Med Sci Monit. 2007;13(9):CR391–C397.

4. Mohajeri-Tehrani MR, Nasiripoor F, Torkaman G, Hedayati M, Annabestani Z, Asadi MR. Effect of low-intensity direct current on expression of vascular endothelial growth factor and nitric oxide in diabetic foot ulcers. J Rehabil Res Dev. 2014;51(5):815–824.

5. Asadi MR, Torkaman G, Hedayati M, Mohajeri-Tehrani MR, Ahmadi M, Gohardani RF. Angiogenic effects of low-intensity cathodal direct current on ischemic diabetic foot ulcers: a randomized controlled trial. Diabetes Res Clin Pract. 2017;127:147–155.

6. Zhao M, Bai H, Wang E, Forrester JV, McCaig CD. Electrical stimulation directly induces pre-angiogenic responses in vascular endothelial cells by signalling through VEGF receptors. J Cell Sci. 2004;117(Pt 3):397–405.

7. Bai H, McCaig CD, Forrester JV, Zhao M. DC electrical fields induce distinct preangiogenic responses in microvascular and macrovascular cells. Arterioscler Thromb Vasc Biol. 2004;24(7):1234–1239.

8. Hampton S, Collis F. Treating a pressure ulcer with bio-electric stimulation therapy. Br J Nurs. 2006;15(6):14–18.

9. Ullah M. A study to detect the efficacy of microcurrent electrical therapy on decubitus wound. J Med Sci. 2007;7(8):1320–1324.

10. Kloth LC, Feedar JA. Acceleration of wound healing with high voltage monophasic, pulsed current. Phys Ther. 1988;68(4):503–508.

11. Griffin JW, Tooms RE, Mendius RA, Clifft JK, Vander-Zwaag R, el-Zeky F. Efficacy of high voltage pulsed current for healing of pressure ulcers in patients with spinal cord injury. Phys Ther. 1991;71(6):433–442.

12. Franek A, Polak A, Kucharzewski M. Modern application of high voltage for enhanced healing of venous crural ulceration. Med Eng Phys. 2000;22(9):647–655.

13. Peters EJ, Lavery LA, Armstrong DG, Fleischli JG. Electric stimulation as an adjunct to heal diabetic foot ulcers: a randomized clinical trial. Arch Phys Med Rehabil. 2001;82(6):721–725.

14. Houghton PE, Kincaid CB, Lovell M, et al. Effect of electrical stimulation on chronic leg ulcer size and appearance. Phys Ther. 2003;83(1):17–28.

15. Houghton PE, Campbell KE, Fraser CH, et al. Electrical stimulation therapy increases rate of healing of pressure ulcers in community-dwelling people with spinal cord injury. Arch Phys Med Rehabil. 2010;91(5):669–678.

16. Franek A, Kostur R, Polak A, et al. Using high voltage electrical stimulation in the treatment of recalcitrant pressure ulcers: results of a randomized, controlled trial. Ostomy Wound Manage. 2012;58(3):30–44.

17. Polak A, Kloth LC, Blaszczak E, et al. Evaluation of the healing progress of pressure ulcers treated with cathodal high voltage monophasic pulsed current: results of a prospective, double-blind, randomized clinical trial. Adv Skin Wound Care. 2016;29(10):447–459.

18. Polak A, Kloth LC, Blaszczak E, et al. The efficacy of pressure ulcer treatment with cathodal and cathodal-anodal high-voltage monophasic pulsed current: a prospective, randomized, controlled clinical trial. Phys Ther. 2017;97(8):777–789.

19. Feedar JA, Kloth LC, Gentzkow GD. Chronic dermal ulcer healing enhanced with monophasic pulsed electrical stimulation. Phys Ther. 1991;71(9):639–649.

20. Gentzkow GD, Alon G, Taler GA, Eltorai IM, Montroy RE. Healing of refractory stage III and IV pressure ulcers by a new electrical stimulation device. Wounds. 1993;5(3):160–172.

21. Jünger M, Zuder D, Steins A, Hahn M, Klyscz T. Treatment of venous ulcers with low frequency pulsed current (Dermapulse): effects on cutaneous microcirculation [in German]. Hautarzt. 1997;48(12):879–903.

22. Lawson D, Petrofsky JS. A randomized control study on the effect of biphasic electrical stimulation in a warm room on skin blood flow and healing rates in chronic wounds of patients with and without diabetes. Med Sci Monit. 2007;13(6):CR258–CR263.

23. Suh H, Petrofsky JS, Lo T, et al. The combined effect of a three-channel electrode delivery system with local heat on the healing of chronic wounds. Diabetes Technol Ther. 2009;11(10):681–688.

24. Petrofsky J, Lawson D, Berk L, Suh H. Enhanced healing of diabetic foot ulcers using local heat and electrical stimulation for 30 min three times per week. J Diabetes. 2010;2(1):41–46.

25. Polak A, Franek A, Taradaj J. High-voltage pulsed current electrical stimulation in wound treatment. Adv Wound Care. 2014;3(2):104–117.

26. Houghton PE. Electrical stimulation therapy to promote healing of chronic wounds: a review of reviews. Chronic Wound Care Manage Res. 2017;4:25–44.

27. Gottrup F, Apelqvist J, Price P; European Wound Management Association Patient Outcome Group. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care. 2010;19(6):239–268.

28. Koel G, Houghton PE. Electrostimulation: current status, strength of evidence guidelines, and meta-analysis. Adv Wound Care. 2014;3(2):118–126.

29. Cardinal M, Eisenbud DE, Phillips T, Harding K. Early healing rates and wound area measurements are reliable predictors of later complete wound closure. Wound Repair Regen. 2008;16(1):19–22.

30. Norton D, McLaren R, Exton-Smith AN. An Investigation of Geriatric Nursing Problems in Hospital. Edinburgh, UK: Churchill Livingstone;1975.

31. Waterlow J. Pressure sores: a risk assessment card. Nurs Times. 1985;81(48):49–55.

32. Sobotka L, ed. Basics in Clinical Nutrition. 4th ed. Prague, Czech Republic: House Galen;2012.

33. Cederholm T, Barazzoni R, Austin P, et al. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017;36(1):49–64.

34. Cederholm T, Bosaeus I, Barazzoni R, et al. Diagnostic criteria for malnutrition — an ESPEN consensus statement. Clin Nutr. 2015;34(3):335–340.

35. White JV, Guenter P, Jensen G, Malone A, Schofield M; the Academy Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus Statement: Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition: Characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). J Parenter Enteral Nutr. 2012;36(3):275–283.

36. Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003;22(3):321–326.

37. Szewczyk M, Sopata M, Jawien A, et al. Zalecenia profilaktyki i leczenia odlezyn. Leczenie Ran. 2010;7(3-4):79–106.

38. Petrofsky JS, Al-Malty AM, Prowse M. Relationship between multiple stimuli and skin blood flow. Med Sci Monit. 2008;14(8):CR399–CR405.

39. Engels JM, Diehr P. Imputation of missing longitudinal data: a comparison of methods. J Clin Epidemiol. 2003;56(10):968–976.

40. Wikstrom S, Svedman P, Svensson H, Wikstrom S, Svedman P, Svensson H. Effect of transcutaneous nerve stimulation on microcirculation in intact skin and blister wounds in healthy volunteers. Scand J Plastic Surg Hand Surg. 1999;33(2):195–201.

41. Kloth LC. Electrical stimulation technologies for wound healing. Adv Wound Care. 2014;3(2):81–90.

42. Brown M, McDonnel MK, Menton DN. Polarity effects on wound healing using electric stimulation in rabbits. Arch Phys Med Rehabil. 1989;70:624–627.

43. Talebi G, Torkaman G, Firoozabadi M, Shariat S. Effect of anodal and cathodal micro-amperage direct current electrical stimulation on injury potential and wound size in guinea pigs. JRRD. 2008;45(1):153–160.

44. Kim TH, Cho H, Lee SM. High-voltage pulsed current stimulation enhances wound healing in diabetic rats by restoring the expression of collagen, α-smooth muscle actin, and TGF-β1. Tahoku J Exp Med. 2014;234(1):1–6.

Potential Conflicts of Interest: The study was funded by the Academy of Physical Education, Katowice, Poland.

Dr. Polak is a lecturer, Department of Physical Therapy, Academy of Physical Education, Katowice, Poland; and a physical therapist, Medical and Rehabilita- tion Center “Medi-Spatz,” Gliwice, Poland. Prof Kucio is a Professor of Medicine, Department of Physical Therapy, Academy of Physical Education, Kato- wice; and an internal medicine specialist and head, Department of Internal Medicine, Multi-specialized Hospital, Jaworzno, Poland. Prof Kloth is a Professor Emeritus of Physical Therapy, Department of Physical Therapy, Marquette University, Milwaukee, WI. Dr. Paczula is a lecturer, Department of Physical Therapy, Academy of Physical Education, Katowice; and a surgical and medical rehabilitation specialist, Rehabilitation Center “Repty,” Tarnowskie Gory, Poland. Dr. Hordynska is a neurologist, a medical rehabilitation specialist, and head, Department of Neurological Rehabilitation, Rehabilitation Center “Repty,” Tarnowskie Gory. Mr. Ickowicz is a lecturer, Department of Physical Therapy, Academy of Physical Education, Katowice; and a physical therapy specialist, Rehabilitation Center “Repty,” Tarnowskie Gory. Prof Blaszczak is an Associate Professor of Medical Sciences, statistical analyst, and biophysicist, Department of Medical Biophysics, Medical University of Silesia, Katowice. Dr. Kucio is a clinical pharmacologist and assistant, Department of Physical Therapy, Academy of Physical Education, Katowice. Dr. Oleszczyk is an internal medicine and medical rehabilitation specialist and head, Rehabilitation Center “Repty,” Tarnowskie Gory. Prof Ficek is an Associate Professor of Medicine, Department of Physical Therapy, Academy of Physical Education, Katowice; and an orthopedic specialist and head, Medical and Rehabilitation Center “Galen-Ortopedia,” Bierun, Poland. Prof Franek is a Professor of Medical Sciences and head, Department of Medical Biophysics, Medical University of Silesia, Katowice. Please address correspondence to: Anna Polak, PT, PhD, Department of Physical Therapy, Academy of Physical Education, Mikolowska 72A, 40-065 Katowice, Poland; email: a.polak@awf.katowice.pl.

Section:

↧

Factors Affecting Wound Healing in Individuals With Pressure Ulcers: A Retrospective Study

February 1, 2018, 12:47 pm

≫ Next: A Retrospective Analysis to Evaluate Seasonal Pressure Injury Incidence Differences Among Hip Fracture Patients in a Tertiary Hospital in East China

≪ Previous: A Randomized, Controlled Clinical Study to Assess the Effect of Anodal and Cathodal Electrical Stimulation on Periwound Skin Blood Flow and Pressure Ulcer Size Reduction in Persons with Neurological Injuries

Issue Number:

Index:

Ostomy Wound Management 2018;64(2):32–39 doi: 10.25270/owm.2018.2.3239

Azize Karahan, PhD, RN; Aysel Abbasoğlu, MSc, RN; Sevcan Avcı Işık, PhD, RN; Banu Çevik, PhD, RN; Çiğdem Saltan, RN; Nalan Özhan Elbaş, PhD, RN, Professor; and Ayşe Yalılı, MSc, RN

Topics:

retrospective study

Pressure Ulcer

wound healing

demographic factors

comorbidity

Abstract

Owing to the number and severity of concomitant factors, pressure ulcers remain a significant problem. A retrospective study of data from adult patients with a pressure ulcer was conducted to identify factors that may affect their healing. Data from patients who were hospitalized between January 1, 2011, and December 31, 2015, in a private Turkish university hospital who had a Stage 2, Stage 3, Stage 4, or unstageable pressure ulcer that was assessed using the Bates-Jensen Wound Assessment Tool (BWAT) were abstracted.

The following variables were examined: demographic characteristics (gender, age, hospital unit, duration of hospitalization), health status and disease data (vital signs, mobility, nutrition, diagnosis, chronic diseases, medication), laboratory values (albumin, hemoglobin, blood glucose), and pressure ulcer characteristics (stage, location, healing status, duration) and pressure ulcer risk status as determined by patient Braden Scale score. Seventy-eight (78) patient records were identified. Patient mean age was 70.8 ± 13.47 years, and length of hospitalization was on average 32.52 ± 27.2 days. Most ulcers (62; 79.5%) were Stage 2 and located in the sacral area (59; 75.6%). Thirty-four (34) patients (43.6%) were discharged and 44 (56.4%) died. At the time of discharge or death, 65.4% of the ulcers had not healed. Patients whose wounds were healed were significantly more likely to have higher hemoglobin and mean arterial pressure, better mobility, received oral nutrition, and discharged from the hospital than patients whose ulcers did not heal. The results suggest that these variables, including Braden Scale and BWAT scores, might be considered when developing a treatment plan of care. Additional studies examining risk factors for nonhealing pressure ulcers, including studies with large samples to facilitate multivariate analyses, are needed.

According to reviews of the literature^1,2 and a systematic review,³ pressure ulcers are associated with adverse physical, social, psychosocial, and economic effects. Pressure ulcers increase the duration of hospitalization; cause loss of labor, activity, and income; and have a negative impact on body image and self-esteem.^1-3 In April 2016, the National Pressure Ulcer Advisory Panel⁴ (NPUAP) suggested the term pressure injury should replace pressure ulcer.

Clinical, prospective, and/or prevalence studies^5-12 have found pressure ulcer frequency varies between 1.6% and 26.8% in acute and long-term care environments. In a study¹³ of patients hospitalized in 209 general medicine clinics in Turkey, the prevalence of pressure ulcers was 5.8% for patients ages 65 years and older; another Turkish study⁸ among 404 patients found a prevalence rate of 10.4%. The NPUAP¹⁴ suggests further prevalence and incidence studies of pressure injuries should be performed.

Many risk factors for pressure ulcers have been identified in descriptive and prevalence studies.^14-18 Intrinsic factors include age, weight, ethnicity, comorbidities, tissue perfusion (such as hemoglobin, blood pressure, and chemical sedation), hypothermia, albumin level, and blood sugar and patient conditions such as sensory disorders, coma, and incontinence. Extrinsic factors include the source of the pressure, pressure duration, moisture, activities of daily life, repositioning type and frequency, friction, and shearing. The Braden Scale was developed by Bergstrom and Braden¹⁹ in 1988 to determine the risk for pressure ulcers; this instrument utilizes many of these risk factors. A validity study for this tool was performed in Turkey in 1997 by Oğuz and Olgun,²⁰ which was repeated in 1998 by Pınar and Oğuz.²¹ The Braden Scale has 6 subscales: sensory perception, mobility, activity, moisture, nutrition, and friction. The first 5 of these subscales are scored on a 1–4 scale; the friction subscale is scored on a 1–3 scale. The total score is expressed on a scale of 6 to 23.¹⁹ Lower scores indicate increased risk of pressure ulcers.^20,21

Pressure ulcers or injury can be an important indicator of the quality of care.²² According to the NPUAP consensus study,²³ many risk factors for pressure ulcers can be prevented or minimized, but complex, nonmodifiable intrinsic and extrinsic factors risk factors such as terminal illness, septic shock, body edema, immobility, and nutrition problems may render some pressure ulcers unavoidable. Therefore, pressure ulcers continue to be a significant problem despite the development of preventive programs.

It is important to evaluate the wound and its healing process to develop a proper and effective approach to wound healing.²⁴ The Bates-Jensen Wound Assessment Tool (BWAT) is among the most valid tools used for the evaluation of pressure ulcers; its use is recommended by the NPUAP.^14-18,22-26 This tool enables the comprehensive evaluation of pressure injuries and facilitates monitoring of the wound healing process.²⁷ Developed by Bates-Jensen,²⁸ this evaluation tool quantitatively defines the physiologically significant properties of the wound and comprehensively evaluates its anatomic properties. The BWAT includes 13 variables that numerically evaluate the status of the ulcer utilizing scores from 1 to 60; an additional section defines the shape and placement of the wound. Higher scores indicate a worse wound state: 1 indicates healthy tissue, 5 indicates wound regeneration, and 60 indicates wound degeneration.²⁹ The reliability coefficient of the scale was found to be 0.91 and the Spearman’s correlation coefficient 0.99.^28,30 A validity-reliability study on the BWAT was performed in Turkey in 2011 by Karahan et al.²⁷

The fact that risk factors such as hemodynamic instability, head-of-bed elevation, septic shock, burns, and terminal illness cannot be ameliorated in some patients with a pressure ulcer indicates the need for additional research regarding assessment. Still, the BWAT enables comprehensive, continuous, objective evaluation of the wound, so it is thought that information obtained from patients evaluated with this tool will contribute to the knowledge of the wound healing process and help determine the factors that affect it. The BWAT also can be used as a guide for planning patient care and have a positive impact on the outcomes of care.^{14,18,22,24,26,27}

The objective of this study was to identify factors that may affect wound healing in individuals with pressure ulcers at a private university hospital.

Methods

Study design and setting. A retrospective study design was used involving data from all adult patients with pressure ulcers admitted to a private university hospital in Turkey whose ulcers were evaluated using the BWAT. The 346-bed hospital includes 79 intensive care unit and 267 inpatient clinic beds. A total of 300 nurses work at the hospital. Patients who need major surgery and other complicated procedures/treatments are admitted to this hospital. Nurses take direct responsibility for the prevention, evaluation, and management of Stage 1 and Stage 2 pressure injuries. Stage 3, Stage 4, or unstageable pressure injuries are treated by nurses and physicians. In this study, patients with Stage 1 pressure ulcers were excluded.

Pressure ulcer prevention program and participants. A pressure ulcer prevention and care program was developed in 2011 at the study hospital. This program included theoretical and clinical training regarding the definition, process, staging, assessment, prevention, and treatment of pressure ulcers and the use of the BWAT and new nursing intervention forms for prevention and management of pressure ulcers. Before the program was introduced, wound assessment and care were not performed in a systematic and objective manner. This program was designed using recent literature- and evidence-based practices. The forms were developed to guide nursing care for the prevention and management of pressure ulcers, and the BWAT was implemented to evaluate ulcers that developed. In-service training was provided to nurses regarding the prevention of pressure ulcers and wound management within the program.

In the clinical area, wound care nurses demonstrated the program content for nursing staff. Wound care nurses evaluated staff nurses during wound assessment and provision of care and provided help when staff nurses could not determine stage of the pressure ulcer or appropriate wound management.

Nurses were instructed on the BWAT for assessment. Wound care nurses explained program protocols during orientation training. Interventions for individual precautions and care were planned and applied for each patient by nursing staff. The program was controlled by the manager/supervisor and wound care nurses. Quality-assured pressure ulcer statistics were obtained, and feedback was provided to nursing staff about these data.

Data collection. A data collection form was developed based on the relevant literature.^{1,10,14,15,22,29} It comprised 15 questions that included demographic characteristics (gender, age, unit, duration of hospitalization), health status and disease data (vital signs, mobility, nutrition, diagnosis, chronic diseases, medication, healing process), laboratory values that might affect pressure ulcer healing (albumin, hemoglobin, blood glucose), pressure ulcer-related characteristics (stage, location, healing status, duration), and patient risk status.

The Braden Scale score, BWAT, and nursing notes also were used to collect data about the pressure ulcer, mobilization, and nutrition. Nurses assessed pressure ulcer risk daily using the Braden Scale. Nursing interventions for wound assessment and management were recorded directly on nursing observation forms for Stage 1 pressure ulcers; the BWAT was used daily for Stage 2, Stage 3, Stage 4, and unstageable pressure ulcers. Data related to patient prognosis was obtained from patient files. All Braden and BWAT scores in the patient files were recorded in the data collection forms for each patient, and mean scores were calculated for both the Braden Scale scores and BWAT. Limited mobility in bed or no mobility was taken into consideration when assessing mobilization problems; mobilization assessment is part of the nursing form and includes 3 options (mobile without assistance, mobile with assistance, and limited mobile in bed/no mobile). Meal consumption and Braden items regarding nutrition were recorded on nursing forms and assessed. If a patient could not sustain oral nutrition, a dietitian was consulted according to the physician’s orders. Nutrition assessment tools were not routinely used for all patients; therefore, the nutrition status data was obtained from nursing and physician notes.

Study procedure. Braden and BWAT scores and questionnaire data were acquired from patient records included in the sample group. Data on Stage 2, Stage 3, Stage 4, and unstageable pressure injuries were obtained via the BWAT, and data on Stage 1 pressure ulcers and wound healing were obtained from nursing observation and quality forms. In patients with more than 1 pressure ulcer, the ulcer with the highest stage (worst ulcer) was analyzed.

Data collection and analysis. Data from all adult patients with a pressure ulcer treated between January 1, 2011, and 31 December 31, 2015 were retrieved for analysis; however, the program is ongoing. After the data were transferred to SPSS version 17.0 (SPSS for Windows, Chicago, IL), independent variables (age, gender, unit, mobility, nutrition, laboratory values, vital signs, healing status, Braden and BWAT scores, and BWAT items) were compared according to wound healing status (healed or not healed pressure ulcer). The total BWAT and Braden scores obtained from the patient files were analyzed for each patient in addition to the first, highest (the worst situation of the wound), and last assessment of the BWAT item scores for each patient. Descriptive statistics (percent, mean, standard deviation [SD]) and chi-squared, Student’s t test, Mann Whitney U test, and Pearson’s correlation coefficient were used for comparison with independent variables and pressure ulcer healing status. A P value <.05 indicated statistical significance.

Results

One hundred, three (103) patients had a Stage 2, Stage 3, Stage 4, or unstageable pressure ulcer. BWAT data could not be located in the records of 25, leaving a study sample of 78 patients. Of these, 41 (52.6%) were female; mean age of all participating patients was 70.8 ± 13.47 (range 22–91); and 47 (60.3%) were admitted to intensive care units and 39 (50%) were admitted to surgical intensive care units and wards. Admitting diagnoses included malignancy (19); cardiovascular (18), respiratory system (11), gastrointestinal (10), nervous (9), and urinary system (7) disease; or other health problems (4). Patients had a mean 2.17 ± 1.32 (range 0–6) chronic diseases, used 4.58 ± 2.83 (range 0–15) prescription drugs, and 41 (52.6%) used drugs that could affect wound healing (ie, immunosuppressants [4], anticoagulants [31], steroids [9], or chemotherapeutic agents [2]). Nutrition was provided orally (32, 41%), enterally (24, 30.8%), and parenterally (22, 28.2%). Forty (40) patients (51.3%) had mobility problems. Sixty-two (62) patients (79.5%) had Stage 2 pressure ulcers, 10 (12.8%) had Stage 3, 3 (3.8%) had Stage 4, and 3 (3.8%) had an unstageable ulcer. The majority of the pressure ulcers (59; 75.6%) were located in the sacral region; 9 patients (11.5%) had a pressure ulcer in more than 1 area. Ten (10) patients (12.8%) developed an infection in their pressure ulcer. The total hospitalization period of the patients was 32.52 ± 27.2 (range 4–143) days; 34 (43.6%) were discharged after healing and 44 (56.4%) died. In 51 patients (65.4%), the pressure ulcer did not heal during the hospitalization period.

The number of patients whose wound healed was lower among patients who had mobility issues (9, 22.5%) than in patients who did not have mobility limitations (18, 47.4%). The number of patients whose wound healed was lower in the parenteral (5, 22.7%) and enteral feeding groups (4, 16.7%) compared to patients who were on an oral diet (18, 56.3%); also, fewer pressure ulcers healed in patients in the deceased group (4, 9.1%) compared to the healed/discharged group (23, 67.6%) (P<.05). A statistically significant difference could not be determined between patient healing status according to gender, age, and the hospital units where they received care (P>.05) (see Table 1). The number of chronic diseases, hospitalization duration, and the use of drugs that could affect wound healing also were not significantly associated with the healing status of the wound (P>.05).

Patients whose pressure ulcer healed had higher hemoglobin levels (10.38 ± 1.72 g/dL) and higher mean arterial pressure (MAP) (87.51 ± 10.10 mm Hg) compared with values of the patients who did not heal (9.14 ± 1.10 and 74.34 ± 12.59, respectively; P<.05). The differences between the blood sugar, albumin, body temperature, and oxygen saturation (SaO2) values were not statistically significant between the healed and nonhealed groups (see Table 2).

The mean Braden Scale score of all patients was 13.58 ± 2.95 (range 6–20); 73 (93.6%) were at risk for pressure ulcer development. Thirty (30, 38.5%) had high risk (≤12), 20 (25.6%) had moderate risk (13–14), 23 (29.5%) had mild risk (15–18), and 5 (6.4%) had a low risk score. The mean Braden Scale score was higher in individuals whose pressure ulcer healed (14.77 ± 2.06) compared to patients whose ulcer did not heal (13.38 ± 3.30) (P<.05) (see Table 3).

The mean total BWAT score was 22.8 ± 5.72 (range 11.7–40). The mean BWAT total score for patients whose pressure ulcer healed (18.36 ± 3.59) was lower than that of patients whose ulcer did not heal (25.20 ± 5.21) (P<.05) (see Table 3).

A weak negative correlation was noted between mean Braden Scale score and mean BWAT score: mean BWAT score increased as mean Braden score decreased (r=-.368, P = .001) (data not shown). In other words, a higher risk for pressure ulcer development was correlated with a more extensive or slower-healing wound. Wound healing status was compared according to the first, highest, and last BWAT total scores. Statistically significant differences were noted among all groups. The first mean BWAT total score of patients whose pressure ulcer healed (19.22 ± 4.25) was lower than that of patients whose ulcer did not heal (23.60 ± 6.39) (P<.001), the middle mean BWAT total score of the wound healing group (21.25 ± 4.88) was lower than that of the nonhealing group (28.98 ± 6.69) P<.001), and the last BWAT total score of the wound healing group (16.33 ± 4.79) was lower than that of the nonhealing group (27.47 ± 6.30) (P<.001) (see Table 4).

Average BWAT item scores during hospitalization were compared according to pressure injury healing status. The scores were lower for all item scores except for undermining, peripheral tissue edema, and peripheral tissue induration for patients whose pressure ulcer healed compared with patients whose pressure ulcer did not heal (P<.05) (see Table 5).

Discussion

Pressure ulcers can be an indicator of nursing quality.³¹ However, not all pressure ulcers can be prevented^14,18,32; the factors that may have precipitated their development also may affect healing. The purpose of this retrospective study was to examine factors affecting pressure ulcer healing.

Age. Elderly patients are at greater risk of developing a pressure ulcer due to many factors.^12,33 The age range of patients included in pressure ulcer studies cited ranged from 49 to 70 years.^17,34-41 The mean age of the patients in the current study was slightly higher (70.8 years). This may be because the study was performed at a university hospital where elderly patients present with greater care needs and more complex clinical situations. In this study, no difference with respect to wound healing was observed between patients younger or older than 65 years of age.

Ulcer stage. In this study, wound healing occurred in 34.6% of the patients during hospitalization; 38.7% of patients had Stage 2, 30.0% of patients had Stage 3, and 0% of patients had Stage 4 or unstageable pressure ulcers. In their retrospective study (N = 209), Aygör et al¹³ reported wound healing occurred in only 2 of 12 patients before discharge. In a retrospective study by Smit et al,⁴² more than half of the 76 patients hospitalized at the authors’ medical intensive care unit experienced pressure ulcer healing and were discharged. In a retrospective study by Park⁴³ involving 155 patients with Stage 2 pressure ulcers in a Korean acute care hospital, 71.5% of patients healed.

In this study, a Stage 2 pressure ulcer was the most frequent type and the type most likely to heal. Previous studies, including prevalence, retrospective, and quasi-experimental studies^{8,13,34,38,42,44} have reported similar results, with the frequency of Stage 2 pressure ulcer reported as 45% to 89%. In a prospective study by Günes⁴⁵ involving 72 patients who had pressure ulcers, 49% were Stage 2, 47% were Stage 3, and 4% were Stage 4. Only 23% of pressure ulcers healed during the study period (8 weeks) and all were Stage 2. According to a retrospective study (N = 265) by Ikechukwu et al,⁴⁶ Stage 4 ulcers were less likely to heal than all other stages.

Gender and injury location. In the current study, the authors detected no gender predominance in patients with pressure ulcers. Similar results have been determined in other studies.^13,17,35,40 Pressure ulcers frequently occur in regions of bony prominence.¹⁴ In this study, pressure ulcers occurred mostly in the sacrococcygeal region (75.6%). Similar results have been obtained in other pressure ulcer prevalence studies, with rates varying between 12% and 70%.^{8,11,12,38,44,47} This is thought to be due to the fact that patients are positioned mostly in the supine position in some hospitals and cannot reposition themselves for various reasons.

Diagnoses, length of hospitalization, and discharge. The results of previous studies have differed in terms of the diagnosis, facility, and average hospitalization time of patients.^{17,34,35,38,41,42} In general, according to a retrospective logistic regression analysis⁴⁸ patients with a pressure ulcer tend to be hospitalized for a longer period compared with those that do not have a pressure ulcer. In the present study, the authors detected no statistically significant relationship between these variables and pressure ulcer healing.

Mobility. According to retrospective and quasi-experimental studies,^17,18,38 repositioning is effective for the prevention of pressure ulcers other than in cases where decreases in capillary action thwart repositioning efforts.⁴⁸ The importance of repositioning is known in clinical practice. However, evidence is insufficient to support an optimal protocol for repositioning,⁴⁹ and a review of the literature⁵⁰ showed repositioning may be contraindicated for some patients. A retrospective study⁵¹ determined that immobile patients (N = 37) with a heel pressure ulcer and a Braden score ≤18 were at risk for developing further pressure ulcers. A prospective study⁴¹ of 369 patients showed a pressure ulcer developed in 37.8% patients who could not be repositioned, whereas 21.9% of the patients who could be repositioned developed a pressure ulcer. A retrospective study⁴³ (N = 155) found repositioning was a significant factor of healing versus nonhealing. In the present study, pressure ulcers healed in 22.5% of patients who had mobility problems during hospitalization, while pressure ulcers healed in 47.4% of patients who did not have mobility problems.

Although 44 patients died, the authors believed that based on their data their complex situations such as terminal illness, hemodynamic instability, chronic diseases or malignancy affected wound healing.

Nutrition. Insufficient nutrition has an adverse effect on wound healing.^14,18,39,52 According to Levine et al,⁴⁹ nutritional optimization has a beneficial effect on pressure injury healing. The European Society for Clinical Nutrition and Metabolism⁵² guideline recommends use of oral nutrition if possible. According to a systematic review by Langer and Fink,⁵³there is no clear evidence of benefit associated with parenteral or enteral nutrition for the treatment of pressure ulcers. In the current study, the number of patients who healed was significantly higher in the oral nutrition than in the enteral and parenteral nutrition group. Although not statistically significant, average blood glucose levels were lower and albumin and hemoglobin levels were higher in patients whose ulcer healed compared with the nonhealing group. Similar results were obtained in a retrospective study⁴³ (N = 155) where hemoglobin was not associated with pressure ulcer healing. On the other hand, a guideline¹⁴ and a review⁴⁹ have shown hemoglobin levels will affect tissue oxygenation and delay wound healing.^14,49 In a prospective study (N = 326), Sung and Park⁵⁴ found pressure ulcer healing was improved when serum albumin level was higher than 2.8 g/dL.

A decrease in blood pressure may disrupt tissue perfusion and have a negative impact on wound healing.^14,17,18 The MAP value of the patients in the present study was 78.90 ± 13.31 mm Hg. The normal MAP value range is 70 mm Hg to 110 mm Hg; therefore, the MAP values in patients with pressure ulcers were closer to the lower limits of the normal range in the present study. In this study, the MAP value of the patients who healed was significantly higher than that of the group that did not heal. The retrospective study by Park⁴³ among 155 Stage 2 pressure ulcer patients found that the mean total MAP value was 87.7 ± 11.2 — 88.6 ± 10.9 and 85.4 ± 11.8 for the wound healing and no wound healing groups, respectively (P<.05). The prospective study by Sung and Park⁵⁴ found pressure ulcer healing improved when the MAP was higher.

Braden score. The Braden Scale is one of the most valid tools for determining the risk of pressure ulcer. The mean Braden score of the patients in the current study was 13.58 ± 2.95; the score varied between 11.9 and 17 in other studies.^{13,36,38,41,42,55} In a retrospective cohort study,³⁴ a pressure ulcer developed in >60% of patients with a Braden score 6 to 9 (very high risk) during hospitalization and in 9% of the patients with a score of 10 to 12. The total Braden Scale score was determined to be highly predictive of pressure ulcer development. In a retrospective study,⁴³ Braden scores were significantly different between patients with Stage 2 pressure ulcers that did and did not heal. In the current study, 38.5% of the patients had a high or very high risk score; patients whose wounds healed had higher scores (lower risk) than patients whose wounds did not heal (P <.05). These results led the authors to affirm the Braden Scale may be an effective tool for predicting PU healing outcomes.

BWAT. The mean total BWAT score of the patients was 22.8 ± 5.72; the scores of patients with healing wounds were significantly lower than scores for patients with no wound healing. A limited number of studies have used the BWAT. In a retrospective cohort study (N = 24), Bates-Jensen et al⁵⁶determined the mean BWAT total score to be 33.63 ± 8.44 for pressure ulcer patients with a spinal cord injury. In the current study, the BWAT item scores of patients whose pressure ulcer healed were lower than patients whose pressure ulcer did not heal except for 3 items (undermining, peripheral tissue edema, and peripheral tissue induration). These results also confirmed that the BWAT is a valid tool for evaluating pressure injuries.

Limitations

The present study has some important limitations. First, the number of patients was limited because the nurses could not evaluate every patient using the BWAT. In addition, some variables such as height, weight, and prealbumin level could not be obtained from the patients’ medical records. The data analysis in this study was affected by the fact that more than half of patients died during the study period and most of them were in the nonhealed group. Employee and environmental or administrative factors were not examined in this study; the authors focused on patient-related factors. Additional prospective and larger scale studies examining all factors that may affect pressure ulcer healing, as well their relationship to each other, are needed.

Conclusion

A retrospective study of Turkish patients’ pressure ulcer data indicated limited mobility, insufficient oral nutrition, low hemoglobin levels, low MAP, and discharge status may affect pressure ulcer healing potential. Health care providers should consider these factors when designing and implementing a comprehensive pressure ulcer treatment plan.

References

1. Karadağ A. Pressure ulcers: assessment, prevention, and treatment [in Turkish]. Cumhuriyet Üniversites iHemşirelik Yüksekokulu Dergisi. 2003;7(2):41–48.

2. Maklebust J. Pressure ulcers: the great insult. Nurs Clin North Am. 2005;40(2):365–389.

3. Gorecki C, Brown JM, Nelson A, et al; European Quality of Life Pressure Ulcer Project group. Impact of pressure ulcers on quality of life in older patients: a systematic review. J Am Geriatr Soc. 2009;57(7):1175–1183.

4. National Pressure Ulcer Advisory Panel. National Pressure Ulcer Advisory Panel Announces a Change in Terminology From Pressure Ulcer to Pressure Injury and Updates the Stages of Pressure Injury. Available at: www.npuap.org/national-pressure-ulcer-advisory-panel-npuap-announces-a-c.... Accessed July 1, 2016.

5. Leblebici B, Turhan N, Adam M, Akman MN. Clinical and epidemiologic evaluation of pressure ulcers in patients at a university hospital in Turkey. J Wound Ostomy Continence Nurs. 2007;34(4):407–411.

6. Uzun U, Alyaz R, Karadağ E. Prospective study: reducing pressure ulcers in intensive care units at a Turkish medical center. J Wound Ostomy Continence Nurs. 2009;36(4):404–411.

7. Jenkins ML, O’Neal E. Pressure ulcer prevalence and incidence in acute care. Adv Skin Wound Care. 2010;23(12):556–559.

8. İnan DG, Oztunç G. Pressure ulcer prevalence in Turkey: a sample from a university hospital. J Wound Ostomy Continence Nurs. 2012;39(4):409–413.

9. Bredesen IM, Bjøro K, Gunningberg L, Hofoss D. The prevalence, prevention and multilevel variance of pressure ulcers in Norwegian hospitals: a cross-sectional study. Int J Nurs Stud. 2015;52(1):149–156.

10. Mehta C, George JV, Mehta Y, Wangmo N. Pressure ulcer and patient characteristics — a point prevalence study in a tertiary hospital of India based on the European Pressure Ulcer Advisory Panel minimum data set. J Tissue Viability. 2015;24(3)123–130.

11. Hassan Al-Wahsh ZM, Wahsheh MA. Period prevalence of pressure ulcer in Jordanian intensive care units. Infect Dis Clin Pract. 2015;23(2):76-80.

12. Leijon S, Bergh I, Terstappen K. Pressure ulcer prevalence, use of preventive measures, and mortality risk in an acute care population a quality improvement project. J Wound Ostomy Continence Nurs. 2013;40(5):469–474.

13. Aygör HE, Sahin S, Sözen S, Baydal B, Aykar FS, Akçiçek F. Features of pressure ulcers in hospitalized older adults. Adv Skin Wound Care. 2014;27(3):122–126.

14. National Pressure Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Available at: www.npuap.org/wp-content/uploads/2014/08/Updated-10-16-14-Quick-Referenc.... Accessed July 12, 2016.

15. Fisher AR, Wells G, Harrison MB. Factors associated with pressure ulcers in adults in acute care hospitals. Adv Skin Wound Care. 2004;17(2):80–90.

16. Wann-Hansson C, Hagell P, Willman A. Risk factors and prevention among patients with hospital-acquired and pre-existing pressure ulcers in an acute care hospital. J Clin Nurs. 2008;17(13):1718–1727.

17. Lee TT, Lin KC, Mills ME, Kuo YH. Factors related to the prevention and management of pressure ulcers. Comput Inform Nurs. 2012;30(9):489–495.

18. Pittman J, Beeson T, Terry C, et al. Unavoidable pressure ulcers: development and testing of the Indiana University Health Pressure Ulcer Prevention Inventory. J Wound Ostomy Continence Nurs. 2016;43(1):32–38.

19. Bergstrom N, Braden BJ. Predictive validity of the Braden Scale among black and white subjects. Nurs Res. 2002;51(6):398–403.

20. Oğuz S, Olgun N. Measurement of risk of the patients with Braden Scale and determination of the effectiveness the planned nursing care on prevention of the pressure ulcer [in Turkish]. Hemşirelik Forumu Dergisi. 1998;3(1):131–135.

21. Pınar R, Oğuz S. Testing the reliability and validity of the Norton and Braden pressure ulcer evaluation scales for the bedridden patient group. VIII [in Turkish]. In: National Nursing Congress Book. Ankara, Turkey: 1997:172–175.

22. Thomas DR. Prevention and treatment of pressure ulcers. J Am Med Dir Assoc. 2006;7(1):46–59.

23. Edsberg LE, Langemo D, Baharestani MM, Posthauer ME, Goldberg M. Unavoidable pressure injury: state of the science and consensus outcomes. J Wound Ostomy Continence Nurs. 2014;41(4):313–334.

24. Agency for Healthcare Research and Quality: Advancing Excellence in Health Care. Preventing Pressure Ulcers in Hospitals. Available at: www.ahrq.gov/professionals/systems/hospital/pressureulcertoolkit/putool5.... Accessed July 12, 2015.

25. Baranoski S. Pressure ulcers: a renewed awareness. Nursing. 2006;36(8):37–41.

26. Yapucu GÜ. Evaluation of chronic wounds [in Turkish]. Cumhuriyet Üniversites iHemşirelik Yüksekokulu Dergisi. 2007;11(3):38–44 (in Turkish).

27. Karahan A, Toruner EK, Ceylan A, Abbasoglu A, Tekindal A, Butukgonenc L. Reliability and validity of a Turkish language version of the Bates-Jensen Wound Assessment Tool. J Wound Ostomy Continence Nurs. 2014;41(4):340–344.

28. Bates-Jensen BM. The pressure score status tool a few thousand assessments later. Adv Wound Care. 1997;10(5):65–73.

29. Bates-Jensen BM. Bates-Jensen Wound Assessment Tool. Available at: www.geronet.med.ucla.edu/centers/borun/modules/Pressure_ulcer_prevention.... Accessed July 25, 2016.

30. Bates-Jensen BM, Vredevoe DL, Brecht ML. Validity and reliability of the pressure sore status tool. Decubitus. 1992;5(6):20–28.

31. Cuddigan J. NDNQI^®: Getting the Numbers — Pressure Injuries Across the US. ©2016 National Pressure Ulcer Advisory Panel. Available at: www.npuap.org/wp-content/uploads/2017/03/Cuddigan-NDNQI-Staging-FINAL.pdf. Accessed August 1, 2017.

32. Black JM, Edsberg LE, Baharestani MM, et al. Pressure ulcers: avoidable or unavoidable? Results of the National Pressure Ulcer Advisory Panel Consensus Conference. Ostomy Wound Manage. 2011;57(2):24–37.

33. Ham HW, Schoonhoven LL, Schuurmans MM, Leenen LL. Pressure ulcer development in trauma patients with suspected spinal injury; the influence of risk factors present in the emergency department. Int Emerg Nurs. 2017;30:13–19.

34. Tescher AN, Branda ME, Byrne TJ, Naessens JM. All at-risk patients are not created equal analysis of Braden pressure ulcer risk scores to identify specific risks. J Wound Ostomy Continence Nurs. 2012;39(3):282–291.

35. Aljezawi M, Tubaishat A. Nosocomial pressure ulcer risk factors in a relatively young adult population results from a purposeful selection logistic regression model. J Dermatol Nurses Assoc. 2014;6(5):244–250.

36. Pokorny ME, Rose MA, Watkins F, Swanson M, Kirkpatrick MK, Wu Q. The relationship between pressure ulcer prevalence, body mass index, and Braden scales and subscales: a further analysis. Adv Skin Wound Care. 2014;27(1):26–30.

37. Gadd MM, Morris SM. Use of the Braden Scale for pressure ulcer risk assessment in a community hospital setting: the role of total score and individual subscale scores in triggering preventive interventions. J Wound Ostomy Continence Nurs. 2014;41(6):535–538.

38. Anderson M, Finch Guthrie P, Kraft W, Reicks P, Skay C, Beal AL. Universal pressure ulcer prevention bundle with WOC nurse support. J Wound Ostomy Continence Nurs. 2015;42(3):217–225.

39. Becker D, Tozo TC, Batista SS, et al. Pressure ulcers in ICU patients: incidence and clinical and epidemiological features: a multicenter study in southern Brazil. Intensive Crit Care Nurs. 2017;42:55–61.

40. O’Brien DD, Shanks AM, Talsma A, Brenner PS, Ramachandran SK. Intraoperative risk factors associated with postoperative pressure ulcers in critically ill patients: a retrospective observational study. Crit Care Med. 2014;42(1):40–47.

41. Slowikowski GC, Funk M. Factors associated with pressure ulcers in patients in a surgical ıntensive care unit. J Wound Ostomy Continence Nurs.2010;37(6):619–626.

42. Smit I, Harrison L, Letzkus L, Quatrara B. What factors are associated with the development of pressure ulcers in a medical ıntensive care unit? Crit Care Nurs. 2016;35(1):37–41.

43. Park KH. A retrospective study using the pressure ulcer scale for healing (PUSH) tool to examine factors affecting stage II pressure ulcer healing in a Korean acute care hospital. Ostomy Wound Manage. 2014;60(9):40–51.

44. Coyer F, Miles S, Gosley S, et al. Pressure injury prevalence in intensive care versus non-intensive care patients: a state-wide comparison. Aust Crit Care. 2017;30(5):244–250.

45. Günes UY. A prospective study evaluating the Pressure Ulcer Scale for Healing (PUSH Tool) to assess stage II, stage III, and stage IV pressure ulcers. Ostomy Wound Manage. 2009;55(5):48–52.

46. Ikechukwu EC, Ayodiipo IO, Emeka AD, Kayode AJ, Michael NI, Deborah OT. Prevalence and factors associated with healing outcomes of hospital-acquired pressure ulcers among patients with spinal cord injury. J Public Health Epidemiol. 2012;4(2):44–47.

47. Engels D, Austin M, McNichol L, Fencl J, Gupta S, Kazi H. Pressure ulcers: factors contributing to their development in the OR. AORN J. 2016;103(3):271–281.

48. Miller N, Frankenfield D, Lehman E, Maguire M, Schirm V. Predicting pressure ulcer development in clinical practice: evaluation of Braden Scale scores and nutrition parameters. J Wound Ostomy Continence Nurs. 2015;43(2):133–139.

49. Levine SM, Sinno S, Levine J, Saadeh PB. Current thoughts for the prevention and treatment of pressure ulcers using the evidence to determine fact or fiction. Ann Surg. 2013;257(4):603–608.

50. White-Chu EF, Reddy M. Pressure ulcer prevention in patients with advanced illness. Curr Opin Support Palliat Care. 2013;7(1):111–115.

51. Delmore B, Lebovits S, Suggs B, Rolnitzky L, Ayello EA. Risk factors associated with heel pressure ulcers in hospitalized patients. J Wound Ostomy Continence Nurs. 2015;42(3):242–248.

52. Lim S, Kim BD, Kim JY, Ver Halen JP. Preoperative albumin alone is not a predictor of 30-day outcomes in pressure ulcer patients: a matched propensity-score analysis of the 2006-2011 NSQIP datasets. Ann Plast Surg. 2015;75(4):439–447.

53. Langer G, Fink A. Nutritional interventions for preventing and treating pressure ulcers. Cochrane Database Syst Rev. 2014;12(6):CD003216.

54. Sung YH, Park KH. Factors affecting the healing of pressure ulcers in a Korean acute care hospital. J Wound Ostomy Continence Nurs. 2011;38(1):38–45.

55. Raju D, Su X, Patrician PA, Loan LA, McCarthy MS. Exploring factors associated with pressure ulcers: a data mining approach. Int J Nurs Stud. 2015;52(1):102–111.

56. Bates-Jensen BM, Guihan M, Garber SL, Chin AS, Burns SP. Characteristics of recurrent pressure ulcers in veterans with spinal cord ınjury. J Spinal Cord Med. 2009;32(1):34–42.

Potential Conflicts of Interest: This study was approved by Baskent University Institutional review Board (Project No: KA 15/250).

Dr. Karahan is an Associate Professor; and Ms. Abbasoğlu, Dr. Işık, and Dr. Çevik are lecturers, Baskent University, Health Sciences Faculty, Department of Nursing, Ankara, Turkey. Ms. Saltan is a wound care nurse, Baskent University Ankara Hospital, Ankara, Turkey. Dr. Elbas is a professor, Baskent University. Ms Yalılı is a research assistant, Health Sciences University, Nursing Faculty, İstanbul, Turkey. Please address correspondence to: Azize Karahan, PhD, RN, Baskent University Health Sciences Faculty, Department of Nursing, Ankara, Turkey email: azize03@yahoo.com or kazize@baskent.edu.tr.

Section:

↧

A Retrospective Analysis to Evaluate Seasonal Pressure Injury Incidence Differences Among Hip Fracture Patients in a Tertiary Hospital in East China

February 1, 2018, 1:03 pm

≫ Next: Reconstruction of a Sacral Pressure Ulcer With an Inferior Gluteal Artery Perforator Flap After Failed Reconstruction Using Bilateral V-Y Advancement Flaps

≪ Previous: Factors Affecting Wound Healing in Individuals With Pressure Ulcers: A Retrospective Study

Issue Number:

Index:

Ostomy Wound Management 2018;64(2):40–44 doi: 10.25270/owm.2018.2.4044

Hong-Lin Chen, MD; Bin Zhu, MMed; Rong Wei, RN; and Zhen-Yu Zhou, MD

Topics:

retrospective study

pressure injury

seasonal variation

hip fractures

elderly

Abstract

Patients with a hip fracture are at high risk for pressure injury. A retrospective review of the electronic medical records of consecutive patients with a hip fracture treated in 2016 in a single tertiary hospital in east China were examined to investigate whether time of year affected the incidence of hospital-acquired pressure injury.

Data collected included demographic characteristics (patient name, hospital number, age, gender, and body mass index); possible risk factors for pressure injury, such as presence of diabetes mellitus, admission hemoglobin, admission albumin, length of surgery, and the lowest and/or last Braden Scale score before pressure injury developed; and pressure injury information, which included time of occurrence (days after surgery), location (sacrum and coccyx, ischial tuberosity, or heel), stage, and treatment outcome. Pressure injury incidence was calculated with 95% confidence intervals (CIs) in each month and season (spring, summer, autumn, and winter). Odds ratios (ORs) and 95% CIs were calculated as estimates of risk. Multivariate logistic regression was used for risk factors. Of the 235 patients with a hip fracture included in the study, 95 (40.4%) were male, 140 (59.6%) were female, and mean age was 70.4 ± 10.5 (range 48–81) years. Thirty-one (31) patients (13.2%, 95% CI 9.1%-18.2%) developed 37 pressure injuries, 30 of which (81.1%) were Stage 1. The incidence of pressure injury was lowest in November (5.0%; 95% CI: 0.0%-24.9%) and highest in June (22.7%; 95% CI: 7.8%-45.4%). Average Braden Scale scores (14.2 ± 3.2) were lower in June than in November (16.6 ± 3.5), owing to differences in the Braden Scale skin moisture subscale. Seasonally, the incidence of pressure ulcers was 20.8% (95% CI: 12.2%-32.0%) in the summer compared to 7.5% (2.5%-16.6%) in autumn (crude OR 3.3; 95% CI:1.0-12.1; P = .025). Multivariate logistic regression analysis showed the Braden Scale score was the only independent risk factor (P<.05) for pressure injury incidence. Adjusting for the Braden score, the OR of summer season was 1.537 (95% CI: 0.964-2.872). The findings suggest that humidity and temperature levels, which are very high in the summer in China, may affect pressure injury incidence and that the Braden Scale score — especially the skin-moisture level subscore — is a valid predictor of pressure injury risk in this population. While more research is needed, additional pressure injury prevention strategies should be provided for patients hospitalized with a hip fracture in the summer months.

Hip fractures are a common trauma in older adults and as the number of elderly persons increases, the incidence of hip fractures likely will increase as well.^1-3 Following surgical repair, these patients are at high risk for pressure injury.⁴ Previous studies^4-7 in these populations have reported a pressure ulcer incidence of 3.4% to 59.8%. Pressure ulcers in patients with hip fractures have been shown in retrospective analyses to lengthen hospital stay⁸ and increase health care costs.⁹ Moreover, pressure ulcers have been shown in a retrospective study¹⁰ (N = 343) to decrease patient survival after a hip fracture; risk for reduced survival to hospital discharge is markedly increased (hazard ratio [HR] 4.25, 95% confidence interval [CI]: 1.35–13.36; P = .013) as is risk for reduced survival at 1 year after surgery (HR 4.15; 95% CI: 2.14–8.06; P<.001), making it crucial to prevent this complication in patients with a hip fracture.

The Braden Scale is an important tool for assessing patient pressure ulcer risk and has been shown in a prospective study¹¹ and a systematic review¹² to offer the best balance between sensitivity and specificity and the best risk estimate. Several studies,^7,13-15 including a prevalence and incidence study,⁷ a secondary analysis of data,¹³ and a prospective cohort study,¹⁵ have investigated risk factors for pressure injury among hip fracture patients. This research found factors such as older age, dehydration, longer wait before surgery, longer intensive care unit stay, longer surgical procedure time, cognitive impairment, higher American Society of Anesthesiologists grade, and impaired mobility were possible risk factors for pressure ulcers in this population.

In the authors’ clinical practice, the incidence of pressure injury in hip fracture patients was observed anecdotally to increase in the summer. Literature about the possible effect of seasonal changes on the incidence of pressure injury in hip fracture patients in east China could not be identified. The purpose of this retrospective study was to examine if the incidence of pressure injury in hip fracture patients varies by month or season.

Methods

Patient population. Discharge data from the electronic medical records of a single tertiary hospital in China were collected and abstracted. Inclusion criteria stipulated participants should be consecutive patients with a hip fracture treated between January 2016 and December 2016 whose records indicated risk for pressure injury pressure ulcer as assessed using the Braden Scale, as well as the presence of a pressure injury Patients with a hip fracture whose pressure injury developed before admission or who died during hospitalization because of serious complications or whose pressure injury records were missing were excluded from the study.

Ethical consideration. Data collection was approved by the medical ethics committee of the Affiliated Hospital of Nantong University for anonymous patient inclusion.

Data collection. The data collected included demographic characteristics (patient name, hospital number, age, gender, and body mass index [BMI]); possible risk factors for pressure injury, such as diabetes mellitus, admission hemoglobin, admission albumin, length of surgery, and the lowest and/or last Braden Scale score before pressure injury developed; pressure injury information, which included time of occurrence (days after surgery), location (sacrum and coccyx, ischial tuberosity, or heel), National Pressure Ulcer Advisory Panel-European Pressure Ulcer Advisory Panel-Pan Pacific Pressure Injury Alliance (NPUAP-EPUAP-PPPIA) classification system stage¹⁶; and treatment outcome. The Braden score was determined by the duty nurse. If a pressure injury did not develop, the lowest Braden score recorded was abstracted; if a pressure injury developed, the Braden score recorded before the pressure injury developed was used. Data were entered into a data entry template designed with EpiData (version 3.1, EpiData Association, Odense, Denmark) and retrospectively reviewed.

If the information was not available on the electronic hospital record, the authors manually searched paper medical records according to the patient’s name and hospital number. If the necessary information could not be found, that case was excluded.

Statistical analysis. Because the statistical hypothesis was that the incidence of pressure injury in hip fracture patients varies with the month or season, hospitalization data were grouped into seasons defined according to the Gregorian calendar. First, pressure injury incidence was calculated with 95% CIs in each month and season (spring, summer, autumn, and winter). A periodogram was drawn to demonstrate the intensity of seasonal patterns. Odds ratios (ORs) and 95% CIs were calculated as estimates of risk. The month or season with the lowest pressure injury incidence was used as the reference category.

A multivariate logistic regression model was used to calculate adjusted ORs for seasonal differences of pressure injury incidence. Again, the season with the lowest pressure injury incidence was used as the reference category. Diabetes mellitus, admission hemoglobin, admission albumin, length of surgery, and Braden Scale scores also were included in the logistic regression model as covariates. Statistical analyses were performed using Stata software, version 11.0 (Statacorp LLC, College Station, TX).

Results

Patient characteristics. Of the 256 patients admitted with a hip fracture, 21 had missing pressure injury information, leaving 235 hip fracture patients (95 [40.4%] male, 140 [59.6%] female) for inclusion in the study. Mean patient age was 70.4 ± 10.5 (range 48–81) years. Thirty-three (33) patients (14.0%) had diabetes (HbA1c >6.5%), mean admission hemoglobin was 112.3 ± 13.9 g/L, and mean admission albumin was 32.6 ± 3.4 g/L. The length of surgery ranged from 45 minutes to 180 minutes. The mean Braden Scale score was 15.1 ± 2.5 (range 10–22) (see Table 1).

Postoperative pressure injury. Thirty-one (31) patients developed 37 pressure injuries, an incidence of 13.2% (95% CI: 9.1%-18.2%). Pressure injuries developed 2 to 5 days after surgery; 18 (48.6%) were on the sacrum and coccyx, 12 (32.4%) on the ischial tuberosities, and 7 (18.9%) on the heel. Based on NPUAP- EPUAP-PPPIA classification, 30 pressure injuries (81.1%) were Stage 1, 5 (13.5%) were Stage 2, 2 (5.4%) were Stage 3, and none (0.0%) were Stage 4. All pressure injuries were managed with hydrocolloid dressings, and all patients were repositioned every 2 hours. All Stage 1 and Stage 2 pressure injuries were completely healed 4 to 10 days after occurrence; the 2 Stage 3 pressure injuries were partially (50% to 80%) healed at the time of discharge (13 to 21 days after surgery.)

Braden Scale scores by season. The mean total Braden Scale score increased from June to August — the highest was during October (16.6 ± 3.7) and November (16.6 ± 3.5) and the lowest during June (14.2 ± 3.2); the moisture subscale was highest in October (3.5 ± 0.4). The remaining 5 Braden subscales showed no changes per month. Average Braden scores were highest in autumn (16.5 ± 3.4) and lowest in summer (14.4 ± 3.2 ) (see Table 1).

Seasonal differences in the incidence of pressure injury. The incidence of pressure injury in hip fracture patients was lowest during the month of November (5.0%; 95% CI: 0.0%-24.9%) and highest during the month of June (22.7%; 95% CI: 7.8%-45.4%). A seasonal trend was observed as well, with incidence peaks occurring in summer (20.8%; 95% CI: 12.2%-32.0%; OR 3.3; 95% CI: 1.0-12.1; P = .025) when compared to autumn (see Table 1).

Of all variables assessed, multivariate logistic regression analysis showed the Braden Scale score was the only independent risk factor for pressure injury incidence in patients with a hip fracture. Pressure injury incidence was highest in the summer season but was not statistically significant. After adjustment per the Braden Scale, the OR for the summer season was 1.537 (95% CI: 0.964-2.872) (see Table 2).

Discussion

A seasonal trend regarding pressure injury was noted in hip fracture patients, with incidence peaking in the summer (20.8%; 95% CI: 12.2%-32.0%). OR was 3.3 (95% CI: 1.0-12.1; P = .025) when compared with the study reference (autumn, 7.5%; the lowest incidence). The results of the current study support the validity of the Braden Scale score as a predictor of pressure injury risk for hip fracture patients; average total Braden Scale scores were lower in the summer, as were the Braden moisture subscale scores. These findings confirm what the authors had experientially observed and may be explained by the hot and humid summer environment. Although all wards in the authors’ hospital are equipped with air conditioners, the environment is still considerably warmer and more humid in the summer than during the other seasons. In June and July each year, the middle and lower reaches of the Yangtze River in China experience the rainy season with continuously overcast weather and very high air humidity. While the high temperature in the ward can be decreased by air conditioning, the high humidity levels are typically not fully addressed.

Studies^17,18 have investigated the most suitable temperature and relative humidity in hospital buildings. One study in China¹⁹ found the measured temperature range acceptable to 80% of the people queried was 18.1˚ C to 25.5˚ C in the winter and 21.9˚ C to 28.4˚ C in summer. The American Society of Heating, Refrigerating and Air-Conditioning Engineers²⁰suggests the relative humidity of these temperature comfort zones should range from 20% to 70%. In China, the relative humidity recommended for a hospital ward is 45% to 70% both in winter and summer.¹⁹ In the authors’ hospital, the relative humidity is always above 90% during the summer months because of the rainy season. The authors recommend placing a thermometer and hygrometer in the ward for hip fracture patients. If the temperature and humidity exceed a certain range, additional pressure injury prevention strategies should be provided. Specifically, measures to reduce skin moisture levels should be employed. For example, in China, hair dryers are used to keep patient skin dry: a randomized controlled trial by Fei-ying et al²¹ discussed the use of hair dryers for pelvic fracture patients and how this practice achieved a lower incidence of pressure injury.

Limitations

This study has limitations. First, the periodogram showed the highest pressure injury incidence occurred in the summer (P = .025), but multivariate logistic regression showed this was not statistically significant (P = .087). This result may be related to the small sample size. Second, temperature and humidity data in the ward were not collected retrospectively and as such cannot be investigated. Third, because this was a retrospective study, the levels of evidence may only ranked 3b.²² Future prospective studies with large samples can address these limitations.

Conclusion

Results of a retrospective review of patient data suggest the incidence of pressure injury in postoperative hip fracture patients may have seasonal variations. During the hot, humid summer environment in China, the incidence of pressure injury was higher than during colder, less humid, seasons. Braden Scale scores and the Braden Scale moisture subscale scores were lower during the summer than during the other seasons (P<.05 for Braden Scale score). Future prospective studies assessing pressure injury prevention strategies during summer months, particularly with respect to decreasing ambient air temperature and humidity levels in wards in China, are warranted. n

References

1. Tian FM, Zhang L, Zhao HY, Liang CY, Zhang N, Song HP. An increase in the incidence of hip fractures in Tangshan, China. Osteoporosis Int. 2014;25(4):1321–1325.

2. Neuburger J, Wakeman R. Is the incidence of hip fracture increasing among older men in England? J Epidemiol Community Health. 2016;70(10):1049-1050.

3. Ha YC, Park YG, Nam KW, Kim SR. Trend in hip fracture incidence and mortality in Korea: a prospective cohort study from 2002 to 2011. J Korean Med Sci. 2015;30(4):483–488.

4. Baumgarten M, Margolis DJ, Orwig DL, et al. Pressure ulcers in elderly patients with hip fracture across the continuum of care. J Am Geriatr Soc. 2009;57(5):863–870.

5. Gumieiro DN, Rafacho BP, Gonçalves AF, et al. Serum metalloproteinases 2 and 9 as predictors of gait status, pressure ulcer and mortality after hip fracture. PLoS One. 2013;8(2):e57424.

6. Norris R, Parker M. Diabetes mellitus and hip fracture: a study of 5966 cases. Injury. 2011;42(11):1313–1316.

7. Lindholm C, Sterner E, Romanelli M, Pet al. Hip fracture and pressure ulcers — the Pan-European Pressure Ulcer Study — intrinsic and extrinsic risk factors. Int Wound J. 2008;5(2):315–328.

8. Rademakers LMF, Vainas T, van Zutphen SW, Brink PR, van Helden SH. Pressure ulcers and prolonged hospital stay in hip fracture patients affected by time-to-surgery. Eur J Trauma Emerg Surg. 2007;33(3):238–244.

9. Shoaibi A. Progression of Stage I Pressure Ulcers in Elderly Hip Fracture Patients [dissertation]. Baltimore, MD: University of Maryland, Baltimore; 2014. Available at: https://archive.hshsl.umaryland.edu/bitstream/10713/4182/1/Shoaibi_umary.... Accessed January 16, 2018.

10. Vidal EI, Moreira DC, Pinheiro RS, et al. Hospital acquired pressure ulcers and markedly decreased survival after a hip fracture. J Am Geriatr Soc. 2012;60(4 suppl):S149.

11. Bergstrom N, Braden BJ, Laguzza A, Holman V. The Braden Scale for predicting pressure sore risk. Nurs Res. 1987;36(4):205–210.

12. Pancorbo-Hidalgo PL, Garcia-Fernandez FP, Lopez-Medina IM, Alvarez-Nieto C. Risk assessment scales for pressure ulcer prevention: a systematic review. J Adv Nurs. 2006;54(1):94–110.

13. Baumgarten M, Margolis D, Berlin JA, et al. Risk factors for pressure ulcers among elderly hip fracture patients. Wound Repair Regen. 2003;11(2):96–103.

14. Baumgarten M, Rich SE, Shardell MD, et al. Care-related risk factors for hospital-acquired pressure ulcers in elderly adults with hip fracture. J Am Geriatr Soc. 2012;60(2):277–283.

15. Houwing RH, Rozendaal M, Wouters-Wesseling W, Buskens E, Keller P, Haalboom JR. Pressure ulcer risk in hip fracture patients. Acta Orthop Scand. 2004;75(4):390–393.

16. National Pressure Ulcer Advisory Panel-European Pressure Ulcer Advisory Panel-Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. 2014. Available at: www.epuap.org/wp-content/uploads/2016/10/final_quick_prevention.pdf. Accessed January 16, 2018.

17. Sookchaiya T, Monyakul V, Thepa S. A Study and Development of Temperature and Relative Humidity Control System in Hospital Buildings in Thailand. Proceedings of the EDU-COM 2008 International Conference. Perth, Western Australia, Australia: Edith Cowan University; 2008:19-21. Available at: http://ro.ecu.edu.au/cgi/viewcontent.cgi?article=1039&context=ceducom Accessed January 16, 2018.

18. Skoog J. Relative air humidity in hospital wards – user perception and technical consequences. Indoor Built Environ. 2006;15(1):93–97.

19. Feng HH. Study on the Thermal Comfort In Hospital Wards. Chongqing, China: Chongqing University; 2015. Available at: https://max.book118.com/html/2016/0130/34356863.shtm. Accessed January 16, 2018.

20. American Society of Heating, Refrigerating and Air-Conditioning Engineers. ASHRAE Standard 62.2. Available at: https://energy.gov/eere/buildings/downloads/ashrae-standard-622-ventilat.... Accessed January 16, 2018.

21. He F, Lu G, Wei X. The application of water decompress cushion and hair dryer in the prevention of pressure ulcer in pelvic fractures. Chinese J Pract Nurs. 2006;22(4):49–50.

22. Phillips B, Ball C, Sackett D, et al. Oxford Centre for Evidence-based Medicine – Levels of Evidence (March 2009). Available at: www.cebm.net/blog/2009/06/11/oxford-centre-evidence-based-medicine-level.... Accessed January 16, 2018.

Potential Conflicts of Interest: This work was supported by a grant from Key Medical Management Program of Nantong Municipal Science and Technology Bureau.

Dr. Chen is an Associate Professor, Nursing School of Nantong University, Nantong, Jiangsu, PR China. Dr. Zhu is a Deputy Chief Surgeon, Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Nantong University and the First People’s Hospital of Nantong City, Nantong, Viangsu, PR China. Ms. Wei is a Deputy Chief Nurse, and Dr. Zhou is a Deputy Chief Surgeon, Department of Orthopaedics, Affiliated Hospital of Nantong University, Nantong, Jiangsu, PR China. Please address correspondence to: Bin Zhu, MMed, Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Nantong University and the First People’s Hospital of Nantong City, Jiangsu Province, PR China. 226001; pphss@126.com

Section:

↧

Reconstruction of a Sacral Pressure Ulcer With an Inferior Gluteal Artery Perforator Flap After Failed Reconstruction Using Bilateral V-Y Advancement Flaps

February 1, 2018, 1:23 pm

≫ Next: A Descriptive, Retrospective Study of Using an Oblique Downward-design Gluteus Maximus Myocutaneous Flap for Reconstruction of Ischial Pressure Ulcers

≪ Previous: A Retrospective Analysis to Evaluate Seasonal Pressure Injury Incidence Differences Among Hip Fracture Patients in a Tertiary Hospital in East China

Issue Number:

Index:

Ostomy Wound Management 2017;63(12):45–48 doi: 10.25270/owm.2018.2.4548

Chi-Yu Wang, MD; Chien-Ju Wu, MD; Tzi-Shiang Chu, MD; Chun-Yu Chen, MD; Chang-Yi Chou, MD; Hao-Yu Chiao, MD; Chun-Kai Chang, MD; and Niann-Tzyy Dai, MD

Topics:

case report

Pressure Ulcer

perforator flap

inferior gluteal artery

Abstract

Many types of flaps are available if surgical reconstruction of a pressure ulcer is indicated, including a gluteus maximus flap, V-Y advancement flap, and superior gluteal artery perforator flap. Regional flap failure can complicate treatment, requiring additional flap surgery. An 80-year old woman with a 2-year history of being unconscious following a cerebrovascular accident presented with a Stage 4 sacral pressure ulcer of 2 months’ duration with eschar and abscess formation.

Because the wound measured 15 × 10 cm², bilateral V-Y advancement flaps were used for surgical closure. However, 1 week later, ischemic change of the wound edges and wound dehiscence were observed. The wound was subsequently closed with an artery perforator (IGAP) flap, an approach that took into consideration religious preference of keeping the body intact. The patient was discharged with a healed wound 6 weeks postoperatively; long-term postoperative surveillance was hindered by the patient’s distance from the care facility (she lived on an outlying island). This is the first case report to describe IGAP flap application in a patient with a sacral pressure ulcer after failed reconstruction using bilateral V-Y advancement flaps.

In the United States, more than 2.5 million patients per year are estimated to develop pressure ulcers.¹ Several types of flaps have been described in retrospective studies^2-7 for coverage of wounds such as pressure ulcers in the sacral area, but the scenario remains complex if the sacral wound recurs or the flap fails. Flap types include the V-Y advancement flap² and the buttock rotation flap³; specific types of perforator flaps include the inferior gluteal artery perforator (IGAP) flap⁶ and the superior gluteal artery perforator (SGAP) flap.⁷To document available treatment options, a case is described of a long-term bedridden patient with a sacral pressure ulcer who received an IGAP after failed reconstruction using bilateral V-Y advancement flaps.

Case Report

Ms. R, an 80-year-old woman with a history of a cerebrovascular accident, type 2 diabetes mellitus, and hypertension managed using angiotensin-converting enzyme inhibitors and biguinide, was unconscious and bedridden for 2 years. She received tube feeding for nutritional support and was cared for on an alternating pressure air mattress in a supine or lateral position. She did not have hip contracture.

Ms. R presented to Tri-Service General Hospital with a Stage 4 (per the definition developed by Shea⁸) sacral pressure ulcer of 2 months’ duration with eschar and abscess formation (see Figure 1A) that occurred, according to her family, due to neglectful home care. She had not received prior surgical intervention; the wound had been treated with neomycin ointment.

Initial laboratory results revealed a white blood cell count of 11.0 × 10³ cells/mm³. Her C-reactive protein level was 5 mg/dL, and her blood urea nitrogen and creatinine levels were 12 mg/dL and 1.0 mg/dL, respectively. Aspartate transaminase and alanine transaminase values were 23 and 14 U/L, respectively. Ms. R’s vital signs were stable with no signs of sepsis on admission.

The soft tissue defect measured approximately 15 cm × 10 cm over the sacrum. After surgical debridement (see Figure 1B), bilateral V-Y advancement flaps were used simultaneously for reconstruction (see Figure 2A). One (1) week following surgery, the wound dehisced and partial skin necrosis occurred (see Figure 2B). After the failed bilateral V-Y advancement flap reconstruction, the sacral soft tissue defect measured approximately 10 cm × 10 cm (see Figure 3A). The wound could not be closed with primary closure and undermined dissection. Additionally, because the angiosome area of the bilateral SGAP flaps had been injured after the bilateral V-Y advancement flap reconstruction, the wound could not be salvaged using SGAP flap reconstruction.

Because of the religious ethics in Taiwanese tradition that demand the maintenance (intactness) of the human body before death, including even just managing a pressure ulcer, Ms. R’s family demanded sacral ulcer reconstruction as soon as possible; letting it heal by secondary intention resulted in poor outcomes according to the authors’ experience. IGAP flap reconstruction was performed 2 weeks after the failed bilateral V-Y advancement flap reconstruction. After intraoperative Doppler assessment, an IGAP flap was harvested measuring approximately 12 cm × 10 cm with an ~10 cm pedicle from the right gluteal crease region. Transposition of the IGAP flap to the sacral defect was performed without complications or any adverse event in an open route as opposed to subcutaneous tunnel fashion to avoid possible pedicle compromise by compression (see Figure 3); hip joint flexion could create complications for the healing of the IGAP flap donor site. Therefore, to prevent wound dehiscence at the flap donor site, a modified ventral splint was applied from the lower leg to the flank with elastic bandage fixation over the knee and flank (see Figure 4) for 3 weeks, at which time the sacral wound and the flap donor site both were healed without complications (see Figure 5). Ms. R was discharged with a healed wound 6 weeks postoperatively. She was not followed-up long-term because she lived on an outlying island, making oversight difficult.

Discussion

Many kinds of flaps, such as a gluteus maximus V-Y advancement flap,² rotation flap,³ transverse lumbar flap,⁴ IGAP flap,^5,6 and SGAP flap,⁷ have been described for coverage of a sacral wound. Although flaps are commonly created by reconstructive surgeons, the condition can become complicated if the sacral pressure ulcer recurs or the flap fails related to surgical skill, nutrition, circulation, and infection, among other factors.

In the present case, because the angiosome area of the superior gluteal artery was injured after the failed bilateral V-Y advancement flap reconstruction, the wound could not be salvaged using SGAP flap reconstruction and subsequently IGAP flap reconstruction was employed.

The vascular territory of the perforator flap remains controversial. Several clinical studies address the vascular territory of IGAP flap. In 1993, Koshima et al⁹ showed that a flap in the gluteal region could be nourished even by a single perforator. In 2007, Ahmadzadeh et al¹⁰ described a detailed dissection of the gluteal region and determined that the vascular area of a single perforator from the inferior gluteal artery measures ~24 cm². However, Nojima et al¹¹ demonstrated a mean vascular territory of 15 cm × 12 cm in an IGAP flap using a single perforator with the dye injection method. In Ms. R’s case, an IGAP flap of approximately 12 cm × 10 cm was harvested without any necrosis.

A flap from the gluteal crease has 2 advantages: 1) the flap is raised from an area different from the previous surgical region and can serve as a secondary option for salvage¹²; and 2) the primary closure of the donor site leaves a scar that avoids maximal pressure zones over bony prominences and is well hidden in the natural gluteal crease.¹³ A major disadvantage of this flap is that it creates a relatively tense donor site wound; in addition, compared to other flaps, it is much harder and time-consuming to harvest the IGAP flap. Owing to increased tension over the gluteal crease, a patient that is bedridden long-term with hip contracture is not a suitable candidate for IGAP flap reconstruction because hip joint flexion could worsen the healing of the IGAP flap donor site due to higher tension over wound edge. Therefore, the most important step for IGAP flap reconstruction is the selection of the patient. In the authors’ experience, a patient who is bedridden long-term and without hip contracture is preferred. In addition, to avoid wound dehiscence at the flap donor site in Ms. R’s case, the authors applied a modified ventral splint as a strong support for 3 weeks; the final donor site condition was satisfactory.

According to medical ethics, before the sacral ulcer reconstruction the authors discussed with the family potential adverse scenarios the patient might encounter through the procedure and postoperative period. However, because of the religious ethics in Taiwanese tradition, her family demanded reconstruction to keep the body intact, requiring surgery.

Conclusion

IGAP flap reconstruction appears to be an alternative technique for surgical closure of a sacral pressure ulcer after failed reconstruction using bilateral V-Y advancement flaps. Because the IGAP flap is raised from an area different from that of the previous operation site, it can serve as a flap for salvage reconstruction from an adequate donor site and avoid flap failure. Long-term follow-up to ensure full healing and functionality of the surgical sites is advisable. n

References

1. Lyder CH. Pressure ulcer prevention and management. JAMA. 2003;289(2):223–226.

2. Ohjimi H, Ogata K, Setsu Y, Haraga I. Modification of the gluteus maximus V-Y advancement flap for sacral ulcers: the gluteal fasciocutaneous flap method. Plast Reconstr Surg. 1996;98(7):1247–1252.

3. Wong CH, Tan BK, Song C. The perforator-sparing buttock rotation flap for coverage of pressure sores. Plast Reconstr Surg. 2007;119(4):1259–1266.

4. Balakrishnan C, Brotherston TM. Transverse lumbar flap for sacral bed sores. Plast Reconstr Surg. 1992;89(5):998–999.

5. Coskunfirat OK, Ozgentas HE. Gluteal perforator flaps for coverage of pressure sores at various locations. Plast Reconstr Surg. 2004;113(7):2012–2017.

6. Lin CT, Ou KW, Chiao HU et al. Inferior gluteal artery perforator flap for sacral pressure ulcer reconstruction: a retrospective case study of 11 patients. Ostomy Wound Manage. 2016;62(1):34–39.

7. Lin CT, Chang SC, Chen SG, Tzeng YS. Modification of the superior gluteal artery perforator flap for reconstruction of sacral sores. J Plast Reconstr Aesthet Surg. 2014;67(4):526–532.

8. Shea JD. Pressure sores: classification and management. Clin Orthop Relat Res. 1975;(112):89–100.

9. Koshima I, Moriguchi T, Soeda S, Kawata S, Ohta S, Ikeda A. The gluteal perforator-based flap for repair of sacral pressure sores. Plast Reconstr Surg. 1993;91(4):678–683.

10. Ahmadzadeh R, Bergeron L, Tang M, Morris SF. The superior and inferior gluteal artery perforator flaps. Plast Reconstr Surg. 2007;120(6):1551–1556.

11. Nojima K, Brown SA, Acikel C, et al. Defining vascular supply and territory of thinned perforator flaps: part I. Anterolateral thigh perforator flap. Plast Reconstr Surg. 2005;116(1):182–193.

12. Higgins JP, Orlando GS, Blondeel PN. Ischial pressure sore reconstruction using an inferior gluteal artery perforator (IGAP) flap. Br J Plast Surg. 2002;55(1):83–85.

13. Scheufler O, Farhadi J, Kovach SJ, et al. Anatomical basis and clinical application of the infragluteal perforator flap. Plast Reconstr Surg. 2006;118(6):1389–1400.

Potential Conflicts of Interest: none disclosed

Dr. Wang is a resident physician at the Division of Plastic and Reconstructive Surgery, Department of Surgery, Kaohsiung Armed Forces General Hospital, Kaohsiung, Taiwan; and at Division of Plastic and Reconstructive Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. Dr. Wu, Dr. Chu, Dr. Chen, Dr. Chou, Dr. Chiao, and Dr. Chang are resident physicians; and Dr. Dai is an attending physician, Division of Plastic and Reconstructive Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center. Please address correspondence to: Niann-Tzyy Dai, MD, Division of Plastic and Reconstructive Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, No. 325, Section 2, Cheng-Gung Road, Taipei, 11490, Taiwan; email: niantzyy@ms17.hinet.net.

Section:

Volume 64 - Issue 3 - March 2018 ISSN 1943-2720

↧

A Descriptive, Retrospective Study of Using an Oblique Downward-design Gluteus Maximus Myocutaneous Flap for Reconstruction of Ischial Pressure Ulcers

March 2, 2018, 9:06 am

≫ Next: A Retrospective Cohort Study to Determine Predictive Factors for Abdominal Wound Disruption Following Colorectal Surgery

≪ Previous: Reconstruction of a Sacral Pressure Ulcer With an Inferior Gluteal Artery Perforator Flap After Failed Reconstruction Using Bilateral V-Y Advancement Flaps

Issue Number:

Index:

Ostomy Wound Management 2018;64(3):40–44 doi:10.25270/owm.2018.3.4044

Chang-Yi Chou, MD; Yu-shan Sun, MD; Yu-jen Shih, MD; Yuan-Sheng Tzeng, MD; Shun-Cheng Chang, MD; Niann-Tzyy Dai, MD; and Chin-Ta Lin, MD

Topics:

retrospective study

Pressure Ulcer

myocutaneous flap

wound healing

recurrence

Abstract

Despite advances in reconstruction techniques, ischial pressure ulcers continue to present a challenge for the plastic surgeon. The purpose of this retrospective study was to evaluate outcomes of using an oblique downward gluteus maximus myocutaneous (GMM) flap for coverage of grade IV ischial ulcers.

Data regarding defect size, flap size, operation time, duration of wound healing, and surgical outcome were abstracted from the medical records of patients whose ischial pressure ulcers had been reconstructed using GMM island flaps between January 2010 and December 2015. The 22 patients comprised 15 men and 7 women with a mean age of 52 (range 16–81) years. Twenty (20) had paraplegia, 6 had a recurrent ischial ulcer, 2 were bedridden following a cerebrovascular accident, 1 had a myelomeningocele status post operation, and 19 were spinal cord injury patients. Follow-up time ranged from 6 to 40 months. Pressure ulcer size ranged from 3 cm x 2 cm to 10 cm x 5 cm (average 22.3 cm²). The average flap size was 158 cm² (15.9 cm x 9.7 cm); the largest was 286 cm² (22 cm x 13 cm). The operating time ranged from 52 minutes to 110 minutes (average, 80 minutes). In 2 cases, wound dehiscence occurred but completely healed after resuturing. One (1) ischial pressure ulcer recurred 6 months following surgery and was successfully covered with a pedicled anterolateral thigh flap. No recurrences or problems were observed in the remaining 20 patients. Time to complete wound healing ranged from 14 to 24 days (average 17.8 days). Treatment of ischial pressure ulcers with GMM flaps allowed for an easy, simple procedure that provided the adequate thickness of soft tissue needed to cover the bony prominence, fill dead space, and cover the lesion. This technique was a reliable and safe reconstructive modality for the management of ischial pressure ulcers, even in recurrent cases.

Ischial pressure ulcers are the most common type of pressure injury to occur in the wheelchair-bound patient; the risk of recurrence is constant despite successful surgical treatment.^1,2 Recurrence rates vary widely from 7% to 48%,² indicating the difficulty in estimating a single factor that influences recurrence, although recurrence typically is related to persistent dead space in the wound cavity, shear forces on the tissue planes, and accumulation of serous fluids.³ Many different types of flaps are available for surgical coverage of ischial pressure ulcers; these include the anterolateral thigh perforator flap,¹ profunda femoris artery perforator flap,² freestyle perforator-based flap,⁴ medial circumflex femoral artery flap,⁵ gracilis muscle flap,⁶ medial gastrocnemius free flap,⁷ inferior gluteal artery perforator flap,⁸ and lateral thigh V-Y flap,⁹ but evidence to aid in the selection of optimal treatment is limited. Due to the high recurrence rate of ischial pressure ulcers,¹⁰ reconstruction design should allow coverage of the ulcer but not limit the use of other flaps in the future.

The oblique downward-design gluteus maximus myocutaneous (GMM) flap is a composite flap that provides adequate thickness of soft tissue to pad pressure points. With careful design, the superior gluteal artery perforator can be preserved for future use.

The purpose of this retrospective study was to evaluate outcomes of patients whose ischial ulcers were treated using the oblique downward-design GMM flap.

Methods

The records of all patients admitted between January 2010 and December 2015 to the Tri-Service General Hospital, Taipei, Taiwan, with a diagnosis of grade IV ischial pressure ulcers who underwent GMM flap surgery were retrieved. Defect size, flap size, operation time, duration of wound healing, and surgical outcome were abstracted from the medical records. Patients were candidates for this surgery if they had a grade IV ischial pressure ulcer. Patients with severe cardiac or pulmonary comorbidities and/or who would not be able to tolerate anesthesia were excluded.

Wound tissue was cultured to assess for wound infection and osteomyelitis; broad-spectrum antibiotics were prescribed preoperatively for each patient and were changed to specific antibiotics if a specific organism was isolated from the wound culture. Presurgical treatment included extensive debridement of necrotic tissue and open drainage. Wet gauze dressing, changed twice a day, was applied for local wound care. After adequate debridement and local wound management that included antibiotic agent treatment, reconstructive procedures were performed when healthy granulation tissue was present at the wound base.

Surgical procedure. All reconstructions using the oblique downward-design GMM flaps were performed by 1 surgical team led by the senior attending physician. After radical debridement and osteotomy of the bony prominence, an elliptical flap was designed from the side closest to the ischial pressure ulcer (see Figure 1). The composite musculocutaneous flap was harvested and shifted downward medially to cover the defect, and the wound was closed in the V-Y manner (see Figure 2). Care was shown to ensure the length of the designed flap was more than twice the size of the defect.

After the operation, a low-residual diet was provided for 2 weeks to reduce defecation and help prevent fecal contamination to the wound; meticulous perineal hygiene was maintained.¹¹ Patients were kept entirely nonweight-bearing on the ischial area for 4 weeks. Pressure was offloaded using an air-fluidizing bed; wheelchair use was avoided. The patient was repositioned to prone position and sidelying every 2 hours until the flap healed (see Figure 3).

Results

Of the 22 patients included in this study (ie, patients who underwent this procedure during the time stipulated), 15 were men and 7 were women, with a mean age of 52 (range 16–81) years. Follow-up extended an average of 20 months and included photography and telephone interviews. The majority of participants (20) had paraplegia; 6 had recurrent ischial ulcers, 2 were bedridden long-term following a cerebral vascular accident, 19 were spinal cord injury patients, and 1 was a patient with a myelomeningocele status post operation (see Table 1).

Average time from initial debridement to reconstruction was 2 weeks (range 1 week to 4 weeks).

Pressure ulcer size ranged from 3 cm x 2 cm to 10 cm x 5 cm (average 22.3 cm²), although the size of the wound base was typically several times larger than that of the skin defect. The average flap size was 158 cm² (15.9 cm x 9.7 cm); the largest was 286 cm² (22 cm x 13 cm). Operating time ranged from 52 minutes to 110 minutes (average 80 minutes). Duration of wound healing ranged from 14 days to 24 days (average 17.8 days). Wound dehiscence occurred in 2 patients but their wounds were completely healed after resuturing. No surgery-related mortality occurred. The longest follow-up was 40 months. Good outcomes (ie, wound healing without surgical complication such as flap necrosis or wound dehiscence) were achieved except for 1 recurrence of an ischial pressure ulcer (patient 2) 6 months after operation; this was treated successfully with a pedicled anterolateral thigh flap. The other 21 patients had no recurrence noted for a follow-up period of 6 to 40 months (average 20.3 months).

Discussion

Reconstructive surgery for pressure ulcer defects presents a difficult challenge; an outcomes analysis¹² showed patients with pressure ulcers often are bedridden, paraplegic, or quadriplegic. Ischial pressure ulcers are the most difficult pressure ulcers to treat because the ischial area is mobile and vulnerable to pressure when a person is in the sitting position.¹³ In addition, position changes involving flexion and extension of the lower extremities influence the tension on and size of the pressure ulcer. According to the report by Conway and Griffith¹⁴on the basic tenets of surgical treatment of pressure ulcers, treatment should involve excision of the ulcer, surrounding scar, underlying bursa, and soft tissue calcifications, if any, as well as radical removal of underlying bone and any heterotopic ossification. Padding bone stumps and filling dead space also were suggested. Inadequate debridement can lead to treatment failure; tissue removal usually reveals dead spaces under the surface of the skin, necessitating further flap reconstruction.

Although different types of flaps (ie, muscle, myocutaneous, and fasciocutaneous) are available for the surgical closure of ischial pressure ulcers, the optimal treatment remains controversial.^1,2,4-9 A systematic review³ revealed recurrence and complication rates of 8.9% and 18.6%, but differences with regard to recurrence or complication rates among musculocutaneous, fasciocutaneous, or perforator-based flaps for pressure ulcer coverage were not significant.

Many factors may affect the occurrence of pressure ulcers, including immobility, incontinence, poor nutritional status, and changes in consciousness.¹⁵ Retrospective chart reviews^16,17 have shown the type of surgical flap should be selected according to its ability to provide the adequate bulk for soft tissue coverage, vascularization, and sensory recovery fundamental to the reconstruction of pressure ulcer, as well as the importance of educating the caregiver on pressure ulcer management, especially pressure redistribution.

Fasciocutaneous flaps based on the anterolateral thigh perforator flap, gluteal perforator flap, gracilis perforator flap, or profunda femoris perforator flap and their various modifications also have been used to treat ischial pressure ulcers.^2,18 Flaps that provide inherent skin coverage and have good blood supply do not necessitate sacrifice of major vessels or nerves of the donor site; insufficient bulk and structural instability are disadvantages when reconstructing a wound with significant depth. Moreover, with the advent of reconstructive microsurgery, the use of free flaps has become the first choice of treatment to cover and reconstruct such defects.¹⁹ However, in the authors’ experience, the use of free flaps presents certain disadvantages, including donor-site morbidity, increased operation time, use of a major leg vessel, and the necessity of microsurgical expertise.

Myocutaneous flaps have sufficient bulk and robust vascularization and have been reported in chart review studies to be the method of choice for the surgical repair of pressure ulcers.^20,21 The muscle part of flaps can be helpful in obliterating dead space and supplying reliable vasculature to cushion the tissue over a pressure-bearing area, and the skin paddle is durable in terms of gliding and tolerating the shearing force. This modified GMM flap also can retain the superior gluteal artery perforator flap should there be recurrence. However, myocutaneous flaps sacrifice muscular function that may destabilize walking and, as such, are not an ideal option in ambulatory patients.²⁰

This retrospective study noted good outcomes in 21 cases (95.5%) during the average follow-up period of 20.3 months with 1 recurrence that was treated with a pedicled anterolateral thigh flap. A mild complication (wound dehiscence) occurred in 2 cases (9.1%), but the ulcers completely healed after resuturing. The average operating time was 80 minutes. In the authors’ experience, this operation time was shorter than other reconstructive methods such as traditional V-Y hamstring advancement flaps, profunda femoris arery perforator flaps, or pedicle anterolateral thigh flaps.

Limitation

The limitation of this study is inherent in its retrospective design and the lack of a control group. A larger prospective trial should be performed to further examine the outcomes of this procedure.

Conclusion

A retrospective examination of patient records showed treatment of ischial pressure ulcers with oblique downward design GMM flaps provided an easy, simple procedure and thick soft-tissue sufficient for covering the bony prominence and filling dead space. This technique can be performed more quickly than traditional surgery involving V-Y hamstring advancement flaps, profunda femoris artery perforator flaps, or pedicle anterolateral thigh flaps and is a reliable, safe reconstructive modality for the management of ischial pressure ulcers, even in recurrent cases. Additional studies are needed to further evaluate the long-term outcomes of this method, including larger patient populations, to compare the different outcomes and complications of the different methods of flap coverage. n

References

1. Santanelli Di Pompeo F, Longo B, Pagnoni M, Laporta R. Sensate anterolateral thigh perforator flap for ischiatic sores reconstruction in meningomyelocele patients. Microsurgery. 2015;35(4):279–283.

2. Kim CM, Yun IS, Lee DW, Lew DH, Rah DK, Lee WJ. Treatment of ischial pressure sores with both profunda femoris artery perforator flaps and muscle flaps. Arch Plast Surg. 2014;41(4):387–393.

3. Sameem M, Au M, Wood T, Farrokhyar F, Mahoney J. A systematic review of complication and recurrence rates of musculocutaneous, fasciocutaneous, and perforator-based flaps for treatment of pressure sores. Plast Reconstr Surg. 2012;130(1):67e–77e.

4. Yang CH, Kuo YR, Jeng SF, Lin PY. An ideal method for pressure sore reconstruction: a freestyle perforator-based flap. Ann Plast Surg. 2011;66(2):179–184.

5. Palanivelu S. Medial circumflex femoral artery flap for ischial pressure sore. Indian J Plast Surg. 2009;42(1):49–51.

6. Lee SS, Huang SH, Chen MC, Chang KP, Lai CS, Lin SD. Management of recurrent ischial pressure sore with gracilis muscle flap and V-Y profunda femoris artery perforator-based flap. J Plast Reconstr Aesthet Surg. 2009;62(10):1339–1346.

7. de la Fuente TP, González I, Calderón-Muñoz F. The role of medial gastrocnemius free flap in coverage of ischial pressure sore in paraplegic patients. Int J Surg. 2008;6(6):e72–e76.

8. Pérez de la Fuente T, González González I, Calderón Muñoz F. The IGAP flap for ischial pressure sore reconstruction in tetraplegic patients. Int J Surg. 2008;6(6):e1–e3.

9. Hayashi A, Maruyama Y, Saze M, Okada E. The lateral thigh V-Y flap for the repair of ischial defects. Br J Plast Surg. 1998;51(2):113–117.

10. Rubayi S, Cousin S, Valentine WA. Myocutaneous flaps. Surgical treatment of severe pressure ulcers. AORN J. 1990;52(1):40–47, 50, 52-55.

11. Bamba R, Madden JJ, Hoffman AN, et al. Flap reconstruction for pressure ulcers: an outcomes analysis. Plast Reconstr Surg Glob Open. 2017;5(1):e1187.

12. Higgins JP, Orlando GS, Blondeel PN. Ischial pressure sore reconstruction using an inferior gluteal artery perforator (IGAP) flap. Br J Plast Surg. 2002;55(1):83–85.

13. Griffith B, Shultz R. The prevention and surgical treatment of recurrent decubitus ulcers in patients with paraplegia. Plast Reconstr Surg. 1961;27(3):248–260.

14. Conway H, Griffith BH. Plastic surgery for closure of decubitus ulcers in patients with paraplegia; based on experience with 1000 cases. Am J Surg. 1956;91(6);946–975.

15. Bergstrom N, Braden B, Kemp M, Champagne M, Ruby E. Predicting pressure ulcer risk: a multisite study of the predictive validity of the Braden Scale. Nurs Res. 1998;47(5):261–269.

16. Foster RD, Anthony JP, Mathes SJ, Hoffman WY. Ischial pressure sore coverage: a rationale for flap selection. Br J Plast Surg. 1997;50(5):374–379.

17. Disa JJ, Carlton JM, Goldberg NH. Efficacy of operative cure in pressure sore patients. Plast Reconstr Surg. 1992;89(2):272–278.

18. Ayestaray B, Proske YM. Perineal and posterior vaginal wall reconstruction with a superior gluteal artery dual perforator-pedicled propeller flap. Microsurgery. 2015;35(1):64–67.

19. Lemaire V, Boulanger K, Heymans O. Free flaps for pressure sore coverage. Ann Plast Surg. 2008;60(6):631–634.

20. Fisher J, Arnold PG, Waldorf J, Woods JE. The gluteus maximus musculocutaneous V-Y advancement flap for large sacral defects. Ann Plast Surg. 1983;11(6):517–522.

21. Chen TH. Bilateral gluteus maximus V-Y advancement musculocutaneous flaps for the coverage of large sacral pressure sores: revisit and refinement. Ann Plast Surg. 1995;35(5):492–497.

Potential Conflicts of Interest: none disclosed

Dr. Chou is a resident, Division of Plastic Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center; and a resident, Department of Surgery, Taoyuan Armed Forces General Hospital, Taipei, Taiwan. Dr. Sun is a fellow, Department of Family and Community Health, Tri-Service General Hospital. Dr. Shih and Dr. Tzeng are physicians, Division of Plastic Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center. Dr. Chang is a physician, Division of Plastic Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center; and a physician, Division of Plastic Surgery, Shuang-Ho Hospital, Taipei Medical University, Taipei, Taiwan. Dr. Dai is chief physician and Dr. Lin is a physician, Division of Plastic Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center. Please address correspondence to: Chin-Ta Lin, MD, Division of Plastic Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, No. 325, Section 2, Cheng-Gung Road, Taipei, Taiwan 11490; email: aarondakimo@yahoo.com.tw

Section:

↧

A Retrospective Cohort Study to Determine Predictive Factors for Abdominal Wound Disruption Following Colorectal Surgery

April 3, 2018, 11:18 am

≫ Next: Prevalence of Skin Tears in Elderly Patients: A Retrospective Chart Review of Incidence Reports in 6 Long-term Care Facilities

≪ Previous: A Descriptive, Retrospective Study of Using an Oblique Downward-design Gluteus Maximus Myocutaneous Flap for Reconstruction of Ischial Pressure Ulcers

Issue Number:

Index:

Ostomy Wound Management 2018;64(4):22–29 doi: 10.25270/owm.2018.4.2229

Mahir Gachabayov, MD, PhD; Karen You, BS; Ryan Sullivan, BS; and Roberto Bergamaschi, MD, PhD, FRCS, FASCRS, FACS

Topics:

surgical wound dehiscence

abdominal surgery

postoperative complications

Abstract

Abdominal wound disruption (AWD) is a postoperative complication that increases length of hospital stay, mortality, and cost. A retrospective cohort study was conducted to identify predictors of AWD, defined in the National Surgical Quality Improvement Program User Guide as a spontaneous reopening of a previously surgically closed (midline) wound that occurs within 30 days after index elective surgery in patients undergoing colorectal surgery.

Data from the American College of Surgeons National Surgical Quality Improvement Program (2006–2012) were searched, supplemented by institutional review board-approved chart review. Patients were identified using Current Procedural Terminology codes for open and laparoscopic abdominal colorectal procedures. Data were collected to predefined worksheets and entered into a statistical analysis program and included demographics; comorbidities; pre- and postoperative laboratory tests including white blood count, blood glucose, and albumin levels; date and type of procedure; wound classification; postoperative complication rate; type of access; time to disruption; surgical site infection (SSI); and use of the SSI intervention/prevention bundle. The Wilcoxon rank sum test was utilized to compare independent continuous variables between the groups, and Fisher’s exact test was utilized to compare categorical variables. Variables with a P value <.2 at univariate logistic regression were included in multivariate logistic regression analysis. Time-to-event variables were compared using Cox regression analysis. Of the 690 patients included in the study, 16 (2.3%) developed an AWD. Mean age was 61.9 ± 15.3 years and 61.3 ± 15.0 years in AWD and non-AWD groups, respectively (P = .704). AWD occurred more frequently in men than women (75% vs. 50%; P = .040) and in patients who did compared to those who did not develop a deep incisional SSI (12.5% vs. 2%; P = .044). Preoperative albumin level was significantly lower in AWD (3.2 ± 0.8 vs. 3.8 ± 0.7; P = .006), as well as the proportion of post-bundle implementation (18.75% vs. 65.7%; P = .041). No significant differences were observed for any of the other variables examined. Per multivariate analysis, male gender (P = .05), absence of SSI bundle (P = .026), and hypoalbuminemia (P = .01) were independent predictors of AWD after elective colorectal resections. Time to AWD was significantly shorter in patients without SSI (P<.001). Results indicate implementation of the SSI bundle decreased AWD rates. Further prospective studies are needed to confirm these findings.

Wound disruption is a postoperative complication that contributes to increased morbidity and mortality rates and direct and indirect costs for individuals and health care providers.¹ Abdominal wound disruption (AWD) is a severe complication of colorectal surgery with reported incidence rates of 0.4% to 3.5% and mortality rates as high as 45%^2-4; it has been referred to in the literature as abdominal wound dehiscence, fascial dehiscence, or burst abdomen.

Attempts to improve surgical outcomes led to the National Veteran’s Administration Surgical Risk study in 1980s,⁵ and the National Surgical Quality Improvement Program (NSQIP) was initiated in 1990s.⁶ Patient Safety Indicators (PSI) were developed by the Agency for Healthcare Research and Quality of the United States Department of Health and Human Services to provide information on potential postoperative complications.⁷ One of the provider level indicators (PSI-14) measures AWD. National rates of postoperative wound disruption were at 0.48 per 100 000 US residents with the Healthcare Cost and Utilization Project, a risk-adjusted rate of 1.11 per 1000 eligible patients in 2008.^8,9

The NSQIP database was used to identify predictors of perineal wound disruption after abdominoperineal excision of the rectum¹⁰ and overall wound disruption after colorectal resections regardless of location of the resection.¹¹ In their retrospective review comparing 363 AWD cases with 1089 controls, van Ramshorst et al² reported AWD leads to evisceration requiring immediate re-operation (100%) and increases the length of hospital stay (P<.001), incisional hernia (P<.001), and mortality rates (16%). Several reports using multivariate logistic regression found heterogeneity among reported predictors of AWD in colorectal surgery.^3,10-12 In a retrospective study of 17 044 cases from the NSQIP database, Webster et al³ reported the independent risk factors for AWD were cerebrovascular accident with no residual deficit, history of chronic obstructive pulmonary disease (COPD), current pneumonia, emergency procedure, operation time >2.5 hours, postgraduate year 4 level resident as surgeon, superficial or deep wound infection, failure to wean from the ventilator, and 1 or more complications other than dehiscence. Wounds classified as clean and return to the operating room during admission were found to be protective factors. In their retrospective study of 2761 patients undergoing major abdominal surgery during a 5-year period, Riou et al¹² found age >65 years, wound infection, pulmonary disease, hemodynamic instability, and ostomies in the incision to be significant predictors of AWD. In another study using NSQIP data, Althumairi et al¹⁰ reported American Society of Anesthesiologists (ASA) classification ≥4 (P = .003), history of smoking (P<.001), history of COPD (P = .03), body mass index (BMI) ≥35 kg/m² (P = .001), and closure with a flap (P<.001) to be risk factors for wound disruption after abdominoperineal excision. In another study that utilized the NSQIP database, Moghadamyeghaneh et al¹¹ found the highest risk of wound disruption was among patients with wound infection (P<.01).

The surgical site infection (SSI) bundle was first introduced by the Institute for Healthcare Improvement¹³ (IHI) in 2001 and included 3 or more evidence-based interventions with the potential to prevent SSI to be implemented in a consistent manner for all patients. The SSI bundle was introduced in the authors’ cohort in 2009 and consisted of 4 groups of interventions: pre-hospital, pre-, intra-, and postoperative (see Figure 1).

One disadvantage of NSQIP data is the lack of information on the use and/or effect of the SSI bundle. To the best of the authors’ knowledge, no studies exist in the literature that evaluate the impact of the SSI bundle on AWD rates. The aim of this study was to identify predictive factors for AWD in patients undergoing colorectal resections.

Materials and Methods

Study design. A retrospective cohort study was conducted using the records of colorectal patients operated on by a single surgeon at a single institution. Demographics and relevant perioperative variables of all patients in the participant use data files who underwent abdominal colorectal surgery at the authors’ institution from 2006 to 2012 were extracted from the NSQIP database (see Table 1). Institutional Review Board approval was obtained before initiating the study, which was designed according to Strengthening the Reporting of Observational Studies in Epidemiology guidelines.¹⁴

Data collection and definitions. Patient records were identified using Current Procedural Terminology codes for open and laparoscopic abdominal colorectal procedures. Data abstracted included demographics; comorbidities; pre- and postoperative laboratory tests including white blood count (WBC), blood glucose, and albumin levels; date and type of procedure; wound classification; postoperative complications, including surgical site infection (SSI); type of access (open vs. laparoscopic); time to disruption; and use of the SSI intervention/prevention bundle. These data were entered into predefined Excel tables. The primary endpoint of the study was wound disruption, defined in the American College of Surgeons NSQIP User Guide¹⁵ as a spontaneous reopening of a previously surgically closed wound that occurs within 30 days after the principal operative procedure. Hyperglycemia was defined as blood glucose level of >140 mg/dL. Hypoalbuminemia was defined as serum albumin level of <3.5 g/dL.

All incisions were closed in layers according to the facility’s Division of Colon and Rectal Surgery wound closure guidelines. The fascia at laparoscopic port sites was closed using single-strand polydioxanone sutures; double-strand polydioxanone loops were employed to close midline laparotomy wounds. No preventive mesh was used. Skin closure was performed using titanium staples or interrupted monofilament sutures.¹⁶

Infection. Superficial SSI was defined in NSQIP as an infection that occurs within 30 days after the operation and involves only skin or subcutaneous tissue of the incision; deep SSI was defined as an infection that occurs within 30 days after the operation, appears to be related to the operation, and involves deep soft tissues (eg, fascial and muscle layers) of the incision. Organ/space SSI was defined as an infection that occurs within 30 days after the operation, appears to be related to the operation, and involves any part of the anatomy (eg, organs or spaces), other than the incision, which was opened or manipulated during an operation.¹⁶

Statistical analysis. Data were entered into SPSS software, version 18 (SPSS Inc, Chicago, IL), for statistical analysis. Mean and standard deviation were used as descriptive statistics for continuous variables; percentage and ratio were used to express categorical variables. Wilcoxon rank sum test was utilized to compare independent continuous variables between the groups. Categorical variables were compared using Fisher’s exact test, and univariate logistic regression was used to identify factors with the most significant impact on wound disruption rates. Variables with a P value <.2 were included in multivariate logistic regression analysis. Continuous variables such as preoperative albumin or blood glucose were converted to dichotomous variables for logistic regression with cut-off values as previously defined (hyperglycemia and hypoalbuminemia). Time-to-event variables were compared using Cox regression analysis. Statistical significance was defined as 2-sided, P≤.05.

Results

Of the 690 patients included in the database, 16 (2.3%) developed a wound disruption. Age, BMI, diagnosis, previous abdominal surgery, diabetes mellitus, chronic steroid use, current dialysis, liver cirrhosis, a history of COPD or neoadjuvant chemo- and radiotherapy use, pre- and postoperative blood glucose level, perioperative hyperglycemia rate, preoperative blood transfusion rate, type of surgery, wound class, type of access, creation of an ostomy at time of surgery, the use of an open wound management technique, and anastomotic leak rates were not significantly different between patients with and without AWD (see Table 1). More men than women (75% vs. 50%; P = .040) and more patients with hypertension requiring medication than those who did not (81% vs. 53%; P = .039) developed AWD. Thirteen (13) of the 16 AWDs developed before implementation of the SSI bundle; the pre-SSI bundle AWD rate was 13 of 379 (3.4%) compared to 3 of 311 (0.96%) following SSI bundle implementation (P = .041). Higher ASA scores were noted more frequently in AWD patients (ASA III–V: 100% vs. 78.3%; P = .026). Preoperative WBC and albumin levels also were significantly different between AWD and non-AWD patients; leukocytosis (11.7 ± 3.7 vs. 9.2 ± 8.0; P = .033) and hypoalbuminemia (3.2 ± 0.8 vs. 3.8 ± 0.7; P = .006) were more common in persons who developed AWD. SSI rates were significantly higher in AWD patients, owing to deep incisional SSIs that were significantly more frequent in AWD patients than in those who did not experience AWD (12.5% vs. 2%) (see Table 1).

Using univariate logistic regression, the most significant factors affecting AWD rates were found to be male gender, ventilator dependency, severe COPD, hypertension requiring medication, ASA class, hypoalbuminemia, overall SSI, deep incisional SSI, and absence of SSI bundle (see Table 2). Male gender, hypoalbuminemia, and absence of SSI bundle (pre-SSI bundle implementation] were the 3 independent predictive factors of AWD (see Table 3).

The mean time-to-AWD in patients with all 3 subtypes of SSI and without SSI was 15.25 ± 12.4 days vs. 15.57 ± 7.7 days. The onset of AWD was significantly later in AWD patients with SSI (P<.001) (see Figure 2). All patients with AWD underwent emergency wound closure and had no recurrent AWD or SSI within 30 postoperative days.

Discussion

AWD is a postoperative complication leading to increased length of hospital stay, mortality, and costs. In their retrospective study including 25 636 eligible patients who had undergone abdominopelvic surgery between January 1, 2008, and December 31, 2012, Shanmugam et al⁹ reported patients with any wound disruption included in the US Nationwide Inpatient Sample had 9.6% excess mortality, 9.4 days of excess hospitalization, and $40 323 in excess hospital charges relative to matched controls. These variables are worse for AWD. A recent European retrospective cohort study¹⁷ showed patients with AWD after laparotomy had 107.5% excess in-hospital mortality, 15.6 days of excess hospitalization, and 14 327 Euros excess cost. A comparative study¹⁸ (N = 967) evaluating long-term outcomes showed among the 37 patients with AWD, 83% developed incisional hernia at a median follow-up of 40 months. These patients also reported significantly worsened body image perception and decreased physical and mental quality-of-life scores.

In the current study, deep incisional SSI rates were significantly higher in patients with AWD. This finding is in line with previous reports evaluating perineal wound disruption after closure with a myocutaneous flap.^10,19 Other NSQIP database studies^11,20 reported superficial incisional and organ/space SSI rates were also significantly higher in patients with AWD.

Independent predictors of AWD in the present cohort included male gender, hypoalbuminemia, and absence of the SSI bundle. Male gender was found to be an independent predictor of AWD in previous studies as well. In a model based on regression coefficients, van Ramshorst et al² and Kenig et al²¹ reported 75% of AWD patients were men with a risk score of 0.7; other studies^17,22 have reported approximately 70% of patients with AWD were men, including a prospective study²² with 50 patients with AWD and a gender ratio of 2.84:1. However, some studies,^10,20,23,24 including 2 retrospective cohort studies with 44 (15 patients with AWD) did not find gender to be a predictor. In their post hoc analysis of data from a recent randomized trial involving 1386 patients who underwent emergency or elective laparotomy, Dahl et al²⁵ found smoking (3.8% smokers vs. 2.4% nonsmokers; P = .04) and alcohol abuse defined as daily intake of more than 4 drinks (15% abusers vs. 2.3% nonabusers; P<.0001) may account for the increased rates of AWD among men in several studies.

Serum albumin level <3.0 g/dL previously was shown to be a predictor of AWD following colorectal surgery.¹¹ In the current cohort, albumin level <3.5 g/dL was an independent predictor of AWD. A previous study²⁶ (N = 108 898) that also used NSQIP data to evaluate the association of hypoalbuminemia with postoperative complications among patients undergoing colorectal resection reported that even modest hypoalbuminemia (3 g/dL ≤ serum albumin level <3.5 g/dL) increased AWD rates.

In most previous studies, the role of SSI bundle implementation in AWD was not reported. The development of a SSI was a predictive but not an independently predictive factor of AWD in the current cohort; use of the SSI bundle was predictive. The SSI bundle, first introduced by the IHI in 2001, was defined as 3 or more evidence-based interventions implemented in a consistent manner for all patients with the potential to prevent SSI.¹³ In the current study, use of the SSI bundle seemed to have the potential to reduce AWD rates in patients after elective colorectal surgery.

Previous research¹¹ reported AWD was preceded by an SSI in 86% of the patients. The pathogenesis of AWD seems to differ in patients with and without SSI. In the current study, time to AWD was significantly shorter in patients who did not develop an SSI. Hence, implementation of SSI bundle and correction of preoperative hypoalbuminemia seems to reduce the risk of wound disruption.

Limitations

Overall, the use of previously acquired data can have inherent inaccuracies. In addition, an important limitation of this study may be that complication rates are underestimated because the NSQIP database only records follow-up data for 30 days postoperatively. Because the NSQIP database does not include all potential variables that may affect AWD (eg, intraoperative variables), not all risk factors could be ascertained.

Conclusion

Male gender, absence of the SSI bundle, and hypoalbuminemia (albumin level <3.5 g/dL) were independent predictors of AWD after colorectal resection. Deep incisional SSI was associated with increased rates of AWD. In this study, implementation of the SSI bundle decreased AWD rates. Further prospective studies are needed to confirm these findings. n

References

1. Sandy-Hodgetts K, Carville K, Leslie GD. Determining risk factors for surgical wound dehiscence: a literature review. Int Wound J. 2015;12(3):265–275.

2. van Ramshorst GH, Nieuwenhuizen J, Hop WC, et al. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010;34(1):20–27.

3. Webster C, Neumayer L, Smout R, et al. Prognostic models of abdominal wound dehiscence after laparotomy. J Surg Res. 2003;109(2):130–137.

4. Carlson MA. Acute wound failure. Surg Clin North Am. 1997;77(3):607–636.

5. Khuri SF, Daley J, Henderson W, et al. The Department of Veterans Affairs’ NSQIP: the first national, validated, outcome-based, risk-adjusted, and peer-controlled program for the measurement and enhancement of the quality of surgical care. National VA Surgical Quality Improvement Program. Ann Surg. 1998;228(4):491–507.

6. Khuri SF. The NSQIP: a new frontier in surgery. Surgery. 2005;138(5):837–843.

7. Agency for Healthcare Research and Quality. Postoperative Wound Dehiscence. Available at: www.qualityindicators.ahrq.gov/Downloads/Modules/PSI/V50/TechSpecs/PSI_5.... Accessed April 22, 2017.

8. Agency for Healthcare Research and Quality. Postoperative Wound Dehiscence (Provider-Level): Rate of Reclosure of Postoperative Disruption of Abdominal wall per 1,000 Cases of Abdominopelvic Surgery. Available at: www.qualitymeasures.ahrq.gov/content.aspx?id=38524&search=psi+14. Accessed April 22, 2017.

9. Shanmugam VK, Fernandez S, Evans KK, et al. Postoperative wound dehiscence: predictors and associations. Wound Repair Regen. 2015;23(2):184–190.

10. Althumairi AA, Canner JK, Gearhart SL, et al. Risk factors for wound complications after abdominoperineal excision: analysis of the ACS NSQIP database. Colorectal Dis. 2016;18(7):O260–O266.

11. Moghadamyeghaneh Z, Hanna MH, Carmichael JC, et al. Wound disruption following colorectal operations. World J Surg. 2015;39(12):2999–3007.

12. Riou JP, Cohen JR, Johnson H Jr. Factors influencing wound dehiscence. Am J Surg. 1992;163(3):324–330.

13. Institute for Healthcare Improvement (IHI). What is a Bundle? Available at: www.ihi.org/resources/Pages/ImprovementStories/WhatIsaBundle.aspx. Accessed April 23, 2017.

14. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007;147(8):573–577.

15. User Guide for the 2014 ACS NSQIP Participant Use Data File (PUF), American College of Surgeons, Chicago, IL. 2014. Available at: https://www.facs.org/~/media/files/quality%20programs/nsqip/nsqip_puf_us.... Accessed April 23, 2017.

16. Connolly TM, Foppa C, Kazi E, Denoya PI, Bergamaschi R. Impact of a surgical site infection reduction strategy after colorectal resection. Colorectal Dis. 2016;18(9):910–918.

17. Gili-Ortiz E, González-Guerrero R, Béjar-Prado L, Ramírez-Ramírez G, López-Méndez J. Postoperative dehiscence of the abdominal wound and its impact on excess mortality, hospital stay and costs [in Spanish]. Cir Esp. 2015;93(7):444–449.

18. van Ramshorst GH, Eker HH, van der Voet JA, Jeekel J, Lange JF. Long-term outcome study in patients with abdominal wound dehiscence: a comparative study on quality of life, body image and incisional hernia. J Gastrointest Surg. 2013;17(8):1477–1484.

19. Althumairi AA, Canner JK, Gearhart SL, Safar B, Sacks J, Efron JE. Predictors of perineal wound complications and prolonged time to perineal wound healing after abdominoperineal resection. World J Surg. 2016;40(7):1755–1762.

20. Rencuzogullari A, Gorgun E, Binboga S, Ozuner G, Kessler H, Abbas MA. Predictors of wound dehiscence and its impact on mortality after abdominoperineal resection: data from the National Surgical Quality Improvement Program. Tech Coloproctol. 2016;20(7):475–482.

21. Kenig J, Richter P, Lasek A, Zbierska K, Zurawska S. The efficacy of risk scores for predicting abdominal wound dehiscence: a case-controlled validation study. BMC Surg. 2014;14:65.

22. Ramneesh G, Sheerin S, Surinder S, Bir S. A prospective study of predictors for post laparotomy abdominal wound dehiscence. J Clin Diagn Res. 2014;8(1):80–83.

23. Aksamija G, Mulabdic A, Rasic I, Aksamija L. Evaluation of risk factors of surgical wound dehiscence in adults after laparotomy. Med Arch. 2016;70(5):369–372.

24. Gómez Díaz CJ, Rebasa Cladera P, Navarro Soto S, et al. Validation of abdominal wound dehiscence’s risk model [in Spanish]. Cir Esp. 2014;92(2):114–119.

25. Dahl RM, Wetterslev J, Jorgensen LN, et al; PROXI Trial Group. The association of perioperative dexamethazone, smoking and alcohol abuse with wound complications after laparotomy. Acta Anaesthesiol Scand. 2014;58(3):352–361.

26. Moghadamyeghaneh Z, Hwang G, Hanna MH, et al. Even modest hypoalbuminemia affects outcomes of colorectal surgery patients. Am J Surg. 2015;210(2):276–284.

27. Lundy JB. A primer on wound healing in colorectal surgery in the age of bioprosthetic materials. Clin Colon Rectal Surg. 2014;27(4):125–133.

Potential Conflicts of Interest: none disclosed

Dr. Gachabayov is a research fellow; Ms. You and Mr. Sullivan are research assistants; and Dr. Bergamaschi is Chief, Division of Colorectal Surgery, State University of New York, Stony Brook, NY. Please address correspondence to: Roberto Bergamaschi, MD, PhD, FRCS, FASCRS, FACS, Taylor Pavilion, Suite D-365, 100 Woods Road, Valhalla, NY 10595; email: rcmbergamaschi@gmail.com

Section:

↧

Prevalence of Skin Tears in Elderly Patients: A Retrospective Chart Review of Incidence Reports in 6 Long-term Care Facilities

April 3, 2018, 11:36 am

≫ Next: A Post-marketing Surveillance Study of Chronic Wounds Treated With a Native Collagen Calcium Alginate Dressing

≪ Previous: A Retrospective Cohort Study to Determine Predictive Factors for Abdominal Wound Disruption Following Colorectal Surgery

Issue Number:

Index:

Ostomy Wound Management 2018;64(4):30–36 doi: 10.25270/owm.2018.4.3036

Joyce Hawk, DNP, CRNP, CWCN; and Mary Shannon, DNP, CWOCN

Topics:

retrospective study

aged

wounds and injury

skin

Prevalence

Abstract

The incidence and prevalence of skin tears in long-term care (LTC) facilities has not been well established. To ascertain the point prevalence of reported skin tears, a retrospective review of incident reports was performed in 6 LTC facilities in western Pennsylvania from November 1, 2016 through December 31, 2016.

Report data, including resident age; gender; mobility limitations; skin tear location, number, and cause (if known); occurrence time (7 am to 3 pm, 3 pm to 11 pm, or 11 pm to 7 am nursing shift); and history of previous skin tears, were abstracted. All data were entered into a statistical analysis program and analyzed using descriptive statistics. Period prevalence was used to determine prevalence rate; an independent t test was used to compare the presence of skin tears between genders. Differences between location and cause of skin tears were evaluated using a multinomial test of related proportions. A test of proportions was used to evaluate skin tear occurrence time (nursing shift) differences. The overall point prevalence rate was 9% (N = 1253 residents) ranging from 6 to 28 skin tears per facility. The average age of residents with a skin tear (n = 119) was 83.5 years. The majority (111, 93%) had mobility limitations. Falls accounted for 38 skin tears (31.9%), followed by propelling in a wheelchair (18, 15.1%; X² =7.14; P = .008). Forearm skin tears (37, 31.1%) occurred significantly more frequently than lower leg skin tears (19, 16%; P = .016). Significantly more skin tears occurred during the 7 am to 3 pm shift (47, 39.5%) and 3 pm to 11 pm shift (49, 41.2%) than during the 11 pm to 7 am shift (23, 19.3%; X² = 5.78; P<.01). The results of this study confirm skin tears are a significant problem among elderly residents in LTC, especially because the reported rate is likely lower than the actual rate. Research to further elucidate the incidence and prevalence of skin tears and associated risk factors is needed to help develop evidence-based risk assessment, classification systems, treatment guidelines, and preventive measures.

Skin is the largest organ. Age-related changes, including thinning of the epidermis, reduced dermal thickness, and shrinking of subcutaneous fat, result in decreased elasticity, dryness, altered sensations and thermoregulation, greater absorption of topical products that can become irritants, skin sagging, and increased risk of separation at the epidermal-dermal junction.¹

Skin tears (STs) are defined as the separation of the epidermis from the dermis (partial-thickness) or separation of the epidermis and dermis from underlying structures (full-thickness)^2-5 caused by shearing, friction, or blunt trauma.^2,4,6 STs are a common and (based on expert opinion) preventable,^1,4,6 painful wound in long-term care (LTC) residents; they are multifactorial in etiology and thought to be underreported.⁷ A retrospective chart review by Malone et al⁷ of ST incident reports (N = 321) from an urban LTC facility, followed by a validation study comparing incident report results with a skin audit, suggested substantial underreporting with only 1 in 3 STs reported by incident report. STs also are thought to increase health care costs^4,8-12; however, health care costs related to treating STs have not been researched. STs can be a source of infection and evolve into a chronic wound and are thought to reduce quality of life.^4,5,11

ST classification systems. Three (3) ST classification systems have been identified in the literature: the Payne-Martin Classification System,² the Skin Tear Classification System (STAR),³ and the International Skin Tear Advisory Panel instrument.⁵ A universal system of classifying STs has not been adopted. In addition to not being well defined, ST classification systems have not been well utilized in health care and in LTC facilities.

ST significance. According to Bryant and Nix,¹³ changes in aging skin impair the body’s ability to heal. If they follow a normal healing trajectory, Type 2 and Type 3 STs (as defined by the Payne-Martin Classification System) will take 14 to 21 days to heal.¹³ The increase in the elderly population as the baby boomer generation ages and potential increases in the number of residents in LTC have implications for the prevalence of STs and their associated burden.

Prevalence. Prevalence describes the burden of a disease or condition in a population and can be used to determine the need for services or attention to that disease or condition. Period prevalence indicates the occurrence of a disease or event in a population over a period of time,¹⁴ usually weeks, months, or years. Prevalence of STs in LTC elderly has not been well established.

Skin tear prevalence. Using the STAR system, a point prevalence study¹⁵ conducted in 2016 (N = 144) on an acute medical ward in Singapore reported a ST prevalence of 6.2%. LeBlanc et al⁶ conducted a cross-sectional quantitative study in a LTC facility in Canada (N = 113) using the Payne-Martin Classification system and found a ST prevalence of 22%. In 2012, a cross-sectional epidemiological study¹⁶ used the STAR classification system among hospitalized adult cancer patients in Brazil (N = 157) and noted a ST prevalence of 3.3%. A point-prevalence study by Santamaria et al¹⁷ examined wounds (including STs) of neonatal, pediatric, and adult inpatients in 83 Western Australia hospitals (N = 5800) over 2 years and reported a ST prevalence of 8% for the year 2007 and 11% for 2008. The Australian Department of Veterans’ Affairs¹⁸ performed a 6-month chart review of wounds among veterans in home care (N = 155) that yielded a ST prevalence of 19.5%. McErlean et al¹⁹ conducted a hospitalwide, cross-sectional study at an Australian hospital (N = 87) using the Payne-Martin Classification system and found a ST prevalence of 11%.

Study Purpose

The purpose of this retrospective review of ST incident reports was to ascertain the prevalence of ST among the elderly in 6 LTC facilities in a region of southwestern Pennsylvania.

Methods

A retrospective chart review design was used to collect all study data from 6 LTC facilities in suburban southwestern Pennsylvania with a total of 1443 beds available (1253 occupied; the number of beds per facility ranges from 139 to 360). Institutional Review Board approval was obtained through Robert Morris University (Moon, PA) and the study was given an “exempt” status.

Elderly was defined as individuals 65 years and older with at least 1 functional impairment or any adult >75 years of age.²⁰ Six (6) LTC facilities located near the researcher were contacted randomly by phone; all 6 agreed to participate. Informed consent was deemed unnecessary, but written permission was obtained from each of the facilities involved in data collection. Facilities were numbered 1 through 6 in alphabetical order by name. Incident reports documenting STs in elderly patients dated from November 1, 2016, to December 31, 2016, were included for data collection.

Instrument. A data collection sheet was developed for this study by the principal investigator. Each of the 6 facilities had its own incident reporting form. The data collection sheet was piloted by reviewing 5 incident reports and modified by the principle investigator to include only items available in the incident reports. No medical records were reviewed for this study; mobility limitations were observed. A ST classification system was not used by any of the 6 facilities participating in the study, and ST descriptions were not well documented; thus, ST classification was not obtained. The investigator and co-investigator reviewed 5 incident reports independently using the data collection sheet to establish interrater reliability. The choice of data collected was based on previous ST studies and on information obtained in the collection sheet piloting and included date of incident report, work shift (7 am to 3 pm, 3 pm to 11 pm, 11 pm to 7 am), gender, date of birth, number of STs, location of STs, cause if known, history of previous STs, and mobility issues (ie, whether residents used a cane, walker, wheelchair, or were nonambulatory). Mobility issues not addressed within the incident report were clarified with facility staff. Incident reports were completed during the shifts the ST occurred or was first observed. The data collection sheets were placed in a secure folder and kept in the possession of the principal investigator at all times during the data collection process.

Study data. All data were abstracted by the principal investigator, de-identified, and entered into SPSS, version 22.0 (IBM Corp, Armonk, NY).

Data analysis. Period prevalence was used to determine prevalence rate. Frequency tables were used to determine percentages for age, location, cause, and shift. An independent t test was used to compare number of STs between genders. A multinomial test of related proportions was used to evaluate the difference between location and cause of ST. A test of proportions was used to evaluate shift differences. The remaining data and history of previous STs were analyzed using descriptive statistics.

Results

The total population of the 6 facilities was 1253 during the study period. From among all incident reports reviewed during the study period, 119 involved a ST. Two (2) ST incident reports were eliminated from further data analysis because the residents did not meet the definition of elderly. The average age of patients with a ST was 83.5 (range 65–103) years, 80 (67.2%) were female, 39 (32.8%) were male, 97 (81.5%) had a history of previous STs, and 111 (93.3%) had mobility issues. The greatest number of STs occurred on the 7–3 and 3–11 shifts (47 and 49 patients, respectively). Falls accounted for the greatest number of STs (38), followed by propelling in a wheelchair (18). The forearm was the most common location (37), followed by the lower extremity (19). In 32 of the incident reports, 12 patients (9 men and 3 women; 37.5%) had a recurrent ST. Of the 119 patients with a ST, 82.4% were 75 years old or above; 107 patients had 1 ST (89.9%) and 12 (10.1%) had 2 STs.

Overall study period prevalence was 9%. Facility 1 had a study period census of 134 with 22 documented STs for a 16% period prevalence. Facility 2 had a study period census of 201 with 6 documented STs for a 3% period prevalence. Facility 3 had a study period census of 264 with 21 documented STs for an 8% period prevalence. Facility 4 had a study period census of 219 and 21 documented STs for a 10% period prevalence. Facility 5 had a total study period census of 264 and 28 documented STs for a 11% period prevalence. Facility 6 had a total study period census of 171 with 21 documented STs for a period prevalence of 12%.

Results of an independent t test regarding gender and STs did not reach statistical significance; the mean number of STs for men and women were identical (M-1.10). Because patients could have multiple STs in different locations, a multinomial test of related proportions was conducted and showed the proportion of forearm tears (31.1%) was significantly greater than the proportion of lower leg tears (X² = 5.78; P = .016) (see Table 1).

Regarding the 2 most common reasons for sustaining a ST, the proportion of STs caused by falls was significantly greater than the proportion of STs caused by propelling in wheelchair (X² +7.14; P = .008) (see Table 1).

The 3–11 shift had the highest proportion of STs (41.2%), but this was not significantly different from the proportion of STs on the 7–3 shift. The 11–7 shift had the least number of STs (23), a significantly lower number than the 7–3 and 3–11 shifts (P<.01) (see Table 1).

Discussion

The reported period prevalence rate of STs in elderly persons residing in LTC in a region of southwestern Pennsylvania was 9%. This rate is lower than reported in 1 LTC in Canada (22%),⁶ a Western Australian hospital in 2008 (11%),¹⁷ an Australian VA home care (19.5%),¹⁸ and an Australian hospital in 2004 (11%)¹⁹; it is higher than in an acute medical ward in Singapore (6.2%),¹⁵ hospitalized cancer patients in Brazil (3.3%),¹⁶ and Western Australian hospital patients in 2007 (8%).¹⁷ The current study findings are clinically significant and suggest STs in elderly persons in LTC are a problem that requires more attention. The 6-facility individual reported point prevalence ranged from 3% to 16%. The reason for this difference is unclear and could be related to reporting or care practices. A larger, multisite prospective study of prevalence across different settings is needed to determine the true extent of STs.

This study suggests STs occur more frequently in women than men, a finding supported by Amaral et al,¹⁶ Chang et al,¹⁵ LeBlanc et al,⁶ and Malone et al,⁷ although a study by Carville and Smith¹⁸ reported more STs in men than women. The average age of LTC residents with STs in this study was high (83.5), similar to results from Carville and Smith,¹⁸ Chang et al,¹⁵ LeBlanc et al,⁶ Malone et al,⁷ and McGough-Csarny and Kopac.²¹ In a 1998 prospective descriptive study (N = 154) of STs in institutionalized elderly, McGough-Csarny and Kopac²¹ reported 72 (81.8%) had functional impairment, which was also supported in findings reported by Chang et al,¹⁵ LeBlanc et al,⁶ and Malone et al,⁷ concurring with the current study findings. The current study reported more STs on the upper body, which also was demonstrated in studies by LeBlanc et al,⁶ Malone et al,⁷ McErlean et al,¹⁹ and McGough-Csarny and Kopac.²¹ In terms of recurrence, 12 patients in the current study had recurring STs; more research is needed in this area. McGough-Csarny and Kopac²¹ showed 79.2% of patients (N =154) had a previous ST. In their cross-sectional, quantitative study among LTC patients in Canada, Leblanc et al⁶ found ST prevalence was noted to be statistically significant (X² = 3.98; P = .46) with correction of continuity, the Pearson chi-square, suggesting the possibility of a relationship between presence of and a clinical history of a ST.

LeBlanc et al⁶ reported banging into equipment as the most frequent cause of ST (36%), whereas Malone et al⁷ reported that bumping into object (12%) and wheelchair use (12%) contributed equally to STs. McGough-Csarny and Kopac²¹ cited wheelchairs (29.9%) as contributing most frequently to ST development, contradicting the current study findings that the most frequent cause of ST was falls. In their hospital audit to determine ST prevalence, McErlean et al¹⁹ found 25% of STs were caused by falls.

STs were more frequently recorded on the 7–3 and 3–11 shifts when peak activities of daily living are occurring. The role of preventive measures during these active shifts require further investigation.

Need for classification system use. One of the many difficulties encountered by wound care consultants is the absence of a universally accepted and used ST classification system, which has been hypothesized to result in better identification, tracking, and treatment.²² A ST classification system was not used in any of the LTC facilities in this study. Researchers are calling for a common validated ST classification system to be adopted — according to LeBlanc et al,²² acceptance and use of a common classification system are paramount to future research. According to expert opinion, STs can be incorrectly diagnosed as pressure ulcers; LeBlanc et al²² propose use of a ST classification system may reduce this error. Unidentified STs can lead to wounds that do not follow a normal healing trajectory, delay provision of preventive measures, and increase health care costs.

Although ST research groups are investigating the possibility, a ST risk assessment tool has not yet been developed. A 3-stage prospective study was conducted by Newall et al²³ to develop a ST risk assessment tool, ensure tool reliability, and validate the instrument in a metropolitan tertiary hospital in Western Australia. This study determined that the study tool had inadequate predictive validity and required further investigation. More research is needed to identify at-risk patients and associated factors and to evaluate the economic impact of ST on health care facilities, best practices in identification, risk factors, prevention, and treatment of ST, as well as education of all health care providers who care for individuals who develop ST. So far, little research has been conducted in this area. No studies were found about the impact of an ST on patient quality of life, thus representing another area of research that needs to be explored. Developing evidence-based practices through research is essential to the understanding, prevention, and treatment of ST.

Implications for Practice

STs require nursing time and attention, including assessment, documentation, and dressing changes that increase health care costs. This study highlights the importance of skin inspection, especially after falls, to assess for STs and institute appropriate treatments. Patients with repeat STs and mobility issues and the elderly should have routine skin inspection and protective measures initiated such as geri-sleeves.

Limitations

Retrospective chart reviews have a number of limitations that include incomplete information, record inaccuracy, the inability to verify information, and reviewer bias.²⁴ Incident reports may not have been completed on all residents who had STs, resulting in a lower, less accurate prevalence rate. Skin tears are considered underreported which could have influenced the prevalence rate found in this study. A larger population size, longer study period, and prospective skin inspections may have resulted in more robust results. Although a number of ST classification systems were noted in the literature, they are not well known and (in the principal investigators’ experience) not utilized in LTC. A common classification system might help health care providers to properly identify ST and develop treatment protocols.

Additional limitations include information collected on the incident reports varied from facility to facility, making collection of additional information such as risk factors, skin characteristics, treatments utilized, and preventive measures instituted difficult to obtain. Incident reports on patients whose age did not fit the definition of elderly were excluded, affecting results. The study was conducted during the winter months when residents are wearing long sleeved/layered clothing, which may have influenced study results. Most LTC facilities are required to report falls, which could account for the finding that STs were most commonly related to a fall. In a descriptive study, White²⁵ found nurses were less likely to report ST unless wounds were severe, large, problematic, or associated with trauma such as a fall. Results of the facilities participating in the study may not be representative of other LTC facilities in Pennsylvania or other areas of the United States. Although the researcher does not recognize any bias in facility selection, this may have been a study limitation, because other facilities in the area were not invited to participate. ST prevalence may reflect poorly on the perception of quality of care within a facility^4,9,21 and have direct implications for LTC facilities.

Conclusion

The results of a study to ascertain the prevalence of ST among elderly persons in LTC in western Pennsylvania highlighted that STs are common. During the 2-month study, the reported point prevalence rate in 6 facilities (N = 1253) was 9%. Most reported STs were related to a fall (38, 31.9%), occurred on forearm (37, 31.1%), and during 7–3 (47, 39.5%) and 3–11 (49, 41.2%) nursing shifts. Determining the reported prevalence of ST in LTC elderly underscores the need for more research and recognition of this problem, particularly because the actual point prevalence is probably higher than the rate observed in this study, which was based on incident reports. Further research such as prospective studies should include the development of evidence-based practices regarding risk factors and risk assessment tools, prevention, treatment, and research on ST impact on quality of life and health care costs. n

References

1. Baranoski S. Skin tears: the enemy of frail skin. Adv Skin Wound Care. 2000;13(3 Pt 1):123–126.

2. Payne RL, Martin ML. Defining and classifying skin tears: need for a common language. Ostomy Wound Manage. 1993;39(5):16-26.

3. Carville K, Lewin G, Newall N, et al. STAR: a consensus for skin tear classification. Prim Intent. 2007;15(1):18–28.

4. LeBlanc K, Baranoski S; Skin Tear Consensus Panel Members. Skin tears: state of the science: consensus statements of the prevention, prediction, assessment, and treatment of skin tears. Adv Skin Wound Care. 2011;24(9 suppl):2–15.

5. LeBlanc K, Baranoski S, Christensen D, et al. International Skin Tear Advisory Panel: a tool kit to aid in the prevention, assessment, and treatment

of skin tears using a simplified classification system. Adv Skin Wound Care. 2013;26(10):459–476.

6. LeBlanc K, Christensen D, Cook J, Culhane B, Gutierrez O. Prevalence of skin tears in a long-term care facility. J Wound Ostomy Continence Nurs. 2013;40(6):580–584.

7. Malone ML, Rozario N, Gavinski M, Goodwin J. The epidemiology of skin tears in the institutionalized elderly. J Am Geriatr Soc.1991:39(6):591–595.

8. Brillhart B. Pressure sore and skin tear prevention and treatment during a 10-month program. Rehabil Nurs. 2005;30(3):85–91.

9. Bank D, Nix D. Preventing skin tears in a nursing and rehabilitation center: an interdisciplinary effort. Ostomy Wound Manage. 2006;52(9):38–40, 44, 46.

10. Groom M, Shannon RJ, Chakravarthy D, Fleck CA. An evaluation of costs and effects of a nutrient-based skin care program as a component of prevention of skin tears in an extended convalescent center. J Wound Ostomy Continence Nurs. 2010;37(1):46–51.

11. Hampton S. How to preserve skin integrity and prevent skin tears. Nurs Resident Care. 2010;12(6):284–286.

12. Carville K, Leslie G, Osseiran-Moisson R, Newall N, Lewin G. The effectiveness of a twice-daily skin moisturizing regimen for reducing the incidence of skin tears. Int Wound J. 2014;11(4):446–453.

13. Bryant RA, Nix DP, ed. Acute & Chronic Wounds: Current Management Concepts. 3rd ed. Philadelphia, PA: Mosby Publishers;2007.

14. Anderson J, Langemo D, Hanson D, Thompson PA, Hunter S. Planning, conducting, and interpreting prevalence and incidence for the wound practitioner. Adv Skin Wound Care. 2013;26(1):35–42.

15. Chang YY, Carville K, Tay AC. The prevalence of skin tears in the acute care setting in Singapore. Int Wound J. 2016;13(5):977–983.

16. Amaral AF, Pulido KC, Santos VL. Prevalence of skin tears among hospitalized patients with cancer [in Portuguese]. Rev Esc Enferm USP. 2013;46(Spec No):44–50.

17. Santamaria N, Carville K, Prentice J. Woundswest: identifying the prevalence of wounds within western Australia’s public health system. Euro Wound Manage Assoc J. 2009;9(3):13–18.

18. Carville K, Smith J. A report on the effectiveness of comprehensive wound assessment and documentation in the community. Prim Intent. 2004;12(1):41–49.

19. McErlean B, Sandison S, Muir D, Hutchinson B, Humphreys W. Skin tear prevalence and management at one hospital. Prim Intent. 2004;12(2):83–88.

20. The Free Medical Dictionary. Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. Available at: http://medical-dictionary.thefreedictionary.com/elderly. Accessed February 8, 2017.

21. McGough-Csarny J, Kopac CA. Skin tears in institutionalized elderly: an epidemiological study. Ostomy Wound Manage. 1998;44(3A suppl):14S–25S.

22. LeBlanc K, Baranoski S, Holloway S, Langemo D. Validation of a new classification system for skin tears. Adv Skin Wound Care. 2013;26(6):263–265.

23. Newall N, Lewin GF, Bulsara MK, Carville KJ, Leslie GD, Roberts PA. The development and testing of a skin tear risk assessment tool. Int Wound J. 2016:14(1)97–103.

24. Hess DR. Retrospective studies and chart reviews. Respir Care. 2004;49(10):1171–1174.

25. White W. Skin tears: a descriptive study of the opinions clinical practice and knowledge base of RNs caring for the aged in high care residential facilities. Prim Intent. 2001;9(4):138–149.

Potential Conflicts of Interest: none disclosed

Dr. Hawk is a nurse practitioner and owner of Hawk Wound Care Consulting LLC, Pittsburgh, PA. Dr. Shannon is a nurse practitioner and owner of Shannon Wound Care Consultants LLC, Chicora, PA. Please address correspondence to: Joyce Hawk, DNP, CRNP, CWCN, 132 Berwyn Road, Pittsburgh, PA 15237; email: hawkjf1@gmail.com.

Section:

↧

A Post-marketing Surveillance Study of Chronic Wounds Treated With a Native Collagen Calcium Alginate Dressing

April 3, 2018, 11:54 am

≫ Next: A Rare Case of Cutaneous Diffuse Large B-cell Lymphoma Presenting as a Chronic “Infectious” Skin Ulcer

≪ Previous: Prevalence of Skin Tears in Elderly Patients: A Retrospective Chart Review of Incidence Reports in 6 Long-term Care Facilities

Issue Number:

Index:

Ostomy Wound Management 2018;64(4):38–43 doi: 10.27250/owm.2018.4.3843

Matthew Sabo, DPM; Lam Le, MD; Raphael A. Yaakov, MS; Marissa Carter, PhD; and Thomas E. Serena, MD

Topics:

clinical study

Wounds

diabetic foot ulcers

venous leg ulcers

Dressings

Abstract

Chronic wounds (ie, wounds that fail to progress through a normal, orderly, timely sequence of repair) continue to pose significant clinical and economic burdens. A prospective, descriptive, 3-week post-marketing surveillance study was conducted across 3 wound care centers in the United States to evaluate the effectiveness of a collagen calcium alginate dressing on chronic wounds in conjunction with standard care (SC) practices (eg, offloading, debridement, compression) to support healing.

Eligible participants had to be >18 years of age, have at least 1 chronic wound, and no known sensitivity to collagen. Demographic characteristics were recorded at the screening visit on case report forms. At each visit, wound-related pain was assessed using the Visual Analog Scale along with wound characteristics including size (using digital planimetry), wound exudate (minimal, moderate, heavy), and odor (none, mild). Participants were monitored for adverse events as well as infection based on signs and symptoms in and around the local wound bed, the deeper structures, and the surrounding skin. An intention-to-treat approach was used for all analyses. If an observation was missing, the last observation carried forward principle was used. For wounds that healed, pain and exudate were set to 0 (no pain/exudate) at visit 4. Descriptive, paired t tests and the Wilcoxon signed rank test were used to analyze the data. Of the 31 participants (15 men, 16 women, mean age 66.6 years), most (13, 42%) had a diabetic foot ulcer or venous leg ulcer (10, 32%); median duration of all wounds was 148 days. Thirty (30) patients completed the study. The mean number of comorbidities was 10.6 ± 6.3, and patients used a mean of 9.3 ± 5.64 prescription or over-the-counter medications. For all wounds combined, mean wound area was 4.8 ± 8.38 cm²at baseline. At week 3, a decrease in wound area of 38.1% was noted (median: 45% ± 42.54; P = .006); 3 wounds healed completely. The change in wound exudate level from visit 1 to visit 4 was statistically significant (P = .006). No adverse events or infections occurred. In this population, the use of etiology-appropriate SC and a collagen calcium alginate dressing resulted in a decrease in wound area after 3 weeks of care. Longer-term studies to confirm these observations and controlled clinical studies to compare the effects of this dressing to other nongauze dressing treatments are needed.

As the result of the aging population and an increase in the number of persons with risk factors such as diabetes, obesity, hypertension, and arterial insufficiency, the incidence of wounds is rapidly increasing.^1,2 Chronic ulcers in particular continue to pose a significant clinical and economic burden; in the United States alone, 6.5 million people are affected and an excess of $20 billion is spent on treatment annually.^1,2

Venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) are among the most frequently encountered chronic ulcers in outpatient wound care practice.² Standard care (SC) in the treatment of DFUs includes debridement, offloading, and infection management; however, according to a meta-analysis³ of 10 control groups from randomized controlled trials (RCTs), <30% of individuals with a DFU will heal within 20 weeks of commencing SC. A more recent randomized controlled trial by Zelen et al⁴ revealed mean time to healing for DFUs treated with SC alone was 57.4 days compared to 23.5 days for dehydrated human amnion/chorion membrane (EpiFix; MiMedx, Marietta, GA) and SC and 47.9 days for a bilayer bioengineered skin substitute (Apligraf; Organogenesis, Canton, MA) and SC. Patients with unresolved ulcers are at risk of cellulitis, osteomyelitis, and amputation. According to evidence-based guidelines presented at a National Institute of Health conference by a panel of advisers,⁵ if a DFU does not decrease in area by 40% after 4 weeks of care, advanced wound therapies should be used.⁵

VLUs treated using multilayer compression therapy also can take months to heal completely. With multilayer compression therapy alone, healing rates range from 30% to 60% at 24 weeks and 70% to 85% by year 1, according to a retrospective cohort study by Margolis et al.⁶ A 12-month recurrence rate is estimated to be between 18% and 28%.⁷ Thus, management and prevention of recurrence should be a priority. Adjunctive therapies with advanced wound care modalities are recommended with SC if progress in healing is not made within 30 days.⁶

In nonhealing wounds, the extracellular matrix (ECM) is disrupted or destroyed and cannot support wound healing. Therefore, it is believed that treatment strategies designed to replace the absent or dysfunctional ECM may be beneficial.⁸ Natural collagen dressings are thought to facilitate healing in the preparation of the wound bed. Collagen has been shown to have an essential role in reducing inflammation, providing a matrix for remodeling and acting as a sacrificial substrate for proteases.⁸ Cutimed Epiona (BSN medical, Hamburg, Germany), a collagen dressing that contains 90% native collagen and 10% calcium alginate, offers a native 3-dimensional (3D) matrix structure that is hypothesized to support the capture and binding of excessive proteases and inflammation-inducing factors in addition to providing support for the proliferation of cells needed for wound repair.⁹ The dressing’s flexible, open-porous 3D structure is designed to allow the collagen to function like an ECM scaffold in which fibroblasts can attach to the dressing and proliferate more rapidly to support granulation tissue ingrowth.⁹ A working group of experts found the dressing has the potential to accelerate healing in wounds that have not responded to basic wound care.⁸

The objective of this prospective, descriptive surveillance study was to evaluate the effectiveness of a collagen dressing administered in conjunction with SC (ie, etiology-appropriate provision of debridement, cleaning, cover dressing, and offloading) in the treatment of chronic wounds over 3 weeks (4 visits: weeks 1, 2, 3, and 4).

Methods

Setting and participants. A prospective post-marketing surveillance study was conducted at 3 wound care centers in the United States. All patients 18 years of age with at least 1 chronic wound (defined as a wound that fails to progress through a normal, orderly, timely sequence of repair^10,11) or any wound in which healing was delayed, stalled, hard to achieve, complex (ie, having 1 or more complicating factors such as exudate, infection, and comorbidities), or not responding to previous treatment, and with no known sensitivity to bovine collagen or other contents of the collagen dressing were included in the study. Participants with third-degree burns and persons who had received an experimental drug or medical device within 7 days before the start of the treatment visit were excluded. In patients with more than 1 wound, the largest wound was included in the study (if other ulcerations were present, they had to be at least 2 cm apart).

Institutional Review Board approval was obtained from the Western Institutional Review Board (Pr. No.: 20151675) and all patients provided written informed consent before study enrollment.

Treatment. SC was provided according to wound etiology. DFUs were offloaded, and VLUs received compression; all study wounds were surgically debrided as clinically indicated and cleansed with saline solution. The dressing was applied weekly and used in accordance with the application recommendations specified by the manufacturer and clinical requirements. The choice of secondary dressings depended on the type of wound, exudate, and patient characteristics; secondary dressings were used at the principal investigator’s discretion (see Table 1). At each visit, wound-related pain was assessed using the Visual Analog Scale. Wound assessments were captured on all visits using digital planimetry (ARANZ Medical, Christchurch, New Zealand). Wound characteristics (exudate [minimal, moderate, heavy] and odor [none, mild]) were noted. Participants were monitored for infection and adverse events throughout the study. Presence of infection was evaluated based on clinical signs and symptoms around the local wound bed, the deeper structures, and the surrounding skin. A participant was considered to have completed the study if he/she had completed all visits or his/her wound healed and the confirmation of healing visit occurred as part of the study.

Data collection and analysis. Data were documented on case report forms and grouped for analysis. For medication grouping, selected indications were reviewed including pain, neuropathic pain, wound pain, for diabetes, dyslipidemia/high cholesterol, renal disorders, hypertension, and mental illness. Wound area was grouped by type of wound, but pain and exudate were not categorized by wound type. Body mass index (BMI; height x weight) was calculated and grouped by underweight, normal weight, overweight, obese, and morbidly obese.

An intention-to-treat (ITT) approach was used for all analyses. For missing observations, the last observation carried forward principle was used. For wounds that healed, wound area, pain, and exudate level were set to 0 at visit 4. Study variables were summarized as means and standard deviations (SDs) for continuous variables unless the data were non-normal, as determined by the Shapiro-Wilk test, in which case medians also were reported. Proportions or percentages were used to outline categorical variables. Paired t tests were used to compare endpoints if data were normally distributed, and the Wilcoxon signed rank test was applied if the data were non-normal and differences existed. To adjust for the family-wise error rate, P values were reported using the Hochberg step-up procedure. Adjusted 2-sided P values <.05 were considered significant. Data were entered into PASW 19 (IBM, Armonk, NY) to perform the statistical testing.

Results

Of the 31 patients screened (15 men, 16 women, mean age 66.6 years), 30 completed the study (97%); 1 patient dropped out after 2 weeks. Four (4) missed the week 2 visit and 1 missed the week 3 visit. Most (90%) of the patients were Caucasian; 10% were African American. The study population was composed of individuals with many serious comorbidities; the mean number of comorbidities per patient was 10.6 (see Table 2). Nearly two thirds of the patients were overweight or obese (61%) and a high proportion had diabetes (65%), hypertension (68%), or neuropathy (48%). Patients used a mean of 9.3 prescribed or over-the-counter medications; the majority were for hypertension (74%), pain (61%), and diabetes management (48%) (see Table 3).

Four (4) patients had multiple wounds; 27 had 1 wound. Seven (7) patients had experienced prior amputations, 6 of whom had DFUs and 1 had a Stage 2 pressure ulcer on the heel as well as a history of peripheral vascular disease and neuropathy. The majority of ulcers in the study were DFUs (42%) and VLUs (32%) (see Table 4).

Mean wound area at first visit was 4.8 ± 8.38 cm² but varied considerably by etiology; for example, the mean area for DFUs was 2.1 ± 1.68 cm² and for VLUs was 8.9 ± 13.21 cm²(see Table 4). The mean duration of the wound at first visit was 301 days; wound age was not grouped by wound type.

Of the 13 DFUs, 12 were offloaded, 6 using total contact casting (TCC; 46%); other offloading methods included Charcot restraint orthotic walker (2 [15%]), offloading shoe (3 [23%]), and a wheelchair (1 [8%]), and 1 (8%) was not offloaded. All VLUs (7 [70%]) received compression using 3M 2-layer compression bandages (3M, St Paul, MN), while others were provided Unna boot (1 [10%]), Tubigrip (1 [10%] minimal compression; Mölnlycke Health Care, Norcross, GA), and unspecified multilayer compression wraps (1 [10%]). Surgical debridement was provided as clinically indicated as follows: no debridement (4 [13%]), 1 debridement (13 [2%]), 2 debridements (5 [16%]) 3 debridement (6 [19%]), and 4 debridements (3 [10%]).

Of the 30 patients who completed the study, 13 reported wound-related pain at their first visit. Mean pain score at visit 1 was 1.6 ± 2.36, and mean pain reported at visit 4 was 1.3 ± 2.05. These differences were not tested statistically. On the other hand, 3 reported some level of pain at visit 4 when they had reported no pain in visit 1.

The proportion of patients with heavy/moderate amounts of exudate decreased between visit 1 and 4 (P = .006; see Table 5). The mean wound area for all wounds at the first visit was 4.8 ± 8.38 cm². The reduction in wound area 3 weeks after the first visit was 38.1% (median: 45% ± 42.54) (P = .006) with steady reductions week by week (see Figure). Of the 31 wounds, 14 (45%) were reduced by 50% or more after 3 weeks (7 DFUs, 3 VLUs, 2 traumatic wounds, 1 surgical wound that was 26 days old at first visit, and 1 pressure ulcer). Complete wound healing occurred in 3 wounds (10%) (2 VLUs and 1 traumatic wound). No infections or adverse events occurred during the study (see Table 4).

Discussion

Although a small number of chronic wounds will respond to SC, complete healing can take months.^3,6 Most of these wounds resist healing due to several factors, such as the severity of the ulcer and the patient’s health status.¹²

A number of patients in this study were overweight or obese; had diabetes, hypertension, or neuropathy; and were taking prescribed or over-the-counter drugs for hypertension, pain, and diabetes. Despite these serious comorbidities, their wounds started healing after patients were enrolled in the study.

Although studies exists regarding the effects of using different collagen dressings (eg, collagen with alginate, collagen with hyaluronic acid, collagen with silver), the current authors found results of previous research vary/conflict for each type of dressing. The authors suggest this would be a good topic for systematic review.

Limitations

Although this study provides evidence that native collagen dressing may be more effective than SC alone, further controlled clinical studies to expand on these promising results should include the use of consistent secondary dressings, offloading, and compression devices. Follow-up studies should examine biofilm activity and explore how collagen dressing influences the microbial population in chronic wounds. Comparative effectiveness research is also needed; future studies should investigate the effect of different collagen dressings. With the continued focus on cost of wound care management, it is pertinent to evaluate the cost-effectiveness.

Conclusion

In this prospective, descriptive, post-marketing surveillance study, 31 patients with a variety of chronic wounds received appropriate standard wound care and a marketed collagen/alginate dressing for a period of 3 weeks. During that time, 3 wounds healed completely, no adverse events occurred, wounds reduced in size an average of 31.8%, and the proportion of wounds with heavy or moderate exudate decreased over the study duration. These results suggest that adding this dressing to SC practices, including offloading DFUs and providing compression for VLUs, has the potential to improve outcomes in patients with chronic wounds and comorbidities that may affect their healing potential. Future controlled clinical studies to ascertain the efficacy of this dressing compared to other nongauze dressing regimens are warranted.

References

1. Sen CK, Gordillo GM, Roy S, et al. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009;17(6):763–771.

2. Frykberg RG, Banks J. Challenges in the treatment of chronic wounds. Adv Wound Care. 2015;4(9):560–582.

3. Margolis D, Kantor J, Berlin J. Healing of neuropathic ulcers receiving standard treatment: a meta-analysis. Diabetes Care. 1999;22(5):692–695.

4. Zelen CM, Serena TE, Gould L, et al. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost. Int Wound J. 2016;13(2):272–282.

5. Steed DL, Attinger C, Colaizzi T, et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006;14(6):680–692.

6. Margolis DJ, Berlin JA, Strom BL. Risk factors associated with the failure of a venous leg ulcer to heal. Arch Dermatol. 1999;135(8):920–926.

7. Ashby RL, Gabe R, Ali S, et al. Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous Leg Ulcer Study IV, VenUSIV): a randomized controlled trial. Lancet. 2014;383(9920):871–879.

8. International consensus. Acellular matrices for the treatment of wounds. An expert working group review. London, UK: Wounds International;2010.

9. Wiegand C, Buhren BA, Bünemann, E, et al. A novel native collagen dressing with advantageous properties to promote physiological wound healing. J Wound Care. 2016;25(12):713–720.

10. Serena TE, Cullen BM, Bayliff SW, et al. Defining a new diagnostic assessment parameter for wound care: elevated protease activity, an indicator of nonhealing, for targeted protease-modulating treatment. Wound Repair Regen. 2016;24(3):589–595.

11. Grey JE, Enoch S, Harding KG. Wound assessment. BMJ. 2006;332(7536):285–288.

12. Anderson K, Hamm RL. Factors that impair wound healing. J Am Coll Clin Wound Spec. 2012;4(4):84–91.

Potential Conflicts of Interest: This research was supported by BSN medical, Hamburg, Germany.

Dr. Sabo is CEO and founder, The Foot and Ankle Wellness Center of Western Pennsylvania, Ford City, PA. Dr. Le is Medical Director, St. John Wound and Hyperbaric Center, Tulsa, OK. Mr. Yaakov is Clinical Project Lead, SerenaGroup^®, Cambridge, MA. Dr. Carter is President, Strategic Solutions, Cody, WY. Dr. Serena is founder and CEO, SerenaGroup^®. Please address correspondence to: Thomas E. Serena, MD, 90 Sherman Street, Cambridge, MA 02140; email: serena@serenagroups.com

Section:

↧

A Rare Case of Cutaneous Diffuse Large B-cell Lymphoma Presenting as a Chronic “Infectious” Skin Ulcer

April 3, 2018, 12:26 pm

≫ Next: A Cross-sectional Study of Nutritional Status, Diet, and Dietary Restrictions Among Persons With an Ileostomy or Colostomy

≪ Previous: A Post-marketing Surveillance Study of Chronic Wounds Treated With a Native Collagen Calcium Alginate Dressing

Issue Number:

Index:

Ostomy Wound Management 2018;64(4):44–47 doi: 10.25270/owm.2018.4.4447

Huapei Song, MD; Yali Gong, MD; Xiaochu Yan, MD; and Jiaping Zhang, MD

Topics:

case report

wound

Infection

cutaneous

lymphoma

Abstract

Cutaneous diffuse large B-cell lymphoma (DLBCL) usually manifests as papules, nodules, or plaques. A rare case of a patient with a chronic skin ulcer and signs and symptoms of infection, including fever and large amounts of yellow wound exudate, is presented.

Fifteen (15) months before diagnosis, a 43-year-old otherwise healthy man noted soreness without apparent cause in his upper chest and a palpable 2 cm x 2 cm focal lump. The patient developed frequent fevers, and the lump enlarged over time, producing purulent exudate. For 14 months, the patient was examined and treated at 5 hospitals, but biopsies, smears, cultures, and various types of nucleic acid testing were negative. Antibiotics to treat the suspected but nonclassified infection were ineffective. Ultimately, debridement and pathological examination of necrotic tissue from the deep sinus revealed DLBCL. The patient was provided chemotherapy, surgical debridement, and negative pressure wound therapy. Wounds started to reduce in size once chemotherapy was initiated. The wound was surgically closed with a split-skin graft, and the patient was discharged 93 days following admission to the authors’ facility. This case illustrates the possibility of cutaneous DLBCL in patients with chronic skin ulcers and infectious manifestation that do not respond to antibiotic therapy. Prompt deep tissue debridement and pathological examination of deep tissue will help confirm the presence of cutaneous DLBCL and guide required chemotherapy.

Chronic skin ulcers are a common complication of diabetes, peripheral vascular disease, infection, and neoplasia. Local ulcer care will be successful only if the underlying cause is correctly identified and medical steps are taken to reverse it. Diffuse large B-cell lymphoma (DLBCL), the most common type of lymphoma, accounts for ~30% to 40% of non-Hodgkin’s lymphoma.¹ Skin is the second most common site of extranodal non-Hodgkin B-cell lymphomas, with an estimated incidence of 0.3/100 000/year.² Cutaneous DLBCL usually manifests as papules, nodules, or plaques; abscesses or ulcers develop only in rare cases.³ The authors’ review of the literature revealed few cases of B-cell lymphomas associated with cutaneous ulceration, and none of them presented as a chronic “infectious” abscess per the case reported herein. The purpose of this case study is to document the presentation of cutaneous DLBCL as a nonhealing wound with signs and symptoms of infection.

Case Report

History. Mr. J, a 43-year-old otherwise healthy man (no underlying disease), was admitted to the authors’ facility, a large comprehensive hospital with 2900 beds, with a nonhealing ulcer on his left chest that was discharging purulent drainage. The patient had begun to feel soreness without apparent cause in his upper left chest 15 months earlier, and a focal lump (2 cm × 2 cm) without tenderness could be palpated. Approximately 1 month later, the mass gradually enlarged, and Mr. J experienced intermittent fever and was hospitalized successively in different hospitals where lymph node biopsy and ulcer exudate, as well as smears, microbial culture, acid-fast staining, and tuberculous/nontuberculous mycobacteria nucleic acid testing, were negative for bacterial or fungal infection.

Several pathological examinations of the wound and adjacent lymph nodes involving immunohistochemical staining and biopsy revealed vascular proliferation accompanied by the infiltration of inflammatory cells. After incision and drainage, Mr. J’s chest and neck wounds failed to heal but large amounts of yellowish exudate were present and samples were sent for microbiological cultures to look for possible bacteria or fungi, with negative results. Mr. J was treated successively with antibiotics including cephalosporin, quinolone, and antituberculosis drugs appropriate to the infectious manifestations but he still developed intermittent fever. A sterile gauze sponge was applied for drainage and the wound was dressed with gauze, foam, alginate, and silver dressings in succession; nothing brought about wound healing.

After approximately 14 months of treatment in 5 hospitals, Mr. J was transferred to the authors’ hospital. Mr. J was running an intermittent body temperature of 36.4˚ C to 38.5˚ C, his vital signs were stable, he was conscious, and the wound did not affect activities of daily living. He reported only mild pain from the chest wound according to visual analogue scale assessments, and he had no comorbidities. Wound exudate was sent for bacterial and fungal cultures multiple times and all returned negative. On day 5 of admission, thoracic and abdominal computed tomography (CT) examinations showed a left cervicothoracic abscess, splenic abscess, and right axillary lymph node enlargement. Splenic puncture and abscess drainage were performed under CT guidance. No bacteria or fungi were found in the drained fluid, and only inflammatory cells were detected in the pathological examination.

On day 11 of admission, bone marrow biopsy results showed active hematopoiesis with prominent myeloid hyperplasia and blood tests showed significantly elevated indicators of infection (white blood cell and neutrophil counts [27.42 x 109/L], C-reactive protein [185.59 mg/L], and erythrocyte sedimentation rate [107 mm/hour]). After anti-infection treatments (eg, penicillin, azithromycin, ceftazidime, imipenem, and metronidazole) were provided in succession in the appropriate dosage and according to the manufacturer instructions, the aforementioned indices did not change significantly. The yellowish exudate from the ulcer increased and sinus depth was 6 cm to 9 cm; neither improved after dressing changes (2 to 3 times every day) or use of sterile gauze sponges in the sinuses to drain the exudate (see Figure 1A).

On day 15 of admission, Mr. J was still experiencing intermittent fever and his blood pressure began to drop, indicating septic shock (lowest blood pressure was 79/42 mm Hg). After antishock therapy with noradrenalin, Mr. J’s blood pressure returned to normal. The following day, the wounds were debrided under general anesthesia and intraoperative exploration revealed deep chest sinuses reaching to the ribs and parietal pleura, with a large amount of cheese-like necrotic tissue packed on the sinus wall. Negative pressure wound therapy (NPWT) was initiated in the operating room and continuously applied at a setting of -100 mm Hg for 6 to 7 days. Mr. J had no fever after the surgery, and the infection indexes gradually decreased to normal. Tissue culture showed no growth of bacteria or fungi.

Diagnosis. Pathological examination of sampled tissues suggested lymphohematopoietic malignancies in the necrotic tissue deep inside the chest wall and lymphoid tissues of the left neck (see Figure 2). Taking into account the morphological and immunological phenotypes and a history of long-term skin ulcers, the diagnosis of DLBCL associated with chronic inflammation was confirmed. A positron emission tomography-CT (PET-CT) examination revealed increased fluorodeoxyglucose (FDG) uptake in the cervicothoracic and right axillary lymph nodes and spleen, indicating invasive lymphoma.

Treatment. Mr. J was provided rituximab, vindesine, epirubicin, cyclophosphamide, and prednisolone (R-CHOP) chemotherapy for 7 days, repeated every 3 weeks in the department of hematology. After 3 rounds of chemotherapy, a follow-up PET-CT scan showed FDG uptake in cervicothoracic soft tissues was reduced significantly in both intensity and scope and the nodular FDG uptake in the spleen also decreased significantly. During the period of chemotherapy, Mr. J’s left cervicothoracic wound gradually decreased in size; deep sinuses in the wounds closed after several surgical debridements and NPWT treatments.

Approximately 11 weeks after admission, the left thoracic wound was debrided and a split-skin graft was applied, after which the cervicothoracic wound healed (see Figure 1B). Mr. J was discharged on day 93 after admission.

Discussion

In this case, the patient had received long-term anti-infection treatments in different hospitals because infection is still a primary consideration when a patient presents with long-term fever, heavy wound exudate, significantly increased inflammatory indices, an early-stage wound biopsy indicating only infiltration of inflammatory cells, and long-term administration of systemic antibiotics have a negligible therapeutic effect. After Mr. J underwent surgical removal of necrotic tissue from his deep lesions, pathological examination led to an unexpected diagnosis of DLBCL. After R-CHOP chemotherapy, the disease was controlled and wounds started to decrease in size. This case suggests DLBCL should be considered in patients with prolonged nonhealing ulcers with local or systemic manifestations of infection that fail to respond to anti-infection therapy.

Prompt treatment (ie, once the patient’s symptoms or clinical examinations are associated with the wounds) if the wound is unresponsive to standard care surgical procedures for the removal of necrotic tissue from deep lesions, along with pathological examination, can help confirm the etiology. The authors believe the yellowish exudate from the wound yielded negative microbiological culture results because it was not the result of an infectious process but rather liquefaction of the lymphoma. The authors’ theory cannot be confirmed because, to the best of their knowledge, this is the first documented case of a cutaneous DLBCL presenting as a chronic skin ulcer with infectious manifestation.

DLBCL can be divided into germinal center cell-like (GCB) and non-GCB subtypes for prognosis assessment according to immunohistochemistry results.⁴ In the current case, the multiple myeloma oncogene 1 (MUM1), CD138, C-myc, and PAX-5 all were positively expressed. MUM1 and CD138 usually are used as non-GCB subtype markers, while C-myc and PAX-5 also indicate poor prognosis.⁵ In addition, PET-CT scans not only improve the accuracy of diagnosis of DLBCL but also help assess treatment efficacy. Numerous studies^6,7 reported patients with a negative scan showed both a better progression-free and a better overall survival rate; these results helped physicians make further treatment decisions. However, the PET scan’s prognostic value has not been consistently proven to surpass the prognostic potential of the International Prognostic Index^6,7 (IPI), a clinical tool developed by oncologists to help predict the prognosis of patients with aggressive non-Hodgkin’s lymphoma. The IPI assigns 1 point for each of the following risk factors: age >60 years; stage III or IV disease; elevated serum lactate dehydrogenase; Eastern Cooperative Oncology Group/Zubrod performance status (a measure of patient cancer status) of 2, 3, or 4; and >1 extranodal site. The sum of the points allotted correlates with the following risk groups: low risk (0–1 points) — 5-year survival of 73%; low-intermediate risk (2 points) — 5-year survival of 51%; high-intermediate risk (3 points) — 5-year survival of 43%; high risk (4–5 points) — 5-year survival of 26%. The IPI was not applied in this case. However, according to the assessment standards, had the IPI been applied, it would indicate low-intermediate risk. Of note, either PET or IPI is valuable for prognosis of DLBCL, which does not affect the therapeutic measures.

Ideally, surgery on patients with DLBCL should be limited to a biopsy to establish the correct histological diagnosis, leaving the treatment with curative intent to radiotherapy and chemotherapy.⁸ In this case, the patient received several surgical debridements combined with NPWT drainage along with chemotherapy. The deep sinuses gradually closed, and the ulcer healed after split-skin grafting.

Conclusion

The possibility of cutaneous DLBCL should be considered in patients with chronic skin ulcers and infectious manifestation that do not respond to antibiotic therapy. Early debridement and pathological examination of tissues from the deep lesion can help determine an accurate diagnosis and prompt treatment that includes surgical debridement and skin grafting after chemotherapy to close ulcers caused by DLBCL.

References

1. Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin’s lymphomas: clinical features of the major histologic subtypes. Non-Hodgkin’s Lymphoma Classification Project. J Clin Oncol. 1998;16(8):2780–2795.

2. Connors JM, Hsi ED, Foss FM. Lymphoma of the skin. Hematology Am Soc Hematol Educ Program. 2002;(1):263–282.

3. Zeltser R, Kalra A, Stadecker MJ, Krejci-Papa N. Unusual presentation of B-cell lymphoma as a cutaneous abscess. J Am Acad Dermatol. 2006;55(2 suppl):S24–S27.

4. Alizadeh AA, Eisen MB, Davis RE, et al. Distinct types of diffuse large B-cell lymphoma identified by gene expression profiling. Nature. 2000;403(6769):503–511.

5. Horn H, Ziepert M, Becher C, et al; German High-Grade Non-Hodgkin Lymphoma Study Group. MYC status in concert with BCL2 and BCL6 expression predicts outcome in diffuse large B-cell lymphoma. Blood. 2013;121(12):2253–2263.

6. Fuertes S, Setoain X, Lopez-Guillermo A, et al. Interim FDG PET/CT as a prognostic factor in diffuse large B-cell lymphoma. Eur J Nucl Med Mol Imaging. 2013;40(4):496–504.

7. Adams HJ, Kwee TC. Prognostic value of interim FDG-PET in R-CHOP-treated diffuse large B-cell lymphoma: systematic review and meta-analysis. Crit Rev Oncol Hematol. 2016;106:55–63.

8. Mouna B, Saber B, Tijani el H, Hing M, Amina T, Hassan E. Primary malignant non-Hodgkin’s lymphoma of the breast: a study of seven cases and literature review. World J Surg Oncol. 2012;10:151.

Potential Conflicts of Interest: This project was supported by National Natural Science Foundation of China (81571900).

Dr. Song is an attending doctor, Dr. Gong is a laboratorian, and Dr. Yan and Dr. Zhang are chief physicians, State Key Laboratory of Trauma, Burns, and Combined Injury, Institute of Burn Research, Southwest Hospital, Third Military Medical University, Chongqing, China. Please address correspondence to: Jiaping Zhang, MD, Institute of Burn Research, Southwest Hospital, Third Military Medical University, Chongqing, China; email: 1980475546@qq.com.

Section:

↧

A Cross-sectional Study of Nutritional Status, Diet, and Dietary Restrictions Among Persons With an Ileostomy or Colostomy

May 7, 2018, 11:28 am

≫ Next: A Meta-analysis to Compare Four-layer to Short-stretch Compression Bandaging for Venous Leg Ulcer Healing

≪ Previous: A Rare Case of Cutaneous Diffuse Large B-cell Lymphoma Presenting as a Chronic “Infectious” Skin Ulcer

Issue Number:

Index:

Ostomy Wound Management 2018;64(5):18–29 doi: 10.25270/owm.2018.5.1829

Ana Lívia de Oliveira, DSc; Ana Paula Boroni Moreira, DSc; Michele Pereira Netto, DSc; and Isabel Cristina Gonçalves Leite, DSc

Topics:

cross-sectional study

Colostomy

Ileostomy

nutritional status

food preferences

Abstract

Little is known about the nutritional status and dietary habits of persons with an intestinal stoma, and no specific dietary guidelines have been established. A cross-sectional study was conducted among patients of a Stoma Patient Health Care Service in Juiz de Fora, Brazil, to compare the nutritional status of persons with an ileostomy or colostomy and to evaluate which foods are avoided most frequently and why.

Anthropometric measurements (weight, height, arm circumference, and triceps and subscapular skinfold thickness) and body fat were assessed. Habitual dietary intake (energy, protein, carbohydrate, fiber, fat, calcium, iron, sodium, potassium, thiamin, riboflavin, vitamin B6, vitamin B3 [niacin], and vitamin B12) was assessed using a validated quantitative food frequency questionnaire. Foods avoided and reasons for avoidance (increased odor, increased gas, increased output, constipation, appliance leakage, and feelings regarding leaving home) were assessed. All data were collected without personal identifiers and stored in electronic files. Data were analyzed descriptively, and the Student’s t test or Mann-Whitney test was used to compare the groups. Chi-squared analysis with Yates’ continuity correction or Fisher’s exact test was employed to examine the differences in the frequency of avoided foods by reasons for avoidance between the 2 groups. Of the 103 participants (52 [50.5%] men, 51 [49.5%] women; mean age 60.5 ± 12.9 years); 63 (61.2%) had a colostomy and 40 (38.8%) had an ileostomy. For both groups combined, time since surgery ranged from 1 to 360 months. Anthropometric measurements and body composition did not suggest nutritional deficiencies and did not differ significantly between groups. Persons with an ileostomy had a significantly lower fat and niacin intake than persons with a colostomy (P<.05). No other dietary intake differences were observed. Avoiding foods due to appliance leakage was more common among participants with an ileostomy (8, 20%) than a colostomy (3, 4.8%), and vegetables and fruits were reported as the most problematic foods. None of the other cited reasons was significantly different. The results of this study confirm that many persons with a stoma adjust their dietary intake and avoid certain foods which, especially in persons with an ileostomy, may increase their risk for nutritional deficiencies. Additional research to assess dietary intake and nutritional status variables as well as patient needs is needed to facilitate the development of specific nutritional status monitoring and dietary recommendations for persons with an ileostomy or colostomy.

The Greek word stoma describes a surgically created opening that allows externalization of digestive, respiratory, and urinary system functions. In the digestive system, a stoma is created when it is necessary to deviate (temporarily or permanently) the normal transit of food and/or elimination of stool.^1-3 Patients are provided an ileostomy or colostomy as a result of a variety of medical conditions, including colorectal cancer, congenital disorders, trauma, inflammatory bowel disease, intestinal obstruction, diverticulitis, and trauma. Among the clinical situations mentioned, colorectal cancer is the most prevalent.^4,5

The intestinal stoma negates voluntary control of physiological elimination,⁶ making the person with a stoma dependent on an external collection device (stoma pouch) that can affect body image and self-esteem as well as social activity and employment capability and productivity. According to a prospective study,⁷ persons with stomas may face problems adapting to and learning how to manage their new anatomy.

The stoma interrupts the absorptive process at the point where it is created, affecting the nature of output and the individual’s ability to absorb nutrients from food. It is necessary to evaluate the patient’s eating behavior because the stoma can bring specific changes depending on the intestinal region where it is formed (ileum or colon).⁸ An ileostomy is placed in the small intestine where nutrients are absorbed, resulting in liquid to semi-liquid stools with abundant digestive enzymes that continuously exit the body. According to an intervention study,⁹ a literature review,¹⁰ and a nutrition guide,¹¹ persons with an ileostomy may incur nutritional losses of calcium; magnesium; iron; vitamins B12, A, D, E, and K; folic acid; water; protein; fat; and bile salts.^9-11 A colostomy is placed in the colon region (sigmoid colon, ascending, descending, or transverse), and fecal formation is intermittent, with near normal defecation ranging from semi-liquid or hard stools with little or no nutritional loss.^9-11

Eating habits can significantly affect the lives of ostomates, positively or negatively influencing the process of adaptation to a stoma. A qualitative, descriptive, exploratory study¹² revealed it is common for persons with a stoma to stop eating or to stop eating foods essential to maintaining proper nutritional support in order to resume their social life. According to a review by Cronin,¹³ dietary advice provided to patients before and after stoma surgery, especially in the first month, is important for their rehabilitation. A cross-sectional study¹⁴has shown patients with a colostomy or ileostomy need individualized nutritional guidance to make appropriate food choices over time.

The literature contains little information regarding nutritional status and dietary habits and does not put forth specific dietary recommendations for persons with a stoma. Within this context, the purpose of this study was to compare the nutritional status of patients with an ileostomy or colostomy and evaluate the foods they avoid most frequently and their reasons for doing so.

Methods and Procedures

Study design and sample. This was a cross-sectional study of patients served by the Stoma Patient Health Care Service in Juiz de Fora, a city of approximately 564 000 inhabitants in southeastern Brazil. This Service provided care for 428 patients monthly. The study was conducted between September 2014 and August 2015. All patients were contacted by telephone and invited to participate as volunteers in the research. The inclusion criteria stipulated participants must have an intestinal stoma (ileostomy or colostomy), be at least 18 years of age, and be physically and mentally capable of completing the interview. All volunteers gave their written informed consent after being provided with oral and written information about the study aims and protocol.

The study was approved by the Human Research Ethics Committee, Federal University of Juiz de Fora (protocol number 516.306).

Anthropometrics and body composition. Weight, height, arm circumference, and triceps and subscapular skinfold thickness were assessed by trained research personnel. Participants were instructed to wear light clothing and to remove any heavy objects before measurement sessions. Weight was measured using a digital weighing scale, and height was measured using a wall-mounted stadiometer. Body mass index (BMI) was calculated from weight and height measurements. Arm circumference was measured with a flexible measuring tape. Triceps and subscapular skinfold were measured using the Lange skinfold caliper. Body fat was measured via bioimpedance (Tanita Corporation, Tokyo, Japan).

Dietary intake assessment. Dietary intake was assessed using the quantitative Food Frequency Questionnaire (FFQ) adapted from the questionnaire developed by Ribeiro and Cardoso,¹⁵ which was previously validated for use in studies involving chronic diseases. Each patient completed the FFQ with the assistance of a trained researcher. Participants were asked to report their usual frequency of consumption of specific foods. The FFQ used for this study was composed of 106 items that focused on 11 food groups (dairy products, meats and by-products, cereals, breads, fruits, vegetables, legumes, nuts and oilseed, sweets, fats, and drinks). Portion size was assessed using standard food measurement utensils. FFQ data were analyzed using food composition tables.^16-18 Additional information on nutritional composition was collected from food labels where applicable.

A questionnaire was developed to ascertain whether stoma patients excluded some food from their eating routine and the reasons for avoidance. The effects of food on the stoma were grouped into 6 possible reasons/responses: increased odor, increased gas, increased output, constipation, appliance leakage, and leaving home. Appliance leakage referred to the displacement of the collector pouch affixed to the abdomen. Leaving home referred to foods patients avoid consuming before leaving home to offset possible discomfort. Patients could choose more than 1 response, and they were asked to list such foods and highlight those that were the most problematic.

Data collection. The first author trained a team of nutrition students to participate in patient assessment on the selected measurement day. All data were collected using a standardized form developed for the study and stored electronically. Researchers completed the paper-and-pencil FFQ by individually asking patients the questions when they visited the Service for care. Information such as gender, age, type of ostomy, and duration of the stoma were obtained directly from medical records. Patient identity was kept anonymous, and patients had the option to refuse to participate with no repercussions.

Statistical analysis. Results from the anthropometrics and body composition data and dietary intake were entered, processed, and analyzed using SigmaPlot, version 12.0 (Systat Software, Inc, San Jose, CA). Demographic and clinical variables were descriptively analyzed. Parametric and nonparametric tests were used based on normality testing (Shapiro-Wilk) and variance homogeneity (Levene) tests. Data are represented as mean ± standard deviation (SD). The Student’s t test or Mann-Whitney test was used to compare the groups (patients with an ileostomy versus those with a colostomy). Chi-squared analysis with Yates’ continuity correction or Fisher’s exact test, where appropriate, was employed to examine the differences in the frequency of avoided foods according to the reason for ileostomy and colostomy patients. A 5% significance level was considered for analysis.

Results

Of the 428 intestinal ostomy patients in the service, 103 met the inclusion/exclusion criteria and/or agreed to participate in the study; 51 (49.5%) were women, 52 (50.5%) were men, 40 (38.8%) had an ileostomy, and 63 (61.2%) had a colostomy. Mean patient age mean age was 60.5 ± 12.9 (range 25–94) years. Time living with the stoma varied greatly among patients (range 1–360 months). Most patients with ileostomy (23 [57.5%]) and colostomy (42 [66.7%]) had the stoma >1 year.

Anthropometric (weight, BMI, arm circumference, triceps and subscapular skinfold) and body composition (body fat) measurements did not differ significantly between groups (see Table 1). Eleven (11) patients (2 with an ileostomy and 9 with a colostomy) refrained from having their triceps, subscapular skinfold, and body fat measurements taken. The dietary data from the FFQ showed habitual dietary intake (energy, protein, carbohydrate, fiber, calcium, iron, sodium, potassium, thiamin, riboflavin, vitamin B6, and vitamin B12) was not different between groups, except for fat and niacin. In the present study, patients with an ileostomy had significantly lower fat intake (58.5 ± 38.5 g and 24.3% ± 7.9%) and niacin levels (13.7 ± 9.2 mg) compared to patients with a colostomy (fat: 82.5 ± 62.8 g and 27.9% ± 6.6%; niacin: 17.9 ± 12.4 mg) (see Table 2).

As might be expected, significantly more ileostomy patients (20%) avoided foods for fear of appliance leakage compared with colostomy patients (4.8%), and vegetables and fruits were reported as the most problematic (see Table 3). The other reasons (increased odor, increased gas, increased output, constipation, and leaving home) reported for avoiding food consumption were similar between groups.

Discussion

Whether temporary or permanent, stomas result in physical changes and may result in dietary restrictions on patients. The amount of intestine remaining after an intestinal stoma is created will determine the individual’s capacity for normal nutritional absorption from food and beverages, making it crucial for health care professionals involved in caring for persons with a stoma to be aware of the type of stoma created, the length of proximal bowel remaining, and the implications for absorption of nutrients to provide optimal nutritional advice and support.¹⁹ To the authors’ knowledge, this is the first time the nutritional status, diet, and foods most frequently avoided have been compared between ileostomy and colostomy patients.

In the present research, the study population had an average age of 60.5 years, similar to other cross-sectional studies involving Italian²⁰ and Brazilian²¹ patients with a stoma. Many patients undergoing stoma surgery are older and have colorectal cancer as the cause of the ostomy, which has a positive association with age, as shown in qualitative²² and prospective²³ studies. In this study, anthropometric characteristics and body composition did not differ between persons with an ileostomy and those with a colostomy. Cross-sectional study data²⁴ suggest that, based on the reported mean BMI (26.8 kg/m²) and body fat (33.8% for women and 21.5% for men), participants in this study did not have nutritional deficits. A BMI of 18.5 to 24.9 kg/m² is generally accepted as the optimal range, although there is some debate about the ideal reference range for older adults. According to a cross-sectional study by Bahat et al,²⁵ a BMI cutoff point of 25 kg/m² may be restrictive for older adults. In fact, the patients in the present study must have a body reserve, considering their age. According to a review by Gary and Fleury,²⁶ older patients often are unable to maintain a nutrient intake adequate to meet their rising metabolic demands when physiological demands increase, such as during an acute illness. As a result, protein and energy stores may be depleted, exacerbating weaknesses and contributing to a decline in functional status.²⁶ Additionally, most persons with a stoma have an underlying disease with an impact on nutritional status.¹⁴

The authors used arm circumference, triceps, and subscapular skinfold measurements because of the difficulty of assessing any measure in the abdominal area due to the presence of the stoma itself, the collection pouch, and the potential presence of complications such as parastomal hernia.²⁷ Despite not having specific anthropometric recommendations for this population, the measures assessed in this study are valid for monitoring nutritional status.

Energy intake was similar between the groups, although ileostomy patients had an energy intake approximately 20% lower than colostomy patients, owing to lower fat intake. Although no specific energy recommendations exist for stoma patients, daily energy intake of ileostomy patients (2046 kcal, on average, for men and women) was similar to World Health Organization²⁸ (WHO) recommendations (2090 kcal, on average, for men and women). The mean energy intake of colostomy patients was 2579 kcal and the WHO recommendation²⁸ was 2088 kcal — the usual intake was 23.5% higher than the recommendation. In fact, the anthropometric assessment showed no depletion of nutritional status or body weight as a result of energy intake.

Decreased fat consumption in the ileostomy group occurs because intestinal transit is faster and effluent are more liquid having not passed through the colon. As a result, persons with an ileostomy produce a higher volume of effluent.¹⁹ Fat may facilitate the stool movement, so ileostomy patients may consume less fat for fear of increased intestinal output. The potential consequences are deficiencies in calories, essential fatty acids, and fat-soluble vitamins.

The consumption of niacin (vitamin B3) also was lower in the ileostomy group. Due to the wide distribution of this vitamin in the food supply, niacin deficiencies are rare, but minor deficiencies of niacin can occur in chronic gastrointestinal disorders that lead to malabsorption.²⁹ Because persons with a stoma (especially an ileostomy) have accelerated intestinal transit and may have malabsorption as a result of bowel resection,^23,30 it is possible they have a loss of niacin absorption in addition to possible reduced intake shown in this study. Therefore, it is essential to monitor blood levels of this vitamin.

The intake of fiber and other nutrients did not differ between groups. Because no specific dietary recommendations exist for persons with a stoma, comparisons were not possible. However, it is essential for the nutritionist to be aware of possible nutritional deficiencies. For example, without a functioning colon, patients with ileostomy will lose 50 to 80 mmols of sodium daily.³¹ According to a review by Fulham,¹⁹ this generally can be replaced by adding the equivalent of an extra teaspoonful of salt daily to food. Screening and monitoring the nutritional status of individuals with a stoma should be an ongoing process, beginning preoperatively and continuing after discharge from hospital.

Because they fear leaking of effluent and injuries to peristomal skin, stoma patients have strong concerns about appliance leakage. These patients have a high-output stoma with a higher concentration of digestive enzymes that can dissolve the hydrocolloid and erode the skin.³² In this study, patients with an ileostomy showed greater fear of appliance leakage and subsequently avoided more foods, especially vegetables and fruits. From the nutritional point of view, maintenance of healthy peristomal skin is vital because it allows good stoma pouch adhesion.³³ Accordingly, dietary guidance is required because it influences wound healing and alters stool quantity, frequency, and consistency.²

On average, ileostomy output consists of 600 mL to 800 mL liquid or very soft effluent per 24 hours, with little odor.³² The person with a colostomy naturally produces formed stools with a characteristic smell and tends to impose dietary restrictions for fear of odor.³⁴ However, in this study no difference regarding fear of increased odor was noted between groups, suggesting that persons with an ileostomy are just as fearful of odor as persons with a colostomy. Dietary guidelines may increase patient confidence in food choices, including suggestions about foods that can control odor, such as buttermilk, yogurt, cranberry juice, parsley, and tomato juice.² In addition, products such as activated charcoal added to the stoma pouch can help reduce odor.³⁵

Fear of increasing stoma output was described as a reason for dietary restrictions by both study groups. It is not known whether the fear of increasing stoma output is related to a fear of loose stools or not. If loose stools are a problem that cannot be resolved with medication or dietary changes, a stoma specialist nurse should be consulted or the patient can try a binding agent such as loperamide under medical supervision.³⁶ It is important to consider that often in the context of care for persons with a stoma, it is observed that eating habits are associated with various myths, and while some beliefs with no scientific basis on diet may be harmless, others may have serious implications for health and well-being.¹² Fear of constipation was reported less frequently by study participants. Although a review of the literature³⁶ found constipation is more common in colostomy patients, differences in the fear of this occurrence were not observed between groups in this study. If the person with a colostomy was prone to constipation or loose stool before the stoma-forming surgery, this issue will likely endure long-term.^36,37 To prevent constipation, patients should be advised to consume adequate amounts of fluids and fiber, especially fruit and vegetables.^36,37

In a cross-sectional study by Floruta,³⁴ increased gas was among the main problems reported by both colostomy and ileostomy patients. This also was observed in the current study as the most reported fear, with no difference between the groups. Avoidance of certain foods such as green vegetables, onions, beans, and carbonated beverages might be useful. Moreover, it is beneficial to guide the patient to refrain from talking while eating to avoid swallowing air.¹ However, the nutritionist should assess each patient individually so dietary self-restrictions do not harm nutritional status.

Several patients in both groups reported avoiding consuming food before leaving home. It is common to find that ostomy patients stop eating, influenced by feelings provided by their current condition.^12,14 Anxiety, insecurity, fear, and doubt may negatively affect eating itself, an event that should be enjoyable.

Limitations

The current study has limitations. The group was not heterogeneous in terms of the duration of the stoma, the reason for its creation, and nutritional status, which may affect the external validity of the results vis-à-vis all persons with an ileostomy or colostomy. The wide range in stoma history (1 to 360 months) may have affected the results and is a consequence of the various reasons for creating a stoma, as well as the patient’s previous nutritional status. Additionally, the absence of specific dietary recommendations and anthropometric measures for persons with a stoma as well as the absence of studies on this topic did not allow comparisons between the published literature and current results. Finally, an inevitable limitation of the FFQ is that all information depends on the respondents’ memory.

Conclusion

The results of this cross-sectional study involving 40 persons with an ileostomy and 63 with a colostomy suggest that, based on anthropometric characteristics, study participants did not have nutritional deficits. However, FFQ results showed persons with an ileostomy had significantly lower fat (g and percent) and niacin (mg) intake than persons with a colostomy. The study also confirmed both groups implement many dietary restrictions to reduce the risk of appliance loosening, increased odor, gas, stoma output, or constipation. Leaving home was also frequently cited as a reason for avoiding certain foods. Vegetables and fruits were included as foods avoided for every risk cited.

Living with a stoma can be challenging and patients need to learn what does and does not work for them to manage the side effects of food on the ostomy, including odor, gas, effluent, constipation, and leakage. Few studies have examined the nutritional status of persons with a stoma and the effects of diet on ostomy function. Longitudinal studies to assess these variables and patient needs are necessary to facilitate the development of specific nutritional recommendations for persons with an ileostomy or colostomy.

Acknowledgments

The authors thank the nurse responsible for the service (Alfeu Gomes de Oliveira Júnior) and his entire team, which provided all the technical assistance with data collection.

References

1. Burch J. Constipation and flatulence management for stoma patients. Br J Community Nurs. 2007;12(10):449–452.

2. Akbulut G. Nutrition in stoma patients: a practical view of dietary therapy. Int J Hematol Oncol. 2011;21(1):61–66.

3. Stumm EMF, Oliveira ERA, Kirschner RM. Profile of ostomized patients. Sci Med. 2008;18(1):26–30.

4. Barbutti RCS, Silva MCP, Abreu MAL. Ostomia, uma difícil adaptação. Rev SBPH. 2008;11(2):27–39.

5. Ferreira-Umpierrez A, Fort-Fort Z. Experiences of family members of patients with colostomies and expectations about professional intervention. Rev Lat Am Enfermagem. 2014;22(2):241–247.

6. Luz ALA, Luz MHBA, Antunes A, et al. Profile of ostomy patients: integrative review of the literature. Cul Cuid. 2014;18(39):115–123.

7. Altuntas YE, Gezen FC, Sahoniz T, et al. Ramadan fasting in patients with a stoma: a prospective study of quality of life and nutritional status. Ostomy Wound Manage. 2013;59(5):26-32.

8. Burch J. Nutrition and the ostomate: input, output and absorption. Br J Community Nurs. 2006;11(8):349–351.

9. Zhou T, Wu XT, Zhou YJ, Huang X, Fan W, Li YC. Early removing gastrointestinal decompression and early oral feeding improve patients’ rehabilitation after colorectostomy. World J Gastroenterol. 2006;12(15):2459–2463.

10. Burch J. Nutrition for people with stomas 2: an overview of dietary advice. Nurs Times. 2008;104(49):26–27.

11. United Ostomy Associations of America (UOAA). Ostomy nutrition guide. Available at: www.ostomy.org. Accessed August 9, 2017.

12. Silva DG, Bezerra ALQ, Siqueira KM, et al. Influence of dietary habits in the social reintegration of a group of people with ostomy. Rev Eletr Enf. 2010;12(1):56–62.

13. Cronin E. Dietary advice for patients with a stoma. Br J Nurs. 2012;21(16):S32–S34,S36–S38,S40.

14. Oliveira AL, Mendes LL, Netto MP, et al. Cross-cultural adaptation and validation of the stoma quality of life questionnaire for patients with a colostomy or ileostomy in Brazil: a cross-sectional study. Ostomy Wound Manage. 2017;63(5):34–41.

15. Ribeiro AB, Cardoso MA. Development of a food frequency questionnaire as a tool for programs of chronic diseases prevention. Rev Nutr. 2002;15(2):239–245.

16. Pinheiro ABV, Lacerda EMA, Benzecry EH, et al. Tabela Para Avaliação de Consumo Alimentar em Medidas Caseiras. 5th ed. São Paulo, Brazil: Atheneu;2008.

17. Núcleo de Estudos e Pesquisas em Alimentação (NEPA/UNICAMP). Tabela Brasileira de Composição de Alimentos (TACO). 4th ed. Campinas, São Paulo, Brazil: UNICAMP;2011.

18. United States Department of Agriculture (USDA). National Nutrient Database for Standard Reference. Available at: https://ndb.nal.usda.gov/ndb/search/list. Accessed October 1, 2016.

19. Fulham J. Providing dietary advice for the individual with a stoma. Br J Nurs. 2008;17(2):S22–S27.

20. Canova C, Giorato E, Roveron G, et al. Validation of a stoma-specific quality of life questionnaire in a sample of patients with colostomy or ileostomy. Colorectal Dis. 2013;15(11):e692–e698.

21. Barbosa MH, Alves PIC, Silva R, et al. Nutritional aspects of intestinal ostomy patients from a city of Minas Gerais state (Brazil) [in Portuguese]. REAS. 2013;2(3):77–87.

22. Emslie C, Browne S, MacLeod U, Rozmovits L, Mitchell E, Ziebland S. ‘Getting through’ not ‘going under’: a qualitative study of gender and spousal support after diagnosis with colorectal cancer. Soc Sci Med. 2009;68(6):1169–1175.

23. Arenas Villafranca JJ, López-Rodríguez C, Abilés J, et al. Protocol for the detection and nutritional management of high-output stomas. Nutr J. 2015;14:45.

24. Pasco JA, Holloway KL, Dobbins AG, Kotowicz MA, Williams LJ, Brennan SL. Body mass index and measures of body fat for defining obesity and underweight: a cross-sectional, population-based study. BMC Obes. 2014;1:9.

25. Bahat G, Tufan F, Saka B, et al. Which body mass index (BMI) is better in the elderly for functional status? Arch Gerontol Geriatr. 2012;54(1):78–81.

26. Gary R, Fleury J. Nutritional status: key to preventing functional decline in hospitalized older adults. Top Geriatr Rehabil. 2002;7(3):40–71.

27. Cowin C, Redmond C. Living with a parastomal hernia. Gastrointest Nurs. 2012;10(1):1-8.

28. World Health Organization. Food and nutrition technical report series — human energy requirements. Joint FAO/WHO/UNU Expert Consultation. Rome, Italy: WHO;2001.

29. Zaraa I, Belghith I, El Euch D, et al. A case of pellagra associated with megaduodenum in a young woman. Nutr Clin Pract. 2013;28(2):218–222.

30. Gupta S, Shen B. Bone loss in patients with the ileostomy and ileal pouch for inflammatory bowel disease. Gastroenterol Rep. 2013;1(3):159–165.

31. Wood S. Nutrition and stoma patients. Nurs Times. 1998;94(48):65–67.

32. Barwell J. High-output stoma management following bowel perforation. Br J Nurs. 2012;21(6):S4–S7.

33. Swash C. Bariatric surgery and implications for stoma care. Br J Nurs. 2016;25(5):S22, S24–S27.

34. Floruta CV. Dietary choices of people with ostomies. J Wound Ostomy Continence Nurs. 2001;28(1):28–31.

35. Sood A, Granick MS, Tomaselli NL. Wound dressings and comparative effectiveness data. Adv Wound Care (New Rochelle). 2014;3(8):511–529.

36. Burch J. Providing information and advice on diet to stoma patients. Br J Community Nurs. 2011;16(10):479–480, 482, 484.

37. Burch J. Resuming a normal life: holistic care of the person with an ostomy. Br J Community Nurs. 2011;16(8):366-373.

Dr. Oliveira, Dr. Moreira, and Dr. Netto are Adjunct Professors, Department of Nutrition; and Dr. Leite is a CNPq Productivity Sponsorship (Process 301101/2016-7) and an Associate Professor, School of Medicine, Department of Public Health, Federal University of Juiz de Fora, Minas Gerais, Brazil. Please address correspondence to: Ana Lívia de Oliveira, Department of Nutrition, Federal University of Juiz de Fora – UFJF, José Lourenço Kelmer, s/n Campus Universitário, CEP 36036-330, Juiz de Fora, Minas Gerais, Brazil; email: analivia.oliveira@ufjf.edu.br.

Section:

↧

A Meta-analysis to Compare Four-layer to Short-stretch Compression Bandaging for Venous Leg Ulcer Healing

May 7, 2018, 11:43 am

≫ Next: Translation and Validation of a Wound-specific, Quality-of-life Instrument (The Wound-QoL) in a Swedish Population

≪ Previous: A Cross-sectional Study of Nutritional Status, Diet, and Dietary Restrictions Among Persons With an Ileostomy or Colostomy

Issue Number:

Index:

Ostomy Wound Management 2018;64(5):30–37 doi: 10.25270/owm.2018.5.3037

Magali Rezende De Carvalho, RN, MSN, CWOCN; Bruno Utzeri Peixoto, RN; Isabelle Andrade Silveira, RN, MSN; and Beatriz G. R. Baptista de Oliveria, RN, PhD

Topics:

meta-analysis

Venous Ulcer

compression bandages

wound healing

evidence-based nursing

Abstract

Compression therapy is the standard of care for venous leg ulcers (VLUs), and some evidence suggests 4-layer compression is more effective than short-stretch bandages. A meta-analysis was conducted to compare the effectiveness of these 2 compression bandages for venous ulcer healing. In March 2016, a systematic review of the literature was conducted to identify randomized controlled trials.

Databases used included Pubmed/MEDLINE, EMBASE, Cochrane Central, the Cumulative Index of Nursing and Allied Health Literature, and the Latin American and Caribbean of Health Sciences Information System. Search terms were varicose ulcer, venous leg ulcer, venous ulceration, leg ulcer, compression bandages, compressive therapy, multilayer system, four-layer system,elastic bandages, short-stretch bandage, short-stretch system, and inelastic bandage. No publication time or language restrictions were imposed, but findings subjected to analysis were limited to results of research that reported healing and healing time using 4-layer and short-stretch compression only. The quality of the studies was assessed using the Jadad scale. Data extracted included study design, country, target population demographics, VLU clinical aspects at baseline, sample size, interventions applied, follow-up period, complete healing, and healing time as outcomes. Relative risk was calculated considering a 95% confidence interval for dichotomous variables (complete healing), and heterogeneity was statistically assessed among the studies using the chi-squared test assuming random effect when I²≥50%. The search yielded 557 papers; 21 met the study criteria for full-text analysis, and 7 met the meta-analysis inclusion criteria. The studies included 1437 patients, average age 70 (range 23–97) years with 1446 venous leg ulcers. Most (5) studies were classified as being at low risk of bias. At 12 and 16 weeks, 259 ulcers (51.08%) healed completely in the 4-layer and 234 (46.34%) in the short-stretch bandage groups, respectively (P = .41). At 24 weeks, 268 ulcers (69.07%) in the 4-layer and 257 (62.23%) in the short-stretch bandage groups, respectively, had healed (P = .16). The 2 bandage systems evaluated were similar in achieving complete healing at their respective study endpoints. The average time for healing was 73.6 ± 14.64 days in the 4-layer and 83.8 ± 24.89 days in the short-stretch bandage groups; no meta-analysis was done for this outcome due the inability to retrieve all the individual patient data for each study. The choice of compression system remains at the discretion of the clinicians based on evidence of effectiveness, patient tolerability, and preference. Additional randomized controlled trials to compare various wound and patient outcomes between different compression systems are warranted.

Venous leg ulcers (VLUs) usually affect the lower part of the leg near the medial malleolus, are associated with venous hypertension, and represent the most advanced stage of chronic venous insufficiency. Due to its high level of morbidity, leg ulcer treatment places a heavy burden on public and private health care service.^1-3

In a retrospective study⁴ that analyzed 250 patients with a history of VLU, the recurrence rate was 55% at 12 months after the ulcer had healed. The prolonged time of treatment and rehabilitation of individuals affected with VLU generates a high cost both for the patient and the health care system.⁵A 2015 systematic review⁶ showed that in the United States alone, $3.5 billion is spent on VLUs annually. The choice of treatment directly affects wound development and healing and should avoid complications such as infection and reduce pain, subsequently improving patient quality of life and optimizing cost effectiveness, which are of high importance for both the patient and the health care institution.^7,8 An Australian retrospective study⁹ concluded that when evidence-based guidelines are not implemented properly, the healing outcome is compromised. It is in this context the health care provider must demonstrate and apply scientific knowledge to provide effective, evidence-based treatment for this type of wound while considering patient individuality.^3,10

Compression therapy is the standard of care for VLU; it is recommended for all patients with VLUs with an ankle brachial index (ABI) >0.8.3 Many compression devices are available; it is the responsibility of the health care provider to properly assess and choose the most suitable type of compression therapy for the patient.^11-13 The type of compression device chosen should be based on evidence of effectiveness, clinical assessment, patient preference and tolerance, and the health care provider’s technical skills.³

The most recent Cochrane systematic review update¹³ (2012) reported a multicomponent bandage system (4-layer bandage [4LB]) is more effective for the management of VLUs than short-stretch bandages (SSBs); patients using the 4-layer bandage healed faster. More evidence has been published since this review was prepared. The purpose of the current study is to determine whether the Cochrane report conclusion is still accurate.

To guide this review, the following question was formulated based on the patient-population-problem, intervention, comparison, outcome research strategy: Does a 4LB system provide superior healing rates in comparison to SSBs in patients with a VLU? In this context, the main objective of this review was to compare the effectiveness of the 4LB to the SSB by using VLU complete healing and healing rate data obtained from randomized controlled trials.

Method

The literature search was performed in March 2016 by 2 independent reviewers using PubMed/MEDLINE, EMBASE, the Cumulative Index of Nursing and Allied Health Literature (CINAHL), Cochrane Central, and the Latin American and Caribbean of Health Sciences Information System (LILACS). The search terms used were varicose ulcer, venous leg ulcer, venous ulceration, leg ulcer, compression bandages, compressive therapy, multilayer system, four-layer system, elastic bandages, short-stretch bandage, short-stretch system, and inelastic bandage. No language or date of publication restrictions were imposed. The search strategy for each database is listed in Table 1.

Inclusion criteria stipulated that articles selected for assessment needed to describe randomized controlled trials that compared a 4LB system with SSBs for VLU healing. Studies that compared bandages with zinc paste, elastic stockings, bandages with fewer layers, and Unna boot, as well as nonrandomized or cost analysis studies, were excluded. Outcomes evaluated were healing time and number of ulcers completely healed, where healing was defined as full epithelialization and no drainage.

Study quality was assessed by 1 of the authors using the Jadad scale.¹⁴ The studies were evaluated regarding study design, blinding, and loss of participants to follow-up. Points were assigned to reviewed studies as follows: 2 points if the study was properly randomized, 2 points when blinding was done correctly, and 1 point when the authors reported withdrawals and dropouts. The studies were scored using a range of 0 to 5 (where 0 is the weakest and 5 is the strongest). A score <2 indicated poor methodological quality.

Study data were summarized in a data extraction form by 2 of the researchers and included study design, country, target population, age, gender, ABI, sample size, interventions applied, follow-up period, withdrawal and/or lost of follow-up, complete healing, and healing time as outcomes.

For analysis of the dichotomous variables (complete ulcer healing), the relative risk (RR) was calculated considering a 95% confidence interval (CI). A subgroup analysis was considered when there were different endpoints for complete healing assessment. Studies that reported complete healing rates at 3 to 4 months were analyzed separately from the studies that reported results at 6 months.

Heterogeneity was statistically assessed using the chi-squared test assuming random effect when I²≥50%. Software Review Manager (RevMan), version 5.3 (The Nordic Cochrane Centre, Copenhagen, Denmark) was used to perform statistical analysis.

Results

After deleting duplicate studies and evaluating the titles and abstracts, 21 studies were selected for review. Of those, 7 met the inclusion criteria for this study; 14 were excluded because the products were not the 2 stipulated for comparison and/or they were nonrandomized or cost-effectiveness studies (see Figure 1). Most (5) studies (71.4%) were done in Europe,^15-19 1 was published in Asia,²⁰ and 1 in North America²¹ (14.3% each). All were published in English.

Table 2 summarizes the main findings of the studies included in this review.

The studies’ follow-up period ranged from 12 to 60 weeks, and the endpoint for complete healing outcome was reported at 12 weeks in 3 studies,^16,17,21 at 16 weeks in 1 study,¹⁸ at 24 weeks in 4 studies,^15-16,19,20 and at 60 weeks (420 days) in 1 study.²¹ The healing time of the VLUs using 4 layers was between 47 and 113 days and for the SSB group was between 43 and 157 days.

Table 3 describes the methodological evaluation through the results of Jadad scale.

All studies were randomized clinical trials; 2 studies^19,20 failed to describe the method used for randomization. Six (6) studies^15-20 failed to blind the participant or the observer. Only 1 study²¹ was able to achieve the maximum Jadad scale score (although the participants were not blinded, the observer was). Two (2) studies^19,20 were considered to have poor methodological quality (Jadad score = 2).

The 7 studies analyzed included a total of 1435 patients, 657 (45.78%) male and 778 (54.48%) female, average age 70 (range 23–97) years, with 1446 ulcers, 720 ulcers treated using 4LB and 726 using SSB. All patients had been diagnosed with venous disease and had an ABI >0.9 mm Hg. The population of each study was considered homogeneous at baseline according to their respective authors. Complete healing occurred in 441 (61.25%) of ulcers in the 4LB group and in 422 ulcers (58.13%) in the SSB group. Healing time was reported in 5 studies and averaged 73.6 ± 14.64 days and 83.8 ± 24.89 days for ulcers treated with 4LB and SSB, respectively. It is important to mention that no meta-analysis was done for this outcome because the reviewers were unable to retrieve individual patient data from each study, making it impossible to calculate the hazard ratio (HR).

Complete healing was reported in 4 studies^16-18,21 at 12 or 16 weeks and in 4 studies^15,16,19,20 at 24 weeks of follow-up (see Figure 2). The VenUs I Study¹⁶ reported the outcome complete healing at 12 and 24 weeks. Meta-analysis showed that at 12 or 16 weeks, 259 (51.08%) ulcers healed completely in the 4LB group versus 234 (46.34%) in the SSB group (RR: 1.07 [95% CI; 0.91-1.27]; P = .41). At 24 weeks, 268 ulcers (69.07%) in the 4LB group and 257 (62.23%) in the SSB group completely healed (RR: 1.13 [95% CI; 0.95-1.34]; P = .16). Forest plot chart analysis showed no superiority in outcomes between the 2 bandage options; both bandages yielded similar complete healing rates.

Discussion

The Cochrane review¹³ published in 2012 compared 4LB and SSB; it included 5 studies, analyzed 797 ulcers, and reported the risk ratio (RR) for complete healing as 0.96 [0.88, 1.05]; P = .34. The current review included 7 studies, analyzing 1446 ulcers, with the RR for complete healing at 12 to 16 weeks of 1.07 (95% CI; 0.91-1.27; P = .41) and at 24 weeks of 1.13 (95% CI; 0.95-1.34; P = .16). Therefore, current meta-analysis reinforced the similarity in the ability of both types of compression to achieve complete healing.

The average time for healing in this analysis was 73.6 ± 14.64 days for ulcers treated with 4LB and 83.8 ± 24.89 days for those provided SSB. Similar results were found in the Cochrane review,¹³ where the average time for healing was 90 days and 99 days for the 4LB group and SSB group, respectively.

Because the 4LB group achieved slightly faster healing, the Cochrane review¹³ concluded it was a statistically significant result. (HR 1.32 [1.09, 1.60]; P = .0039). However, another review²² that included 6 trials and 1168 ulcers that analyzed the same outcomes found no statistical difference in time to healing between the 2 types of compression (HR 0.88 [95% CI; 0.76-1.6]; P = .08). These results oppose the findings of the current review and the Cochrane review¹³ regarding time to healing.

When the concern is the need to apply ideal pressure for improving the functioning of the calf pump, both bandage systems provide the pressure recommended by the Wound Ostomy Continence Nurses’ Algorithm for treatment of VLUs.²³ If the consideration is utilizing a system that provides higher pressures when patients are in a vertical position, a review²³ comparing the types of bandages available for treating VLUs found that a low elasticity system presents a major advantage by providing high pressure while walking and low pressure during rest in order to counteract the high hydrostatic pressure in the veins.²⁴

Regardless of the compression system chosen, the expertise of the health care provider and the ability of the patient to tolerate the compression are crucial factors for achieving good outcomes using compression therapy.^9,18,21

Limitations

Although no restriction was imposed regarding language or date of publication, the search results may have inadvertently not included studies that upon further research (eg, exploration of study citations) may have provided additional information. This current review did not facilitate inclusion of the HR estimate for time to healing because the reviewers were unable to retrieve the individual patient data for each included, nor did it include other important outcomes, such as reduction of wound size/area and quality of life. Although all of the 7 studies analyzed were randomized controlled clinical trials, 2 failed to describe the randomization method used and the method for blinding,^19-20 which resulted in a low score on the Jadad Scale, owing to high probability of bias (total score <2). Moreover, it must be taken into consideration that in an interventional study where the bandage types differ substantially from each other and where inevitably the participant notices which type of bandage has been applied, blinding of the parties involved (participant and health care provider) is challenging to achieve.

Conclusion

A meta-analysis of 7 randomized controlled clinical trials (most classified as being at low risk of bias) that compared use of 4LB and SSB in terms of VLU healing showed no significant differences in the proportions of ulcers healed after 12 to 16 weeks (RR: 1.07 [95% CI; 0.91-1.27]; P = .41) or 24 weeks (RR: 1.13 [95% CI; 0.95-1.34]; P = .16). The choice of compression therapy remains dependent on the evaluation and professional skills of the health care provider, in addition to its tolerability and patient preference. More randomized controlled trials are needed to assess healing rates and healing time to determine which compression system offers the best results for the patients with VLUs.

References

1. Lima LVS, Sousa ATO, Costa ICP, Silva VDM. Conhecimento de pessoas com úlceras vasculogênicas acerca da prevenção e dos cuidados com as lesões. Rev Estima. 2014;1(1):22–30.

2. Nogueira GA, Oliveira BGRB, Santana RF, Cavalcanti ACD. Nursing diagnoses in patients with chronic venous ulcer: observational study. Rev Eletr Enf. 2015;17(2):333–339.

3. de Carvalho MR, de Andrade IS, de Abreu AM, Leite Ribeiro AP, Peixoto BU, de Oliveira BG. All about compression: a literature review. J Vasc Nurs. 2016;34(2):47–53. doi: 10.1016/j.jvn.2015.12.005.

4. Finlayson K, Parker CN, Miller C, et al. Predicting the likelihood of venous leg ulcer recurrence: the diagnostic accuracy of a newly developed risk assessment tool [published online ahead of print March 13, 2018]. Int Wound J. doi: 10.1111/iwj.12911.

5. Reis DB, Peres GA, Zuffi FB, Ferreira LA, Dal Poggetto MT. Cuidados aos portadores de úlcera venosa: percepção dos enfermeiros da Estratégia de Saúde da Família. Rev Min Enferm. 2013;17(1):101–106.

6. de Carvalho MR. Comparison of outcomes in patients with venous leg ulcers treated with compression therapy alone versus combination of surgery and compression therapy: a systematic review. J Wound Ostomy Continence Nurs. 2015;42(1):42–46. doi.org/10.1097/WON.0000000000000079.

7. Medeiros ABA, Frazão CMFQ, Fernandes MICD, Andriola IC, Lopes MVO, Lira ALBC. Association of socioeconomic and clinical factors and tissue integrity outcome of patients with ulcers. Rev Gaúcha Enferm. 2016;37(1):e54105.

8. Malaquias SG, Bachion MM, Sant’ana SM, Dallarmi CC, Lino Junior Rde S, Ferreira PS. People with vascular ulcers in outpatient nursing care: a study of sociodemographic and clinical variables [in Portuguese]. Rev Esc Enferm USP. 2012;46(2):302–310.

9. Edwards H, Finlayson K, Courtney M, Graves N, Gibb M, Parker C. Health service pathways for patients with chronic leg ulcers: identifying effective pathways for facilitation of evidence based wound care. BMC Health Serv Res. 2013;13:86–96. doi: 10.1186/1472-6963-13-86.

10. Nogueira GA, Camacho ACLF, Oliveira BGRB, Santos LSF. Characterization of the protocols related to wounds: an integrative review. Rev Enferm UFPE. 2015;9(3):7723–7728.

11. WOCN Wound Committee. A Quick Reference Guide for Lower-Extremity Wounds: Venous, Arterial, and Neuropathic. 2013. Available at: http://c.ymcdn.com/sites/www.wocn.org/resource/collection/E3050C1A-FBF0-...(2013).pdf. Accessed November 10, 2016.

12. Scottish Intercollegiate Guidelines Network (SIGN). Part of NHS Quality Improvement Scotland. Management of Chronic Venous Leg Ulcers. 2010. Available at: www.sign.ac.uk/sign-120-management-of-chronic-venous-leg-ulcers.html. Accessed November 10, 2016.

13. O’Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2012;11:CD000265. doi: 10.1002/14651858.CD000265.pub3.

14. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1–12.

15. Franks PJ, Moody M, Moffatt CJ, et al; Wound Healing Nursing Research Group. Randomized trial of cohesive short-stretch versus four-layer bandaging in the management of venous ulceration. Wound Repair Regen. 2004;12(2):157–162.

16. Iglesias C, Nelson EA, Cullum NA, Torgerson DJ; VenUS Team. VenUS I: a randomised controlled trial of two types of bandage for treating venous leg ulcers. Health Technol Assess. 2004;8(29):1–105.

17. Ukat A, Konig M, Vanscheidt W, Münter KC. Short-stretch versus multilayer compression for venous leg ulcers: a comparison of healing rates. J Wound Care. 2003;12(4):139–143.

18. Partsch H, Damstra RJ, Tazelaar DJ, et al. Multicentre, randomised controlled trial of four-layer bandaging versus short-stretch bandaging in the treatment of venous leg ulcers. Vasa. 2001;30(2):108–113.

19. Scriven JM, Taylor LE, Wood AJ, Bell PR, Naylor AR, London NJ. A prospective randomised trial of four-layer versus short stretch compression bandages for the treatment of venous leg ulcers. Ann Royal Coll Surg Engl. 1998;80(3):215–220.

20. Wong IK, Andriessen A, Lee DT, et al. Randomized controlled trial comparing treatment outcome of two compression bandaging systems and standard care without compression in patients with venous leg ulcers. J Vasc Surg. 2012;55(5):1376–1385.

21. Harrison MB, Vandenkerkhof EG, Hopman WM, Graham ID, Carley ME, Nelson EA; Canadian Bandaging Trial Group. The Canadian Bandaging Trial: evidence-informed leg ulcer care and the effectiveness of two compression technologies. BMC Nurs. 2011;10:20. doi: 10.1186/1472-6955-10-20.

22. Nelson EA, Harrison MB; Canadian Bandage Trial Team. Different context, different results: venous ulcer healing and the use of two high-compression technologies. J Clin Nurs. 2014;23(5-6):768–773.

23. Ratliff CR, Yates S, McNichol L, Gray M. Compression for primary prevention, treatment, and prevention of recurrence of venous leg ulcers: an evidence-and consensus-based algorithm for care across the continuum. J Wound Ostomy Continence Nurs. 2016;43(4):347–364. doi: 10.1097/WON.0000000000000242.

24. Partsch H. Compression for the management of venous leg ulcers: which material do we have? Phlebology. 2014;29(1 suppl):140–145.

Ms. De Carvalho is a wound care nurse and Mr. Peixoto is a registered nurse, Antonio Pedro Hospital; Ms. Silveira is an intensive care nurse and a PhD Student, Academic Program in the Health Care Sciences Department; and Ms. Oliveira is a PhD Professor, Academic Program in the Health Care Sciences Department, Federal Fluminense University, Rio de Janeiro, Brazil. Please address correspondence to: Magali Rezende De Carvalho, RN, MSN, CWOCN, Federal Fluminense University, Rua Dr. Celestino, 74 – Centro, Niteroi, Rio de Janeiro, Brazil 24020-091; email: magalirecar@gmail.com.

Section:

↧

Translation and Validation of a Wound-specific, Quality-of-life Instrument (The Wound-QoL) in a Swedish Population

May 7, 2018, 11:58 am

≫ Next: Management of a Complex Lower Limb Open Fracture in a Teenage Patient: A Case Report

≪ Previous: A Meta-analysis to Compare Four-layer to Short-stretch Compression Bandaging for Venous Leg Ulcer Healing

Issue Number:

Index:

Ostomy Wound Management 2018;64(5):40–46 doi: 10.25270/owm.2018.5.4046

Ann-Mari Fagerdahl, RN, PhD; and Gunnar Bergström, PhD

Topics:

wounds and injuries

Quality of Life

validation studies

reliability

symptom assessment

Abstract

Hard-to-heal wounds can compromise patient quality of life (QoL); thus, assessing QoL is an important aspect of wound management. The aim of this study, conducted from August 2015 to July 2016, was to translate a wound-specific instrument, the Wound-QoL, into the Swedish language and context and validate its ability to assess QoL in a population of patients with wounds of various etiologies.

The Wound-QoL, derived from 3 existing wound care QoL instruments, is a paper-and-pencil tool comprised of 17 Likert-style questions addressing 3 categories (Body, Psyche, and Everyday Life) to provide a global score. The instrument was translated into Swedish and its psychometric properties (reliability, validity, responsiveness, and ceiling and floor effect) were tested in a convenience sample of 88 Swedish outpatients (64 men [73%], mean age 67 [range 27–96] years) with hard-to-heal wounds (mean duration 10 months) of varying etiologies. Participants completed the questionnaires at baseline in the beginning of the study and at 6 weeks; they also had the opportunity to comment on the questionnaire. Reliability was analyzed using Cronbach’s alpha coefficient (0.70 or higher was considered acceptable). Criterion validity was examined using a generic European QoL instrument, considered the gold standard, as the comparator. Descriptive statistical analysis was performed for presentation of the demographic and wound variables. Standardized response mean was used to assess internal responsiveness. All tests were 2-sided with 95% confidence interval; the results were considered significant at P<.05. QoL scores of the study population in the different domains measured with the Wound-QoL instrument varied from 1.11 to 1.72. Reliability was excellent, with internal consistency of 0.78-0.92 and test-retest stability of 0.80-0.88; standardized response mean showed small to moderate sensitivity; and validity was found to be slightly moderate to moderate. No signs of ceiling or floor effect could be detected. The Swedish version of the Wound-QoL instrument was found to be a reliable and valid tool for measuring health-related QoL in patients with hard-to-heal wounds in Sweden and demonstrated the potential to be used in a clinical setting to detect QoL issues during wound treatment. Further psychometric studies need to be performed to validate the instrument in patient groups with acute wounds, with different wound treatments, and for patients treated in nonspecialized wound care settings such as home care.

Hard-to-heal (ie, wounds that fail to heal within an expected time frame and order¹) can compromise patient quality of life (QoL), as shown in both qualitative and quantitative research.^2,3 A review⁴ of randomized controlled trials and comparative studies of nonhealing wounds published between 2003 and 2009 shows >300 different endpoints are used to evaluate wound management; the majority of the endpoints are directly related to complete wound healing (perceived as the most meaningful endpoint) with healing rates and time for complete healing as primary outcomes.⁵ However, experts tend to focus on patient-related outcomes such as QoL in research of nonhealing wounds.⁶

Health-related quality of life (HRQOL) is a multidimensional concept and can be defined as a person’s subjective perception of his/her overall physical and mental health.⁷HRQOL in patients with venous leg ulcers has been addressed in systematic reviews^3,8,9 that demonstrate the negative impact of these wounds on patient well-being. Similar results have been found in several reviews of both quantitative and qualitative studies among patients with diabetic foot ulcers⁷ and pressure ulcers.^10,11

HRQOL can be measured with generic instruments that lend a broad perspective on health and target nonspecific patient groups. Commonly used generic instruments for assessing HRQOL in patients with wounds are the Short Form-36 (SF-36), a 36-item, patient-completed survey that consists of 8 scaled scores; and the EuroQol Five-dimensional Descriptive System (EQ-5D-3L).¹²The EQ-5D-3L consists of 2 parts; the first covers 5 dimensions (mobility, self-care, ability to undertake usual activities, pain/discomfort, and anxiety/depression); the 3 answer options are no problems, some problems, and difficult problems, which generate an index to be used in analysis. The second part consists of a Visual Analog Scale (VAS) where the respondents rate their perception of their health by marking a line. The VAS scale ranges from 0 to 100, where 0 indicates the worst possible conditions and 100 indicates the best possible conditions.

Instruments also have been developed to target the experience of health-related life aspects specific to a disease or condition.¹³ When measuring HRQOL of patients, descriptive or comparative studies recommend use of a combination of a generic instrument and a condition-specific instrument.¹⁴ The Cardiff Wound Impact Schedule¹⁵ (CWIS) was developed to meet the need for a wound-specific HRQOL instrument. This 47-item tool was designed to measure general health, physical symptoms, daily life, social life, and overall QoL in patients with chronic wounds. The instrument has been translated and validated into several languages and contexts^16-18 including Swedish.¹⁹ However, the CWIS instrument has drawbacks; patients have described the questionnaire as too extensive, and several validation studies^19,20 of the instrument noted a relatively high dropout rate during psychometric testing. In view of these problems, a new wound-specific HRQOL instrument was created, the Wound-QoL. The aim of this study was to validate the translation of the Wound- QoL instrument into Swedish language and context.

Materials and Methods

The Wound-QoL instrument. The Wound-QoL instrument was developed by the Institute for Health Services Research in Dermatology and Nursing at University Medical Center, Hamburg, Germany, to fulfill a need for a short, easy-to-use, multidimensional questionnaire measuring HRQOL in patients with hard-to-heal wounds.²⁰ The instrument is a combination of the English CWIS and 2 German wound specific instruments, The Freiburg Life Quality Assessment for Wounds and the Wurzburg Wound Score. Together, the 3 questionnaires comprised a total of 92, 5-point Likert-scaled items from which 17 items were extracted and prospectively analyzed in a virtual validation study. The items were assigned to 3 subscales according to the domains Body (items 1–5), Psyche (items 6–10), and Everyday living (items 11–16). The subscales were summed for an overall global score together with an additional question regarding financial impact. Each item is rated by the respondent on a 5-point Likert-scale where 0 = not at all and 4 = very much; 4 was the worse rated level of HRQOL (see Figure 1).

The psychometric properties (reliability, validity, responsiveness, ceiling and floor effect) then were tested in a validation study performed at 2 different German wound centers with a total sample size of 227 patients with hard-to-heal wounds of various etiologies, showing satisfactory psychometric properties according to internal consistency (Cronbach alpha >0.80), convergent validity (0.5-0.7), and responsiveness (P≤.001).²¹ The instrument also was tested for test-retest reliability in a study of 100 patients with hard-to-heal wounds using intraclass correlation (ICC). The result showed excellent reliability (range 0.79-0.86) calculated from the questionnaires, with an interval of 3 to 7 days between first and second completion.²²

The translation process. The English version of the Wound-QoL instrument was translated into Swedish according to instructions by the Standard Linguistic Validation Process created by MAPI Research Institute,²³ a 7-step process that includes forward and backward translation and pilot testing. The translation process was a collaboration between independent translators and the research group. The re-translated version was sent to the creators of the original version of the instrument, the Institute for Health Services Research in Dermatology and Nursing at University Medical Center, Hamburg, Germany, who evaluated the translation, made adjustments, and gave their approval.

Materials and data collection. Using convenience sampling methods, patients >18 years old with hard-to-heal wounds treated at an outpatient wound clinic in a large city in Sweden were recruited while visiting the clinic for their scheduled wound treatment between August 2015 and July 2016. Patients with less than adequate cognition to complete the questionnaire and patients who had not mastered the Swedish language were excluded.

The patients were asked to complete the Swedish version of the Wound-QoL instrument as well as the generic HRQOL instrument EQ-5D-3L at baseline at study enrollment and after 6 weeks. For the 6-week follow-up, the questionnaires were either distributed at a planned revisit at the wound clinic or sent to the patients with a letter of instruction and a postage-prepaid envelope with instructions to return the forms within 1 week. The patients completed the questionnaires in paper-and-pencil format, then data were transferred into a computer file for analysis. Basic demographic information and wound data, including gender, age, and type and duration of the wound, were obtained from either the patient or his/her medical record in the wound clinic. Patients also were asked in an open-ended question to describe their general experience of completing the Wound-QoL questionnaire; the responses were registered as field notes by the researcher.

All patients gave their verbal informed consent to participate in the study. Patient confidentiality was ensured by coding the questionnaires and records; encoding was handled solely by the researcher in accordance with the Swedish Data Protection Act (SFS,1998:204). The study was performed according to the Helsinki Declaration, and study approval was obtained by the local Ethics Committee (2015/714-31).

Psychometric analysis and statistics. Data from all questionnaires were transferred into a computer program to assess reliability, validity, responsiveness, and ceiling and floor effects. SPSS version 23.0 (IBM, Armonk, NY) was used for all calculations, and all tests were 2-sided with a 95% confidence interval. The results were considered significant at P <.05. Descriptive statistical analysis was performed for presentation of the demographic and wound variables.

Reliability. Reliability was measured with internal consistency to estimate the correlation between the different items for each domain at baseline using Cronbach’s alpha coefficient; Cronbach’s alpha 0.70 or higher was considered acceptable.²⁴ Stability (test-retest reliability) of the instrument over time was measured with an ICC of patients who rated their health as unchanged in the EQ-5D-3L at the 6-week follow-up. An acceptable level of ICC in this study was considered >0.70.²⁵

Validity. Validity in this study was assessed by measuring criterion validity comparing the scores of the Wound-QOL to the gold-standard instrument (EQ-5D-3L), a process similar to that used by the developers of the Wound-QOL instrument.²⁰ All 3 domains of the Wound-QoL instrument together with the global score were compared to the EQ-5D-3L time trade-off (TTO) index and to the EQ-5D-3L VAS (ie, the patient’s self-rated health). The correlations were calculated with Spearman’s rho due to data on an ordinal level and were expected to be negative and moderately strong based on the correlation from the development process.²⁰ A moderately strong correlation was defined as 0.3 to 0.49 according to Cohen.²⁶

Responsiveness. Standardized response mean (SRM) was used for assessing responsiveness, a measurement of the ability of the instrument to detect clinically important changes. The calculation was performed by dividing the difference between baseline and 6-week follow-up in the group assessing their health as improved at the 6-week follow up according to the EQ-5D-3L questionnaire. SRM <0.5 is considered as small ability to detect change, 0.5–0.8 is moderate, and >0.8 is large.²⁷

Ceiling and floor effect. Ceiling and floor effects occur when the scores of an instrument reach the maximum or minimum possible score. If this is noted in 15% or more of the questionnaires, it is hard to detect improvement or decline in the rated health status.²⁸

Results

Of the 103 patients who agreed to participate in the study and completed the questionnaires at baseline, 92 (89%) completed the questionnaires at the 6-week follow-up. Of those, 4 patients were excluded; they were wheelchair users and not able to answer the EQ-5D-3L questions regarding mobility. Thus, 88 questionnaires (participants included 64 men [73%] and 24 women [27%], mean age 67 [range 27–96] years) were analyzed. All included patients had hard-to-heal wounds with a duration >6 weeks; the most common wound (36, 42%) was a diabetic foot ulcer. The mean QoL score at baseline measured with the Wound-QoL instrument for the different domains and global score ranged from 1.11 to 1.39; measured with the EQ-5D-3L, the index mean at baseline was 0.52 with a mean VAS score of 62 (see Table 1). All patients described the questionnaire as being easy to understand and not too extensive or time-consuming to complete.

Reliability. Cronbach’s alpha coefficient showed an excellent internal consistency for each of the 3 domains (Body [0.78], Psyche [0.89], and Everyday life [0.90]). Internal consistency for the overall global score of the Wound-QoL instrument had an alpha of 0.92.

Test-retest analysis was performed on questionnaires of the 29 patients who rated their perception of health at the 6-week follow-up as unchanged. All of the domains showed excellent stability with ICC >75 (Body [0.80], Psyche [0.84], and Everyday life [0.81]). The overall global score of the instrument also was excellent (ICC 0.88).

Validity. Criterion validity was calculated by correlating the overall global score and the different domains of the Wound-QoL instrument with the EQ-5D-3L index value (TTO) and the EQ-5D-3L VAS scale (see Table 2). The correlations were moderate for the category Everyday life (-0.44) and for the overall global score (-0.44). Criterion validity for the categories Body (-0.35) and Psyche (-0.32) was slightly less than moderate. All correlations were significant (P<.01).

Responsiveness. Internal responsiveness was assessed using SRM in the group that stated health was improved after 6 weeks per the EQ-5D-3L. The results presented in Table 3 show moderate SRM for the domains Body (0.60) and Psyche (0.51). The SRM was small for Global score (0.45) and for the domain Everyday life (0.30), which also was a nonsignificant value for the change from first assessment to 6 week follow-up.

Ceiling and floor effect. The Wound-QoL instrument showed no signs of unacceptable ceiling or floor effect. No participant received the lowest or the highest possible score in the overall global score (see Table 4).

Discussion

The aim of this study was to translate the Wound-QoL, a wound-specific HRQOL instrument, into the Swedish language and context and validate the new version. The results of psychometric testing of the Swedish version showed acceptable reliability, validity, and responsiveness as well as no signs of ceiling and floor effect. These findings indicate the instrument could be used in a clinical setting to assess HRQOL in patients with hard-to-heal wounds in Sweden.

When assessing the external validity of the Swedish version of the Wound-QoL instrument, the only reference data available are from the creation of the original instrument; no other validation studies of the instrument have been published. The psychometric properties of the Swedish version proved to be similar to those of the original version of the Wound-QoL^20-22 with regard to reliability, validity, responsiveness, and ceiling and floor effect. Also, the actual scores of perceived HRQOL measured with the Wound-QoL instrument were similar; the result with a range at baseline from 1.11 to 1.39 compared with the result of Sommer et al²² with scores ranging from 0.90 to 1.57. Both studies had the lowest scores in the Body domain. Together, this indicates acceptable external validity.

From their general comments, patients found the questionnaire was easy and not too extensive to complete, unlike the experiences related to the CWIS.¹⁹ A qualitative study²⁹ using an open-ended question identified the key elements of using a HRQOL instrument successfully as a screening tool in the clinical setting determined it should not be time-consuming and not be perceived as a burden to the patient or staff. The results of the current study indicate the Wound-QoL instrument can be used as a clinical tool to detect HRQOL issues during wound treatment that need to be addressed; its use is not limited to research purposes.

During the 26th conference of the European Wound Management Association,³⁰ some issues were noted regarding 1 item of the original Wound-QoL instrument, (item number 12, “…climbing stairs has been difficult because of the wound”). Some reports indicate patients viewed the question as offensive, especially if they had already provided a negative response to the previous question that states, “…I have had trouble moving about because of the wound.” The German creators of the original version of the instrument had made some calculation after removing item number 12 without affecting the psychometric scores in a negative way.³⁰ In turn, the current researchers similarly removed the data in question without impacting the results of psychometric property item responses (data not shown). Thus, the instrument may be further shortened to 16 questions, but this new version of the instrument would need to undergo proper psychometric testing.

Limitations

When designing this study, the EQ-5D-3L was considered the gold standard for assessment of criterion validity in accordance with the creation of the original Wound-QoL instrument.²⁰ In retrospect, this may be criticized particularly when evaluating the results of the psychometric properties of criterion validity showing moderate and less moderate values for the 3 domains. In the creation of the CWIS, which is 1 of the instruments used to develop the Wound-QoL, the SF-36 was used as the gold standard, and this instrument also was used for the Swedish validation study of the CWIS.^15,19 The SF-36 may perhaps have been a better choice as gold standard because it is more extensive and described problems with ceiling and floor effect of the EQ-5D-3L. This could have had a negative influence on the result because it may have been more problematic to detect changes.³¹

In addition, the creators of the original instrument acknowledge that having data from their study only from specialist centers with expertise in wound management²¹ may limit their findings. This is also the case in this validation study of the Swedish version and leaves the generalizability of the result in patients treated in primary care and other nonspecialist wound health care units open for discussion.

Another limitation of this study can be seen in the test-retest assessment of reliability. Most commonly, a follow-up time of approximately 1 week is used for performing this test.²⁴ In this study, the decision was made to use the same follow-up measurement for both test-rest and responsiveness to decrease the burden for the included patients so they just needed to fill in the questionnaires twice. As such, using the EQ-5D-3L items where patients can rate their perceived health status as worsened, unchanged, or improved, the data of the 6-week follow-up could be used for both measurements.

Conclusion

A study to assess the results of translating into Swedish and to validate the wound-specific Wound-QoL showed the instrument has acceptable psychometric properties and is a reliable and valid tool for measuring HRQOL in patients with hard-to-heal wounds in Sweden. Further psychometric studies need to be performed validating the instrument in patient groups with acute wounds, with different wound treatment, and for patients treated in nonspecialized wound clinics such as home care.

Acknowledgements

The authors thank the Swedish Tissue Viability Nurse Association its valuable contribution to this study.

References

1. Vowden P. Hard-to-heal wounds made easy. Wounds Int. 2011;2(4).

2. Ebbeskog B, Ekman SL. Elderly persons’ experiences of living with venous leg ulcer: living in a dialectal relationship between freedom and imprisonment. Scand J Caring Sci. 2001;15(3):235–243.

3. Persoon A, Heinen MM, van der Vleuten CJ, de Rooij MJ, van de Kerkhof PC, van Achterberg T. Leg ulcers: a review of their impact on daily life. J Clin Nurs. 2004;13(3):341–354.

4. Gottrup F, Apelqvist J, Price P; European Wound Management Association. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care. 2010;19(6):237–268.

5. Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment, United States. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegula-toryInformation/Gui... Accessed April 11, 2018.

6. Jeffcoate WJ, Bus SA, Game FL, Hinchliffe RJ, Price PE, Schaper NC; International Working Group on the Diabetic Foot and the European Wound Management Association. Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality. Lancet Diabetes Endocrinol. 2016;4(9):781–788.

7. Hogg FR, Peach G, Price P, Thompson MM, Hinchliffe RJ. Measures of health-related quality of life in diabetes-related foot disease: a systematic review. Diabetologia. 2012;55(3):552–565.

8. Green J, Jester R, McKinley R, Pooler A. The impact of chronic venous leg ulcers: a systematic review. J Wound Care. 2014;23(12):601–612.

9. Phillips P, Lumley E, Duncan R, et al. A systematic review of qualitative research into people’s experiences of living with venous leg ulcers. J Adv Nurs. 2017;74(3):550–563.

10. Gorecki C, Brown JM, Nelson EA, et al; European Quality of Life Pressure Ulcer Project Group. Impact of pressure ulcers on quality of life in older patients: a systematic review. J Amer Geriatr Soc. 2009;57(7):1175–1183.

11. Spilsbury K, Nelson A, Cullum N, Iglesias C, Nixon J, Mason S. Pressure ulcers and their treatment and effects on quality of life: hospital inpatient perspectives. J Adv Nurs. 2007;57(5):494–504.

12. Oien RF, Akesson N, Forssell H. Assessing quality of life in patients with hard-to-heal ulcers using the EQ-5D questionnaire. J Wound Care. 2013;22(8):442–444, 446–447.

13. Garratt A, Schmidt L, Mackintosh A, Fitzpatrick R. Quality of life measurement: bibliographic study of patient assessed health outcome measures. BMJ. 2002;324(7351):1417.

14. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care. 1989;27(3 suppl):S217–S232.

15. Price P, Harding K. Cardiff Wound Impact Schedule: the development of a condition-specific questionnaire to assess health-related quality of life in patients with chronic wounds of the lower limb. Int Wound J. 2004;1(1):10–17.

16. Acquadro C, Price P, Wollina U. Linguistic validation of the Cardiff Wound Impact Schedule into French, German and US English. J Wound Care. 2005;14(1):14–17.

17. Huang Y, Wu M, Xing P, et al. Translation and validation of the Chinese Cardiff Wound Impact Schedule. Int J Low Extrem Wounds. 2014;13(1):5–11.

18. Jaksa PJ, Mahoney JL. Quality of life in patients with diabetic foot ulcers: validation of the Cardiff Wound Impact Schedule in a Canadian population. Int Wound J. 2010;7(6):502–507.

19. Fagerdahl AM, Boström L, Ulfvarson J, Bergström G, Ottosson C. Translation and validation of the wound-specific quality of life instrument Cardiff Wound Impact Schedule in a Swedish population. Scand J Caring Sci. 2014;28(2):398–404.

20. Blome C, Baade K, Debus ES, Price P, Augustin M. The “Wound-QoL”: a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014;22(4):504–514.

21. Augustin M, Conde Montero E, Zander N, et al. Validity and feasibility of the Wound-QoL questionnaire on health-related quality of life in chronic wounds. Wound Repair Regen. 2017;25(5):852–857.

22. Sommer R, Augustin M, Hampel-Kalthoff C, Blome C. The Wound-QoL questionnaire on quality of life in chronic wounds is highly reliable. Wound Repair Regen. 2017;25(4):730–732.

23. Acquadro C, Conway K, Giroudet C, Mear I. Linguistic Validation Manual for Patient-reported Outcomes (PRO) Instruments. Lyon, France: Mapi Research Institute;2004.

24. Streiner D, Norman G. Health Measurement Scales: A Practical Guide to Their Development and Use. New York, NY: Oxford University Press;2008.

25. Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60(1):34–42.

26. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NY: L. Erlbaum Associates;1988.

27. Middel B, van Sonderen E. Statistical significant change versus relevant or important change in (quasi) experimental design: some conceptual and methodological problems in estimating magnitude of intervention-related change in health services research. Int J Integr Care. 2002;2:e15.

28. McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res. 1995;4(4):293–307.

29. Hagelin CL, Wengström Y, Tishelman C, Fürst CJ. Nurses’ experiences of clinical use of a quality of life instrument in palliative care. Contemp Nurs. 2007;27(1):29–38.

30. Blome C. The Wound-QoL questionnaire measures wound-specific quality of life. Presented at the European Wound Management Association Conference; May 15, 2016; Bremen, Germany.

31. Johnson JA, Pickard AS. Comparison of the EQ-5D and SF-12 health surveys in a general population survey in Alberta, Canada. Med Care. 2000;38(1):115–121.

Dr. Fagerdahl is a perioperative nurse and researcher, Wound Centre, Södersjukhuset, Department of Clinical Science and Education; and Dr. Bergström is a researcher, Unit of Intervention and Implementation Research for Worker Health, IMM Institute of Environmental Medicine, Karolinska Institutet Södersjukhuset, Stockholm, Sweden. Please address correspondence to: Ann-Mari Fagerdahl, Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet Södersjukhuset, S - 118 83 Stockholm, Sweden; email: ann-mari.fagerdahl@ki.se.

Section:

↧

Management of a Complex Lower Limb Open Fracture in a Teenage Patient: A Case Report

May 7, 2018, 12:12 pm

≫ Next: A Prospective, Explorative Study to Assess Adjustment 1 Year After Ostomy Surgery Among Swedish Patients

≪ Previous: Translation and Validation of a Wound-specific, Quality-of-life Instrument (The Wound-QoL) in a Swedish Population

Issue Number:

Index:

Ostomy Wound Management 2018;64(5):47–52 doi: 10.25270/owm.2018.5.4752

Prof. Davor Mijatović, MD, PhD; Sanda Smuđ Orehovec, MD; Prof. Tomislav Đapić, MD, PhD; Vilena Vrbanović Mijatović, MD, PhD; and Marko Mance, MD

Topics:

Case Study

tibial fracture

adolescent

Limb Salvage

reconstructive surgical procedures

Abstract

The challenges of managing Gustilo IIIB tibial fractures (ie, high energy trauma with a contaminated wound >10 cm in length, severe comminution [“crumbling”] or segmental fractures, and periosteal stripping) in children are unique in part because no clear guidelines exist and the injuries may cause short-term and long-term complications. Repeated wound debridement and secondary reconstruction are required in approximately 20% of these cases in both adults and children. A 13-year-old girl presented with severe polytrauma including an open Gustilo type IIIB fracture of the left lower leg.

The patient declined limb amputation; a multidisciplinary team (plastic, pediatric, orthopedic-trauma surgeons, pediatrician, psychiatrist, clinical pharmacologist, anesthesiologist, physiotherapist, nurses) was assembled in order to give the patient the best chance of a successful outcome. Multiple limb salvage and reconstructive procedures including wound debridements, necrectomies, long-term negative pressure wound therapy, soft tissue reconstructions, external bone fixation, bone osteosynthesis, multiple skin grafts, and free-flap reconstruction were provided over a period of 6 months with great success. The patient is doing well 3 years after initial injury and is walking without complications. A multidisciplinary approach and structured treatment plan are important to minimize complications, avoid unnecessary delays in treatment, decrease morbidity, and provide the patient with the best result possible. Studies examining optimal treatment strategies for children and adolescents with these complicated fractures are needed.

Managing Gustilo IIIB tibial fractures in children and adolescents presents unique challenges. In children, these fractures are associated with a 4.5% incidence of neurovascular compromise requiring intervention, 1.5% primary amputation, and 1.2% mortality rates; repeated wound debridement and secondary plastic surgery are required in approximately 20% of fractures.¹ In the pediatric population, open fractures account for approximately 5% of all tibia fractures,^2,3 which should raise awareness regarding the severity of these injuries.

A trend toward better results has been noted in younger children and those with a low Gustilo-Anderson fracture grade. Higher fracture grades according to the Gustilo classification (see Table 1) are associated with a higher complication rate and longer union times (ie, time needed for the fracture reduction to stabilize without any gap formation).¹ According to a review of the literature,⁴ these injuries should be treated with delayed wound closure and may require a skin graft or a flap. According to a systematic review of literature by Baldwin et al,⁵ surgical fracture stabilization usually is required and the option of external fixation seems appropriate for the management of grade III open fractures.

Open tibial fractures in adults have been studied extensively, and detailed treatment strategies have been developed by the AO Trauma Foundation⁶; wound irrigation and debridement, fracture stabilization, and delayed primary wound closure or early flap coverage are basic principles of management. However, no clear guidelines or protocols exist regarding the management of open tibial fractures in children, which makes these cases challenging for physicians. It is unclear whether open fractures of the tibia in children should be managed according to the same principles followed in adults, because the literature does not facilitate scientifically based conclusions of management strategy or identification of possible risk factors in children. In a combined retrospective and prospective review, Bartlett et al⁷ studied 23 fractures in children ages 3.5 years to 14.5 years (18 boys and 5 girls) that included 6 type II, 8 type IIIA, and 9 type IIIB fractures. The authors concluded open tibia fractures in children differ from similar fractures in adults in that soft tissues have excellent healing capacity, devitalized bone that is not contaminated or exposed can be saved and will become incorporated, and external fixation can be maintained until the fracture has healed. The authors also noted periosteum in young children can form new bone even when there is bone loss. A review by Gougoulias et al¹ suggested a lack of long-term follow-up examinations, despite the fact these injuries in the pediatric population can lead to angular deformity and leg length discrepancy. With no clear guidelines in the treatment of such injuries in children, the purpose of this paper is to document the outcome of the authors’ approach and describe the methods used to successfully treat and rehabilitate a child with a complicated Gustilo IIIB open fracture.

Case Report

History. Ms. A was admitted to the authors’ facility in January 2014 at age 14 years. When she was 11 years old, she was sold to a family and became the victim of human trafficking. At the age of 12 years, she experienced a spontaneous abortion, after which she managed to escape her captors and was placed into a government-run home where the case first was reported to authorities. Ms. A was hospitalized on 2 different occasions at the local county hospital due to psychological problems. She was diagnosed with anxiety disorder, reaction to severe stress, and adjustment disorder for which she was treated with counseling, oral antidepressives, and anxiolitics.

After 1 year at the childcare facility, she allegedly heard she would be returned to her captors. This information and fear were the trigger for attempting suicide; she jumped off a 3-story building. Ms. A experienced severe polytrauma, including a closed fracture of the right tibia and fibula and an open tibial fracture on the left leg with an extremely contaminated large skin and soft tissue defect of about 50% of the total lower leg volume, severe fracture comminution (bone “crumbling”), and periosteal stripping. She suffered other injuries that further complicated her recovery, including fractures of her pelvic bones (acetabulum and right ischiopubic bone); basilar skull; left frontal, orbital, and zygomatic bones; and right sphenoid bone and nasal bones. Ms. A also had a diffuse cerebral contusion and bleeding into the maxillary, ethmoidal, frontal, and sphenoid sinuses. Due to thoracic contusion and bilateral contusion of the lungs, her condition was further complicated by respiratory failure.

Treatment. Soon after Ms. A was admitted to the county hospital, surgery for the leg trauma was postponed due to head and thoracic injuries, and cast immobilization was placed. Three (3) days later, Ms. A developed compartment syndrome (a relatively uncommon complication in open fracture injuries in children¹) of the left lower leg and underwent a fasciectomy and placement of an external fixator. The primary fasciectomy (that resulted in a large tissue necrosis and local infection) was delayed because the cast immobilization covered the leg and during the next 3 days, the neurocirculatory status of the leg was not properly checked.

Two (2) weeks after the initial injury, Ms. A was transferred to the authors’ Department of Plastic and Reconstructive Surgery where her lower leg was examined. Local findings included an open tibial fracture with external fixation, necrotic muscles of the anterior and lateral muscle compartments, purulent secretions, and a skin defect measuring 33 cm x 20 cm with necrotic edges, exposing the entire length of the lateral, posterior, and anterior aspects of the lower leg (see Figure 1). Additionally, Ms. A had a closed fracture of the right lower leg, also with external fixation.

Upon her arrival, a surgeon performed a necrectomy and wound debridement of the necrotic skin and muscle tissue of the left lower leg and applied constant negative pressure wound therapy (NPWT) at -120 mm Hg that was changed every 4 to 5 days for the next 3 weeks (see Figure 2).

After optimization of the wound bed, the external fixator was removed and osteosynthesis was performed using cortical screws. The residual soft tissue defect was filled using a free microvascular latissimus dorsi flap, anastomosing the thoracodorsal artery and vein to the popliteal artery and vein, respectively. To cover the skin defect, a split-thickness skin graft harvested from her left thigh region was placed (see Figure 3). Within 72 hours, the donor tissue developed dark discoloration and a loss of Doppler signal. It was surgically removed due to flap failure and tissue necrosis. To close the skin and soft-tissue defect, NPWT again was applied at the same setting (-120 mm Hg) and changed every 4 to 5 days for the next 5 months. During this period, several split-thickness skin grafts from the left thigh were harvested and placed to cover the residual skin defect, after which NPWT was reapplied as previously described (see Figures 4, 5). In the last month of her treatment, Ms. A also underwent a total of 22, 1-hour hyperbaric chamber treatments.

Two (2) months after the initial injury, the external fixator on the right lower leg was removed, the right tibia was manually repositioned, and osteosynthesis was achieved using an intramedullary nail. During the same surgical procedure, the screws previously placed in left lower leg were removed, necrectomy of necrotic bone of the proximal part of the left tibia was performed, and an external fixator again was positioned. Ms. A was hospitalized for a total of 6 consecutive months.

Immediately upon arrival and throughout hospitalization, a pediatric psychiatrist monitored Ms. A on a daily basis. Ms. A was treated with anxiolitic and antidepressive medications — diazepam, 10 mg per day, and sertraline, 25 mg per day. She also underwent weekly psychotherapy consultations. During her stay, multiple wound, urine, blood, and central venous catheter cultures were taken, and appropriate antibiotics were prescribed according to the antibiogram results. Bacterial isolates from wound cultures included Enterococcus faecalis, Pseudomonas aeruginosa, Staphylococcus species, and Acinetobacter baumannii.

Prognosis. Six (6) months after admission, Ms. A was discharged from the Department of Plastic and Reconstructive Surgery and transferred to the Department of Orthopedics, afebrile with all wounds closed. She underwent 5 separate additional surgical procedures at the Department of Orthopaedic Surgery.

The first surgical procedure involved elongation of the left Achilles tendon, tenotomy of the left posterior tibial muscle, and capsulotomy of the left posterior talocrural and subtalar joints. The second and third surgical procedures were tenotomies of the left digital flexor muscles and the abductor muscle of the left thumb. The fourth procedure was to correct the patient’s pes cavus using the Steindler technique (ie, muscle and fascia stripping from the plantar surface of the calcaneus). The last procedure was performed to correct pseudoarthrosis of the left lower leg using an Ilizarov apparatus that was removed 3 months later.

Ms. A’s early postoperative status at the Department of Orthopedic Surgery was satisfactory. She was independently mobile with the aid of crutches and orthotics.

Follow-up. Ms. A’s follow-up was performed based on common clinical practice in the authors’ department. At her 18-month follow-up, Ms. A was afebrile, all wounds were closed, and she experienced no discomfort. No edema was noted on her lower limbs, her left knee was flexed to about 75˚ with the aid of orthotics, and she was mobile (see Figures 6, 7). She continued to receive regular psychiatric counselling and remains on her psychiatric medications.

Discussion

Open tibial fractures have been studied extensively in adults, and detailed treatment strategies have been developed that include wound irrigation and debridement, fracture stabilization, and delayed primary wound closure or early flap coverage as basic principles of management. No clear guidelines exist regarding the management of open tibial fractures in children.¹

Glass et al⁴ performed a systematic review of the literature and evaluated Gustilo grade IIIB tibial shaft fractures in preadolescent and adolescent children with regard to both the skeletal and soft tissue management and patients’ outcome. The authors found that in 54 children with grade IIIB tibial fractures, mean union (complete fracture closure) time was 31 weeks and included 33 weeks for 42 adolescents and 23 weeks for 12 preadolescents. This difference tended toward statistical significance. Delayed union (a failure to reach bony union by 6 months post-injury) occurred in 22% and nonunion (an arrest in the fracture repair process or progressive evidence of nonhealing of a fracture of a bone) in 13% of patients, mostly in adolescents. Of the 45 fractures, 2 covered by vascularised flaps and 3 of 9 treated without flaps developed deep infection (P = .028). The authors also found no correlation between method of skeletal fixation and union time. They concluded that Gustilo IIIB tibial shaft fractures in preadolescents tended toward faster healing with fewer complications, irrespective of the method of skeletal fixation, and adolescent healing times were similar to adults. Soft tissue closure without flaps was associated with deep infection in one third of patients, requiring debridement and flap cover. Adequate debridement and flap cover was suggested in all cases, irrespective of age.

As noted earlier from their combined retrospective and prospective review, Bartlett et al⁷ evaluated treatment protocol for type II and type III open tibial fractures in children over a 10-year period (1984 to 1993). They sought to determine whether severe open tibial fractures in children behave like similar fractures in adults. The authors found open tibial fractures in children differ from similar fractures in adults in that soft tissues have excellent healing capacity, devitalized bone that is not contaminated or exposed can be saved and will become incorporated, and external fixation can be maintained until the fracture has healed. Periosteum in young children can form bone even in the face of bone loss.

For the patient in this report, after latissimus dorsi flap deterioration the main issue for discussion became further therapeutic possibilities: free flap, pedicle flap, “cross leg” fasciocutaneous flap, or amputation. It was necessary to compare the advantages and disadvantages of each approach and modality of treatment. The patient was not willing to lose her leg, and none of the above-mentioned reconstructive options was ideal because of the extent of bone and soft tissue defects. NPWT proved to be helpful even in this severe case, although it is not a reconstructive method and requires a considerable amount of time and patience. In this case, NPWT helped provide an acceptable healing result, even though the injuries were severe and contaminated. In their review of literature, Setter and Palomino³ found external fixation remains a successful treatment option for unstable tibial shaft fractures. However, the question remains whether Ms. A would have derived more benefit from leg amputation and a functional prosthesis than from all procedures performed when considering the long duration of hospitalization (a total of 10 months), the large amount of antibiotics and other medication she received, and many episodes of general anesthesia she endured. Amputation remains an option for Ms. A to decide for herself in the future.

Tibial fractures must be managed by a multidisciplinary team (plastic, pediatric, orthopedic-trauma surgeon, pediatrician, psychiatrist, clinical pharmacologist, anesthesiologist, physiotherapist, nurses) due to their complexity in order to give the patient the best chance of a successful outcome.⁸ A multidisciplinary approach optimizes the patient’s treatment and may avoid delays by having multiple specialists simultaneously involved in the case; hence, minimizing confusion, delay in treatment, and contradictory treatment modalities; decreasing the chance for or spread of infection; monitoring the status of the wound and skin grafts and flaps; and providing constant patient care. It remains unclear whether open tibial fractures in children should be managed according to the principles followed in adults. Carefully designed prospective cohort studies with a large number of children would be of value. Adequate follow-up is necessary to assess the long-term effects in the growing skeleton, and outcome studies based on general health measures are needed.

Conclusion

With no clear guidelines in the treatment of such injuries in children, a child with multiple injuries including a complicated Gustilo IIIB open fracture was managed with long-term antibiotic treatment, debridements, necrectomies, internal and external bone fixation, long-term NPWT, skin grafting, free flap reconstruction, multiple soft tissue reconstructions, physical therapy, and psychiatric care. A multidisciplinary approach and structured treatment plan are important to minimize complications, avoid unnecessary delays in treatment, and decrease morbidity, providing the patient with the best result possible. Further studies that include a larger patient population are needed to create clear and concise guidelines and optimal treatment strategies for children and adolescents with these complicated fractures. n

References

1. Gougoulias N, Khanna A, Maffulli N. Open tibial fractures in the paediatric population: a systematic review of the literature. Br Med Bull. 2009;91:75-85. doi: 10.1093/bmb/ldp019.

2. Palmu SA, Auro S, Lohman M, Paukku RT, Peltonen JI, Nietosvaara Y. Tibial fractures in children. A retrospective 27-year follow-up study. Acta Orthopa. 2014;85(5):513–517. doi:10.3109/17453674.2014.916489.

3. Setter KJ, Palomino KE. Pediatric tibia fractures: current concepts. Curr Opin Pediatr. 2006;18(1):30–35.

4. Glass GE, Pearse M, Nanchahal J. The ortho-plastic management of Gustilo grade IIIB fractures of the tibia in children: a systematic review of the literature. Injury. 2009;40(8):876–879. doi: 10.1016/j.injury.2008.12.010.

5. Baldwin KD, Babatunde OM, Huffman GR, Hosalkar HS. Open fractures of the tibia in the pediatric population: a systematic review. J Child Orthop. 2009;3(3):199–208. doi:10.1007/s11832-009-0169-6.

6. Rüedi T, Buckley RE, Moran CG. AO Principles of Fracture Management. Vol 1. Stuttgart, Germany: Thieme;2007:96.

7. Bartlett CS 3rd, Weiner LS, Yang EC. Treatment of type II and type III open tibia fractures in children. J Orthop Trauma. 1997;11(5):357–362. doi: 10.1007/s11832-009-0169-6

8. Moore Z, Butcher G, Corbett LQ, McGuiness W, Snyder RJ, van Acker K. Exploring the concept of a team approach to wound care: managing wounds as a team. J Wound Care. 2014;23(suppl 5b):S1-S38. doi: 10.12968/jowc.2014.23.Sup5b.S1.

9. Gustilo RB, Merkow RL, Templeman D. The management of open fractures. J Bone Joint Surg Am. 1990;72(2):299–304.

10. Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am. 1976;58(4):453–458.

11. Gustilo RB, Mendoza RM, Williams DN. Problems in the management of type III (severe) open fractures: a new classification of type III open fractures. J Trauma. 1984;24(8):742–746. doi:10.1097/00005373-198408000-00009.

Dr. Mijatović is a professor, Plastic, Reconstructive and Aesthetic Surgery, University of Zagreb, School of Medicine; and Chief of Staff, Plastic, Reconstructive and Aesthetic Surgery ward at the University Hospital Center, Zagreb, Croatia. Dr. Smuđ Orehovec is a plastic, reconstructive, aethetic surgery specialist, University Hospital Center, Zagreb. Prof. Đapić is a professor of orthopedic surgery, University of Zagreb, School of Medicine; and a pediatric surgeon, Department of Orthopaedic Surgery, University Hospital Center, Zagreb. Dr. Vrbanović Mijatović is a specialist in anesthesiology and reanamatology, Department of Anesthesiology, Clinical Hospital Centre, Zagreb. Dr. Mance is a fourth-year resident, Plastic, Reconstructive and Aesthetic Surgery, University Hospital Center, Zagreb. Please address correspondence to: Sanda Smuđ Orehovec, MD, Clinical Hospital Centre, Zagreb, Department of Surgery, Division of Plastic, Reconstructive and Breast Surgery, Kišpatićeva 12, 10000 Zagreb, Croatia; email: sanda.smud@gmail.com.

Section:

Volume 64 - Issue 6 - June 2018 ISSN 1943-2720

↧

A Prospective, Explorative Study to Assess Adjustment 1 Year After Ostomy Surgery Among Swedish Patients

June 7, 2018, 7:07 am

≫ Next: A Descriptive, Cross-sectional Study to Assess Pressure Ulcer Knowledge and Pressure Ulcer Prevention Attitudes of Nurses in a Tertiary Health Institution in Nigeria

≪ Previous: Management of a Complex Lower Limb Open Fracture in a Teenage Patient: A Case Report

Issue Number:

Index:

Ostomy Wound Management 2018;64(6):12–22 doi: 10.25270/owm.2018.6.1222

Jeanette Fingren, ET, RN; Elisabet Lindholm, Med Lic, RN; Charlotta Petersén, ET, RN; Anne-Marie Hallén, ET, RN, MSc; and Eva Carlsson, PhD, RN, ET

Topics:

follow up study

Ostomy

adjustment

Quality of Life

nursing

Abstract

Having ostomy surgery changes a person’s life. To assess adjustment to life with an ostomy and quality of life (QOL) 1 year after ostomy surgery, a prospective, explorative study was conducted among patients of a stoma clinic at a university hospital in Sweden.

All consecutive patients who had undergone nonemergent or emergency surgery involving formation of an ostomy and who received regular follow-up at the ward and at the outpatient clinic during the first year by an enterostomal therapist (ET) were prospectively included in the study; their demographic information (including age, gender, diagnosis/reason for an ostomy, nonemergent or emergency surgery, ostomy type, preoperative counselling/siting [Yes/No], self-sufficiency in stoma care, professional activity, and whether they lived with a spouse/partner) was recorded upon admission to the study. Participants independently completed the Ostomy Adjustment Scale (OAS), a 36-item instrument, with each response scored from worst to best adjustment (1 to 6) for a total score ranging from 36–216. The tool addresses 5 factors: normal functioning, functional limitations, negative affect, positive role function, and positive affect. In addition, QOL was assessed using a visual analogue scale (0 to 100 mm) along with 2 open-ended QOL questions. Quantitative and qualitative data were included on the same questionnaire and were entered into an Excel file by 2 of the researchers. The quantitative data were transferred to statistical software for analysis; the qualitative data were analyzed according to Graneheim and Lundman. Descriptive statistics were used for quantitative data and based on nonparametric analysis, and qualitative data were analyzed using content analysis. Of the 150 patients eligible for inclusion (82 women, 68 men, median age 70 [range 21–90] years), 110 (73%) underwent nonemergent surgery, 106 (71%) had a colostomy, and 44 (29%) had an ileostomy. Most ostomies were created due to cancer (98, 65%) and inflammatory bowel disease (28, 19%), and 90% of participants were self-sufficient in ostomy care. The overall median score on the OAS was 162 with no significant differences between genders and diagnoses. The OAS scores for patients who did versus did not have preoperative counselling by an ET were 163 and 150, respectively (P = .313). Mean OAS scores were 136 for patients with cancer and an ileostomy and 163 for patients with cancer and a colostomy. Patients with cancer and an ileostomy had a significantly worse adjustment (mean 3.6 ± 1.32) than patients with cancer and a colostomy (mean 4.4 ± 1.21) in the factor Normal function (P = .015). Lowest adjustment scores were in the areas of sexual activities and attractiveness and participating in sports and physical activities; the highest scores concerned contact with an ET, feeling well informed, and knowing the correct methods of handling the ostomy. The median score for QOL for all patients was 76 (interquartile range 59–86). Three (3) categories emerged from the qualitative content analysis as obstacles to QOL: ostomy-related concerns and impact on life, limitations in physical and social activities, and negative impact on physical and mental health. The ET was found to have an important role in education and counselling to promote adjustment to life with an ostomy from preoperative to follow-up care. Future explorative studies are needed to determine how patients want questions about sex and sensitive issues to be designed and how the ET can best discuss sexuality and intimacy after ostomy surgery.

Undergoing ostomy surgery inflicts major change in a person’s life. Losing control of fecal elimination can lead to trauma, with feelings of frustration and loss. Having ostomy surgery requires adaptations to changes in daily life and can affect self-image and body image owing to concerns about intimacy and sexuality. For some persons, the stoma also may change their work situation and social life.^1-5 These consequences of ostomy surgery have been addressed in different types of studies, such as qualitative interviews,¹ cross-sectional questionnaires,² reviews,³ descriptive questionnaires,⁴ and qualitative meta-synthesis⁵ and observed by enterostomal therapists (ETs) in daily practice. The estimated number of persons with an ostomy is between 750 000 and 1 000 000 in the United States⁶ and 43 000 in Sweden.⁷

Andrews and Roy^8,9 described adaptation as a process in which people use conscious awareness and choice to create integration. They state health is the process of being and becoming an integrated and whole person. Their goal for nursing is the promotion of adaptation in 4 modes: physiological, self-concept, role function, and interdependence, which contributes to the person’s health and quality of life (QOL). A person with an ostomy will experience a change in bodily functions and, based on his or her level of adaptation, respond to that change in either a positive or negative way.

A prospective, single-center study from Israel¹⁰ including 105 patients (median age 65 years, 57% men) undergoing nonemergent surgery between 2006 and 2008 compared independence parameters and QOL in patients that were sited previous to ostomy surgery to persons that were not and described patients’ ability to manage their stoma by themselves as an important factor in their adaptation to the new situation. The independence parameters and QOL were shown to be significantly lower in patients whose stoma was not preoperatively sited. For the patient to be able to manage the ostomy, the ostomy must be well-constructed and in a place where it is visible to the patient.

Four (4) prospective studies (1 British,¹¹ N = 3970; and 3 Swedish^12-14, including 180, 144, and 207 patients, respectively) have shown when the ostomy height is too low, patients will experience peristomal skin complications. The British study¹¹ was conducted 3 weeks after surgery in patients from 93 ostomy care services; 34% of the ostomies were evaluated as problematic, and ostomy height had the greatest individual influence on the incidence of problematic ostomies. In 1 Swedish study¹² following 180 patients (colostomy [n =122], median age 69 years; loop ileostomy [n = 38], median age 61 years; and ileostomy [n=20], median age 59 years) during the 2 years after surgery almost all patients with an end ileostomy or loop ileostomy with an ostomy height <20 mm had leakage and skin problems, as did half of the patients with an end colostomy and an ostomy height <5 mm. Similar results were seen in patients undergoing acute abdominal surgery, where the researchers prospectively evaluated ostomy-related complications and ostomy configuration in 144 patients (median age 67 years) and where 21% to 57% of patients with a low ostomy had peristomal skin problems during the first 2 weeks. Another Swedish study¹⁴ evaluated stomal and peristomal complications after regular follow-up (5 times) by an ET 1 year after surgery in 207 patients (median age 70 [range 19–94] years, 53% women). The use of convexity was significantly more common among patients with a colostomy height of ≤5 mm than patients with stomas >5 mm. These studies demonstrate the potential for stomal and peristomal skin complications. A systematic review¹⁵ that included 4 cross-sectional studies (number of patients not reported) and 3 longitudinal studies (N = 5037) found that patients with severe peristomal skin complications, severe leakage, and severe problems adjusting to the ostomy were noted to have significantly lower Health-Related Quality of Life (HRQOL) scores than patients reporting less severe or no problems.

A recently published, population-based, cross-sectional Danish study¹⁶ including 644 patients with an ostomy because of rectal cancer (median age 72 years, 64% men) reported 41% of participants had skin complications and 59% had leakage. In >65% of these patients, the ostomy had an impact on QOL; the authors concluded patient counselling and follow-up regarding complications needed to be improved. An Australian qualitative, unstructured interview study¹ explored men’s and women’s experiences adapting to a stoma. The study included 18 patients who completed interviews plus an additional 14 participants who answered questionnaires. Mean age was 45 years, and time since surgery ranged from 6 months to 42 years. Regular follow-up regarding ostomy complications and emotional support and counselling in the new situation were shown to be the motivation for wanting to adapt to life with an ostomy. Similar results were seen in a cross-sectional Swedish questionnaire study² using the validated Quality of Care from the Patient’s Perspective questionnaire in 91 patients with a colostomy (mean age 69 [range 42–87] years, 26 women/23 men) or ileostomy (mean age 49 [range 20–92] years, 25 women/17 men) due to rectal cancer or inflammatory bowel disease (IBD).

A study that focused on sexual issues for patients with ostomies³ has shown that how people with a stoma adapt to the changes imposed by ostomy surgery is critical to their health, sexuality, and mental and physical well-being. Findings from the review by Pittman et al¹⁵ aiming to determine the influence of intestinal ostomy surgery on HRQOL showed impairment regarding HRQOL domains and was most severe during the immediate postoperative period and continued to rise steadily during the first postoperative year. A recently published cross-sectional study¹⁷ from Norway including 158 patients (56% men) showed the degree of ostomy-specific adjustment measured with the Ostomy Adjustment Scale (OAS) appeared to be an important predictor for HRQOL (Short Form-36) and overall QOL in patients with an ostomy. Junkin and Beitz³ reported men and women experience similar fears associated with the ostomy such as noise, odor, leakage, and that their partners will leave them. These problems are often more pronounced in the later adaptation process, when the patient’s postoperative phase and possible treatment are complete. The ET is known to have an important role in improving patients’ adaptation during pre- and post-recovery and in the follow-up period.

One (1) year after ostomy, surgery patients can be expected to have recovered from their surgery and additional treatments and start their journey toward a new life. The aim of the present study was to describe patients’ adjustment to life with an ostomy 1 year after surgery and to identify patients with a lower adjustment score. A further aim was to assess and describe obstacles to achieving QOL.

Methods

Setting and patients. A prospective, exploratory study to assess adjustment to life with an ostomy and QOL 1 year after ostomy surgery was conducted among consecutive patients treated at the University Hospital outpatient stoma care clinic at one of the largest colorectal units in Sweden from September 2009 to March 2012. Four (4) ETs were responsible for the stoma care clinic. All patients who had undergone nonemergent and emergency surgery for the formation of a colostomy, end ileostomy, or loop ileostomy were included in the study. The included patients had regular postoperative follow-up by an ET on the ward and at the outpatient clinic at intervals of 10 to 14 days postdischarge and 6 weeks, 3 months, 6 months, and 1 year post surgery. Patients who were re-operated during their first year postsurgery, patients with a urostomy, patients with double ostomies, and patients with cognitive impairment were excluded. An interpreter or a significant other able to translate the questions was permitted for patients who were unable to understand Swedish. Eligible patients received oral and written information about the study from the ET at the 1-year follow-up.

Upon receipt of their voluntary and written consent, participants were given a paper-and-pencil questionnaire to answer in a quiet space at the hospital or at home. The completed questionnaire either was placed in the designated hospital mailbox or returned in a prepaid envelope. Patients had 4 weeks to respond. Persons who did not answer the questionnaire by the first deadline received a reminder. Patient confidentiality was ensured using a unique code entered on the OAS questionnaire (not the patient name) and into a case report form with clinical data; data were confidential but not anonymous to facilitate follow-up. The coding list was separately stored in a locked cabinet. Demographic and study variables were recorded by the ET responsible for administering the questionnaire to the patient at the 1-year follow-up appointment on a specially designed case report form at admission to the study and included age, gender, diagnosis/reason for ostomy, nonemergent or emergency surgery, type of ostomy, preoperative counseling (Yes/No), self-sufficiency in stoma care, professional activity, and living with a spouse/partner (Yes/No).

Preoperative counselling and follow-up by the ET nurse. Nonemergently operated patients had one session of preoperative counselling with the ET nurse, at which time the ostomy also was sited. Each patient had a designated ET from preoperative period to follow-up. The ET provided at least 1 patient education session postoperatively, which included advice on managing the ostomy (elimination and changing appliance routines), skin care instruction, diet recommendations, intimacy advice, and how to make life work with an ostomy (work, travel, social activities, and sport and physical activities), and one discharge consultation. Through conversation with the patient and observation at successive follow-ups, the ET continued to assess the patients’ ability to manage the ostomy on their own (ie, patients were asked to demonstrate appliance application and removal). In addition, the ET and the patient observed the peristomal skin to rule out peristomal skin complications, discussed changing routines and elimination, and evaluated how well the patient had been able to incorporate the ostomy into daily life, including psychological issues such as coping with the ostomy and concerns regarding sex.

Questionnaire. Adjustment was evaluated using the OAS.¹⁸ The OAS is a questionnaire designed to assess respondents’ adjustment to the physical, psychological, and social changes that occur after ostomy surgery. The original version consisted of 34 items. The questionnaire has been validated in English¹⁹ and translated into Swedish and validated in a Swedish population, with 2 items regarding contact with an ET nurse added.²⁰ The 36 items are rated on a 6-point Likert scale ranging from disagree sharply to agree completely. The possible score for each item ranged from 1 to 6 (worst to best adjustment), with possible total scores ranging from 36 to 216.

The OAS addresses 5 factors¹⁹: Factor 1 is normal functioning (items 1, 2, 4, 5) despite the ostomy, Factor 2 is functional limitations (items 3, 6, 9, 27, 29, 30, 32), Factor 3 is negative affect (items 10, 11, 16, 17, 26), Factor 4 comprises positive role function (items 7, 8) and negative feeling about the body (item 13), and Factor 5 is overall a positive affect factor (items 15, 24, 33, 34).

Quality of life. Patients were asked to give a personal definition of good QOL²¹ by responding to the statements, “Describe what you think contributes to a good QOL” and “Describe what you think is an obstacle to good QOL.” Participants could give multiple answers to the questions. An additional question was posed: “How do you perceive your QOL today?” Responses were scored on a visual analogue scale (VAS) from 0 to 100 mm where 0 indicates the worst possible and 100 the best possible score.

Data and statistical analysis. The complete questionnaire included the 36 OAS questions, the VAS question about QOL (quantitative data), and 2 open-ended questions (qualitative data). The quantitative data from the questionnaires were entered into an Excel file (Microsoft Corp, Redmond, WA) by 2 of the researchers. Analyses of patients’ descriptions of QOL were conducted using qualitative content analysis according to Graneheim and Lundman.²² The qualitative data were analyzed using Excel for Mac, 2011 Version 14.6.9(Microsoft Corp, Redmond, WA). Responses to each questionnaire were read several times to obtain an overall picture of the content. Two (2) of the authors served as evaluators, searching the responses for words and phrases regarding obstacles to QOL that were relevant to participants’ experiences of living with an ostomy. The evaluators classified words, sentences, or paragraphs containing related content into what were defined as meaning units, which they subsequently condensed, abstracted, and labelled with a code. The various codes then were sorted into categories. The other authors had a validating role throughout the analysis process until consensus regarding the categories was reached.

Descriptive statistics of quantitative data were reported as mean, standard deviation (SD), median, interquartile range (IQR), and range based on the level of measurement for the outcome variable. Because the data were not normally distributed, they were based on nonparametric analysis techniques. Continuous variables were analyzed using the Mann-Whitney U test. Categorical data were analyzed with Fisher’s exact test and chi-squared test. A P value <.05 was considered significant. For missing items in the OAS, the average score was calculated and substituted for the mean overall score if at least half of the items were answered. The Pearson correlation coefficient was used to explore associations between the total OAS score and VAS. Quantitative data were analyzed using SPSS Statistics for Windows, Version 22.0 (IBM Corp, Armonk, NY).

Ethical considerations. The patients were informed of the study orally and in writing at the outpatient clinic at the 1-year follow-up appointment and gave their informed consent in writing. Patient confidentiality was secured by a unique code entered on the OAS questionnaire and into a case report form with clinical data. The research project was approved by the regional ethical review board in Gothenburg Reg. no. Ö176-03) and followed the Declaration of Helsinki guidelines.

Results

Clinical data. Of the 189 patients who were eligible for inclusion, 153 (81%) agreed to participate and completed the questionnaires. No significant difference was noted between the 36 patients that did not respond to the questionnaires regarding gender and age, although they were slightly younger (median age 64 [range 19–89] years compared to 70 [range 21-90] years; P = .094). Three (3) of the patients answered fewer than half of the questions in the questionnaire and were excluded from the analysis. Thus, the study population consisted of 150 patients (79% of the total population), comprising 82 women and 68 men with a median age of 70 (range 21–90) years. Of these, 96 (64%) were living with a partner and 110 (73%) had undergone nonemergent surgery. More than half of the participants (98, 65%) had a diagnosis of cancer and 28 (19%) had IBD. The majority (106, 71%) had a colostomy, among which 79 (75%) were age 65 to 90 years, and the most common diagnosis/reason for the colostomy was colorectal cancer (81, 76%). In contrast, patients with an ileostomy (44, 29%) were mostly 20 to 64 years old and the most common diagnosis was IBD (23, 52%). The majority (90%) of all the participants could manage the ostomy by themselves (see Table 1).

Ostomy adjustment. The overall median score on the OAS was 162 (IQR 134–183), which was 75% of the maximum score. No statistically significant differences in OAS scores were noted between men and women or regarding the different diagnoses (cancer, IBD, others). The median OAS scores by ostomy type included colostomy 164 (IQR 136–185), 76% of the maximum score, and ileostomy 151 (IQR 127–182), 70% of the maximum score; P<.282. The median OAS score was 136 (63% of maximum score) for patients with an ileostomy due to cancer compared to 163 (75% of maximum score) in patients with a colostomy due to cancer (P = .129). The OAS for patients who had preoperative counselling by an ET was 163 (75% of the maximum score) compared to 150 (69% of the maximum score) for patients who were not counselled (P = .313). Table 2 shows the scores for the individual OAS items.

The items with the lowest and highest OAS score. The OAS item scores for the whole group were lowest/worst (mean <4) for the following 8 items (item descriptions are truncated; items with an asterisk were scored in reverse):

8: “enjoy sexual activities” (2.1);

7: “able to work” (2.9);

27: “not as sexually attractive” (3.0)*;

5: “participate in sports and physical activities” (3.6);

3: “many things I would like to do with no ostomy” (3.6)*;

6: “limit the number of activities” (3.7)*;

30: “worry something embarrassing will occur in connection with normal sexual activity” (3.9)*; and

9: “lack of self-confidence because of ostomy” (3.9)*.

The highest/best scores (mean >5) were for the following 7 items:

21: “well informed about ostomy” (5.5);

36: “I avoid telling my ET about changes in ostomy and function” (5.4)*;

34: “the ostomy reminder of receiving good medical care” (5.2);

20: “I avoid telling doctor about changes in ostomy and function” (5.2)*;

11: “At times resent friends who do not have an ostomy” (5.2)*;

35: I feel like a complainer when have to contact my ET about ostomy” (5.2)*; and

22 “convinced of knowing the correct methods of handling ostomy” (5.1).

Factor distribution of the OAS. Figures 1, 2 , and 3 present the results of the OAS factor distribution (Factors 1–5). Patients with an ileostomy had lower scores in the factors Normal functioning, Functional limitations, and Positive role function compared to patients with a colostomy. Physical role function was lower for patients with cancer. When dividing the study population in different age groups, Functional limitations and Physical role function were lower for the age groups 45–64 years and 65–74 years. Patients with cancer and an ileostomy had a significantly worse adjustment (mean 3.6 ± 1.32) than patients with cancer and a colostomy (mean 4.4 ± 1.21) in the factor Normal function (P = .015) (no figure shown).

Quality of life (VAS). The median QOL score for all patients was 76 (IQR 59–86). Patients with an ileostomy had a median score of 70 (IQR 54–81) versus a median score of 77 (IQR 61–87) for persons with a colostomy. The Pearson correlation between the total score of the OAS and QOL was r = 0.519 (P<.0001). For patients in the 25th percentile of the OAS total score, the median value for QOL on VAS was 56, whereas in the rest of the study population it was 80. The patients in the 25th percentile were >65 years (70%); more patients had undergone emergency surgery and 38% had an ileostomy in the 25th percentile versus 25% in the rest of the study population.

QOL open-ended questions. Of the 150 participants who answered the OAS, 101 (67%) answered the open-ended questions about QOL. The responses pertaining to good QOL concerned good health, having a normal life, socializing with family and friends, and having rewarding leisure time. Patients provided indepth answers regarding obstacles to QOL that included sentences (not just a few words); these were analyzed using manifest content analysis.³ Three (3) categories emerged from the qualitative content analysis as obstacles for QOL: ostomy-related concerns and impact on life, limitations in physical and social activities, and negative impact on physical and mental health.

Ostomy-related concerns and impact on life. Concerns directly related to the ostomy included fear of leakage, shame about noise and odor, and not feeling fresh. Some participants were also concerned about frequent visits to the bathroom. One (1) participant described having a limited choice of clothes when going to a party, and another mentioned not being able to eat good food. The stoma also was described as a horrible disease by 1 participant and as making it more difficult to meet a partner by another. Not accepting the new life with a stoma and isolation also were described by 4 of the participants.

Limitations to physical and social activities. Participants described being limited in daily activities due to reduced strength and that some activities demanded more physical involvement. Participants also described not being able to travel like they did before, while others had refrained not only from travelling but also from swimming, sunbathing, and participating in nature and sport activities. Activities also required more planning than before.

Negative impact on physical and mental health. Six (6) participants described lack of physical health, 1 person described pain, and another that his/her sex life was “not working.” Participants also described feeling blue, worried, and depressed; 4 said their worry had to do with whether the cancer would return.

Discussion

This study aimed to describe adjustment to life with an ostomy 1 year after surgery and QOL and obstacles to QOL. The main findings of this study include that the overall median score on the OAS was 162 (75% of the maximum score) with no differences between men and women or among the different reasons for surgery. Persons with an ileostomy due to cancer had the lowest OAS score. Patients with an ileostomy had lower adjustment than patients with a colostomy. QOL was lower for patients in the 25th percentile of the total OAS score (>65 years, having undergone emergency surgery), where a higher percentage of patients with an ileostomy in that group was noted.

The lowest adjustment scores for specific items concerned sexual activities and attractiveness and participating in sports and physical activities; the highest scores concerned contact with an ET, feeling well-informed, and knowing the correct methods of handling the ostomy; 90% could manage the ostomy by themselves.

A descriptive questionnaire study²³ that included 147 patients from 2 settings (49% women, mean age of 65 years, 74% response rate) reported a mean OAS score of 159.5 (78% of maximum score) was lowered by distress over affording and obtaining ostomy supplies. These results were not reflected in the present study but can be explained by no or limited costs for ostomy supplies in Sweden. The OAS score was similar to the present study scores, but patients had their ostomy for a median of 10 years compared to 1 year in the present study where further adjustment could be anticipated. A recently published cross-sectional study¹⁷ among 158 patients (44% women, mean age 64 years), recruited from the customer registers of 8 surgical suppliers and pharmacies across Norway, was conducted to determine whether adjustment to an ostomy can predict HRQOL and/or overall QOL. The average OAS score was 150.2 (73.6% of the maximum score); 70% had their ostomies >1 year.²⁴ The OAS also has been used in 2 longitudinal questionnaire studies on patients with an ileanal pouch (IPAA)²⁴ and on patients with a continent ileostomy because of IBD²⁵ where patients scored a median of 6 (highest score) on 28 out of 36 items. Compared with the present study, patients with IBD and an ileostomy (40 patients) scored a median of 6 on only 9 of the 36 items. The median total OAS score was 181 among persons with IPAA,²⁴ 171 among persons with a continent ileostomy,²⁵ and 162 among persons with an ileostomy in the present study. Patients in the previous studies had a follow-up time of 15 years (IPAA) and a median age of 51 compared to 31 years (continent ileostomy) and a median age of 60 years and 1-year follow-up and a median age of 55 for patients with IBD and an ileostomy in the present study.

Among patients in the present study, 90% were able to manage their ostomy by themselves. This compares favorably with the study by Person et al¹⁰ where only 15% could manage their ostomies. The regular and standardized follow-up (ie, 4 to 5 times during the first year and when needed) by an ET (including counselling and education) at an outpatient clinic resulted in patients feeling confident about managing their ostomy and well-informed and secure about telling the ET and the surgeon about changes in ostomy function when needed. This was reflected in the highest OAS scores for those items. Persons who had preoperative counselling by an ET also scored 13 points higher on the OAS total. Similar results were shown in the descriptive questionnaire study (N = 147) by Haugen et al,²³ where the more helpful the patients found the preoperative education provided by the wound, ostomy, and continence nurse, the better their adjustment, as indicated by a higher OAS score. Weekly group interactions during a 6-week period also were shown to be beneficial to patients in a quasi-experimental, single-center Turkish study²⁶ in terms of social adaptation compared to controls (n = 23, median age 55.5 years, 52% men vs. n = 27, median age 54 years, 67% men). Patients also reported having learned to solve problems encountered in ostomy care and daily life. In a descriptive questionnaire study²⁷ from China conducted 4 months postoperatively (54 patients, age range 40–70 years, 47 men), a significant difference in psychosocial adjustment was found between persons who did and did not independently care for their own ostomy (P = .05). Persons with high levels of knowledge and independence had a high level of psychosocial adjustment. In a qualitative meta-synthesis from China⁵ that included 16 qualitative studies exploring the effect of personal awareness and behavioral choices on having a stoma, 3 themes were identified: altered self, restricted life, and overcoming restrictions. A recently published qualitative study²⁸ that included 12 participant interviews (age range 30–70 years) conducted at 3, 9, and 15 months following ostomy surgery showed that assisting people with an ostomy to develop competent stoma self-care skills will promote social adaptation and self-acceptance. All of these studies,^{5,17,23,26,27} including the present research, point to the importance of the patient learning self-care skills and incorporating the ostomy into everyday life and how the ET has an important role in educating and counselling from preoperative care to postsurgical follow-up.

Of the 8 questions with the lowest OAS scores, 3 were related to sex and intimacy. Participants reported having more difficulty enjoying sex, were anxious that something embarrassing would occur during intimacy, and felt less sexually attractive. This was reflected in the qualitative analysis, where fear of leakage, shame about noise and odor, and not feeling fresh were expressed. According to a descriptive questionnaire study⁴ among 21 persons with an ileostomy (mean age 51 years, 12 women/9 men) for a median of 21 years due to IBD, the greatest concern was intimacy. According to the study by Manderson,¹ body image and sexuality play an important role in an individual’s ability to adjust to body change. Previous studies, including a descriptive study conducted in China,²⁷ have described the limited opportunities for conversation about sex and sexual life in health care for patients^3,27 and for partners.²⁹ The results of a focus-group²⁹ study including 9 spouses (mean age 62 [range 49–74 years], 6 women/3 men) with the aim to illuminate spouses’ perceptions of living with a partner who had undergone stoma surgery because of rectal cancer showed the importance of offering patients and their partners the opportunity to have structured counselling about sex and intimacy. Annon’s³⁰ 4-stage model (Permission, Limited Information, Specific Suggestions, and Intensive Therapy — PLISSIT) is used in sexual counselling and facilitates patient permission to discuss sexuality while the health professional listens carefully, provides specific suggestions, and is alert to opportunities to refer for more intensive counselling or therapy. The PLISSIT model has been tested in a Turkish case-control study for patients with ostomies.³¹ During the intervention, 8 individual home visits were made to the patients in the study group (mean age 44 years, 70% men) to evaluate and discuss the sexual problems they were experiencing and to suggest solutions according to the PLISSIT model. The mean scores for sexual satisfaction for these participants improved significantly compared to the control group (mean age 44 years, 67% men; P<.05). It is important for the ET to discuss sexual issues with the patient and when possible involve the partner in the conversation. The first consideration is to determine whether patients want to discuss sexual issues and to respect their wishes. People with ostomies who have difficulties conveying and communicating their feelings depend on support to express themselves. Thus, the ET can facilitate adaptation to the new situation. However, if the ET feels uncomfortable talking about sexual issues, more training in sexology and communication will be needed.

Two (2) other items that generated a low OAS score concerned limitations in activity; some participants felt insecure about participating in sports and physical activities or set limits on the number of activities in which they were involved. Such concerns also were evident in the open-ended question regarding obstacles to good QOL. The ostomy was seen as an obstacle to participating in physical activities such as swimming, exercise, and outdoor life, and greater planning was required when travelling and participating in social life. After surgery, patients can set limits for themselves and the ostomy itself may not always be the obstacle; rather, the issue may be a psychological one. Together with the ET, patients can set realistic goals and challenge themselves. Talking about patients’ desire to return to activities in which they participated before the operation is of great importance to provide the tools needed for them to take control of their own lives. Emotional support, conversation, and counselling in the new life situation proved to be the basis for motivation to want to adapt to the changed life with an ostomy.³

The content analysis did not yield any new items regarding obstacles to QOL, but it gave a little more depth to some items already reflected in the OAS questions. This indicates the continued relevance of the OAS, although it was developed more than 30 years ago. The category Limitation in physical and social activities was well-reflected in the OAS item “Participate in sports and physical activities,” where 1 of the 4 lowest OAS scores was noted. Other studies^24,25 that also used the OAS to analyze obstacles to QOL showed patients with continent ileostomies had elimination impediments associated with the inconvenience of using public restrooms and having to plan bowel evacuation in advance. For patients with an IPAA, food restrictions and influence of restroom access on social life were seen as obstacles.

Adjusting to life with an ostomy takes time. Using the OAS provides an option for evaluating adaptation over time in conversation with the individual patient. Although no statistical differences were found in total OAS scores between groups, a 13-point difference was noted in scores of persons with a colostomy and ileostomy and versus persons who did and did not have preoperative counselling with an ET.

The OAS scores of patients with an ileostomy versus a colostomy due to cancer were 27 points lower; this is of clinical relevance because an improvement to a patient’s score of, for example, 1 point on 13 items would reflect a better adjustment for the individual patient. In addition, using the information provided by the OAS may help clinicians provide patient-relevant information, support, and advice to help patients form realistic expectations about their lives with an ostomy and improve adaptation in areas where there are concerns.

The OAS is a relevant instrument for clinical use if the ET chooses to work according to Roy’s^8,9 nursing goals. The OAS aims to measure the physical, psychological, and social changes that occur after an ostomy operation. These areas compare with Roy’s goal for nursing — that is, the promotion of adaptation in each of the 4 functional modes: physiological, self-concept, role function, and interdependence — thereby contributing to the person’s health and QOL. If the patient completes the questionnaire before each follow-up, the ET can assess items with lower adjustment and focus follow-up on those items, discussing these with the patient and developing a plan to increase adjustment to life with an ostomy.

Patients with an ileostomy due to cancer had the lowest adjustment scores in the present study. This is a new result and needs further research. In particular, older patients with an ileostomy who cannot manage their ostomies by themselves may have to depend more on health care professionals than those with a colostomy. Patients needing chemotherapy as an additional treatment for their cancer also are affected by more fecal output from the ileostomy, requiring that clinicians pay special attention to these patients as part of follow-up.

Limitations

It is difficult to compare OAS scores from the present study with previous research due to differences in areas such as population, type of ostomy, time with an ostomy, differences in follow-up by an ET, cultural differences, and cost-related differences in patient access to ostomy equipment. An additional 2 questions were added to the original instrument in the present study; this meant the authors used the percentage of maximum for comparison with other studies. The strength of this study is that it was prospective and that all patients had the same follow-up schedule with an ET for the period 1 year post surgery. It would have been interesting to see how adjustment is influenced by less regular follow-up than in the present study, because patients in some hospitals may only have 1 or 2 follow-up visits because of the shortage of ETs or how the stoma care clinics are organized. This means that patients are not evaluated concerning complications, adjustment, and QOL for longer intervals and have to make contact with the ET by themselves when problems occur.

Conclusion

This prospective, explorative study assessed adjustment to life with an ostomy and QOL 1 year after ostomy surgery in 150 Swedish patients. Adjustment measured with the OAS was 75% of the maximum score with no significant differences between men and women or between the different diagnoses/reasons for ostomy surgery. However, patients with an ileostomy had a lower adjustment (70% of maximum) score compared to patients with a colostomy (76% of maximum). Patients with an ileostomy due to cancer had the lowest adjustment scores (63% of maximum score) versus 75% of maximum score in patients with a colostomy due to cancer. The OAS scores for patients who had preoperative counselling by an ET versus persons who did not were 75% versus 69% of maximum score, respectively, underscoring the important role of preoperative counselling in long-term adjustment and QOL. The 3 OAS items with the lowest scores were related to sex and intimacy, which was reflected in the qualitative analysis in the category, Ostomy-related concerns and impact on life. Future explorative studies are needed, both in terms of individual and focus group interviews, to unveil how patients want information about sex and sensitive issues to be designed and presented and how they want the ET to best communicate and discuss these issues after ostomy surgery.

Acknowledgements

The researchers thank the patients who participated in this study.

References

1. Manderson L. Boundary breaches: the body, sex and sexuality after stoma surgery. Soc Sci Med. 2005;61(2):405–415.

2. Persson E, Gustavsson B, Hellström AL, Lappas G, Hultén L. Ostomy patients’ perceptions of quality of care. J Adv Nurs. 2005;49(1):51–58.

3. Junkin J, Beitz JM. Sexuality and the person with a stoma: implications for comprehensive WOC nursing practice. J Wound Ostomy Continence Nurs. 2005;32(2):121–128.

4. Carlsson E, Bosaeus I, Nordgren S. What concerns subjects with inflammatory bowel disease and an ileostomy? Scand J Gastroenterol. 2003;38(9):978–984.

5. Tao H, Songwathana P, Isaramalai SA, Zhang Y. Personal awareness and behavioural choices on having a stoma: a qualitative meta-synthesis. J Clin Nurs. 2014;23(9-10):1186–1200.

6. United Ostomy Associations of America. 2017. Quality of Life for People With Ostomies and Continent Diversions. Available at: www.ostomy.org. Accessed April 2, 2018.

7. Dental and Pharmaceutical Benefits Agency. An Assessment of the Ostomy Market in Sweden (in Swedish). Available at: www.tlv.se/Medicinteknik/.../En-kartlaggning-av-stomimarknaden-i-Sverige. Accessed April 24, 2017.

8. Andrews H, Roy C. The Adaptation Model. Norwalk, CT: Appleton & Lange;1991.

9. Roy C, Andrews H. The Roy Adaptation Model. 2nd ed. Stamford, CT: Appleton & Lange;1999.

10. Person B, Ifargan R, Lachter J, Duek SD, Kluger Y, Assalia A. The impact of preoperative stoma site marking on the incidence of complications, quality of life, and patient’s independence. Dis Colon Rectum. 2012;55(7):783–787.

11. Cottam J, Richards K, Hasted A, Blackman A. Results of a nationwide prospective audit of stoma complications within 3 weeks of surgery. Colorectal Dis. 2007;9(9):834–838.

12. Persson E, Berndtsson I, Carlsson E, Hallén AM, Lindholm E. Stoma-related complications and ostomy size — a 2-year follow-up. Colorectal Dis. 2010;12(10):971–976.

13. Lindholm E, Persson E, Carlsson E, Hallén AM, Fingren J, Berndtsson I. Ostomy-related complications after emergent abdominal surgery: a 2-year follow-up study. J Wound Ostomy Continence Nurs. 2013;40(6):603–610.

14. Carlsson E, Fingren J, Hallén AM, Petersén C, Lindholm E. The prevalence of ostomy-related complications 1 year after ostomy surgery: a prospective, descriptive, clinical study. Ostomy Wound Manage. 2016;62(10):34–48.

15. Pittman J, Kozell K, Gray M. Should WOC nurses measure health-related quality of life in patients undergoing intestinal ostomy surgery? J Wound Ostomy Continence Nurs. 2009;36(3):254–265.

16. Feddern ML, Emmertsen KJ, Laurberg S. Life with a stoma after curative resection for rectal cancer: a population-based cross-sectional study. Colorectal Dis. 2015;17(11):1011–1017.

17. Indrebø KL, Natvig GK, Andersen JR. A cross-sectional study to determine whether adjustment to an ostomy can predict health-related and/or overall quality of life. Ostomy Wound Manage. 2016;62(10):50–59.

18. Olbrisch ME. Development and validation of the Ostomy Adjustment Scale. Rehabil Psychol. 1983;28(1):3–12.

19. Burckhardt CS. The Ostomy Adjustment Scale. Rehabil Psychol. 1990;35(3):149–155.

20. Brydolf M, Berndtsson I, Lindholm E, Berglund B. Evaluation of a Swedish version of the Ostomy Adjustment Scale. Scand J Caring Sci. 1994;8(3):179–183.

21. Padilla GV, Ferrell B, Grant MM, Rhiner M. Defining the content domain of quality of life for cancer patients with pain. Cancer Nurs.1990;13(2):108–115.

22. Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurs Educ Today. 2004;24(2):105–112.

23. Haugen V, Bliss DZ, Savik K. Perioperative factors that affect long-term adjustment to an incontinent ostomy. J Wound Ostomy Continence Nurs. 2006;33(5):525–535.

24. Berndtsson IE, Carlsson EK, Persson EI, Lindholm EA. Long-term adjustment to living with an ileal pouch-anal anastomosis. Dis Colon Rectum. 2011;54(2):193–199.

25. Berndtsson I, Lindholm E, Ekman I. Thirty years of experience living with a continent ileostomy: bad restrooms--not my reservoir--decide my life. J Wound Ostomy Continence Nurs. 2005;32(5):321–326.

26. Karabulut HK, Dinç L, Karadag A. Effects of planned group interactions on the social adaptation of individuals with an intestinal stoma: a quantitative study. J Clin Nurs. 2014;23(19-20):2800–2813.

27. Cheng F, Meng AF, Yang LF, Zhang YN. The correlation between ostomy knowledge and self-care ability with psychosocial adjustment in Chinese patients with a permanent colostomy: a descriptive study. Ostomy Wound Manage. 2013;59(7):35–38.

28. Thorpe G, McArthur M. Social adaptation following intestinal stoma formation in people living at home: a longitudinal phenomenological study. Disabil Rehabil. 2017;39(22):2286–2293.

29. Persson E, Severinsson E, Hellström AL. Spouses’ perceptions of and reactions to living with a partner who has undergone surgery for rectal cancer resulting in a stoma. Cancer Nurs. 2004;27(1):85–90.

30. Annon J. The PLISSIT model: a proposed conceptual scheme for the behavioral treatment of sexual problems. J Sex Educ Ther. 1976;2(1):1–15.

31. Ayaz S, Kubilay G. Effectiveness of the PLISSIT model for solving the sexual problems of patients with stoma. J Clin Nurs. 2009;18(1):89–98.

Potential Conflicts of Interest: The study was conducted with grants from the Local Research and Development Board for Gothenburg and Södra Bohuslän, Sweden, No. VGFOUGSB-107201.

Ms. Fingren is an enterostomal therapy nurse; Ms. Lindholm is a registered nurse; Ms. Petersén is an enterostomal therapy nurse; and Ms. Hallén is an enterostomal therapy nurse, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska University Hospital/ Östra, Gothenburg, Sweden. Dr. Carlsson is an Associate Professor, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska University Hospital/Östra; and a senior lecturer, Institute of Health and Care Sciences, Sahlgrenska Academy, and the Centre for Person-Centred Care (GPCC), University of Gothenburg, Sweden. Please address correspondence to: Eva Carlsson, PhD, RN, ET, Department of Surgery/Colorectal Unit, Sahlgrenska University Hospital/Östra, Diagnosvägen 16 SE-416 85 Göteborg, Sweden; email: eva.k.carlsson@vgregion.se.

Section:

Volume 64 - Issue 6 - June 2018 ISSN 1943-2720

↧

A Descriptive, Cross-sectional Study to Assess Pressure Ulcer Knowledge and Pressure Ulcer Prevention Attitudes of Nurses in a Tertiary Health Institution in Nigeria

June 7, 2018, 7:50 am

≫ Next: Adenocarcinoma at the Ileostomy Site After a Proctocolectomy for Ulcerative Colitis and/or Familial Adenomatous Polyposis: An Overview

≪ Previous: A Prospective, Explorative Study to Assess Adjustment 1 Year After Ostomy Surgery Among Swedish Patients

Issue Number:

Index:

Ostomy Wound Management 2018;64(6):24–28 doi: 10.25270/owm.2018.6.2428

Deborah Tolulope Esan, RN, RM, BNSc, MPH; Ayodeji Akinwande Fasoro, BSc, FBIT, MSc; Elizabeth Funmilayo Ojo, BSc, MSc, PhD; and Brenda Obialor, RN, RM, BNSc

Topics:

cross-sectional survey

Pressure Ulcer

Prevention

nursing education

Nigeria

Abstract

Globally, higher-than-expected pressure ulcer rates generally are considered a quality-of-care indicator. Nigeria currently has no national guidelines for pressure ulcer risk assessment, prevention, and treatment. A descriptive cross-sectional study was conducted to assess the pressure ulcer knowledge and the attitude of nurses regarding pressure ulcer prevention in a tertiary health institution in Nigeria.

During a period of 2 months, nurses were recruited to complete a 25-item paper/pencil survey that included participant demographic information (6 items), pressure ulcer knowledge questions (11 items), and statements on participants’ attitude toward pressure ulcer prevention (8 items). Data were entered manually into statistical analysis software, analyzed, and presented using descriptive statistics (frequencies and percentages). The majority of the 90 nurse participants were female (60, 66.7%), 45 (50%) were married, and 75 (83.3%) had 1 to 10 years’ experience in nursing practice; 69 (76.7%) had received special training on pressure ulcer prevention. Overall, 58 (64.4%) nurses had correct pressure ulcer knowledge and 67 (74.4%) had a positive attitude toward preventing pressure ulcers. However, 56 nurses (62.2%) disagreed with regular rescreening of patients whom they deemed not at risk of developing pressure ulcer, and 70 (77.8%) believed pressure ulcer prevention should be the joint responsibility of both nurses and relatives of the patients. Thus, the majority of the 90 nurses knew the factors responsible for pressure ulcers and how to prevent them, but nurses need to be orientated to the fact that pressure ulcer risk screening of all patients with limited mobility is an integral part of their job and that it is important that nurses enlighten patients and their relatives on how to prevent pressure ulcers.

Background

A pressure ulcer (also known as a decubitus ulcer, pressure sore, bed sore, or pressure injury) is commonly defined as a “localized injury to the skin and/or underlying tissue usually over a bony prominence as a result of pressure or pressure in combination with shear.”¹ Pressure ulcers usually are classified according to their severity/amount of tissue damage observed by the clinician. According to a 2007 cross-sectional study,² approximately 1.7 million patients per year were reported to develop pressure ulcers in the United States. The incidence of pressure ulcers varies between developed and developing countries. Estimated incidence rates of 8.3% to 25.1% were reported in developed countries and 2.1% to 31.3% in developing countries.³ Pressure ulcers are recognized globally as one of the 5 most common causes of harm to patients⁴ and are increasingly being described as an indicator of the quality of care provided by health care organizations.^5,6

Results of cross-sectional studies on knowledge and attitude of nurses toward pressure ulcer prevention have been inconsistent. The use of different knowledge scales and grading such as high, low, good, poor, appropriate, inappropriate, and adequate and inadequate knowledge and attitude has made it almost impossible to compare most studies. Cross-sectional studies^7,8 from developed countries such as those conducted in 1997 and 2007 in the US, 2007 in Spain,⁹ and 2009 in Sweden¹⁰ reported nurses have good, adequate, or appropriate knowledge on the prevention of pressure ulcers. In contrast, a 2011 cross-sectional study¹¹ in a Belgian hospital showed nurses had a poor knowledge of pressure ulcer prevention. Similarly contradictory findings also have been reported in other cross-sectional studies among nurses in developing countries, showing low/poor knowledge levels among 91 nurses in Bangladesh¹² and 111 nurses in Nigeria,¹³ moderate knowledge among 248 nurses in Ethiopia,¹⁴ and high knowledge among 105 health care workers in Saudi Arabia.¹⁵ Similar findings apply to the attitude of nurses toward pressure ulcer prevention. Cross-sectional studies reported unsatisfactory attitude,¹⁵ moderate levels of attitude,^11,12 and favorable attitudes.¹⁶

Currently, no national guidelines exist in Nigeria for pressure ulcer risk assessment, prevention, and treatment. Recommendations for care are based on international guidelines and caregiver experience.¹³ A 2004 study¹⁷ on pressure ulcer prevalence among spinal cord injured patients in Gombe state, Nigeria reported 16 out of 28 patients (57%) developed pressure ulcers after being admitted to hospitals. This study also showed pressure ulcer prevention depends on clinician knowledge of and attitude toward pressure ulcers and their prevention. The Ethiopian study revealed nurse compliance with clinical guidelines regarding pressure ulcer prevention practice is poor and they put a low priority on pressure ulcer prevention.¹⁶ Observational studies^18,19 have shown inadequate knowledge is a barrier to using the guidelines in clinical practice, while adequate knowledge about pressure ulcer prevention among nurses not only improves pressure ulcer care, but it also reduces the length of hospital stay. Questions and concerns about situations regarding whether pressure ulcers are unavoidable still remain.²⁰

The purpose of this descriptive study was to assess the knowledge and attitude of nurses with regard to pressure ulcer prevention.

Methods and Procedures

This descriptive, cross-sectional study was conducted at Federal Teaching Hospital Ido-Ekiti (FETHI) in Ido-Ekiti, a suburban area located in Ido-Osi Local Government Area, Ekiti State, Nigeria. FETHI is a 280-bed tertiary institution formerly known as Federal Medical Centre, Ido-Ekiti. The target population of this study consists of all nurses working in the medical, gynecology, pediatrics, accidents and emergency, surgical, and orthopedic wards of FETHI. A purposive sampling method was adopted in selecting nurses from the research population. Nurses on duty at the time of visit for the survey were approached and recruited for the study. The study questionnaire was developed by the researchers and pretested among 10 nurses in the department of Nursing at Afe Babalola University (Ado Ekiti, Nigeria) to ascertain the clarity and validity of the questionnaire and to measure the dependent variables (pressure ulcer knowledge and pressure ulcer prevention attitude). The questionnaire was checked for face and content validity before and after the pretest, respectively, by 2 clinicians in the field of nursing, and 2 epidemiologists/ biostatisticians. The constructs were reviewed by checking the internal consistency to establish the content validity of the questionnaire after the pretest. The sample size was calculated using a proportion of 0.32621 and desired precision of 0.1 at 95% confidence interval. After necessary adjustments, it was determined a total of 93 respondents was needed for the study.

Questionnaire instrument. The structured questionnaire consisted of 3 sections (A, B, and C). Section A (6 items) assessed sociodemographic variables such as gender, age, marital status, educational level, years of experience, and acknowledgment of special training on pressure ulcer prevention after obtaining their nursing qualification/license to practice. Section B comprised 11 items that assessed nurse knowledge of pressure ulcers. The questions tested nurses’ knowledge on pressure ulcer etiology, prevention, care, legal implication, staff influence, and recent practice of pressure ulcer prevention; 8 items were single-choice questions and 3 items were multiple-choice questions. Each correct response was worth 1 point (maximum score was 11). Scores equal to or higher than the median were categorized as high/adequate knowledge and scores equal to or below the median were categorized as low/inadequate knowledge. Total minimum and maximum scores for section B were 5 and 11, respectively.

Section C comprised 8 items on attitude and included statements answered using a Likert scale with 5 options ranging from strongly agree to strongly disagree; responses reflected participant reaction to the statements. Positive responses were worth 1 point and negative responses received no points. Scores equal to or higher than the median were categorized as positive attitude and scores equal to or below the median were categorized as negative attitude. Total minimum and maximum scores for section C were 3 and 8, respectively.

Questionnaire completion. The questionnaires were printed on paper and administered to nurses in the medical, gynecology, pediatrics, accidents and emergency, surgical, and orthopedic wards. The nurses were informed about the purpose of the research and that participation was voluntary. After obtaining participant verbal consent, the questionnaires were administered in January and February 2017. The questionnaires were administered individually to the nurses while at work. Participants were able to fill in the questionnaires within 5 to 10 minutes, and the questionnaires were retrieved immediately. The questionnaires ensured the anonymity of the respondents; each questionnaire was assigned a serial number. The researchers ensured that the nurses completed the questionnaires in their presence to avoid respondent bias. Clearance to conduct the study was obtained from the university and the hospital before the respondents were approached. This is akin to an Institutional Review Board (IRB) approval.

Data collection. All the variables were coded before they were entered into the statistical software. For example, male gender was coded 1 and female gender was 2. Summary statistics were calculated for the sociodemographic characteristics. Pressure ulcer knowledge questions and attitude toward pressure ulcer prevention statements were summed to generate scores. The scores then were recoded into groups.

Data analysis. Data were entered manually and were analyzed using the Statistical Package for Social Sciences (SPSS) version 20.0 (IBM Corporation, Armonk, NY). Data were presented using descriptive statistics (frequencies and percentages).

Results

Sociodemographic characteristics of respondents. Of the 93 possible participants, 90 completed the questionnaire. The majority of the respondents were female (60, 66.7%), 45 (50%) were married, 35 (38.9%) were 30 to 34 years old, 75 (83.3%) had diploma in nursing, and 75 (83.3%) had between 1 and 10 years of experience in nursing practice (see Table 1).

Knowledge of respondents on pressure ulcer. The majority of nurses (69, 76.7%) had received special training on pressure ulcer prevention since they started their nursing practice. The mean knowledge score was 8.0 ± 1.36 (out of 11); the median score was 8.0. Overall, 58 nurses (64.4%) had adequate knowledge about pressure ulcer etiology, prevention, care, legal implication, staff influence, and recent practice involving pressure ulcer prevention. Approximately 49% correctly identified all the factors responsible for pressure ulcers, and 31 (34.4%) knew about recent pressure ulcer prevention practices, which included turning patients every 2 hours, changing the patient’s linen when soiled, the importance of patients eating a balanced diet, and teaching the patient range-of-motion exercise (see Table 2).

Attitude of respondents toward pressure ulcer prevention. The mean attitude score was 5.91 ± 1.25 (out of 8); the median score was 6.0. Overall, 67 nurses (74.4%) had a positive attitude (score equal to or higher than the median) toward pressure ulcer prevention (see Table 3). Nearly all nurses (85, 94.4%) agreed that pressure ulcer documentation and identification are part of their job description.

Discussion

Nurses’ knowledge of pressure ulcers and prevention. Pressure ulcer prevention is vital in every health care facility. In this study, despite the fact 69 (76.7%) reported they had special training in pressure ulcer prevention, 58 (64.4%) had adequate knowledge on pressure ulcer etiology, prevention, care, legal implication, staff influence, and recent pressure ulcer prevention practices. This finding is similar to a cross-sectional study conducted among 217 nurses of a government hospital in Addis Ababa, Ethiopia, where 61.2% had adequate knowledge of pressure ulcer prevention.¹⁶ The current study showed 35.6% had inadequate knowledge, which is lower than the 57.8% and 73% inadequate knowledge among Bangladeshi and Jordanian nurses, respectively.^12,19 Inadequate knowledge levels could be the result of a lack of education and training; however, knowledge score results of the current study were lower than those of health care providers at a rehabilitation hospital in Saudi Arabia, where 73.3% of participants in a cross-sectional study were found to have adequate knowledge using the Pressure Ulcer Knowledge Test.¹⁵ This higher proportion could have been related to the fact that participants included nurses, physical therapists, occupational therapists, and rehabilitation therapists who may have had more knowledge about pressure ulcers. However, nurses were found to have better knowledge scores than some other health professionals included in the study. Although the cutoff point in the study used to identify participants having sufficient knowledge was ≥70%, 73.3% met the criterion,¹⁵ compared to study findings of 71.3% reported among 75 intensive care unit nurses in 2 American hospitals,⁷ and 78% among nurses from Montana.⁸

In the current study, 52 nurses (57.8%) correctly identified how to prevent heel pressure ulcers from the options provided. Options on the best way to prevent heel ulcers included raising the foot end of a bed, using a cotton pad, using a pillow under the patient’s leg, applying soap and water, and gently massaging the area. Approximately 34% had knowledge about recent practices for pressure ulcer prevention. A cross-sectional study²¹ among 95 Nigerian nurses reported 32.6% of the nurses practiced massage of patient’s bony prominences for 10 to 30 minutes, and the nurses were not consistent in turning schedule frequencies. This is a clear indication of a gap in the knowledge of modern ways to prevent pressure ulcers. It is assumed that limited nurse knowledge of recent evidence-based recommendations for pressure ulcer prevention affect practice.

Nurses’ attitude toward pressure ulcer prevention. Ajzen and Fishbein²² suggested that an individual’s likelihood of exhibiting positive behavior and practices usually is likely influenced by a positive attitude. Nearly three quarters of the nurses in this study had a positive attitude toward pressure ulcer prevention. Other studies have reported that 68.4% of nurses had a favorable attitude toward pressure ulcers prevention¹⁶ and that 56.5% had a positive attitude.⁷ Both are lower than those in the current study. Nearly all (94.4%) of current participants believed documentation and identification of pressure ulcers are part of their job description; they also believed the incidence of pressure ulcers is an indication of poor care. This is similar to another report that showed 98.1% of health professionals were concerned about pressure ulcer prevention in their practice.¹⁵ In the current study, 37.8% believed regular screening of patients for pressure ulcers is necessary if the patient is not perceived to be at risk, a much lower proportion than reported by others.¹⁵

Study Limitations

The nonrandomization of the sample and the sample size may limit results and does not allow the generalization of findings to the entire population of nurses in the state and Nigeria and beyond. Other studies involving larger samples with multispecialty providers and more health institutions are necessary to increase understanding regarding this topic. Additional research also should assess actual nursing practices and adherence of health care professionals and patients to pressure ulcer prevention guidelines.

Conclusion

This study assessed pressure ulcer prevention knowledge and pressure ulcer prevention attitudes among 90 nurses in a tertiary health care facility. The majority (58, 64.4%) had knowledge scores higher than or equal to the median score, which was inferred to be adequate knowledge, and 67 (74.4%) nurses had attitude scores higher than or equal to the median score, which was inferred as having a positive attitude toward pressure ulcer prevention. Because 65.6% were found not to have knowledge on recommended recent prevention practices, education and training are needed. Approximately 62.2% of the nurses surveyed do not consider it important to screen patients they feel are not at risk of developing pressure ulcers. Nurses need to be orientated to the fact that screening all patients with limited mobility and implementing pressure ulcer prevention strategies is an integral part of their job.

References

1. European Pressure Ulcer Advisory Panel, National Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide, 2014. Washington, DC: National Pressure Ulcer Advisory Panel; 2014. Available at: www.npuap.org/wp-content/uploads/2014/08/Updated-10-16-14-Quick-Referenc... Accessed July 23, 2016.

2. Pieper B. Mechanical forces: pressure, shear and friction. In: R. Bryant R, Nix D, eds. Acute and Chronic Wounds: Current Management Concepts. St. Louis, MO: Mosby/Elsevier; 2007:205–234.

3. Hulsenboom MA, Bours GJJW, Halfens RJG. Knowledge of pressure ulcer prevention: a cross-sectional and comparative study among nurses. BMC Nurs. 2007;6(1):2.

4. Robinson M. Australian Council on Healthcare Standards. Primary Intention. 2005;13(3):104–117.

5. Thomas DR. Prevention and treatment of pressure ulcers. J Am Med Dir Assoc. 2006;7(1):46–59.

6. Melleiro MM, Tronchin DM, Baptista CM, Braga AT, Paulino A, Kurcgant P. Pressure ulcers prevalence indicators and patient falls incidence in teaching hospitals in the city of São Paulo. Rev Esc Enferm USP. 2015;49(2):55-59.

7. Pieper B, Mattern JC. Critical care nurses’ knowledge of pressure ulcer prevention, stating and description. Ostomy Wound Manage. 1997;43(2):22–26,28,30-31.

8. Zulkowski K, Ayello E, Wexler S. Certification and education: do they affect pressure ulcer knowledge in nursing? Adv Skin Wound Care. 2007;20(1):34–38.

9. Pancorbo-Hidalgo P, García-Fernández F, López-Medina I, López-Ortega J. Pressure ulcer care in Spain: nurses’ knowledge and clinical practice. J Adv Nurs. 2007;58(4):327–338.

10. Källman U, Suserud BO. Knowledge, attitudes and practice among nursing staff concerning pressure ulcer prevention and treatment--a survey in a Swedish healthcare setting. Scand J Caring Sci. 2009;23(2):334–341.

11. Beeckman D, Defloor T, Schoonhoven L, Vanderwee K. Knowledge and attitudes of nurses on pressure ulcer prevention: a cross-sectional multicenter study in Belgian hospitals. Worldviews Evid Based Nurs. 2011;8(3):166–176.

12. Islam S, Sae-Sia W, Khupantavee N. Knowledge, attitude, and practice on pressure ulcer prevention among nurses in Bangladesh. Paper presented at: 2nd International Conference on Humanities and Social Sciences, Faculty of Liberal Arts, Prince of Songkla University, Diseases Palliative Care; April 10, 2010; Songkhla, Thailand.

13. Ilesanmi RE, Ofi BA, Adejumo PO. Nurses’ knowledge of pressure ulcer prevention in Ogun State, Nigeria: results of a pilot study. Ostomy Wound Manage. 2012;58(2):24–32.

14. Nuru N, Zewdu F, Amsalu S, Mehretie Y. Knowledge and practice of nurses towards prevention of pressure ulcer and associated factors in Gondar University Hospital, Northwest Ethiopia. BMC Nurs. 2015;14(1):34.

15. Kaddourah B, Abu-Shaheen AK, Al-Tannir M. Knowledge and attitudes of health professionals towards pressure ulcers at a rehabilitation hospital: a cross-sectional study. BMC Nurs. 2016;15:17.

16. Dilie A, Mengistu D. Assessment of nurses’ knowledge, attitude, and perceived barriers to expressed pressure ulcer prevention practice in Addis Ababa Government Hospitals, Addis Ababa, Ethiopia, 2015. Adv Nurs. 2015:796927. Available at: http://dx.doi.org/10.1155/2015/796927. Accessed August 20, 2016.

17. Onche II, Yiltock SK, Obiano SJ. Pressure ulcers in spinal cord injury patients in Gombe, Nigeria. Nigerian J Orthop Trauma. 2004;3(1):57–60.

18. Maravilla JC, Lucero MH, Alejo TEY, et al. The knowledge of nurses in pressure ulcer prevention and their attitude towards the use of Braden scale. In: Proceedings from the Sigma Theta Tau International 23rd International Nursing Research Congress; July 2012; Brisbane, Australia.

19. Qaddumi J, Khawaldeh A. Pressure ulcer prevention knowledge among Jordanian nurses: a cross-sectional study. BMC Nurs. 2014;13(1):6.

20. Black JM, Edsberg LE, Baharestani MM, et al. Pressure ulcers: avoidable or unavoidable? Results of the National Pressure Ulcer Advisory Panel Consensus Conference. Ostomy Wound Manage. 2011;57(2):24–37.

21. Adejumo PO. Nurses’ perception of activities at preventing pressure sore among selected patients at the University College hospital, Ibadan. W African J Nurs. 2010;21(2):90–98.

22. Ajzen I, Fishbein M. The influence of attitudes on behavior. In: Albarracín D, Johnson BT, Zanna MP, eds. The Handbook of Attitudes. Mahwah, NJ: Erlbaum;2005:173–221.

Potential Conflicts of Interest: none disclosed

Ms. Esan is a lecturer, Department of Nursing; Mr. Fasoro is a lecturer, Department of Public Health; Dr. Ojo is a lecturer, Department of Nursing; and Ms. Obialor is an undergraduate student, Department of Nursing, College of Medicine and Health Sciences, Afe Babalola University, Ado-Ekiti, Nigeria. Please address correspondence to: Ayodeji A. Fasoro, Department of Public Health, College of Medicine and Health Sciences, Afe Babalola University, P.M.B. 5454, Ado-Ekiti, Nigeria; email: akinfasoro@abuad.edu.ng

Section:

Volume 64 - Issue 6 - June 2018 ISSN 1943-2720

↧

Adenocarcinoma at the Ileostomy Site After a Proctocolectomy for Ulcerative Colitis and/or Familial Adenomatous Polyposis: An Overview

June 7, 2018, 8:15 am

≫ Next: A Descriptive, Cross-sectional Study Among Chinese Patients to Identify Factors that Affect Psychosocial Adjustment to an Enterostomy

≪ Previous: A Descriptive, Cross-sectional Study to Assess Pressure Ulcer Knowledge and Pressure Ulcer Prevention Attitudes of Nurses in a Tertiary Health Institution in Nigeria

Issue Number:

Index:

Ostomy Wound Management 2018;64(6):30–40 doi: 10.25270/owm.2018.6.3040

Samuel D. James, MD; Alexander T. Hawkins, MD, MPH; and Amosy E. M’Koma, MD, PhD

Topics:

Literature Review

malignant neoplasm

Ileostomy

ulcerative colitis

familial adenomatous polyposis

Abstract

Adenocarcinoma that occurs at the ileostomy site after proctocolectomy (TPC) with an end ileostomy for ulcerative colitis (UC) and/or familial adenomatous polyposis (FAP) is a late and uncommon complication. To ascertain the rate of adenocarcinoma at the empirical ileostomy site following TPC, a review of the literature was conducted. PubMed, MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, EMBASE, Google search engine, and the Cochrane Database were investigated for research published between January 1975 and December 2016.

Search criteria included English language and human-only publications; broad search terms related to UC, FAP, ileostomy procedures, and dysplasias were used. Abstracts were eliminated if they were foreign language and nonhuman studies; editorials also were excluded. Secondary and hand/manual searches of reference lists, other studies cross-indexed by authors, reviews, commentaries, books, and meeting abstracts also were performed. Data extracted included age at diagnosis, operation technique, interval to ileostomy cancer, age when cancer was diagnosed, histology for both UC and FAP patients, and subsequent treatment. Papers were included on the basis of available evidence for each specific point of interest. Final and conclusive agreement was assessed with the k statistics during the title review and abstract review. Studies that did not report original data also were excluded. A total of 5753 publications were identified; 5697 publications did not conform to inclusion criteria and were eliminated. Among the reviewed publications (all case studies), 57 patients were diagnosed with ileostomy adenocarcinoma after TPC; 42 had UC, and 15 had FAP. The interval between TPC operation and ileostomy cancer diagnosis ranged from 3 to 51 years for UC and from 9 to 40 years for FAP, with a mean interval of 30 and 26 years, respectively. Biopsies were performed of all polypoid lesions found at the stoma site. Patients were treated with wide excision and refashioning (diversion) of the stoma. While adenocarcinoma arising at the mucocutaneous junction at the ileostomy site with adjacent skin invasion after TPC for UC and FAP appears to be rare, patients and clinicians need to be aware of this potential complication even years after surgery and regular screening is recommended.

Background

A permanent end ileostomy is recommended/indicated for patients who are not eligible for an ileal pouch, those who suffer from ileal pouch failure and/or poor baseline continence, and those who are dissatisfied with a temporary end ileostomy. Proctocolectomy intervention involves the removal of the entire colon and rectum while preserving bowel continuity, evacuation, continence/deferral, discrimination, and fertility. Some of these patients will subsequently require pouch excision with a creation of a permanent end ileostomy due to pouch failure.^1-5

According to standard surgical treatment procedure, a total proctocolectomy (TPC) is performed in patients with drug-refractory fulminant ulcerative colitis (UC)^1-3 and/or familial adenomatous polyposis (FAP) because these persons carry the adenomatous polyposis coli gene.² In addition, according to prospectively maintained database studies,^4,5 TPC is performed in carefully selected patients with Crohn’s disease of the colon (Crohn’s colitis), although it is not a recommended first-line treatment. Further, according to the Japanese Society for Cancer of the Colon and Rectum (JSCCR) 2012 Guidelines for the treatment of colorectal cancer,^2,6the TPC procedure is indicated as a second-line treatment option for hereditary nonpolyposis colorectal cancer,⁶ synchronous colorectal cancer,⁷ and severe colorectal constipation refractory to conservative drug treatment.² According to the JSCCR, TPC with an ileal pouch provides the opportunity to avoid a permanent ileostomy.⁸ According to meta-analyses, one third of patients with UC¹ and almost all patients with FAP⁹ will eventually require surgery to create a temporary stoma. In this regard, prospective observational studies have shown 3 types of surgeries are recommended: conventional TPC with permanent ileostomy,^10,11 restorative proctocolectomy (RPC) with ileal pouch anal anastomosis (IPAA), and total abdominal colectomy with ileorectal anastomosis (IRA).^8,9 According to cross-sectional studies, RPC is now the standard procedure for treating UC¹² and FAP.¹³ The emphasis for each procedure is different, with conventional proctocolectomy indicated and the surgical options commonly including colectomy with IRA and RPC.¹³

Brooke¹⁴ introduced the total colectomy procedure with eversion/diversion ileostomy in 1952.^15-19 According to standard/recommended surgical operation procedure,⁸2 types of ileostomy commonly are performed for UC and/or FAP patients (see Figure 1): end/terminal ileostomy after subcolectomy (see Figure 1A) and diverting loop ileostomy after proctocolectomy and ileal pouch-anal anastomosis (see Figure 1B). Since the introduction of total colectomy, a number of complications associated with the procedure have been observed.^14-20 These complications include skin excoriations, retraction or prolapsed of the stoma, stenosis, intestinal obstruction, abscess, fistula, ileitis, and inflammatory polyps.^14,16 The development of adenocarcinoma with invasion into adjacent skin^20,21 at the ileostomy meatus^20,21 or at the mucocutaneous junction of the ileostomy site is readily apparent, with changes easily recognized, although case reports and series have found it to be uncommon (see Figure 2).^22-24 However, case control studies have shown metaplastic cell growth at the ileostomy site can result in adenocarcinoma with invasion into adjacent skin.²⁵

A review of the literature was conducted to critically assess and evaluate research studies that address the rate of adenocarcinoma arising at the ileostomy site following TPC surgery for UC and/or FAP.

Methods

A review of the literature was conducted for research regarding adenocarcinoma arising at the ileostomy site in patients who had undergone ileostomy following proctocolectomy for UC and FAP published between January 1975 and December 2016 using PubMed, Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Current Nursing and Allied Health Literature (CINAHL), the Cochrane library, Web of Science, and the Google search engine. The following search terms were used: familial adenomatous polyposis, colectomy, total proctocolectomy, ileorectal anastomosis, Kock pouch, continent ileostomy, restorative proctocolectomy, ileal pouch-anal anastomosis, ileostomy, villous adenomas, adenocarcinoma, dysplasia, ileostomy neoplasia, ileostomy cancer, and mucosectomy. Secondary and hand/manual searches of reference lists, other studies cross-indexed by authors, reviews, commentaries, books, and meeting abstracts also were performed. All publications describing subsequent ileostomy site adenocarcinoma and management after TPC in humans were reviewed by the authors, and any queries or questions on inclusion were decided by the senior author. Studies that were published in languages other than English and did not use human subjects and editorials were excluded. Papers were included on the basis of available evidence for each specific point of interest. Final and conclusive agreement was determined using k statistics during the title review and abstract review. Data extracted from the publications included study type, age at diagnosis, operation technique, interval from surgery to ileostomy cancer diagnosis, age when ileostomy cancer was diagnosed, histology, and bowel pathology adjacent to tumor for both UC and FAP patients.

Data collection and analysis. The data were first collected to a spreadsheet based on the most recent available evidence for each specific point of interest. Final and conclusive agreement was assessed with the k statistic during the title review and abstract review. If the value was >0.6, the titles were reviewed and divided into 2 sets; each was reviewed by 1 of the 2 researchers. If the value was <0.6, reviewers discussed discrepancies, followed by other assessments of agreement.

Results

Of the total of 5753 publications identified, 5697 did not conform to inclusion criteria: 977 were duplicate and 3799 were not relevant to the topic, leaving 921 full-text articles that were reviewed. Out of 921 reviewed articles, 865 were further excluded because they were not English-language publications and/or nonhuman studies. Ultimately, 56 qualified for inclusion in this review. All were case reports; no prospective studies, randomized controlled trials, or meta-analyses were identified. As a result, neither incidence nor prevalence could be calculated.

Of the 57 reported cases of ileostomy orifice (stomal site) adenocarcinoma, 42 occurred in TPC-UC patients^15-22,25-53 and 15 in TPC-FAP patients^53-65 (see Table 1 and Table 2). Ileostomy cancer with adjacent skin invasion was reported in 1 TPC-UC patient.²¹

Polypoid adenocarcinomas tended to arise decades after ileostomy creation^21,23,42; the reported interval between TPC operation and ileostomy cancer diagnosis ranged from 3 to 51 years for UC and from 9 to 40 years for FAP,^23,26,58 with a mean interval of 30 and 26 years, respectively. The occurrence of this complication was not limited to the traditional Brooke ileostomy.⁴²

Management of these tumors was uniform across studies. Upon histological diagnosis of intramucosal well- to moderately differentiated adenocarcinoma, patients underwent a wide local resection of the tumor and the surrounding skin with adequately wide margins, as well as lymph node dissection and reconstruction of the ileostomy site.

The prognoses regarding functionality and patient quality of life were generally good after surgery, allowing for individual considerations of age, past medical history, presentation, and staging of the disease.

Ileostomies also were associated with a number of other complications in 11 patients and included skin excoriation, stenosis, parastomal herniation, intestinal obstruction, retraction or prolapse of the stoma, abscess, fistula formation, and ileitis⁴⁰ (see Figure 3 and Figure 4).

Discussion

This overview found 56 case studies of patients diagnosed with stoma site adenocarcinoma — 42 cases described TPC-UC and 14 described TPC-FAP patients. Ileostomy cancer (Ica) with adjacent skin invasion was reported in 2 TPC-UC patients.²¹ No case series, prevalence, or incidence studies were identified.

Currently, no drugs can cure UC or FAP. Conservative therapies for symptomatic relief for UC include the use of immunomodulatory drugs and human anti-tumor necrosis factor alpha monoclonal antibodies. These options are not curative. Long-term use of these agents suppresses the immune system, leading to severe side effects, and/or causes the disease to become refractory to the drugs. In these instances, patients will eventually require TPC (and ileal pouch-anal anastomosis with temporary ileostomy) to control their symptoms.^8,13 Patients with FAP are generally healthy, are not taking immunosuppressive medications, and have a normal bowel except for the presence of adenomas. Virtually all surgically untreated patients with FAP inevitably develop cancer in their lifetime because they carry the adenomatous polyposis coli gene; thus, prophylactic TPC is indicated.⁶⁶ Patients with a long-standing ileostomy following TPC for UC and FAP appear to be at a greater risk of developing adenocarcinoma at the ileostomy site than persons with an end ileostomy due to other non-UC and/or no FAP disease.^{15,16,22,30,39,40,48} Two (2) etiologies of ileostomy cancer can develop. First, long-duration ileostomies can result in several chronic pathologic conditions, including repetitive peristomal exposure, trauma caused by ill-fitting devices, and chronic mechanical and chemical irritation of the mucocutaneous junction associated with changes in the bacterial flora and milieu in and around the stoma.⁶⁴ Over time, these environmental risk factors may lead to metaplasia, dysplasia, and ultimately carcinoma.⁶¹ The second theory refers to the inherent predisposition of FAP patients to bowel adenomas after ileostomy. A case report⁶³ showed samples from these cancer patients were positive for K-ras mutation as well as immunostaining for β-catenin and p53, suggesting the presence of genetic alterations that predisposed them to ileostomy adenocarcinoma.

Most of the cases of adenocarcinoma at the ileostomy site have been reported within the past 5 years, suggesting a rise in disease incidence. The timing of this observed rise corresponds to end of a biologic latency period for the Brooke ileostomy.¹⁴ Therefore, it seems reasonable to postulate that the number of cases of adenocarcinoma at the ileostomy site may increase in an aging population with patients who have undergone the Brooke ileostomy, although at this time, data to support this hypothesis are lacking.

Conventional proctocolectomy often leads to permanent ileostomy.^10,11 Adenocarcinoma arising in the abnormally placed small bowel mucosa (ie, mucosa not in its anatomically correct location or the stoma was not created correctly) may occur years after the surgery and is beginning to garner attention. The cause is not clear, but physical trauma and chemical irritation may predispose the ileal mucosa to colonic metaplasia, dysplasia, and adenoma, which ultimately result in malignant changes^15,17 (ie, adenocarcinoma⁴⁰). Practicioners will need to perform biopsies on all polyps arising at the mucocutaneous junction and nonprolapse associated polyps that have appeared elsewhere on the stoma after an ileostomy in order to screen for ileostomy cancers.¹⁶

UC. Primary adenocarcinoma arising at the ileostomy site is a rare and infrequently reported complication after TPC for UC.⁴³ The earliest case of adenocarcinoma arising at the ileostomy site after TPC for UC was documented in 1969.²⁶ The current literature search of English-language publications yielded 42 case reports on patients diagnosed with Ica after TPC for UC to date. ICa with adjacent skin invasion also has been reported in 2 post TPC-UC patients. Barclay et al⁶⁷reported the incidence of small intestinal malignancy in the general population to be 0.7 per 100 000. Suarez et al¹⁵ estimated the incidence of ICa in the UK to be 0.2 to 0.4 per 100 000 patients who had undergone ileostomy creation. The findings of the current review yielded case studies only. While not sufficient to make reliable conclusions about the rate of ICa, it may suggest that although rare, ICa may occur more frequently than small intestinal carcinoma. Incidence was not part of the analysis because the studies were not TPC/ICa-specific to either UC or FAP.

The pathogenesis of ICa is unclear.^68,69 Some studies^16,22,43,62 suggest the generative epithelial hyperproliferation brought about by chronic irritation at the mucocutaneous junction is a factor. Additionally, physical trauma and/or irritation from chemical agents such as those used as stoma adhesives also may cause colonic metaplasia, adenoma, and ultimately carcinoma.⁷⁰ Changes in the bacterial flora also have been reported to be associated with cancer occurrence,⁷¹ as well as an association between ileitis or backwash ileitis and mucosal dysplasia and cancer transformation.⁷² It appears the sequence starts with chronic inflammation and ends with colonic epithelial metaplasia.^25,67 Cytological atypia and architectural abnormalities are thought to possibly ensue in dysplasia, which ultimately leads to carcinoma. In contrast, while examining their patient with ileostomy adenocarcinoma, Metzger et al²⁴ found no signs of inflammation at the ileostomy site and no evidence of Crohn’s disease in the terminal ileum.

Most ileostomy carcinomas reported in the literature appear to be slow-growing, mucin-secreting adenocarcinoma.^16,45 However, the vast majority of reported adenocarcinoma cases seemed to occur in patients who had undergone colectomy for UC,¹⁶ compared to a fewer number of cases in patients who had undergone colectomy for FAP.^23,58,62This may be because FAP patients are healthy without inflammation except for the presence of adenomas.⁶⁶

FAP. Epidemiological studies⁶⁴ have shown FAP patients are highly vulnerable to extracolonic gastrointestinal cancers, with an incidence of 0.7 per 100 000 patients. Ileal adenomas associated with FAP are a common finding, and approximately 20% of FAP patients have adenomatous polyps in the ileum.⁷³ Recent meta-analyses following TPC for FAP have confirmed the presence of multiple ileal adenomas and an increase in ileal mucosal proliferation. The earliest case on carcinoma arising at the ileostomy site after TPC for FAP was documented in 1982.⁵⁴ Ileal polyps and adenocarcinoma at the end ileostomy site, although considered rare, frequently manifest themselves subsequent to TPC in FAP patients.^{23,54,58,61,73} This review of the literature revealed 14 cases of ICa after TPC for FAP with an average interval between TPA and an ICa diagnosis of 26 years. The incidence of ICa after TPC, which is a recommended prophylactic surgery for FAP, is greater than its incidence in the general population.^54,62 The case report by Hamilton et al⁷⁴ noted the presence of ileal polyps (benign adenomas) in 9 FAP-postcolectomy patients.

A case report and histologic mucin study from University of Tokyo proposed 4 possible hypotheses for the etiology of ICa,⁶¹ supported by case-controlled studies from other institutions.^{22-24,61,64,71,75} First, chronic mechanical or chemical irritation at the stoma mucocutaneous junction may result in cancer growth over time. Second, backwash ileitis in TPC patients may result in malignant growth, as illustrated in the case report by Roberts et al.²² Third, colorectal mucosal migration or retention also may result in malignant growth, as reported in 2 publications included in this overview.^23,64 Finally, colonic metaplasia within the ileal mucosa at the ileostomy site can progress to cancer.^24,61,70,75

Genetic changes also can contribute to the development of Ica following TPC for FAP. In their investigation of genetic alterations in ileostomy adenoma and carcinoma, Herring et al⁷⁶ and Hata et al⁶³ reported the presence of K-ras mutation and the loss of heterozygosity (LOH) at chromosome 17p (p53) in their study samples. K-ras mutation was detected in samples from ileostomy polyps using the 2-step polymerase chain reaction-restriction fragment length polymorphism (RFLP), while no mutations were detected in normal ileum. The mutation in codon 12 of the K-ras oncogene altered it from GGT to GAT (Asp). LOH at p53 was detected in ileostomy polyps. Immunostaining for β-catenin in humans, a dual function protein involved in regulation and coordination of cell-to-cell adhesion and gene transcription, was detected in the adenomatous and carcinomatous portions but was not detected in normal ileum. Immunostaining for p53 was focally positive in the carcinomatous portions and negative for normal ileum.⁶³

Clinical and exploration genotype-phenotype correlation studies^60,77 have demonstrated that symptoms of FAP, including extracolonic manifestations, are correlated with the genotype or mutations of the adenomatous polyposis coli gene. The severity of the polyps depends on the mutation site. Mutations between codon 1309 and 1328 are associated with a more severe disease, while those between codon 1020 and 1169 as well as those located downstream of the mRNA (3’) end of the gene are associated with an attenuated form of FAP.^78,79

ICa patients may present with a variety of symptoms, including bowel obstruction and complaints such as ileostomy site irritation, pain, and bleeding.^20,21 Any suspicious signs or symptoms such as bleeding, pain, or polyp-like lesions at the ileostomy site should prompt a biopsy followed by histological examination, because neoplastic features may be overshadowed by inflammatory changes.²¹ Early detection of malignant lesions may increase the success of surgical treatment.²¹ The appropriate recommended treatment for ICa is a wide stoma site excision with ileostomy site reconstruction.^21,62 Adjuvant therapy, especially for patients with nodal disease, may have additional benefits.⁶² Patient education is important to encourage early disease detection as the lesions typically appear late (on average, 27 years after ileostomy) based on the case report studies identified in this and other studies.^21,53,65 Proper cancer care is necessary because these tumors have significant recurrence and metastatic potential.^26,33 Lymph node metastasis is reported to occur in 19% of patients, with a survival rate of at least 85%.²⁴

Characteristics of parastomal malignancy. Patients typically present with a parastomal mass, reducible parastomal hernia, fungating mass at the ileostomy site accompanied by chronic skin irritation, lethargy, dehydration, small bowel obstruction, and difficulty with proper placement of the stoma appliance.⁵³ Common differential diagnoses for parastomal lesions include contact dermatitis, psoriasis, and pyoderma gangrenosum due to constant contact of the surrounding skin with feces. This chronic irritation more commonly causes a dermatological condition rather than a malignancy. Malignancy must be validated histologically. Biopsy of the mass is essential to distinguish it from other more common differentials. Computed tomography scan is often used to visualize the extent of the mass.^50,53 Treatment may involve surgical excision and relocation of the stoma or a laparotomy with resection of the terminal small bowel, ileostomy, and abdominal wall skin, and creation of a new terminal ileostomy.

Conclusion

This overview of the literature, based on 56 articles reporting adenocarcinoma cases arising at ileostomy site, found 42 cases of TPC-operated for UC and 15 patients of TPC-operated for FAP. Patients who have a long-standing ileostomy may be at risk for ileostomy adenocarcinoma at the stoma with potential of invasion into the adjacent skin. While direct causality has not been established, repetitive peristomal exposure to chronic mechanical and chemical irritation at the mucocutaneous junction may play a role. Additionally, changes in the bacterial flora and milieu in and around the stoma orifice can contribute to cancer development. The cases presented suggest patients with ICa usually present first with peristomal skin changes that are unresponsive to conservative treatment measures. Therefore, yearly ileostomy site surveillance by medical personnel such as ostomy care nurses, attending physicians, colorectal surgeons, and gastroenterologists is highly recommended, supplemented by frequent examination by the patients themselves. Suspicious symptoms and lesions should prompt a thorough examination followed by a biopsy, careful histologic examination and, if needed, excision or wide resection of the anterior abdominal wall and reconstruction of the stoma. The case studies identified highlight the importance of regular screening, especially in persons who have had their ileostomy for many years.

Acknowledgment

The authors thank the Meharry Office for Scientific Editing and Publications for scientific editing support (NIH/S21MD000104).

References

1. Langholz E, Munkholm P, Davidsen M, Binder V. Colorectal cancer risk and mortality in patients with ulcerative colitis. Gastroenterology. 1992;103(5):14–51.

2. Furst A. [Differential indications for ileoanal pouch anastomosis: ulcerative colitis, familial adenomatous polyposis, synchronous colorectal cancer — Crohn’s disease, constipation]. Chirurg. 2017;88(7):555–558.

3. Lightner AL, Mathis KL, Dozois EJ, et al. Results at up to 30 years after ileal pouch-anal anastomosis for chronic ulcerative colitis. Inflamm Bowel Dis. 2017;23(5):781–790.

4. Le Q, Melmed G, Dubinsky M, et al. Surgical outcome of ileal pouch-anal anastomosis when used intentionally for well-defined Crohn’s disease. Inflamm Bowel Dis. 2013;19(1):30–36.

5. Shen B, Patel S, Lian L. Natural history of Crohn’s disease in patients who underwent intentional restorative proctocolectomy with ileal pouch-anal anastomosis. Aliment Pharmacol Ther. 2010;31(7):745–753.

6. Ishida H, Iwama T, Tomita N, et al. [Diagnosis and management of hereditary colorectal cancer according to the JSCCR Guidelines 2012 for the Clinical Practice of Hereditary Colorectal Cancer]. Nihon Rinsho. 2014;72(1):143–149.

7. Lee BC, Yu CS, Kim J, et al. Clinicopathological features and surgical options for synchronous colorectal cancer. Medicine (Baltimore). 2017;96(9):e6224.

8. M’Koma AE, Wise PE, Muldoon RL, Schwartz DA, Washington MK, Herline AJ. Evolution of the restorative proctocolectomy and its effects on gastrointestinal hormones. Int J Colorectal Dis. 2007;22(10):1143–1163.

9. Bulow S, Bulow C, Vasen H, Jarvinen H, Bjork J, Christensen IJ. Colectomy and ileorectal anastomosis is still an option for selected patients with familial adenomatous polyposis. Dis Colon Rectum. 2008;51(9):1318–1323.

10. Kilic E, Taycan O, Belli AK, Ozmen M. [The effect of permanent ostomy on body image, self-esteem, marital adjustment, and sexual functioning]. Turk Psikiyatri Derg. 2007;18(4):302–310.

11. Das P, Smith JJ, Tekkis PP, Heriot AG, Antropoli M, Nicholls RJ. Quality of life after indefinite diversion/pouch excision in ileal pouch failure patients. Colorectal Dis. 2007;9(8):718–724.

12. Parks AG, Nicholls RJ. Proctocolectomy without ileostomy for ulcerative colitis. Br Med J. 1978;2(6130):85–88.

13. McLaughlin SD, Clark SK, Tekkis PP, Ciclitira PJ, Nicholls RJ. Review article: restorative proctocolectomy, indications, management of complications and follow-up--a guide for gastroenterologists. Aliment Pharmacol Ther. 2008;27(10):895–909.

14. Brooke BN. The management of an ileostomy, including its complications. Lancet. 1952;2(6725):102–104.

15. Suarez V, Alexander-Williams J, O’Connor HJ, et al. Carcinoma developing in ileostomies after 25 or more years. Gastroenterology. 1988;95(1):205–208.

16. Attanoos R, Billings PJ, Hughes LE, Williams GT. Ileostomy polyps, adenomas, and adenocarcinomas. Gut. 1995;37(6):840–844.

17. Carter D, Choi H, Otterson M, Telford GL. Primary adenocarcinoma of the ileostomy after colectomy for ulcerative colitis. Dig Dis Sci. 1988;33(4):509–512.

18. Smart PJ, Sastry S, Wells S. Primary mucinous adenocarcinoma developing in an ileostomy stoma. Gut. 1988;29(11):1607–1612.

19. Starke J, Rodriguez-Bigas M, Marshall W, Sohrabi A, Petrelli NJ. Primary adenocarcinoma arising in an ileostomy. Surgery. 1993;114(1):125–128.

20. Abela J. Ileostomy Adenocarcinoma. A case report. MMJ. 2004;16(4):42.

21. Annam V, Panduranga C, Kodandaswamy C, Suresh DR. Primary mucinous adenocarcinoma in an ileostomy with adjacent skin invasion: a late complication of surgery for ulcerative colitis. J Gastrointest Cancer. 2008;39(1-4):138–140.

22. Roberts PL, Veidenheimer MC, Cassidy S, Silverman ML. Adenocarcinoma arising in an ileostomy. Report of two cases and review of the literature. Arch Surg. 1989;124(4):497–499.

23. Johnson JA 3rd, Talton DS, Poole GV. Adenocarcinoma of a Brooke ileostomy for adenomatous polyposis coli. Am J Gastroenterol. 1993;88(7):1122–1124.

24. Metzger PP, Slappy AL, Chua HK, Menke DM. Adenocarcinoma developing at an ileostomy: report of a case and review of the literature. Dis Colon Rectum. 2008;51(5):604–609.

25. Berman JJ, Ullah A. Colonic metaplasia of ileostomies. Biological significance for ulcerative colitis patients following total colectomy. Am J Surg Pathol. 1989;13(11):955–960.

26. Sigler L, Jedd FL. Adenocarcinoma of the ileostomy occurring after colectomy for ulcerative colitis: report of a case. Dis Colon Rectum. 1969;12(1):45–48.

27. Cuesta MA, Donner R. Adenocarcinoma arising at an ileostomy site: report of a case. Cancer. 1976;37(2):949–952.

28. Johnson WR, McDermott FT, Pihl E, Hughes ESR. Adenocarcinoma of an ileostomy in a patient with ulcerative colitis. Dis Colon Rectum. 1980;23(5):351–352.

29. Baciewicz F, Sparberg M, Lawrence JB, Poticha SM. Adenocarcinoma of an ileostomy site with skin invasion: a case report. Gastroenterology. 1983;84(1):168–170.

30. Stryker SJ. Primary stomal adenocarcinoma. An unusual complication of ileostomy. Dis Colon Rectum. 1983;26(1):47–49.

31. Bedetti CD, DeRisio VJ. Primary adenocarcinoma arising at an ileostomy site. An unusual complication after colectomy for ulcerative colitis. Dis Colon Rectum. 1986;29(9):572–575.

32. Vasilevsky CA, Gordon PH. Adenocarcinoma arising at the ileocutaneous junction occurring after proctocolectomy for ulcerative colitis. Br J Surg. 1986;73(5):378.

33. Longo WE, Stephan RN, True LD, August DA, McCullough WB. Recurrent ileal mucinous adenocarcinoma in an ileostomy. J Clin Gastroenterol. 1986;8(2):192–194.

34. O’Connell PR, Dozois RR, Irons GB, Scheithauer BW. Squamous cell carcinoma occurring in a skin-grafted ileostomy stoma. Report of a case. Dis Colon Rectum. 1987;30(6):475–478.

35. Coen LD, Lambert WG, Gray PB. Adenocarcinoma at the ileo-cutaneous junction following subtotal colectomy for ulcerative colitis. Case report. Acta Chir Scand. 1988;154(11-12):685–686.

36. Ewing HP, Manolas SG. Primary adenocarcinoma arising at an ileostomy site: an unusual cause of bowel obstruction. Aust N Z J Surg. 1989;59(11):898–899.

37. Pellissier PE, David A, Coppéré H, et al. [Primary adenocarcinoma of the ileostomy after total proctocolectomy for ulcerative colitis]. Gastroenterol Clin Biol. 1990;14(8-9):672–674.

38. Ferrandez Rivera M, Baltar Boileve J, et al. [Adenocarcinoma at an ileostomy site after colectomy for ulcerative colitis] J Chi (Paris). 1990;127(8-9):412–415.

39. Gadacz TR, McFadden DW, Gabrielson EW, Ullah A, Berman JJ. Adenocarcinoma of the ileostomy: the latent risk of cancer after colectomy for ulcerative colitis and familial polyposis. Surgery. 1990;107(6):698–703.

40. Carey PD, Suvarna SK, Baloch KG, Guillou PJ, Monson JR. Primary adenocarcinoma in an ileostomy: a late complication of surgery for ulcerative colitis. Surgery. 1993;113(6):712–715.

41. Listinsky CM, Halpern NB, Workman RB, Herrera GA. Ultrastructural and immunocytochemical features of a case of neuroendocrine carcinoma developing in a prior ileostomy site. Ultrastruct Pathol. 1994;18(5):503–509.

42. Cox CL, Butts DR, Roberts MP, Wessels RA, Bailey HR. Development of invasive adenocarcinoma in a long-standing Kock continent ileostomy: report of a case. Dis Colon Rectum. 1997;40(4):500–503.

43. Reissman P, Avroutis O, Cohen DY, Shiloni E. Ileostomy-site colonic metaplasia with adenocarcinoma after proctocolectomy for ulcerative colitis. Am J Gastroenterol. 1997;92(10):1932–1933.

44. Carne PW, Farmer KC. Squamous-cell carcinoma developing in an ileostomy stoma: report of a case. Dis Colon Rectum. 2001;44(4):594.

45. Pranesh N. Lymphoma in an ileostomy. Postgrad Med J. 2002;78(920):368–369.

46. Ramanujam P, Venkatesh KS. An unusual case of squamous cell carcinoma arising at the stomal site: case report and review of the literature. J Gastrointest Surg. 2002;6(4):630–631.

47. Achneck HE, Wong IY, Kim PJ, Fernandes MA, et al. Ileostomy adenocarcinomas in the setting of ulcerative colitis. J Clin Gastroenterol. 2005;39(5):396–400.

48. Agabiti E, Loganathan A, Rimmer M, Eames RA, Cullen PT. Cancer of ileostomy: a late complication of colectomy for ulcerative colitis. Acta Chir Belg. 2005;105(1):99¬–101.

49. Azem J, López-Cano M, Ponseti JM, et al. Ileostomy-site adenocarcinoma after proctocolectomy for ulcerative colitis. Int J Colorectal Dis. 2005;20(6):549–550.

50. Quah HM, Samad A, Maw A. Ileostomy carcinomas a review: the latent risk after colectomy for ulcerative colitis and familial adenomatous polyposis. Colorectal Dis. 2005;7(6):538–544.

51. Mohandas S, Lake S. Primary adenocarcinoma of ileostomy: case report with review of the literature. Case Rep Med. 2010;2010:921328.

52. Chang A, Davis B, Snyder J, Pulskamp S, et al. Considerations for diagnosis and management of ileostomy-related malignancy: a report of two cases. Ostomy Wound Manage. 2014;60(5):38–43.

53. Procaccino L, Rehman S, Abdurakhmanov A, McWhorter P, et al. Adenocarcinoma arising at ileostomy sites: two cases and a review of the literature. World J Gastrointest Surg. 2015;7(6):94–97.

54. Roth JA, Logio T. Carcinoma arising in an ileostomy stoma: an unusual complication of adenomatous polyposis coli. Cancer. 1982;49(10):2180–2184.

55. Ross DS, Bussing R, Dietrich J. Carcinoma arising in an ileostomy. IMJ Ill Med J. 1987;172(3):163–166.

56. Primrose JN, Quirke P, Johnston D. Carcinoma of the ileostomy in a patient with familial adenomatous polyposis. Br J Surg. 1988;75(4):384.

57. Lopez JF, Granger P, Dupre A. [Malignant degeneration on ileostomy for rectocolonic polyposis]. J Chir (Paris). 1991;128(4):201–203.

58. Gilson TP, Sollenberger LL. Adenocarcinoma of an ileostomy in a patient with familial adenomatous polyposis. Report of a case. Dis Colon Rectum. 1992;35(3):261–265.

59. Lux N, Wedell J, Busch M, van Calker H. [Adenocarcinoma of the ileostomy after total proctocolectomy in familial polyposis. A case report and synthesis of previously published cases]. Chirurg. 1993;64(5):416–418.

60. Wu JS, McGannon EA, Church JM. Incidence of neoplastic polyps in the ileal pouch of patients with familial adenomatous polyposis after restorative proctocolectomy. Dis Colon Rectum. 1998;41(5):552–556.

61. Mimura T, Kuramoto S, Yamasaki K, Kaminishi M. Familial adenomatous polyposis: a case report and histologic mucin study. J Clin Gastroenterol. 1999;28(4):372–376.

62. Iizuka T, Sawada T, Hayakawa K, Hashimoto M, Udagawa H, Watanabe G. Successful local excision of ileostomy adenocarcinoma after colectomy for familial adenomatous polyposis: report of a case. Surg Today. 2002;32(7):638–641.

63. Hata K, Watanabe T, Kawamura YJ, et al. K-ras mutation and loss of heterozygosity at 17p with beta-catenin accumulation in intramucosal carcinoma of the ileostomy in familial adenomatous polyposis: a case report. Dig Dis Sci. 2003;48(12):2310–2314.

64. Shenoy S, Cassim R. Ileostomy adenocarcinoma associated with familial adenomatous polyposis (FAP): new problem in old disease. Int J Colorectal Dis. 2009;24(12):1475–1476.

65. Huntington JT, Stanich PP, Harzman AE. Adenocarcinoma arising from an end ileostomy in a patient with familial adenomatous polyposis. Clin Gastroenterol Hepatol. 2017;15(4):A27–A28.

66. Smith JC, Schäffer MW, Ballard BR, et al. Adenocarcinomas after prophylactic surgery for familial adenomatous polyposis. J Cancer Ther. 2013;4(1):260–270.

67. Barclay TH, Schapira DV. Malignant tumors of the small intestine. Cancer. 1983;51(5):878–881.

68. Eaden J, Abrams K, Ekbom A, Jackson E, Mayberry J. Colorectal cancer prevention in ulcerative colitis: a case-control study. Aliment Pharmacol Ther. 2000;14(2):145–153.

69. Levi GS, Harpaz N. Intestinal low-grade tubuloglandular adenocarcinoma in inflammatory bowel disease. Am J Surgical Pathol. 2006;30(8):1022–1029.

70. Deutsch AA, McLeod RS, Cullen J, Cohen Z. Results of the pelvic-pouch procedure in patients with Crohn’s disease. Dis Colon Rectum. 1991;34(6):475–477.

71. Gorbach SL, Nahas L, Weinstein L. Studies of intestinal microflora: a unique microbial ecology. Gastroenterology. 1967;53(6):875–880.

72. Schlippert W, Mitros F, Schulze K. Multiple adenocarcinomas and premalignant changes in “backwash” ileitis. Am J Med. 1979;66(5):879–882.

73. Parc YR, Olschwang S, Desaint B, Schmitt G, Parc RG, Tiret E. Familial adenomatous polyposis: prevalence of adenomas in the ileal pouch after restorative proctocolectomy. Ann Surg. 2001;233(3):360–364.

74. Hamilton SR, Bussey HJ, Mendelsohn G, et al. Ileal adenomas after colectomy in nine patients with adenomatous polyposis coli/Gardner’s syndrome. Gastroenterology. 1979;77(6):1252–1257.

75. Hartley JE, Fazio VW, Remzi FH, et al. Analysis of the outcome of ileal pouch-anal anastomosis in patients with Crohn’s disease. Dis Colon Rectum. 2004;47(11):1808–1815.

76. Herring JA, Hall CC, Johnson JA, et al. K-ras mutation in a tubular adenoma originating at an ileostomy in a familial adenomatous polyposis patient. Am J Gastroenterol. 1996;91(3):587–591.

77. Bertario L, Russo A, Sala P, et al. Multiple approach to the exploration of genotype-phenotype correlations in familial adenomatous polyposis. J Clin Oncol. 2003;21(9):1698–1707.

78. Crabtree MD, Tomlinson IP, Hodgson SV, Neale K, Phillips RK, Houlston RS. Explaining variation in familial adenomatous polyposis: relationship between genotype and phenotype and evidence for modifier genes. Gut. 2002;51(3):420–423.

79. Friedl W, Meuschel S, Caspari R, et al. Attenuated familial adenomatous polyposis due to a mutation in the 3’ part of the APC gene. A clue for understanding the function of the APC protein. Hum Genet. 1996;97(5):579–584.

Potential Conflicts of Interest: This research was supported by Meharry Schools of Medicine and Graduate Studies and Research; National Institutes of Health (NIH)/National Institute of Diabetes and Digestive and Kidney Diseases-R21DK095186; Vanderbilt University Institute for Clinical and Translational Research (VICTR-CTSA)-1UL1RR024975-01; NIH/National Center for Advancing Translational Sciences VICTR-2UL1TR000445-06; NIH/National Cancer Institute (NCI)-3U54CA091408–09S1; and NIH/NCI-3U54CA091408–09S2.

Dr. James is an Assistant Professor of Pathology, Department of Pathology, Meharry Medical College School of Medicine, Nashville General Hospital, Nashville, TN; and an Assistant Professor of Pathology, Department of Pathology, Microbiology, and Immunology, Tennessee Valley Health Systems VA Medical Center, Vanderbilt University Medical Center, Nashville, TN. Dr. Hawkins is an Assistant Professor of Surgery, Department of Surgery, Vanderbilt University School of Medicine. Dr. M’Koma is an Associate Professor of Surgery and Cancer Biology, Department of Biochemistry, Cancer Biology, Neuroscience and Pharmacology, Meharry Medical College School of Medicine; and adjunct Associate Professor of Surgery, Department of Surgery, Vanderbilt University School of Medicine. Please address correspondence to: Amosy E. M’Koma, MD, PhD, Department of Biochemistry, Cancer Biology, Neuroscience and Pharmacology, Meharry Medical College School of Medicine, Nashville, TN 37208-3599; email: amkoma@mmc.edu.

Section: