Abstract

Physiological, psychological, and social problems may affect adaptation to living with a stoma. A descriptive, cross-sectional study was conducted between March 2017 and June 2017 among patients culled from a manufacturer’s database to identify factors that influence psychosocial adjustment in Chinese patients with an enterostoma.

Patients with a history of ostomy surgery ≥1 month prior and who were ≥18 years of age, completed a primary school education, and able to communicate in Chinese were eligible to participate unless they had a history of psychosis, cognitive impairment, or participation in other research programs. After providing informed consent, participants completed a questionnaire that addressed demographic (age, gender, employment, educational level, marital status, medical payment method, living status, and area of residence) and stoma-related (date of surgery, preoperative stoma siting, ostomy appliance type, peristomal complications, regular defecation, stoma self-care ability, stoma-related communication with medical staff, level of understanding regarding stoma knowledge and care skills, appliance change knowledge/experience, and leakage history) factors. Social support was assessed using the 10-item Social Support Revalued Scale (SSRS), and 3 dimensions of adjustment (acceptance, continuous worry, and positive life attitude) were assessed using the 20-item Chinese version of the Ostomy Adjustment Inventory (OAI). Questionnaires were administered via an online survey platform. Data were analyzed descriptively, and single-factor analysis and stepwise multiple linear regression were applied to identify the factors that influenced the adjustment level. Incomplete (missing >2 questions), incorrect, or hastily completed (within 600 seconds) records were excluded from analysis. Of the 1109 persons who returned the questionnaire, 1010 (91.1%) completed the entire survey (564 men [55.8%] and 446 women [44.2%], mean age 56.62 ± 15.62 years); 823 (81.5%) had a colostomy and 187 (18.5%) had an ileostomy. The OAI dimension continuous worry was negatively and significantly associated with all 3 dimensions of the SSRS, including subjective support (r = 0.259), objective support (r = 0.259), and utilization of support (r = 0.289), while the dimension acceptance was positively associated with both subjective support (r = 0.082) and objective support (r = 0.074) (all P values <.05). Using multiple linear regression, residence area, peristomal complication, regular defecation, leaking, self-care ability, communication with medical staff regarding ostomy, understanding knowledge or skill needed for stoma care, utilization of social support, and total score of social support were found to be significantly associated with ostomy adjustment level (all P values <.05). Patients living in an urban area, with no history of peristomal complications, who had regular defecation, had not experienced leaking, had better self-care ability, frequently communicated with medical staff, had a high level understanding about knowledge or skill of stoma, and had higher social support scores had higher adjustment scores. Knowledge of the factors that enhance or hinder adaptation of the patient to the ostomy is an important tool in the clinician’s care armamentarium.  

Colorectal cancer is a common malignant disease, ranking third in incidence in the world behind lung cancer and breast cancer. Since 1992, 1 million new colorectal cancer patients have been diagnosed every year worldwide, with an annual increase of 1.2% in morbidity.¹ In China, the morbidity and mortality of colorectal cancer have increased in recent years, ranking it the fifth leading cause of death.² In addition to the detrimental effect of cancer itself, most colorectal cancer survivors must deal with an ostomy as a part of their treatment.³Ostomy refers to a surgical procedure that results in an artificial opening in the abdominal wall (stoma) through which bodily waste is excreted.⁴ In the United States, approximately 100 000 patients receive a colostomy or ileostomy every year,⁵ while in the United Kingdom, approximately 135 000 patients receive a neostoma every year, including more than 100 000 colostomy patients.⁶ In 2005, China had more than 1 million colostomy patients, with an annual rise of 100 000.⁷

Although a colostomy is regarded as life-saving surgery, it causes many changes to the body image and lifestyle of the patient; a phenomenological study found it to detrimentally affect self-image⁸ and impose long-term impacts on physical and psychological status.⁹ A systematic review¹⁰ and a literature review¹¹ reported low quality of life (QoL) among patients with an ostomy.^10,11 Furthermore, qualitative analysis^12,13 has found that a low QoL score is mainly attributable to psychosocial issues. Therefore, it is of great importance to explore the factors that affect psychosocial adjustment in ostomates.

Globally, China has the highest rate of new cases of colorectal cancer every year (25.3 million), making up 18.6% of new colorectal cancer cases across the world in 2012.¹¹ However, few studies have reported on psychosocial adjustments and potentially related factors in Chinese patients with ostomy.^14-16 Hu et al¹⁵ conducted a retrospective, cross-sectional study among 129 colostomy patients in 5 hospitals in Guangzhou (Guanadong Province, China) using the Ostomy Adjustment Scale developed by Olbrisch and Ziegler.¹⁷ The authors observed that 33.3% of patients displayed a low and 63.6% of patients showed a medium adjustment level. Patient self-care ability, spouse’s acceptance of the stoma, and peristomal complications were associated with adjustment level.¹⁵ In their cross-sectional study, Cheng et al¹⁶ investigated 54 Chinese patients with a permanent colostomy and found that self-care ability was correlated with adjustment level, which was in line with the results of another cross-sectional survey by Su et al¹⁴ that evaluated 122 patients with a temporary colostomy. According to 2 descriptive cross-sectional studies,^18,19 gender, family and social support, stoma self-care efficacy, interpersonal relationships, and the location of the stoma also may impact the adjustment level of ostomates. 

A cross-sectional study²⁰ found psychosocial adjustment plays an important role in self-management and is a critical factor in predicting the QoL of ostomates after surgery. Therefore, the aim of the current study was to identify factors that influence psychosocial adjustment in Chinese patients with an enterostoma.

Materials and Methods

Study design and population. From March 2017 to June 2017, enterostomy patients from the Coloplast Corp (Humlebaek, Denmark) Chinese database were invited to participate in the study. The company sent a study invitation letter and a link to complete an online questionnaire and patient consent form via the Wenjuanxing platform (www.wjx.cn), 1 of the largest online survey platforms in China. The 66 000 patients in the company’s database were from 22 provinces, 4 autonomous regions of ethnic minorities, and 4 directly controlled municipalities of China. The inclusion criteria for this study stipulated participants must be ≥18 years of age, have had surgery ≥1 month prior, have at least a primary school education, and be able to communicate in Chinese. Patients were excluded if they had a urostomy, a history of psychosis, cognitive impairment, and/or participation in other research programs. Patients who failed to answer at least 2 questions, provided wrong answers (eg, provided 2 responses to 1 question), or (because completion of the survey was expected 10 take 10 to 15 minutes) completed the questionnaire within 600 seconds were excluded. 

The questionnaire was designed by the present researchers and had been preliminarily tested and improved in a study (unpublished) conducted in February 2017. In the preliminary study, 77 patients with colostomies were recruited from 3 hospitals in Beijing; 74 questionnaires were completed. The questionnaire was revised according to patient suggestions. To calculate the sample size for the current study, the standard deviation of the mean adjustment score was set to 10.25 ± 2.0, with a 2-sided α of 0.05 and β of 0.1. The sample size was estimated at 554.

The demographic characteristic variables collected included age, gender, employment (yes, no), educational level (≤9 years, >9 years), marital status (married, unmarried), medical payment method (self-paying, not self-paying), living status (live alone, not live alone), and residence area (urban, rural). Stoma-related data also were collected and included date of surgery, stoma siting before surgery (yes, no), type of ostomy appliance (1- or 2-piece), history of peristomal complications (yes, no), regular defecation (ie, whether the ostomate had a relatively fixed time of defecation and defecated 1 to 3 times every day after surgery; yes, no), stoma self-care ability (completely self-care, mostly self-care, relied mostly on others, relied completely on others), communication with medical staff regarding colostomy (never, sometimes [1 to 4 times per week], frequently [≥4 times per week]), level of understanding regarding stoma knowledge and care skills (complete, partly, do not understand [ie, ostomy patients do not understand knowledge and care skills for stoma at all]), when the patient learned how to change the ostomy appliance (before discharge, 1 week after discharge, other time), and stoma leakage during past 3 months (yes, no) (see Table 1). All data in the survey platform were kept anonymous; only core researchers in the current project had access to the data. 

Measurement tools. 

Social Support Revalued Scale (SSRS). Social support was assessed using the SSRS, which was formulated by Xiao and Yang²¹ in 1986. The 10-item SSRS evaluated 3 dimensions of social support: subjective support, objective support, and support utilization. Subjective support referred to how respected, supported, and understood the individual felt in his/her social context. Objective support referred to concrete support from society, such as financial support and support from a social network or organization. Support utilization was defined as how the individual used social support. The scoring system for the 10 items on the SSRS was as follows: items 1, 3, 4, and 5 represented subjective support; item 2 represented objective support; and items 8 through 10 represented social support. For items 1–4 and 8–10, there were 4 choices yielding scores of 1, 2, 3 and 4 (higher scores indicated more social support). For item 5 (which represented subjective support), there were 4 choices: A, no; B, very little; C, generally; D, all. These choices provided scores of 1, 2, 3, and 4, respectively. For items 6 (financial support) and 7 (psychological support), no source yielded a score of 0; if several sources of support were selected from a list of possible sources, a score commensurate with the number of sources selected was earned. The total SSRS score ranged from 11 to 60 points and was classified into 3 categories: low social support (<35 points), medium social support (35 to 47 points), and high social support (>47 points). The Cronbach α of the total scale was 0.896 and Cronbach α of the 3 dimensions were 0.849, 0.825, and 0.833, respectively.²²

Ostomy Adjustment Inventory (OAI). The psychosocial adjustment level to the stoma was measured using the Chinese version of the OAI, which was translated and modified from the English version of the Ostomy Adjustment Inventory-23 (OAI-23) in 2011.²³ The English version of the OAI-23 includes 4 dimensions and 23 items, including acceptance (9 items), continuous worry (5 items), social intercourse (4 items), and indignation (2 items).²⁴ In contrast, the Chinese version of the OAI comprises 3 dimensions (acceptance, continuous worry, and positive life attitude) and 20 items. Responses were provided using a 5-category Likert scale ranging from 0 to 4 points, where 0 = strongly agree and 4 = strongly disagree regarding the dimension continuous worry and where 0 = strongly diasgree and 4 = strongly agree regarding the dimensions acceptance and positive life attitude. The total OAI scores ranged from 0 to 80 points and were classified into 3 categories: low adjustment level (<40 points), medium adjustment level (40 to 60 points), and high adjustment level (>60 points). A Cronbach α of 0.886 was found for the total OAI score, and continuous worry, positive life attitude, and acceptance were 0.704, 0.885, and 0.779, respectively.²³ The Cronbach’s α for 2-week test-retest reliability were 0.836, 0.807, and 0.764 for continuous worry, positive life attitude, and acceptance, respectively.²³ The Cronbach α of this scale was 0.913 and the Cronbach α of the 3 dimensions were 0.891, 0.872, and 0.864, respectively, according to the results of the preliminary (unpublished) study indicating that the translated Chinese version is highly reliable.

Ethical considerations. The current study was approved by the Ethics Committee of Xuanwu Hospital Capital Medical University (Beijing, China). The objective and method of research were explained to the patients before the questionnaire was made available online, and written consent of the patient or a family member was obtained. 

Data collection. The questionnaire data were collected directly into the online survey platform. Only core researchers in the current project had access to data.

Data analysis. The general demographic data and stoma-related data were statistically described using mean and standard deviation. Qualitative variables were described using frequency and percentage. Single-factor analysis was conducted to analyze the adjustment level of the classified variables. A t test and 1-way analysis of variance were applied to analyze data with normal distribution and homoscedasticity. Kruskal-Wallis H and Mann-Whitney U tests were applied for data without a normal distribution and heterogeneity of variance. Pearson correlation analysis was performed to measure correlations between ostomy adjustment level and social support. An independent t test was used to compare the mean score of the overall psychological adjustment. Stepwise multiple linear regression was applied for regression analysis to identify the factors that significantly influenced the ostomy adjustment level. The inclusion criteria was 0.05, and the removal criteria was 0.10. Two-sided P<.05 was regarded as having statistical significance. SPSS, version 22 (IBM, Armonk, NY) was used for all data analysis.

Results

Baseline characteristics. Of the 1109 invited persons who returned their questionnaire and signed a patient consent form through the online survey platform, 99 were excluded (80 patients had a urostomy, 10 finalized the questionnaire within 600 seconds, 7 had incorrect answers, and 2 were <18 years of age). The remaining 1010 patients included 564 men (55.8%) and 446 women (44.2%), with a mean age of 56.62 ± 15.12 years. The majority of patients (686, 67.9%) were younger than 65 years, employed (532, 52.7%), married (875, 86.6%), did not self-pay for medical treatment (849, 84.1%), did not live alone (962, 95.2%), and lived in an urban area (709, 70.2%). Of these patients, 651 (64.5%) had their stoma sited before surgery, 823 patients (81.5%) received a colostomy (678 [67.1%] permanent, 332 [32.9%] temporary) and 187 (18.5%) had an ileostomy. After enterostomy surgery, 195 (19.3%) patients experienced peristomal complications; the 3 most common complications were irritant dermatitis, allergic dermatitis, and parastomal hernia, accounting for 48.7%, 19.5%, 15.6%, respectively. Eight hundred, one (801, 79.3%) did not defecate regularly, and 732 (72.5%) experienced leakage during the past 3 months. Regarding self-care ability, 251 patients (24.9%) performed their own care, 345 patients (34.2%) performed most of their ostomy care, 264 patients (26.1%) mostly relied on others, and 150 patients (14.8%) completely relied on others. More than half of the patients (558, 55.2%) communicated with medical staff regarding their enterostomy and 682 (67.5%) learned how to change the appliance before discharge (see Table 1). 

Ostomy adjustment and social support levels. The mean OAI score was 33.25 ± 8.44, representing a low adjustment level in general (see Table 2). The mean scores OAI scores were 14.80 ± 7.53, 8.52 ± 1.91 and 9.92 ± 2.30 for continuous worry, positive life attitude, and acceptance, respectively. The average social support score was 40.16 ± 8.22, which represents medium levels of social support (see Table 3). The dimension continuous worry was significantly associated with all 3 dimensions of social support including subjective support (r = 0.259), objective support (r = 0.259), and utilization of support (r = 0.289) (see Table 4), while the dimension acceptance was associated with both subjective support (r = 0.082) and objective support (r = 0.074) (all P values <.05). The total OAI score was significantly associated with all dimensions of social support.

Ostomy adjustment score in relation to risk factors. By comparing the distributions of the ostomy adjustment score to the categories of different risk factors, the authors observed that patients with a higher education level, who were not self-paying, who lived in urban areas, who did not have peristomal complications, who defecated regularly, and who had not experienced leaking during past 3 months had higher OAI scores (see Table 5). However, in multiple linear regression, only area of residence, peristomal complications, regular defecation, leaking, self-care ability, communication with medical staff regarding ostomy, stoma knowledge or care skills, utilization of social support, and total score of social support were found to have statistical significance (all P values <.05) (see Table 6).

Discussion

The current study identified several factors that may influence the psychological adjustments to having a stoma among Chinese patients. Area of residence, having a history of peristomal complications, regular defecation, leaking of the appliance, self-care ability, communication with medical staff regarding the stoma, self-rated confidence in stoma knowledge or care skills, and social support were associated with ostomy adjustment level.

The mean adjustment score was 33.25 ± 8.44, which was slightly lower than the results observed in a prospective, multicenter study by Karadag et al²⁵ in Turkey (N = 135, mean OAI-23 score of 48.63 ± 13.75). This difference may be due to the fact that the Chinese version of the OAI only contained 20 items compared to 23 items in the English version used in the Karadag study.²⁵ However, the mean score in the current study was comparable to another descriptive Chinese study¹⁶ using the same Chinese version of the OAI-20 (mean score 45.112 ± 13.358). 

 The incidence of colorectal cancer has been increasing rapidly in recent years in China and has resulted in an annual increase of 100 000 new ostomy patients.⁷ Thus, attention regarding how to improve adjustment to an ostomy is increasing. The current study revealed ostomy patients who had better self-care ability, frequently communicated with medical staff, had a higher level of understanding/knowledge/skill of stoma care, and lived in urban area had significantly better adjustment scores. Also, the results showed that higher social support scores were significantly correlated with higher adjustment level, which indicated that more support from family, friends, and society led to a higher adjustment level. This finding was in line with a prospective multicentered study by Piwonka and Merino²⁶ (N = 60), the empirical study by Karadag et al²⁵ (N = 135), and a cross-sectional study by Wang and Chen²⁷ (N = 301). The clinical medical staff should encourage the patient to take an active part in social activities and work hard to psychologically accept the stoma, as well as increase the patient’s confidence and ability to manage the stoma.²⁸ 

Some patients have been found to be more adaptive after surgery because they had obtained self-care skills.²⁹ However, in the current study only 24.9% of patients frequently communicated with the medical staff. Experience has taught practitioners that through communication with medical staff, the patient may obtain information on disease development, be involved in treatment decisions, and acquire guidance regarding self-care, making it easier to adapt to the stoma. Medical staff needs to communicate with the patient as necessary and provide more channels to communicate health information based on patient preferences. 

This study also revealed 19.3% of patients experienced peristomal complications. This is somewhat lower than the results of 2 other Chinese studies that reported rates of 35.66% and 31.5%.^12,15 Patients with peristomal complications had lower levels of social psychological adjustment, which was supported by the results of a prospective study³⁰ and a literature review.³¹ The most common complications in the current study were irritant dermatitis (48.7%), allergic dermatitis (19.5%), and parastomal hernia (15.6%). In addition, complications such as stomatorrhagia and stoma prolapse often led to pain that affects the normal use of ostomy bag, thereby lowering the adjustment level and patient QoL.³² 

The occurrence of leaking 3 months after surgery and regular defecation are factors that influenced adaptation level. This study found 72.3% of patients experienced leakage. Patients who experienced leaking had a lower adjustment level than those who did not, which underscores the need to enhance patient education during hospitalization, improve stoma-related knowledge and care skills, arrange for follow-ups after discharge, and encourage timely assistance and guidance from professionals. Furthermore, 79.3% of patients had irregular defecation. Enterostomy patients may have an increase in defecation frequency and irregular times of defecation because colon movement is not easy to control.³³ Therefore, clinicians need to 1) focus on establishing regular defecation for the patient as soon as possible after surgery, 2) direct the patient to receive regular defecation training, 3) help the patient re-establish regular defecation, and 4) encourage patients to take full advantage of enterostomy outpatient services and enterostomal therapists in order to improve continuity of care.

Limitations 

The adjustment level of the patient changes with time and is a dynamic process. Additionally, the sample size does not represent enterostomy patients as a whole. The questionnaire for this research was distributed through a network platform, so the return rate was not ensured. In addition, the reason for the ostomy was not considered. The reason may have had an undocumented influence on adjustment, per previous research.

Conclusion

This research shows that ostomates have low social psychological adjustment levels to their new reality. Social support, stoma self-care ability, communication with medical staff, peristomal complications, understanding related to stoma knowledge and skill, utilization of support, the presence of leaking within 3 months, residence area, and regular defecation were found to influence the adjustment level of enterostomy patients. Therefore, clinicians need to perform specific interventions based on risk factor evaluations during clinical care to help patients improve their adaptation to the stoma and subsequently improve their quality of life. Additionally, the impact of Chinese culture should be considered when generalizing this finding internationally. n

Acknowledgment

The authors are grateful to the patients, families, and caregivers who participated in this study.

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Ms. Xian is an enterostomal therpist; Ms. Y. Zhang is a registered nurse;  Ms. Yang is a supervisor nurse; Ms. X. Zhang is a nurse practitioner; and Ms. Wang is a vice professor, Xuanwu Hospital Capital Medical University-Department of General Surgery, Xicheng District, Bejing, PR China. Please address correspondence to: Xinran Wang, Vice Professor, Xuanwu Hospital Capital Medical University-Department of General Surgery, No. 45 Changchun Street, Xicheng District, 100053, Beijing, PR China; email: xwgsd2017@hotmail.com

Abstract

The sacral area is the most common site for pressure injuries (PIs) associated with prolonged supine bedrest. In previous studies, an anisotropic multilayer prophylactic dressing was found to reduce the incidence of PIs and redistribute pressure. The purpose of the current study was to further investigate relationships between design features and biomechanical efficacy of sacral prophylactic dressings.

Using computer modeling, the anisotropic multilayer dressing and a hypothetical dressing with different mechanical properties were tested under dry and 3 levels of moist/wet conditions.  Sixteen (16) finite element model variants representing the buttocks were developed. The model variants utilized slices of the weight-bearing buttocks of a 28-year-old healthy woman for segmentation of the pelvic bones and soft tissues. Effective stresses and maximal shear stresses in a volume of interest of soft tissues surrounding the sacrum were calculated from the simulations, and a protective endurance (PE) index was further calculated. Resistance to deformations along the direction of the spine when wet was determined by rating simulation outcomes (volumetric exposures to effective stress) for the different dressing conditions. Based on this analysis, the anisotropic multilayer prophylactic dressing exhibited superior PE (80%), which was approximately 4 times that of the hypothetical dressing (22%). This study provides additional important insights regarding the optimal design of prophylactic dressings, especially when exposed to moisture. A next step in research would be to optimize the extent of the anisotropy, particularly the property ratio of stiffnesses (elastic moduli).

A pressure ulcer (PU) or pressure injury (PI) as now termed in the United States and Australia is defined as a localized site of tissue damage that typically develops near a bony prominence as a result of sustained mechanical loads applied to soft tissues.¹ The sacral area is the most common site for PIs associated with prolonged supine bedrest; the weight of the lower trunk and pelvis subject skin, fat, and muscle tissues enveloping the sacrum to sustained cell and tissue deformations.^1-3 Clinical studies^2,3 report that approximately 30% of these PUs are category 3 to category 4 or deep tissue injuries (DTIs), scaled according to international guidelines,¹ that later evolve into open wounds that affect all tissue layers, down to the bone. In addition to the compressive and tensile loads that are present in weight-bearing sacral soft tissues, biomechanical analyses have identified shear loads as being dominant, given the high curvature of the (nearly rigid) sacral bone and stiffness gradients of the layered soft tissue structure.⁴ Computer modeling in particular shows these internal shear loads can be further intensified when patients slide downward in bed due to gravity (especially if the head of the bed is elevated) or during repositioning for PI prevention, comfort, or providing patient hygiene.⁴ 

PI prevention is now an important focus of many health care organizations, government agencies, the medical industry, and academic research worldwide; efforts and resources are directed at finding preventive interventions that have consistently proven successful over time. One important successful preventive measure is the use of adequate prophylactic dressings. Santamaria et al⁵ conducted the first large-scale, randomized controlled trial (RCT), the “Border Trial,” in which Mepilex Border Sacrum (MBS) anisotropic multilayer dressings and heel dressings (Mölnlycke Health Care, Gothenburg, Sweden) were prescribed to trauma and critically ill patients (N = 440) in the hospital’s emergency department. The PU rates in the dressing group were compared to those of a control group receiving standard care including use of a low-air-loss bed, ongoing Braden risk assessments, and regular repositioning and skin inspections. Results of a similarly designed RCT with an equivalent sample size (N = 366) were reported by Kalowes et al.⁶ Both studies concluded that use of the aforementioned multilayer sacral and heel dressings, combined with preventive care, resulted in a statistically significant reduction in the incidence rate and severity of hospital-acquired PUs in intensive care patients. In another comparative cohort study,⁷ the Santamaria group found that the multilayer dressing variant having the same material composition as the MBS for protecting the heels was clinically effective in reducing intensive care unit-acquired heel PUs in a cohort of 150 patients. 

An adequate prophylactic dressing has a structure and composition that can absorb deformation energy (strain energy in engineering terms), especially shear loads, capturing this energy in the dressing structure and not in the tissues, as demonstrated in previously published biomechanical (computer modeling) studies by the current authors.^8-11 The dressing is further designed to reduce the frictional forces between clothing and mattress, provide local cushioning, and redistribute bodyweight-associated pressures, as well as manage the microclimate and humidity of the skin.^8-11 Likewise, the beneficial effect of the anisotropic feature of the multilayer dressing (termed deep defense by the manufacturer) has been described and characterized as stiffness with a directional preference (ie, the dressing is more flexible and stretchable in its lateral direction than in the longitudinal direction of the human body).^10,11 Using the finite element (FE) method described in a previous study,⁹ the current authors simulated different clinically relevant scenarios and biomechanical characteristics of high-risk groups, such as frail elderly persons and persons with diabetes, and assessed the biomechanical performance and efficacy of the multilayer dressing in these scenarios.¹¹ Their research consistently found a considerable reduction in exposure to skin and deep tissue deformations when the anisotropic multilayer dressings were applied, which may help explain the outcomes of the above RCTs from a scientific bioengineering perspective. 

Fluids tend to accumulate in a prophylactic dressing over time (even though the skin is intact) as a result of normal sweating, fever, or incontinence; these fluids affect the functioning of the dressing and the integrity and biomechanical properties of the skin.⁴ In particular, based on fundamental knowledge regarding how water absorption affects the strength and stiffness of porous materials (such as paper or cloth), the accumulation of fluids may affect different mechanical characteristics of a prophylactic dressing, including its stiffness properties and directional preference, the coefficient of friction and geometry. Each of these potential changes may impact the protective efficacy of the dressing over time. Accordingly, it is important to ensure that a prophylactic dressing continues to provide stable protection to tissues (including when wet) over the entire timespan of use, defining its durability. However, the effect of moisture on these dressings has not been tested. 

The purpose of the current study was to further investigate relationships between design features and biomechanical efficacy of sacral prophylactic dressings. Specifically, the authors aimed to simulate and study the performance of the MBS anisotropic multilayer dressing and a hypothetical dressing comprising the features of a similar dressing, but which become isotropic after absorbing fluids. The authors focused on the effect of wetness on the elastic properties of the dressings. The hypothesis was that the sustainability of the anisotropy characteristic in wet conditions is critical for the dressing to maintain its protective efficacy over time (ie, durability). 

Methods 

In order to investigate the biomechanical efficacy of sacral prophylactic dressings in protecting soft tissues after absorbing fluids, the authors developed 16 FE model variants representing the buttocks with either the anisotropic multilayer dressing or with a hypothetical dressing (see Table 1). The concept of the hypothetical dressing is based on commercially available dressings that were tested experimentally. However, to create comparable models of the MBS dressing and a hypothetical one, which needed to be identical in shape to the MBS but have different mechanical behavior (and hence, was not a “real” product), the hypothetical elastic moduli obtained in tests^8,11 of some commercial products on the same geometric model that had been devised to represent the MBS were used. Specifically, the performance of the anisotropic multilayer dressing (which, according to manufacturer data, preserves its anisotropy feature when wet¹¹) was compared to a hypothetical dressing that loses its anisotropy as fluid contents build up. The amounts of fluids are based on transepidermal water loss (TEWL) values taken from Kottner et al.¹² These 3 fluid values include TEWL for lower back and buttocks of approximately 10 (g/[m²/h]), which corresponds to 0.025 (mL/[cm²/day]) in the dressing, and the higher levels (0.075, 0.15 [mL/(cm²/day)]) were taken in order to investigate a more substantial accumulation of fluids — for example, when excess perspiration or incontinence is present. Both types of dressings (anisotropic multilayer versus hypothetical) were tested for wetness levels when pure compressive bodyweight loading was applied and also for a combined compression and shear loading mode, consistent with the current authors’ previously published work.^10,11 Effective and maximal shear stresses developed in the soft tissues at the sacral region in supine weight-bearing were systematically compared using a standard hospital mattress for each examined case (see Table 1).  

Geometry. A 3-dimensional (3D) anatomical model of the buttocks recently developed by the authors’ group for methodological, comparative sacral dressing studies^10,11 was used in this work. Briefly, 76 T1-weighted axial magnetic resonance imaging (MRI) slices of the weight-bearing buttocks of a 28-year-old healthy woman were imported to the ScanIP module of the Simpleware software package (Synopsis Inc, Mountain View, CA) for segmentation of the pelvic bones and soft tissues.¹³ Details regarding the MRI machine, scan protocol, and medical ethical approval are available elsewhere.¹⁰ The authors focused on a volume of interest (VOI) of 27.8 cm x 17.4 cm x 5.6 cm, incorporating the sacral bone and surrounding soft tissues. This allowed researchers to optimize computer power and make the numerical calculations effective where the tissue distortion phenomena relevant to sacral pressure ulcers occurred (see Figure 1a). 

As in the authors’ previously published work,^8-11 the anisotropic multilayer dressing included 3 physical material layers in the modeling: polyurethane foam (PUR), a nonwoven (NW) layer, and the airlaid (AL) layer. Consistent with previous studies,^8-11 the authors considered the innermost Safetac layer as a tied interface between the soft tissue component and the PUR foam layer, and the outermost “backing film” layer was represented as frictional sliding between the AL layer and the mattress (see Figure 1b).^8-11 However, the shape of the anisotropic multilayer dressing was not adopted from the authors’ previous work; rather, it was recreated using the ScanIP module of Simpleware to comply with the newest anisotropic multilayer dressing design launched in 2017. To complete the generation of the model geometry, a flat foam mattress was added under the buttocks in the ScanIP module of Simpleware.

Numerical methods. Meshing of the tissues, multilayer dressings, and mattress model components was performed using the ScanIP module of Simpleware.¹³ Four (4)-node linear tetrahedral elements were used in all model components. In order to obtain optimal accuracy but minimize complexity of the numerical solution and the associated computational power, mesh refinements were applied locally at the skin-dressing and mattress-dressing interfaces. 

The FE simulations were set up using the PreView module of FEBio (Ver.1.19; University of Utah, Salt Lake City, UT), analyzed using the Pardiso linear solver of FEBio (http://mrl.sci.utah.edu/software/febio) (Ver. 2.5.0), and post-processed using PostView of FEBio (Ver. 1.10.2).¹⁴ Converging time steps were chosen for numerical data collection so that the resulting reaction force was within a 2% difference from the target reaction force (description to follow). The time for solving each simulation case, using a 64-bit Windows 8-based workstation with 2×Intel Xeon E5-2620 2.00 GHz CPU and 64 GB of RAM, ranged between 7 and 12 hours. 

Mechanical properties of the dressing and tissues. Constitutive laws and mechanical properties of the tissue components and the mattress were adopted from the literature. Specifically, the sacrum was assumed to be a linear-elastic isotropic material with elastic modulus of 7 GPa and a Poisson’s ratio of 0.3.^15-17 The soft tissues were assumed to be nearly incompressible (Poisson’s ratio of 0.49) and nonlinear isotropic, with their large deformation behavior described by an uncoupled Neo-Hookean model with the following SED function W:

where Gins (the instantaneous shear modulus) is 2 kPa,¹⁷λi (I = 1,2,3) are the principal stretch ratios, K (the bulk modulus) is 1 MPa , and J = det(F) where F is the deformation gradient tensor. Specifically, material constants reported by Oomens et al¹⁸ were used to calculate an effective soft tissue Gins comprised of 60% skin and 40% fat, as in the authors’ previous modeling work of the buttocks.¹⁰ 

The anisotropic multilayer dressing has significantly different stiffness properties in the vertical versus the horizontal directions (anisotropy), while the hypothetical dressing has less distinct directional stiffness properties. The elastic moduli of the multilayer dressing at the X and Y directions (ie, the spinal and lateral directions, respectively) were measured in the authors’ laboratory and in the anisotropic dressing’s testing facilities with the authors maintaining oversight of the experimental protocol and data (see Table 2). The ratio between the elastic moduli at the Y direction over the X direction was found to be 6.6 for the anisotropic multilayer and approximately 1.8 for other commercially available dressings in the dry condition. The elastic moduli and the ratio of moduli at the Y direction over the X direction also were measured for the 3 levels of wetness in moist dressings: 0.025, 0.075, and 0.15 (mL/[cm²]) (see Table 2). For the hypothetical dressing in its wet conditions, a modulus ratio of unity was assigned based on measurements of commercial prophylactic dressings loaded with the above wetness levels and then mechanically tested in tensile loading at the X and Y directions. In other words, the hypothetical dressing was considered to become linear-elastic isotropic when wet (at any of the above 3 wetness levels), which is a potential material softening response known to exist in some wet porous materials (such as wet paper). A Poisson’s ratio of 0.258 was chosen for all dressings based on published experimental data.¹⁹ The mattress was considered isotropic linear-elastic, with an elastic modulus of 50 kPa and a Poisson’s ratio of 0.3, based on literature.^8,9,20 

Body loads applied to the buttocks and boundary conditions. Downward displacements of 5.5 mm to 6.48 mm were applied on the top surface of the model in order to simulate the descent of the weight-bearing sacrum during supine bedrest or a 45˚ Fowler’s position, with the anisotropic multilayer or hypothetical dressings in the dry and 3 wet dressing conditions. A total reaction force of 40 Newtons was obtained in all simulations that represented approximately 7% of the total bodyweight of the subject; this was transmitted focally at the sacral region. Therefore, the comparison between all simulation cases was conducted under the same (7% bodyweight) conditions for consistency of outcome measures across the different model variants. In the combined compression and shear loading scenario (representing sliding in bed due to gravity), a horizontal displacement of the same magnitude was added in the Y direction. The bottom surface of the mattress was fixed for all motions, and tied interfaces were defined at the bone-soft tissue boundaries as well as between the soft tissues and the dressing. Frictional sliding was defined between the dressing and mattress, with the coefficient of friction set to 0.35.^8,19 

Biomechanical outcome measures. Effective and maximal shear stresses within the VOI were compared across all simulation cases. Volumetric exposures of soft tissues below the sacrum (in the VOI) to elevated effective stresses also were compared and examined using stress exposure histogram (SEH) charts. As a final step after evaluating the volumetric exposure of soft tissues to stresses and plotting the SEHs, the protective endurance (PE) of the anisotropic multilayer dressing versus the hypothetical dressing (in percents) was calculated as follows: 1) the relative difference in the area under the SEH (A) for dry (d) and wet (w) cases of each dressing was calculated relative to the case in which no dressing was used: 

2) the protective endurance (PE) of a given dressing was defined as: 

Hence, the PE is an objective, standardized, and quantitative indicator of the preservation of biomechanical protection that a certain dressing provides to the soft tissues while being wet with respect to its (ideal) protective efficacy when it is dry. Because the present modeling is deterministic (and not probabilistic), each combination of dressing conditions (type of dressing, level of moisture, and loading mode as specified in Table 1) was simulated once. A detailed description of the chosen FE computer modeling and simulation approach is provided in the authors’ previous work.⁹ 

Data management. The FE simulation data were directly imported to and post-processed using PostView (US National Institutes of Health, Washington, DC), a post-processor software designed to visualize and analyze results from a FEBio analysis.¹⁴ The displacement applied on the top surface of the model was increased incrementally for numerical convergence purposes, so the resulting reaction forces between the buttocks and the support surface were within <1.8% difference of the aforementioned target reaction force. The effective and maximal shear stresses data that developed in the soft tissues within a cubical VOI in a size of 9 cm x 9 cm x 2.5 cm were pooled for each dressing type in the dry and 3 wet conditions, under pure compression due to bodyweight and separately under combined compression and shear loading. Further, the volumetric exposure of soft tissues below the sacrum in the aforementioned VOI was compared to elevated effective stresses and a SEH was plotted per each dressing type and dryness/wetness condition. A PE index then was calculated for each dressing type according to the algorithm described. Because all simulation data are deterministic, no variability exists in the modeling outcomes per each specific case of input dataset; hence, statistical analyses were not applicable in this study (please see a detailed explanation in the authors’ previous work⁹). 

Results 

Although 16 FE models were created, results from only the 14 that provided sufficient convergence (see the “Data management” section for convergence criterion) were analyzed. Specifically, the simulation case for a 0.15 (mL/cm²) moisture level in the hypothetical dressing was excluded due to extremely low dressing stiffness properties in this scenario that caused numerical convergence problems and resulted in incomparable simulation data for this specific case. The prominent difference noted in the average effective stress and average maximal shear stress between the anisotropic multilayer dressing and the hypothetical dressing was for the transition from dry to a (mildly) wet condition. Specifically, effective tissue stresses at the sacral region were between 0.3 kPa and 0.75 kPa for both dressing types in their dry condition. Within that range, tissue stresses increased up to 18% for the wet hypothetical dressing, but only 9.9% for the wet anisotropic multilayer dressing. Interestingly, the simulated rise in fluid contents from the lowest level of 0.025 (mL/cm²) to the greater moisture loads (0.075 and 0.15 [mL/cm²]) had a minor influence on tissue stress levels near the sacrum (ie, an approximately 2% increase in tissue stresses for the 2 dressing types for the 0.3 kPa to 0.75 kPa and 0.2 kPa and 0.5 kPa effective and shear stress domains in tissues, respectively). 

Effective stress distribution in the soft tissues near the sacrum when the model was subjected to combined compression and shear loads in dry dressing conditions and in a wet condition of 0.075 (mL/cm²) moisture level is shown in Figure 2 for the 2 dressing types. The colored bar attached to the figures that show effective stress and shear stress distributions in soft tissues indicates high versus low stress exposure in tissues. The highest stress values (in kPa units) are depicted in warm colors (red/yellow) and the lowest values are shown in cool colors (blue/green). The colors between these 2 are equally divided according to maximum and minimum stress values. Peak effective stresses increased within the 0.3 kPa to 0.75 kPa domain by 11.6% and 3.4% in the wet hypothetical and anisotropic multilayer dressings, respectively (see Figure 2). Consistent with these data, the rise in maximal tissue shear stresses for the same moisture contents was within the same domain for both dressing types, 0.2 kPa to 0.5 kPa; however, the peak shear stress was shifted more for the wet hypothetical dressing condition than for the anisotropic multilayer dressing, a difference of 10.2% and 3.4%, respectively (see Figure 3). 

Modeling calculations of cumulative volumetric exposures of the soft tissues under the sacrum to effective stress under combined compression and shear loading indicated the stress exposures within the entire 3D mass of soft tissues near the sacrum of the supine body were up to a peak of 1.2 kPa (see Figure 4a). However, the type of the dressing used affected the distribution of exposure to high versus low tissue stresses, predominantly for the wet conditions. Specifically, a comparison of the cumulative volumetric exposure of the soft tissues adjacent to the sacrum to effective stresses due to simultaneous compression and shear are shown in Figure 4a for both dressing types in dry and wet conditions (see Figure 4b). The wet hypothetical dressing caused a considerable rise in tissue stress levels, particularly within the 0.2 kPa to 1 kPa stress domain, whereas the anisotropic multilayer dressings did not (see Figure 4b). This is also evident and quantifiable by means of the PE values, following the algorithm of calculations specified in equations 2 through 4. These calculations show the PE of the anisotropic multilayer dressing is approximately 80%, compared to 22% for the hypothetical dressing. 

Discussion 

A modeling framework was used to investigate the relationship between moisture in prophylactic dressings and the biomechanical protection provided by such dressings, and specifically, to compare the mechanical stresses developing in the soft tissues near the sacrum due to bodyweight loads in dry versus wet conditions for 2 specific types of dressings. The hypothesis was that the sustainability of the anisotropic characteristic of the dressing in wet conditions is critical for the dressing to maintain its protective efficacy. The present modeling work supported this hypothesis.

This study builds upon the authors’ previously published work with regard to the biomechanical modes of action and function of prophylactic dressings in PI and DTI prevention.^10,11 The present study was conducted to further investigate biomechanical efficacy of dressings used prophylactically over the time of use after absorbing body fluids that accumulate in the dressing. 

Specifically, when comparing the tissue stress magnitudes developed at the different wetness levels, a difference in the transition from dry to a mildly wet dressing condition was observed, and stresses then approximately stabilized regardless of the additional increase in level of wetness. Importantly, this difference was considerably more pronounced for the hypothetical dressing, which underwent greater changes in mechanical properties with exposure to fluids. In contrast, the anisotropic multilayer dressing maintained its high modulus ratio, indicating strong anisotropy, which is a factor of its engineering design (see Table 2). 

The simulation data indicate that any absorption of fluids in the dressing, even to a small extent, could potentially influence the mechanical properties and behavior of the dressing and subsequently its biomechanical efficacy in prophylaxis. Accordingly, the capacity of the anisotropic multilayer dressing to preserve approximately 80% of its ideal function (determined in dry conditions) even when wet (see Figures 2 through 4 and the related PE data) is highly important in real-world clinical scenarios, where patients are sweating and/or may have incontinence issues.

An explanation for the above differences between the 2 types of dressings is that while the anisotropic multilayer dressing continues to function as an anisotropic dressing with a directional stiffness preference when wet, the hypothetical dressing functions as a nearly isotropic dressing; hence, it has limited ability to protect the soft tissues, as reported in prior research.¹¹ Specifically, the high modulus ratio (strong anisotropy) of the anisotropic multilayer dressing makes it much stiffer in the longitudinal direction of the dressing (the direction of the spine), which is also the direction of potential downward sliding of the body due to gravity (especially if the head of the bed is elevated). Because the anisotropic multilayer dressing is considerably stiffer along the line of the spine and given that it can maintain this property in wet conditions, the anisotropic multilayer dressing will act to preserve tissue shape and minimize tissue distortions in that longitudinal direction. By minimizing tissue distortions when wet, the anisotropic multilayer dressing effectively protects tissues of all patients, considering that normal perspiration always accumulates in the dressing, even if no other factors such as acute fever or incontinence caused (more substantial) fluid accumulation. The latter point is important, because a slightly wet dressing and a heavily wet (same) dressing behave similarly from a biomechanical perspective; thus, the dressing is able to provide a consistent, stable protective efficacy across the possible range of fluid accumulation, which makes a dressing reliably appropriate for PI prevention.  

This study introduced use of the PE index — an objective, quantitative, and standardized measure of the efficacy of prophylactic dressings subjected to altered conditions such as wetness accumulation. The PE is a straightforward method used for calculation once an adequate modeling framework is in place. Here, the PE was found to be distinctly greater for the anisotropic multilayer dressing when compared to the hypothetical dressing. This result remains consistent with the authors’ previous studies regarding the contribution of the anisotropy in the dressing structure to its biomechanical efficacy and highlights the importance of stable measures of efficacy in changing conditions such as exposure to perspiration or urine over the course of use.

In previously published work, the current authors compared the biomechanical PI prevention capacity of a hypothetical dry prophylactic dressing lacking directional stiffness preferences with that of the dry MBS anisotropic dressing.¹¹ By means of the FE method, it was demonstrated that the anisotropic dressing design reduced tissue loads, particularly when shear forces were present at the dressing-support surface interface. In such conditions, the hypothetical isotropic multilayer dressing yielded 52% and 39% reductions in exposure to the low and high SED domains in tissues, respectively; whereas, the anisotropic MBS dressing reduced tissue exposures by as much as 60% in both domains. These results revealed the benefits of the anisotropy design feature for prophylactic dressings; however, the durability of the biomechanical protective performances in wet dressing states has not been investigated before the present work.  

Limitations

Assumptions and limitations are inevitable in any computational modeling work. First, the MRI anatomy used is that of a healthy adult. Hence, the selected anatomy does not necessarily represent pediatric patients and all the possible anatomical variations and risk factors in adults, particularly with respect to bony, malnourished, or obese patients who are at a risk for developing PIs.^9,11 Likewise, pathophysiological changes in the mechanical stiffness of the tissues (eg, due to potentially existing scars or an evolving edema) were not considered. Moreover, the Poisson’s ratio of the dressing materials is an effective value for all layers (taken together), because it is technically problematic to measure Poisson’s ratios of very thin structures such as the individual layers of the dressing. Nevertheless, the authors believe these assumptions are reasonable, and they facilitated the systematic, standard and objective quantitative comparisons reported here. These data should be fundamental for computer-aided design of improved or new dressings and would help inform future methodological studies of efficacy of prophylactic dressings over time and use. 

Conclusion 

The purpose of this modeling study was to further investigate relationships between design features and biomechanical efficacy of sacral prophylactic dressings, particularly when exposed to moisture. The multilayer anisotropic prophylactic MBS dressing was found to exhibit superior PE, which was approximately 4 times that of the hypothetical dressing.  The present results are especially relevant to the common scenario of external shear loads applied to the sacral area that are caused by gravity pulling the body downward in bed, as well as the presence of moisture. A next step in research would be to optimize the extent of the anisotropy, particularly the property ratio of stiffnesses (elastic moduli). Although low anisotropy (toward an isotropic dressing) was shown to be less efficient in alleviating tissue loads in the model, an upper limit to the property ratio above which biomechanical effectiveness is not increased or even decreases should be considered. A second feature that interacts with the aforementioned stiffness property ratio is the ability of the dressing to evaporate or clear moisture, and hence maintain its anisotropy feature as well as its PE stability for hours and days, which requires laboratory studies of evaporation capacity of different dressing designs. 

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 May 23, 2018.

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

3. Vanderwee K, Clark M, Dealey C, Gunningberg L, Defloor T. Pressure ulcer prevalence in Europe: a pilot study. J Eval Clin Pract. 2007;13(2):227–235.

4. Gefen A. Why is the heel particularly vulnerable to pressure ulcers? Br J Nurs.  2017;26(suppl 20):S62–S74.

5. Santamaria N, Gerdtz M, Sage S, et al. A randomized controlled trial of the effectiveness of soft silicone foam multi-layer 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.

6. Kalowes P, Messina V, Li M. Five-layered soft silicone foam dressing to prevent pressure ulcers in the intensive care unit. Am J Crit Care. 2016;25(6):e108–e119.

7. 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.

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

9. 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.

10. Levy A, Gefen A. Assessment of the biomechanical effects of prophylactic sacral dressings on tissue loads: a computational modeling analysis. Ostomy Wound Manage. 2017;63(10):48–55.

11. Levy A, Schwartz D, Gefen A. The contribution of a directional preference of stiffness to the efficacy of prophylactic sacral dressings in protecting healthy and diabetic tissues from pressure injury: computational modelling studies. Int Wound J. 2017;14(6):1370–1377.

12. Kottner J, Lichterfeld A, Blume-Peytavi U. Transepidermal water loss in young and aged healthy humans: a systematic review and meta-analysis. Arch Dermatol Res. 2013;305(4):315–323.

13. Simpleware® Ltd. ScanIP, +FE, +NURBS and +CAD Reference Guide ver. 5.1, 2012. Available at: www.simpleware.com/software/. Accessed June 18, 2018. 

14. Maas SA, Ellis BJ, Ateshian GA, Weiss JA. FEBio: finite elements for biomechanics. J Biomech Eng. 2012;134(1):11005.

15. Linder-Ganz E, Shabshin N, Itzchak Y, Gefen A. Assessment of mechanical conditions in sub-dermal tissues during sitting: a combined experimental-MRI and finite element approach. J Biomech. 2007;40(7):1443–1454.

16. Palevski A, Glaich I, Portnoy S, Linder-Ganz E, Gefen A. Stress relaxation of porcine gluteus muscle subjected to sudden transverse deformation as related to pressure sore modeling. J Biomech Eng. 2006;128(5):782–787.

17. Gefen A, Haberman E. Viscoelastic properties of ovine adipose tissue covering the gluteus muscles. J Biomech Eng. 2007;129(6):924–930.

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

19. 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.

20. 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.

Abstract

Three-dimensional (3D) printing technology can generate objects in almost any shape and geometry. This technique also has clinical applications, such as the fabrication of specific devices based on a patient’s anatomy. A demonstration study is presented of a 54-year-old man who needed a thermoplastic splint to limit arm movement while a dehisced left shoulder wound healed.

The patient’s upper extremity was scanned using the appropriate noncontact scanner and 3D technology software, and the polylactic acid splint was printed over the course of 66 hours. This patient-specific splint was worn during the day, and after 2 weeks the wound was healed sufficiently to permit hospital discharge. Creation of an individualized splint is one of many potential medical uses of 3D technology. Although the lengthy printing time imposes limitations, the implications for practice are positive.

The digitization of manufacturing using cutting-edge software, materials, robots, new processes (notably 3-dimensional [3D] printing), and web-based services has revolutionized production methods.¹ Traditional production methods involve machining parts from blocks of material and then screwing or welding them together. Products now can be designed on a computer and printed on a 3D printer, which basically creates the object by building upon successive layers of material. Such printers can produce numerous objects that are too complex for a traditional factory to handle. The development of 3D printing has evolved in 4 successive stages: rapid prototyping in the early 1990s, rapid tooling in the late 1990s, direct manufacturing in the late 2000s, and home fabrication, with end-users manufacturing objects using 3D printing equipment at home, in the early 2010s.² 

The application of 3D printing in medical fields requires regulatory compliance; for example, a medical device should be approved by United States Food and Drug Administration (FDA) before marketing. The first 3D-printed item — a titanium skull implant — was created in 2006.³ This type of device has since been employed successfully in other scenarios where 3D printing has opened a world of potential medical applications.⁴ Similar to the first prototyping phase developed in industry, medical doctors use routine medical images, such as computerized tomography (CT) or magnetic resonance imaging (MRI), to construct 3D models. The 3D model then can be either manipulated in a computer or printed for treatment planning or surgical simulation.^5-7 

When they were first made, 3D-printed organs were created to train junior physicians. The 3D-image and printout could accurately represent the anatomy of the specific patient and the senior physician could explain the surgical planning to the patient and residents or interns. This use has evolved. Similar to the 3D printing rapid tooling developed in industry, surgeons have demonstrated that 3D printing is feasible and promising to use as a surgical guide for complex surgical procedures, such as surgical treatment of complex acetabular fractures⁸ and (as shown in a case study) improvement of joint function after reconstruction of a malignant bone tumor around the knee joint.⁹ In liver tumor surgery, for example, the 3D-image and printout can adequately show the hepatic and portal veins, enabling the surgeon to plan the surgical route to avoid bleeding. Using 3D technology in both treatment planning and surgical simulation has shown promising results.^8,9 

Patient-specific implants involve the direct manufacture and fabrication of end-use products with 3D printers that have been used to create shoulder, hip, and craniomaxillofacial implants.^10-12 Facilities may use bioprinters that utilize 3D printing techniques to combine cells, growth factors, and biomaterials to fabricate biomedical parts with natural tissue characteristics; this process is still in the very early stages.^13,14 Home fabrication (ie, end users manufacturing objects themselves using 3D equipment) is still under development in the industry.² 

In 2015, a Forbes report¹⁵ predicted “3D-printed hip and knee replacements, as well as other common internal and external medical devices, will be in mainstream use within 2 to 5 years.” Within the year, the US FDA approved 3D-printed oral medication (tablets)¹⁶ used to treat epilepsy, 3D-printed medical implants, 3D-printable material used as a denture base,¹⁷ and the first patient-specific cervical rod¹⁸ using 3D printing technology. 

To keep pace with the technological revolution and offer patients the newest options, the authors have been working on 3D printing at the Taipei Veterans General Hospital (Taipei, Taiwan) since October 2015. Taiwan FDA released 3D printing guidance in January 2018; thus far, 3D printing technologies are utilized mainly for modeling and surgical guides as previously described, because such use presents a low risk for patients. 

Because the authors could find no literature on the risks and benefits of creating 3D devices for medical application, the purpose of this case study was to describe the use of 3D printing technologies to generate a patient-specific splint device for wound care. 

Case Report

History. Mr. C was 54 years old when he was diagnosed with hepatocellular carcinoma for which he underwent a hepatectomy in 2011. Two (2) months later, he experienced persistent muscle soreness and tingling pain over his center trunk. A whole-body bone scan revealed bone metastasis over his left proximal humerus. Preoperative x-rays revealed an osteolytic lesion over his left proximal humerus with pending pathological fracture (see Figure 1). He subsequently underwent left hemishoulder arthroplasty in December 2011. The tumor was widely resected, as shown in the intraoperative photograph (see Figure 2). After tumor excision, the bone defect was reconstructed by long-stem hemiarthroplasty, and a titanium alloy artificial joint was implanted (see Figure 3). After reconstruction, Mr. C returned to normal daily life.

In December 2015, Mr. C noticed persistent, painful swelling of his left shoulder; infection was diagnosed based on routine clinical signs but without culture or biopsy. Orthopedic surgeons at the authors’ facility debrided and then closed the wound over his left shoulder with mesh and tape in April 2016. Wound discharge was noted 3 months later, and progressive shoulder pain and redness recurred in August 2016; septic arthritis was diagnosed. Due to deep infection, the artificial joint prosthesis was resected and high-dose vancomycin-impregnated polymethylmethacrylate was inserted to control the infection (see Figure 4). 

Plastic surgeons reconstructed the defect using a latissimus dorsi muscle flap and split-thickness skin graft on November 23, 2016; 5 months later, Mr. C visited the outpatient department with new wound dehiscence and was readmitted to the hospital for debridement and local flap repair in April 2017. During his hospital stay, Mr. C was asked to decrease movement of his left hand to facilitate wound healing. His physicians noticed that he constantly used his right hand to hold his left hand. They decided to use 3D technology to generate a patient-specific splint (PSS) to help immobilize the arm. Use of a readily available type of splint was avoided because Mr. C had just undergone debridement and local flap repair, and using a ready-made splint would involve the painful bending of his arm and potential added tension on the wound.

Modeling. The dimensions of the patient’s whole arm were captured using a handheld 3D scanner (Eva; Artec 3D, Luxembourg) that uses safe, structured, light-scanning technology to capture an object’s dimensions and shape. The scanner is equipped with post-processing software that can erase unneeded portions of an object. In this case, Mr. C’s upper extremity was scanned; the result is shown in Figure 5. Based on the 3D upper extremity model scanned, computer-aided design (CAD) software (Meshmixer; Autodesk, San Rafael, CA) was utilized to build the splint model. Clinicians marked the area on the computer model that required the splint and extracted the relevant dimensions, extending the surface area to 3-mm thickness to obtain the 3D splint model (see Figure 6). 

The 3D model was saved in an stereolithography (.stl) file format. Using this file, this printer technology creates an object by building up material layer by layer; logically, the bigger the object, the longer the printing time. Numerous professional 3D printing companies provide outsourcing worldwide.

3D printing. The authors’ 3D printing equipment center includes D-Force 500 (D-Force. Taiwan, Kaohsiung, Taiwan), Form 2 (Formlabs, Inc, Somerville, MA), UpBox (Tiertime, Beijing, China), and other home assembly components (users assemble the device). The D-Force 500 was selected for use because it has the capacity to print longer objects, and the arm splint needed to be approximately 400 mm long. Printing took approximately 66 hours and polylactic acid, a biodegradable thermoplastic derived from renewable resources such as corn starch or sugar cane, was used to create the splint. As shown in Figure 7, Velcro straps were attached to affix the splint on the patient. 

If any events interrupt the process, the printing must be repeated; for example, if the filament tangles, the printing process may fail. This occurred in the process of creating the splint, but ultimately printing was successful. 

Splint application. Once the splint was applied, the hospital course of care went smoothly. Mr. C wore the PSS during the day and rested his arm on a soft pillow at night. Because the PSS helped Mr. C hold and protect his left hand, the splint appeared to help expedite the wound healing process. The wound showed signs of healing, presumably because tension on the wound was reduced; no pain or swelling was noted and signs of infection no longer were present. Mr. C was discharged in stable condition <2 weeks after his admission for debridement and flap repair. The wound continued to appear to be healing at the postdischarge follow-up 1 week after discharge. Because Mr. C had terminal liver cancer, he decided not to have any artificial joint implant on his left shoulder, choosing instead to occasionally wear the splint for support. After returning to normal daily life, he wrote an appreciation letter to the Hospital Superintendent, noting that the PSS promoted his wound healing. 

Discussion

The digitization of the manufacturing process via 3D printing has dramatically changed production methods of items previously available only through standard production means.¹ According to a review article²⁰ and the authors’ experience using 3D applications in medical fields, the greatest advantage of 3D printing technology in medical applications is the ability to produce patient-specific devices. For example, news in medical field and reviews^12,15,21 note the application of 3D printing to customize prosthetics and implants represents significant value for both patients and physicians. 

To the best of the authors’ knowledge, no studies have reported the creation of a splint using 3D technology.^22,23 Although 3D technology can create a splint without the need to touch the wound (as would occur using traditional thermoplastic materials), the 66-hour production time represented a serious limitation of 3D printing a splint. However, the benefits of not coming in direct contact with the wound outweighed the disadvantages of the print time. Furthermore, given that the left artificial joint was removed, the patient required fixation that might not have been possible using a traditional immobilization device. The 3D-printed PSS also demonstrated the advantage of customization; in addition, material costs were almost the same as that of traditional thermoplastic material. 

Conclusion

To limit arm movement while a dehisced wound healed, 3D-printing technology was successfully used to create a PSS device. The main limitation of the using the 3D printing technology for this patient was the amount of time required (66 hours) to print the splint. With the utility and availability of 3D printing hardware progressing, the use of more precise and rapid 3D printers in the near future is expected.² n

References

1. The third industrial revolution. The Economist. 2012. Available at: www.economist.com/node/21553017. Accessed June 19, 2018.

2. Rayna T, Striukova L. From rapid prototyping to home fabrication: how 3D printing is changing business model innovation. Technological Forecasting Soc Change. 2016;102(1):214–224.

3. Silloc. About Xilloc: Brief history. Available at: www.xilloc.com/company/about-us/. Accessed June 4, 2018.

4. Jones N. Science in three dimensions: the print revolution. Nature. 2012;487(7405):22–23.

5. Cheung CL, Looi T, Lendvay TS, Drake JM, Farhat WA. Use of 3-dimensional printing technology and silicone modeling in surgical simulation: development and face validation in pediatric laparoscopic pyeloplasty. J Surg Educ. 2014;71(5):762–767.

6. Kurenov SN, Ionita C, Sammons D, Demmy TL. Three-dimensional printing to facilitate anatomic study, device development, simulation, and planning in thoracic surgery. J Thorac Cardiovasc Surg. 2015;149(4):973–979.

7. Rose AS, Kimbell JS, Webster CE, Harrysson OL, Formeister EJ, Buchman CA. Multi-material 3D models for temporal bone surgical simulation. Ann Otol Rhinol Laryngol. 2015;124(7):528–536.

8. Merema BJ, Kraeima J, Ten Duis K, et al. The design, production and clinical application of 3D patient-specific implants with drilling guides for acetabular surgery. Injury. 2017;48(11):2540–2547.

9. Wang FP, Zhu J, Peng XJ, Su J. The application of 3D printed surgical guides in resection and reconstruction of malignant bone tumor. Oncol Lett. 2017;14(4):4581–4584.

10. Lu MX, Min L, Xiao C, et al. Uncemented three-dimensional-printed prosthetic replacement for giant cell tumor of distal radius: a new design of prosthesis and surgical techniques. Cancer Manag Res. 2018;10:265-277.

11. Wang SS, Wang L, Liu Y, et al. 3D printing technology used in severe hip deformity. Exp Ther Med. 2017;14(3):2595–2599.

12. Hatamleh MM, Bhamrah G, Ryba F, Mack G, Huppa C. Simultaneous computer-aided design/computer-aided manufacture bimaxillary orthognathic surgery and mandibular reconstruction using selective-laser sintered titanium implant. J Craniofac Surg. 2016;27(7):1810-–1814.

13. Daly AC, Cunniffe GM, Sathy BN, Jeon O, Alsberg E, Kelly DJ. 3D bioprinting of developmentally inspired templates for whole bone organ engineering. Adv Healthc Mater. 2016;5(18):2353–2362.

14. Lee JM, Yeong WY. Design and printing strategies in 3D bioprinting of cell-hydrogels: a review. Adv Healthc Mater. 2016;5(22):2856–2865.

15. Columbus L. Gartner’s Hype Cycle For 3-D Printing, 2015: Medical Products Driving Market Growth. Forbes. 2015. Available at: www.forbes.com/sites/louiscolumbus/2015/08/28/gartners-hype-cycle-for-3-.... Accessed June 4, 2018.

16. Chai X, Chai H, Wang X, et al. Fused deposition modeling (FDM) 3D printed tablets for intragastric floating delivery of domperidone. Sci Rep. 2017;7(1):2829.

17. Krassenstein E. DENTCA Receives FDA Approval for World’s First Material for 3D Printed Denture Bases. 2015. Available at: https://3dprint.com/87913/dentca-fda-3d-print/. Accessed June 4, 2018.

18. Butler O’Neal B. 3D Technology Allows MEDICREA to Create New FDA-Approved Spinal Implants Giving Patients Dramatic Relief. 2016. Available at: https://3dprint.com/132030/medicrea-spinal-implants/. Accessed June 4, 2018.

19. Autodesk. Free software for making awesome stuff. 2017. Available at: www.meshmixer.com/. Accessed June 4, 2018.

20. Banks J. Adding value in additive manufacturing: researchers in the United Kingdom and Europe look to 3D printing for customization. IEEE Pulse. 2013;4(6):22–26.

21. Mertz L. Dream it, design it, print it in 3-D: what can 3-D printing do for you? IEEE Pulse. 2013;4(6):15–21.

22. Mikolajewska E, Macko M, Ziarnecki L, Stańczak S, Kawalec P, Mikołajewski D. 3D printing technologies in rehabilitation engineering. J Health Sci. 2014;4(12):78–83.

23. Lin HH, Lonic D, Lo LJ. 3D printing in orthognathic surgery — a literature review. J Formos Med Assoc. 2018;117(1):547-558.

Potential Conflicts of Interest: This work was supported in part by a Taipei Veterans General Hospital Research Grant (V106 E-003-1, V107 D39-001-MY2-1, and V107C-198), Taiwan.

Dr. Wu is the Division Chief, Therapeutical and Research Center, Musculoskeletal Tumor, Department of Orthopedic Surgery and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan; and an Assistant Professor, Institute of Clinical Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan. Dr. Shih is a visiting staff member, Division of Plastic and Reconstructive Surgery, Taipei Veterans General Hospital; and a lecturer, Department of Surgery, School of Medicine, National Yang-Ming University. Dr. CM Chen is a visiting staff member, Department of Orthopedic Surgery and Traumatology, Taipei Veterans General Hospital; and a lecturer, Institute of Clinical Medicine, National Yang-Ming University. Dr. G Chen is a resident, Division of Plastic and Reconstructive Surgery, Taipei Veterans General Hospital; and a lecturer, Department of Surgery, National Yang-Ming University. Dr. WM Chen is Vice Superintendent, Taipei Veterans General Hospital; and the Associate Dean, Institute of Clinical Medicine, School of Medicine, National Yang-Ming University. Ms. Huang is a physiotherapist, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Mr. Hung is a physiotherapist, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Mr. Wang is a research assistant, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Mr. Yu is a research assistant, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Dr. CK Chang is a visiting staff member, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Dr. BC Chang is a visiting staff member, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital; and an Assistant Professor, Department of Biomedical Engineering, Chung Yuan Christian University, Taoyuan City, Taiwan. Dr. Lin is the Divisional Chief of Rehabilitative Treatment for Physical Dysfunction, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Dr. Wang is a Researcher, Rehabilitation and Technical Aids Center and Division of Experimental Surgery; and a Professor, Institute of Hospital and Health Care Administration, National Yang-Ming University. Please address correspondence to: Shyh-Jen Wang, PhD; email: wangsj@vghtpe.gov.tw; or Pei-Hsin Lin, MD, PhD; email: phlin2@vghtpe.gov.tw.

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.⁵ A 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.

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.⁷ HRQOL 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).¹² The 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

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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.

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 

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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.

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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.

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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.

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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.

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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. 

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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

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,^2,6 the 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,⁸ 2 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 al⁶⁷ reported 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.^23,58,62 This 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).

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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.

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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.

Abstract

Physiological, psychological, and social problems may affect adaptation to living with a stoma. A descriptive, cross-sectional study was conducted between March 2017 and June 2017 among patients culled from a manufacturer’s database to identify factors that influence psychosocial adjustment in Chinese patients with an enterostoma.

Patients with a history of ostomy surgery ≥1 month prior and who were ≥18 years of age, completed a primary school education, and able to communicate in Chinese were eligible to participate unless they had a history of psychosis, cognitive impairment, or participation in other research programs. After providing informed consent, participants completed a questionnaire that addressed demographic (age, gender, employment, educational level, marital status, medical payment method, living status, and area of residence) and stoma-related (date of surgery, preoperative stoma siting, ostomy appliance type, peristomal complications, regular defecation, stoma self-care ability, stoma-related communication with medical staff, level of understanding regarding stoma knowledge and care skills, appliance change knowledge/experience, and leakage history) factors. Social support was assessed using the 10-item Social Support Revalued Scale (SSRS), and 3 dimensions of adjustment (acceptance, continuous worry, and positive life attitude) were assessed using the 20-item Chinese version of the Ostomy Adjustment Inventory (OAI). Questionnaires were administered via an online survey platform. Data were analyzed descriptively, and single-factor analysis and stepwise multiple linear regression were applied to identify the factors that influenced the adjustment level. Incomplete (missing >2 questions), incorrect, or hastily completed (within 600 seconds) records were excluded from analysis. Of the 1109 persons who returned the questionnaire, 1010 (91.1%) completed the entire survey (564 men [55.8%] and 446 women [44.2%], mean age 56.62 ± 15.62 years); 823 (81.5%) had a colostomy and 187 (18.5%) had an ileostomy. The OAI dimension continuous worry was negatively and significantly associated with all 3 dimensions of the SSRS, including subjective support (r = 0.259), objective support (r = 0.259), and utilization of support (r = 0.289), while the dimension acceptance was positively associated with both subjective support (r = 0.082) and objective support (r = 0.074) (all P values <.05). Using multiple linear regression, residence area, peristomal complication, regular defecation, leaking, self-care ability, communication with medical staff regarding ostomy, understanding knowledge or skill needed for stoma care, utilization of social support, and total score of social support were found to be significantly associated with ostomy adjustment level (all P values <.05). Patients living in an urban area, with no history of peristomal complications, who had regular defecation, had not experienced leaking, had better self-care ability, frequently communicated with medical staff, had a high level understanding about knowledge or skill of stoma, and had higher social support scores had higher adjustment scores. Knowledge of the factors that enhance or hinder adaptation of the patient to the ostomy is an important tool in the clinician’s care armamentarium.  

Colorectal cancer is a common malignant disease, ranking third in incidence in the world behind lung cancer and breast cancer. Since 1992, 1 million new colorectal cancer patients have been diagnosed every year worldwide, with an annual increase of 1.2% in morbidity.¹ In China, the morbidity and mortality of colorectal cancer have increased in recent years, ranking it the fifth leading cause of death.² In addition to the detrimental effect of cancer itself, most colorectal cancer survivors must deal with an ostomy as a part of their treatment.³Ostomy refers to a surgical procedure that results in an artificial opening in the abdominal wall (stoma) through which bodily waste is excreted.⁴ In the United States, approximately 100 000 patients receive a colostomy or ileostomy every year,⁵ while in the United Kingdom, approximately 135 000 patients receive a neostoma every year, including more than 100 000 colostomy patients.⁶ In 2005, China had more than 1 million colostomy patients, with an annual rise of 100 000.⁷

Although a colostomy is regarded as life-saving surgery, it causes many changes to the body image and lifestyle of the patient; a phenomenological study found it to detrimentally affect self-image⁸ and impose long-term impacts on physical and psychological status.⁹ A systematic review¹⁰ and a literature review¹¹ reported low quality of life (QoL) among patients with an ostomy.^10,11 Furthermore, qualitative analysis^12,13 has found that a low QoL score is mainly attributable to psychosocial issues. Therefore, it is of great importance to explore the factors that affect psychosocial adjustment in ostomates.

Globally, China has the highest rate of new cases of colorectal cancer every year (25.3 million), making up 18.6% of new colorectal cancer cases across the world in 2012.¹¹ However, few studies have reported on psychosocial adjustments and potentially related factors in Chinese patients with ostomy.^14-16 Hu et al¹⁵ conducted a retrospective, cross-sectional study among 129 colostomy patients in 5 hospitals in Guangzhou (Guanadong Province, China) using the Ostomy Adjustment Scale developed by Olbrisch and Ziegler.¹⁷ The authors observed that 33.3% of patients displayed a low and 63.6% of patients showed a medium adjustment level. Patient self-care ability, spouse’s acceptance of the stoma, and peristomal complications were associated with adjustment level.¹⁵ In their cross-sectional study, Cheng et al¹⁶ investigated 54 Chinese patients with a permanent colostomy and found that self-care ability was correlated with adjustment level, which was in line with the results of another cross-sectional survey by Su et al¹⁴ that evaluated 122 patients with a temporary colostomy. According to 2 descriptive cross-sectional studies,^18,19 gender, family and social support, stoma self-care efficacy, interpersonal relationships, and the location of the stoma also may impact the adjustment level of ostomates. 

A cross-sectional study²⁰ found psychosocial adjustment plays an important role in self-management and is a critical factor in predicting the QoL of ostomates after surgery. Therefore, the aim of the current study was to identify factors that influence psychosocial adjustment in Chinese patients with an enterostoma.

Materials and Methods

Study design and population. From March 2017 to June 2017, enterostomy patients from the Coloplast Corp (Humlebaek, Denmark) Chinese database were invited to participate in the study. The company sent a study invitation letter and a link to complete an online questionnaire and patient consent form via the Wenjuanxing platform (www.wjx.cn), 1 of the largest online survey platforms in China. The 66 000 patients in the company’s database were from 22 provinces, 4 autonomous regions of ethnic minorities, and 4 directly controlled municipalities of China. The inclusion criteria for this study stipulated participants must be ≥18 years of age, have had surgery ≥1 month prior, have at least a primary school education, and be able to communicate in Chinese. Patients were excluded if they had a urostomy, a history of psychosis, cognitive impairment, and/or participation in other research programs. Patients who failed to answer at least 2 questions, provided wrong answers (eg, provided 2 responses to 1 question), or (because completion of the survey was expected 10 take 10 to 15 minutes) completed the questionnaire within 600 seconds were excluded. 

The questionnaire was designed by the present researchers and had been preliminarily tested and improved in a study (unpublished) conducted in February 2017. In the preliminary study, 77 patients with colostomies were recruited from 3 hospitals in Beijing; 74 questionnaires were completed. The questionnaire was revised according to patient suggestions. To calculate the sample size for the current study, the standard deviation of the mean adjustment score was set to 10.25 ± 2.0, with a 2-sided α of 0.05 and β of 0.1. The sample size was estimated at 554.

The demographic characteristic variables collected included age, gender, employment (yes, no), educational level (≤9 years, >9 years), marital status (married, unmarried), medical payment method (self-paying, not self-paying), living status (live alone, not live alone), and residence area (urban, rural). Stoma-related data also were collected and included date of surgery, stoma siting before surgery (yes, no), type of ostomy appliance (1- or 2-piece), history of peristomal complications (yes, no), regular defecation (ie, whether the ostomate had a relatively fixed time of defecation and defecated 1 to 3 times every day after surgery; yes, no), stoma self-care ability (completely self-care, mostly self-care, relied mostly on others, relied completely on others), communication with medical staff regarding colostomy (never, sometimes [1 to 4 times per week], frequently [≥4 times per week]), level of understanding regarding stoma knowledge and care skills (complete, partly, do not understand [ie, ostomy patients do not understand knowledge and care skills for stoma at all]), when the patient learned how to change the ostomy appliance (before discharge, 1 week after discharge, other time), and stoma leakage during past 3 months (yes, no) (see Table 1). All data in the survey platform were kept anonymous; only core researchers in the current project had access to the data. 

Measurement tools. 

Social Support Revalued Scale (SSRS). Social support was assessed using the SSRS, which was formulated by Xiao and Yang²¹ in 1986. The 10-item SSRS evaluated 3 dimensions of social support: subjective support, objective support, and support utilization. Subjective support referred to how respected, supported, and understood the individual felt in his/her social context. Objective support referred to concrete support from society, such as financial support and support from a social network or organization. Support utilization was defined as how the individual used social support. The scoring system for the 10 items on the SSRS was as follows: items 1, 3, 4, and 5 represented subjective support; item 2 represented objective support; and items 8 through 10 represented social support. For items 1–4 and 8–10, there were 4 choices yielding scores of 1, 2, 3 and 4 (higher scores indicated more social support). For item 5 (which represented subjective support), there were 4 choices: A, no; B, very little; C, generally; D, all. These choices provided scores of 1, 2, 3, and 4, respectively. For items 6 (financial support) and 7 (psychological support), no source yielded a score of 0; if several sources of support were selected from a list of possible sources, a score commensurate with the number of sources selected was earned. The total SSRS score ranged from 11 to 60 points and was classified into 3 categories: low social support (<35 points), medium social support (35 to 47 points), and high social support (>47 points). The Cronbach α of the total scale was 0.896 and Cronbach α of the 3 dimensions were 0.849, 0.825, and 0.833, respectively.²²

Ostomy Adjustment Inventory (OAI). The psychosocial adjustment level to the stoma was measured using the Chinese version of the OAI, which was translated and modified from the English version of the Ostomy Adjustment Inventory-23 (OAI-23) in 2011.²³ The English version of the OAI-23 includes 4 dimensions and 23 items, including acceptance (9 items), continuous worry (5 items), social intercourse (4 items), and indignation (2 items).²⁴ In contrast, the Chinese version of the OAI comprises 3 dimensions (acceptance, continuous worry, and positive life attitude) and 20 items. Responses were provided using a 5-category Likert scale ranging from 0 to 4 points, where 0 = strongly agree and 4 = strongly disagree regarding the dimension continuous worry and where 0 = strongly diasgree and 4 = strongly agree regarding the dimensions acceptance and positive life attitude. The total OAI scores ranged from 0 to 80 points and were classified into 3 categories: low adjustment level (<40 points), medium adjustment level (40 to 60 points), and high adjustment level (>60 points). A Cronbach α of 0.886 was found for the total OAI score, and continuous worry, positive life attitude, and acceptance were 0.704, 0.885, and 0.779, respectively.²³ The Cronbach’s α for 2-week test-retest reliability were 0.836, 0.807, and 0.764 for continuous worry, positive life attitude, and acceptance, respectively.²³ The Cronbach α of this scale was 0.913 and the Cronbach α of the 3 dimensions were 0.891, 0.872, and 0.864, respectively, according to the results of the preliminary (unpublished) study indicating that the translated Chinese version is highly reliable.

Ethical considerations. The current study was approved by the Ethics Committee of Xuanwu Hospital Capital Medical University (Beijing, China). The objective and method of research were explained to the patients before the questionnaire was made available online, and written consent of the patient or a family member was obtained. 

Data collection. The questionnaire data were collected directly into the online survey platform. Only core researchers in the current project had access to data.

Data analysis. The general demographic data and stoma-related data were statistically described using mean and standard deviation. Qualitative variables were described using frequency and percentage. Single-factor analysis was conducted to analyze the adjustment level of the classified variables. A t test and 1-way analysis of variance were applied to analyze data with normal distribution and homoscedasticity. Kruskal-Wallis H and Mann-Whitney U tests were applied for data without a normal distribution and heterogeneity of variance. Pearson correlation analysis was performed to measure correlations between ostomy adjustment level and social support. An independent t test was used to compare the mean score of the overall psychological adjustment. Stepwise multiple linear regression was applied for regression analysis to identify the factors that significantly influenced the ostomy adjustment level. The inclusion criteria was 0.05, and the removal criteria was 0.10. Two-sided P<.05 was regarded as having statistical significance. SPSS, version 22 (IBM, Armonk, NY) was used for all data analysis.

Results

Baseline characteristics. Of the 1109 invited persons who returned their questionnaire and signed a patient consent form through the online survey platform, 99 were excluded (80 patients had a urostomy, 10 finalized the questionnaire within 600 seconds, 7 had incorrect answers, and 2 were <18 years of age). The remaining 1010 patients included 564 men (55.8%) and 446 women (44.2%), with a mean age of 56.62 ± 15.12 years. The majority of patients (686, 67.9%) were younger than 65 years, employed (532, 52.7%), married (875, 86.6%), did not self-pay for medical treatment (849, 84.1%), did not live alone (962, 95.2%), and lived in an urban area (709, 70.2%). Of these patients, 651 (64.5%) had their stoma sited before surgery, 823 patients (81.5%) received a colostomy (678 [67.1%] permanent, 332 [32.9%] temporary) and 187 (18.5%) had an ileostomy. After enterostomy surgery, 195 (19.3%) patients experienced peristomal complications; the 3 most common complications were irritant dermatitis, allergic dermatitis, and parastomal hernia, accounting for 48.7%, 19.5%, 15.6%, respectively. Eight hundred, one (801, 79.3%) did not defecate regularly, and 732 (72.5%) experienced leakage during the past 3 months. Regarding self-care ability, 251 patients (24.9%) performed their own care, 345 patients (34.2%) performed most of their ostomy care, 264 patients (26.1%) mostly relied on others, and 150 patients (14.8%) completely relied on others. More than half of the patients (558, 55.2%) communicated with medical staff regarding their enterostomy and 682 (67.5%) learned how to change the appliance before discharge (see Table 1). 

Ostomy adjustment and social support levels. The mean OAI score was 33.25 ± 8.44, representing a low adjustment level in general (see Table 2). The mean scores OAI scores were 14.80 ± 7.53, 8.52 ± 1.91 and 9.92 ± 2.30 for continuous worry, positive life attitude, and acceptance, respectively. The average social support score was 40.16 ± 8.22, which represents medium levels of social support (see Table 3). The dimension continuous worry was significantly associated with all 3 dimensions of social support including subjective support (r = 0.259), objective support (r = 0.259), and utilization of support (r = 0.289) (see Table 4), while the dimension acceptance was associated with both subjective support (r = 0.082) and objective support (r = 0.074) (all P values <.05). The total OAI score was significantly associated with all dimensions of social support.

Ostomy adjustment score in relation to risk factors. By comparing the distributions of the ostomy adjustment score to the categories of different risk factors, the authors observed that patients with a higher education level, who were not self-paying, who lived in urban areas, who did not have peristomal complications, who defecated regularly, and who had not experienced leaking during past 3 months had higher OAI scores (see Table 5). However, in multiple linear regression, only area of residence, peristomal complications, regular defecation, leaking, self-care ability, communication with medical staff regarding ostomy, stoma knowledge or care skills, utilization of social support, and total score of social support were found to have statistical significance (all P values <.05) (see Table 6).

Discussion

The current study identified several factors that may influence the psychological adjustments to having a stoma among Chinese patients. Area of residence, having a history of peristomal complications, regular defecation, leaking of the appliance, self-care ability, communication with medical staff regarding the stoma, self-rated confidence in stoma knowledge or care skills, and social support were associated with ostomy adjustment level.

The mean adjustment score was 33.25 ± 8.44, which was slightly lower than the results observed in a prospective, multicenter study by Karadag et al²⁵ in Turkey (N = 135, mean OAI-23 score of 48.63 ± 13.75). This difference may be due to the fact that the Chinese version of the OAI only contained 20 items compared to 23 items in the English version used in the Karadag study.²⁵ However, the mean score in the current study was comparable to another descriptive Chinese study¹⁶ using the same Chinese version of the OAI-20 (mean score 45.112 ± 13.358). 

 The incidence of colorectal cancer has been increasing rapidly in recent years in China and has resulted in an annual increase of 100 000 new ostomy patients.⁷ Thus, attention regarding how to improve adjustment to an ostomy is increasing. The current study revealed ostomy patients who had better self-care ability, frequently communicated with medical staff, had a higher level of understanding/knowledge/skill of stoma care, and lived in urban area had significantly better adjustment scores. Also, the results showed that higher social support scores were significantly correlated with higher adjustment level, which indicated that more support from family, friends, and society led to a higher adjustment level. This finding was in line with a prospective multicentered study by Piwonka and Merino²⁶ (N = 60), the empirical study by Karadag et al²⁵ (N = 135), and a cross-sectional study by Wang and Chen²⁷ (N = 301). The clinical medical staff should encourage the patient to take an active part in social activities and work hard to psychologically accept the stoma, as well as increase the patient’s confidence and ability to manage the stoma.²⁸ 

Some patients have been found to be more adaptive after surgery because they had obtained self-care skills.²⁹ However, in the current study only 24.9% of patients frequently communicated with the medical staff. Experience has taught practitioners that through communication with medical staff, the patient may obtain information on disease development, be involved in treatment decisions, and acquire guidance regarding self-care, making it easier to adapt to the stoma. Medical staff needs to communicate with the patient as necessary and provide more channels to communicate health information based on patient preferences. 

This study also revealed 19.3% of patients experienced peristomal complications. This is somewhat lower than the results of 2 other Chinese studies that reported rates of 35.66% and 31.5%.^12,15 Patients with peristomal complications had lower levels of social psychological adjustment, which was supported by the results of a prospective study³⁰ and a literature review.³¹ The most common complications in the current study were irritant dermatitis (48.7%), allergic dermatitis (19.5%), and parastomal hernia (15.6%). In addition, complications such as stomatorrhagia and stoma prolapse often led to pain that affects the normal use of ostomy bag, thereby lowering the adjustment level and patient QoL.³² 

The occurrence of leaking 3 months after surgery and regular defecation are factors that influenced adaptation level. This study found 72.3% of patients experienced leakage. Patients who experienced leaking had a lower adjustment level than those who did not, which underscores the need to enhance patient education during hospitalization, improve stoma-related knowledge and care skills, arrange for follow-ups after discharge, and encourage timely assistance and guidance from professionals. Furthermore, 79.3% of patients had irregular defecation. Enterostomy patients may have an increase in defecation frequency and irregular times of defecation because colon movement is not easy to control.³³ Therefore, clinicians need to 1) focus on establishing regular defecation for the patient as soon as possible after surgery, 2) direct the patient to receive regular defecation training, 3) help the patient re-establish regular defecation, and 4) encourage patients to take full advantage of enterostomy outpatient services and enterostomal therapists in order to improve continuity of care.

Limitations 

The adjustment level of the patient changes with time and is a dynamic process. Additionally, the sample size does not represent enterostomy patients as a whole. The questionnaire for this research was distributed through a network platform, so the return rate was not ensured. In addition, the reason for the ostomy was not considered. The reason may have had an undocumented influence on adjustment, per previous research.

Conclusion

This research shows that ostomates have low social psychological adjustment levels to their new reality. Social support, stoma self-care ability, communication with medical staff, peristomal complications, understanding related to stoma knowledge and skill, utilization of support, the presence of leaking within 3 months, residence area, and regular defecation were found to influence the adjustment level of enterostomy patients. Therefore, clinicians need to perform specific interventions based on risk factor evaluations during clinical care to help patients improve their adaptation to the stoma and subsequently improve their quality of life. Additionally, the impact of Chinese culture should be considered when generalizing this finding internationally. n

Acknowledgment

The authors are grateful to the patients, families, and caregivers who participated in this study.

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8. Thorpe G, Arthur A, McArthur M. Adjusting to bodily change following stoma formation: a phenomenological study. Disabil Rehabil. 2016;38(18):1791–1802.

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10. Vonk-Klaassen SM, de Vocht HM, den Ouden ME, Eddes EH, Schuurmans MJ. Ostomy-related problems and their impact on quality of life of colorectal cancer ostomates: a systematic review. Qual Life Res. 2016;25(1):125–133.

11. Minervini A, Serni S, Vittori G, et al. Current indications and results of orthotopic ileal neobladder for bladder cancer. Expert Rev Anticancer Ther. 2014;14(4):419–430.

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Ms. Xian is an enterostomal therpist; Ms. Y. Zhang is a registered nurse;  Ms. Yang is a supervisor nurse; Ms. X. Zhang is a nurse practitioner; and Ms. Wang is a vice professor, Xuanwu Hospital Capital Medical University-Department of General Surgery, Xicheng District, Bejing, PR China. Please address correspondence to: Xinran Wang, Vice Professor, Xuanwu Hospital Capital Medical University-Department of General Surgery, No. 45 Changchun Street, Xicheng District, 100053, Beijing, PR China; email: xwgsd2017@hotmail.com

Abstract

The sacral area is the most common site for pressure injuries (PIs) associated with prolonged supine bedrest. In previous studies, an anisotropic multilayer prophylactic dressing was found to reduce the incidence of PIs and redistribute pressure. The purpose of the current study was to further investigate relationships between design features and biomechanical efficacy of sacral prophylactic dressings.

Using computer modeling, the anisotropic multilayer dressing and a hypothetical dressing with different mechanical properties were tested under dry and 3 levels of moist/wet conditions.  Sixteen (16) finite element model variants representing the buttocks were developed. The model variants utilized slices of the weight-bearing buttocks of a 28-year-old healthy woman for segmentation of the pelvic bones and soft tissues. Effective stresses and maximal shear stresses in a volume of interest of soft tissues surrounding the sacrum were calculated from the simulations, and a protective endurance (PE) index was further calculated. Resistance to deformations along the direction of the spine when wet was determined by rating simulation outcomes (volumetric exposures to effective stress) for the different dressing conditions. Based on this analysis, the anisotropic multilayer prophylactic dressing exhibited superior PE (80%), which was approximately 4 times that of the hypothetical dressing (22%). This study provides additional important insights regarding the optimal design of prophylactic dressings, especially when exposed to moisture. A next step in research would be to optimize the extent of the anisotropy, particularly the property ratio of stiffnesses (elastic moduli).

A pressure ulcer (PU) or pressure injury (PI) as now termed in the United States and Australia is defined as a localized site of tissue damage that typically develops near a bony prominence as a result of sustained mechanical loads applied to soft tissues.¹ The sacral area is the most common site for PIs associated with prolonged supine bedrest; the weight of the lower trunk and pelvis subject skin, fat, and muscle tissues enveloping the sacrum to sustained cell and tissue deformations.^1-3 Clinical studies^2,3 report that approximately 30% of these PUs are category 3 to category 4 or deep tissue injuries (DTIs), scaled according to international guidelines,¹ that later evolve into open wounds that affect all tissue layers, down to the bone. In addition to the compressive and tensile loads that are present in weight-bearing sacral soft tissues, biomechanical analyses have identified shear loads as being dominant, given the high curvature of the (nearly rigid) sacral bone and stiffness gradients of the layered soft tissue structure.⁴ Computer modeling in particular shows these internal shear loads can be further intensified when patients slide downward in bed due to gravity (especially if the head of the bed is elevated) or during repositioning for PI prevention, comfort, or providing patient hygiene.⁴ 

PI prevention is now an important focus of many health care organizations, government agencies, the medical industry, and academic research worldwide; efforts and resources are directed at finding preventive interventions that have consistently proven successful over time. One important successful preventive measure is the use of adequate prophylactic dressings. Santamaria et al⁵ conducted the first large-scale, randomized controlled trial (RCT), the “Border Trial,” in which Mepilex Border Sacrum (MBS) anisotropic multilayer dressings and heel dressings (Mölnlycke Health Care, Gothenburg, Sweden) were prescribed to trauma and critically ill patients (N = 440) in the hospital’s emergency department. The PU rates in the dressing group were compared to those of a control group receiving standard care including use of a low-air-loss bed, ongoing Braden risk assessments, and regular repositioning and skin inspections. Results of a similarly designed RCT with an equivalent sample size (N = 366) were reported by Kalowes et al.⁶ Both studies concluded that use of the aforementioned multilayer sacral and heel dressings, combined with preventive care, resulted in a statistically significant reduction in the incidence rate and severity of hospital-acquired PUs in intensive care patients. In another comparative cohort study,⁷ the Santamaria group found that the multilayer dressing variant having the same material composition as the MBS for protecting the heels was clinically effective in reducing intensive care unit-acquired heel PUs in a cohort of 150 patients. 

An adequate prophylactic dressing has a structure and composition that can absorb deformation energy (strain energy in engineering terms), especially shear loads, capturing this energy in the dressing structure and not in the tissues, as demonstrated in previously published biomechanical (computer modeling) studies by the current authors.^8-11 The dressing is further designed to reduce the frictional forces between clothing and mattress, provide local cushioning, and redistribute bodyweight-associated pressures, as well as manage the microclimate and humidity of the skin.^8-11 Likewise, the beneficial effect of the anisotropic feature of the multilayer dressing (termed deep defense by the manufacturer) has been described and characterized as stiffness with a directional preference (ie, the dressing is more flexible and stretchable in its lateral direction than in the longitudinal direction of the human body).^10,11 Using the finite element (FE) method described in a previous study,⁹ the current authors simulated different clinically relevant scenarios and biomechanical characteristics of high-risk groups, such as frail elderly persons and persons with diabetes, and assessed the biomechanical performance and efficacy of the multilayer dressing in these scenarios.¹¹ Their research consistently found a considerable reduction in exposure to skin and deep tissue deformations when the anisotropic multilayer dressings were applied, which may help explain the outcomes of the above RCTs from a scientific bioengineering perspective. 

Fluids tend to accumulate in a prophylactic dressing over time (even though the skin is intact) as a result of normal sweating, fever, or incontinence; these fluids affect the functioning of the dressing and the integrity and biomechanical properties of the skin.⁴ In particular, based on fundamental knowledge regarding how water absorption affects the strength and stiffness of porous materials (such as paper or cloth), the accumulation of fluids may affect different mechanical characteristics of a prophylactic dressing, including its stiffness properties and directional preference, the coefficient of friction and geometry. Each of these potential changes may impact the protective efficacy of the dressing over time. Accordingly, it is important to ensure that a prophylactic dressing continues to provide stable protection to tissues (including when wet) over the entire timespan of use, defining its durability. However, the effect of moisture on these dressings has not been tested. 

The purpose of the current study was to further investigate relationships between design features and biomechanical efficacy of sacral prophylactic dressings. Specifically, the authors aimed to simulate and study the performance of the MBS anisotropic multilayer dressing and a hypothetical dressing comprising the features of a similar dressing, but which become isotropic after absorbing fluids. The authors focused on the effect of wetness on the elastic properties of the dressings. The hypothesis was that the sustainability of the anisotropy characteristic in wet conditions is critical for the dressing to maintain its protective efficacy over time (ie, durability). 

Methods 

In order to investigate the biomechanical efficacy of sacral prophylactic dressings in protecting soft tissues after absorbing fluids, the authors developed 16 FE model variants representing the buttocks with either the anisotropic multilayer dressing or with a hypothetical dressing (see Table 1). The concept of the hypothetical dressing is based on commercially available dressings that were tested experimentally. However, to create comparable models of the MBS dressing and a hypothetical one, which needed to be identical in shape to the MBS but have different mechanical behavior (and hence, was not a “real” product), the hypothetical elastic moduli obtained in tests^8,11 of some commercial products on the same geometric model that had been devised to represent the MBS were used. Specifically, the performance of the anisotropic multilayer dressing (which, according to manufacturer data, preserves its anisotropy feature when wet¹¹) was compared to a hypothetical dressing that loses its anisotropy as fluid contents build up. The amounts of fluids are based on transepidermal water loss (TEWL) values taken from Kottner et al.¹² These 3 fluid values include TEWL for lower back and buttocks of approximately 10 (g/[m²/h]), which corresponds to 0.025 (mL/[cm²/day]) in the dressing, and the higher levels (0.075, 0.15 [mL/(cm²/day)]) were taken in order to investigate a more substantial accumulation of fluids — for example, when excess perspiration or incontinence is present. Both types of dressings (anisotropic multilayer versus hypothetical) were tested for wetness levels when pure compressive bodyweight loading was applied and also for a combined compression and shear loading mode, consistent with the current authors’ previously published work.^10,11 Effective and maximal shear stresses developed in the soft tissues at the sacral region in supine weight-bearing were systematically compared using a standard hospital mattress for each examined case (see Table 1).  

Geometry. A 3-dimensional (3D) anatomical model of the buttocks recently developed by the authors’ group for methodological, comparative sacral dressing studies^10,11 was used in this work. Briefly, 76 T1-weighted axial magnetic resonance imaging (MRI) slices of the weight-bearing buttocks of a 28-year-old healthy woman were imported to the ScanIP module of the Simpleware software package (Synopsis Inc, Mountain View, CA) for segmentation of the pelvic bones and soft tissues.¹³ Details regarding the MRI machine, scan protocol, and medical ethical approval are available elsewhere.¹⁰ The authors focused on a volume of interest (VOI) of 27.8 cm x 17.4 cm x 5.6 cm, incorporating the sacral bone and surrounding soft tissues. This allowed researchers to optimize computer power and make the numerical calculations effective where the tissue distortion phenomena relevant to sacral pressure ulcers occurred (see Figure 1a). 

As in the authors’ previously published work,^8-11 the anisotropic multilayer dressing included 3 physical material layers in the modeling: polyurethane foam (PUR), a nonwoven (NW) layer, and the airlaid (AL) layer. Consistent with previous studies,^8-11 the authors considered the innermost Safetac layer as a tied interface between the soft tissue component and the PUR foam layer, and the outermost “backing film” layer was represented as frictional sliding between the AL layer and the mattress (see Figure 1b).^8-11 However, the shape of the anisotropic multilayer dressing was not adopted from the authors’ previous work; rather, it was recreated using the ScanIP module of Simpleware to comply with the newest anisotropic multilayer dressing design launched in 2017. To complete the generation of the model geometry, a flat foam mattress was added under the buttocks in the ScanIP module of Simpleware.

Numerical methods. Meshing of the tissues, multilayer dressings, and mattress model components was performed using the ScanIP module of Simpleware.¹³ Four (4)-node linear tetrahedral elements were used in all model components. In order to obtain optimal accuracy but minimize complexity of the numerical solution and the associated computational power, mesh refinements were applied locally at the skin-dressing and mattress-dressing interfaces. 

The FE simulations were set up using the PreView module of FEBio (Ver.1.19; University of Utah, Salt Lake City, UT), analyzed using the Pardiso linear solver of FEBio (http://mrl.sci.utah.edu/software/febio) (Ver. 2.5.0), and post-processed using PostView of FEBio (Ver. 1.10.2).¹⁴ Converging time steps were chosen for numerical data collection so that the resulting reaction force was within a 2% difference from the target reaction force (description to follow). The time for solving each simulation case, using a 64-bit Windows 8-based workstation with 2×Intel Xeon E5-2620 2.00 GHz CPU and 64 GB of RAM, ranged between 7 and 12 hours. 

Mechanical properties of the dressing and tissues. Constitutive laws and mechanical properties of the tissue components and the mattress were adopted from the literature. Specifically, the sacrum was assumed to be a linear-elastic isotropic material with elastic modulus of 7 GPa and a Poisson’s ratio of 0.3.^15-17 The soft tissues were assumed to be nearly incompressible (Poisson’s ratio of 0.49) and nonlinear isotropic, with their large deformation behavior described by an uncoupled Neo-Hookean model with the following SED function W:

where Gins (the instantaneous shear modulus) is 2 kPa,¹⁷λi (I = 1,2,3) are the principal stretch ratios, K (the bulk modulus) is 1 MPa , and J = det(F) where F is the deformation gradient tensor. Specifically, material constants reported by Oomens et al¹⁸ were used to calculate an effective soft tissue Gins comprised of 60% skin and 40% fat, as in the authors’ previous modeling work of the buttocks.¹⁰ 

The anisotropic multilayer dressing has significantly different stiffness properties in the vertical versus the horizontal directions (anisotropy), while the hypothetical dressing has less distinct directional stiffness properties. The elastic moduli of the multilayer dressing at the X and Y directions (ie, the spinal and lateral directions, respectively) were measured in the authors’ laboratory and in the anisotropic dressing’s testing facilities with the authors maintaining oversight of the experimental protocol and data (see Table 2). The ratio between the elastic moduli at the Y direction over the X direction was found to be 6.6 for the anisotropic multilayer and approximately 1.8 for other commercially available dressings in the dry condition. The elastic moduli and the ratio of moduli at the Y direction over the X direction also were measured for the 3 levels of wetness in moist dressings: 0.025, 0.075, and 0.15 (mL/[cm²]) (see Table 2). For the hypothetical dressing in its wet conditions, a modulus ratio of unity was assigned based on measurements of commercial prophylactic dressings loaded with the above wetness levels and then mechanically tested in tensile loading at the X and Y directions. In other words, the hypothetical dressing was considered to become linear-elastic isotropic when wet (at any of the above 3 wetness levels), which is a potential material softening response known to exist in some wet porous materials (such as wet paper). A Poisson’s ratio of 0.258 was chosen for all dressings based on published experimental data.¹⁹ The mattress was considered isotropic linear-elastic, with an elastic modulus of 50 kPa and a Poisson’s ratio of 0.3, based on literature.^8,9,20 

Body loads applied to the buttocks and boundary conditions. Downward displacements of 5.5 mm to 6.48 mm were applied on the top surface of the model in order to simulate the descent of the weight-bearing sacrum during supine bedrest or a 45˚ Fowler’s position, with the anisotropic multilayer or hypothetical dressings in the dry and 3 wet dressing conditions. A total reaction force of 40 Newtons was obtained in all simulations that represented approximately 7% of the total bodyweight of the subject; this was transmitted focally at the sacral region. Therefore, the comparison between all simulation cases was conducted under the same (7% bodyweight) conditions for consistency of outcome measures across the different model variants. In the combined compression and shear loading scenario (representing sliding in bed due to gravity), a horizontal displacement of the same magnitude was added in the Y direction. The bottom surface of the mattress was fixed for all motions, and tied interfaces were defined at the bone-soft tissue boundaries as well as between the soft tissues and the dressing. Frictional sliding was defined between the dressing and mattress, with the coefficient of friction set to 0.35.^8,19 

Biomechanical outcome measures. Effective and maximal shear stresses within the VOI were compared across all simulation cases. Volumetric exposures of soft tissues below the sacrum (in the VOI) to elevated effective stresses also were compared and examined using stress exposure histogram (SEH) charts. As a final step after evaluating the volumetric exposure of soft tissues to stresses and plotting the SEHs, the protective endurance (PE) of the anisotropic multilayer dressing versus the hypothetical dressing (in percents) was calculated as follows: 1) the relative difference in the area under the SEH (A) for dry (d) and wet (w) cases of each dressing was calculated relative to the case in which no dressing was used: 

2) the protective endurance (PE) of a given dressing was defined as: 

Hence, the PE is an objective, standardized, and quantitative indicator of the preservation of biomechanical protection that a certain dressing provides to the soft tissues while being wet with respect to its (ideal) protective efficacy when it is dry. Because the present modeling is deterministic (and not probabilistic), each combination of dressing conditions (type of dressing, level of moisture, and loading mode as specified in Table 1) was simulated once. A detailed description of the chosen FE computer modeling and simulation approach is provided in the authors’ previous work.⁹ 

Data management. The FE simulation data were directly imported to and post-processed using PostView (US National Institutes of Health, Washington, DC), a post-processor software designed to visualize and analyze results from a FEBio analysis.¹⁴ The displacement applied on the top surface of the model was increased incrementally for numerical convergence purposes, so the resulting reaction forces between the buttocks and the support surface were within <1.8% difference of the aforementioned target reaction force. The effective and maximal shear stresses data that developed in the soft tissues within a cubical VOI in a size of 9 cm x 9 cm x 2.5 cm were pooled for each dressing type in the dry and 3 wet conditions, under pure compression due to bodyweight and separately under combined compression and shear loading. Further, the volumetric exposure of soft tissues below the sacrum in the aforementioned VOI was compared to elevated effective stresses and a SEH was plotted per each dressing type and dryness/wetness condition. A PE index then was calculated for each dressing type according to the algorithm described. Because all simulation data are deterministic, no variability exists in the modeling outcomes per each specific case of input dataset; hence, statistical analyses were not applicable in this study (please see a detailed explanation in the authors’ previous work⁹). 

Results 

Although 16 FE models were created, results from only the 14 that provided sufficient convergence (see the “Data management” section for convergence criterion) were analyzed. Specifically, the simulation case for a 0.15 (mL/cm²) moisture level in the hypothetical dressing was excluded due to extremely low dressing stiffness properties in this scenario that caused numerical convergence problems and resulted in incomparable simulation data for this specific case. The prominent difference noted in the average effective stress and average maximal shear stress between the anisotropic multilayer dressing and the hypothetical dressing was for the transition from dry to a (mildly) wet condition. Specifically, effective tissue stresses at the sacral region were between 0.3 kPa and 0.75 kPa for both dressing types in their dry condition. Within that range, tissue stresses increased up to 18% for the wet hypothetical dressing, but only 9.9% for the wet anisotropic multilayer dressing. Interestingly, the simulated rise in fluid contents from the lowest level of 0.025 (mL/cm²) to the greater moisture loads (0.075 and 0.15 [mL/cm²]) had a minor influence on tissue stress levels near the sacrum (ie, an approximately 2% increase in tissue stresses for the 2 dressing types for the 0.3 kPa to 0.75 kPa and 0.2 kPa and 0.5 kPa effective and shear stress domains in tissues, respectively). 

Effective stress distribution in the soft tissues near the sacrum when the model was subjected to combined compression and shear loads in dry dressing conditions and in a wet condition of 0.075 (mL/cm²) moisture level is shown in Figure 2 for the 2 dressing types. The colored bar attached to the figures that show effective stress and shear stress distributions in soft tissues indicates high versus low stress exposure in tissues. The highest stress values (in kPa units) are depicted in warm colors (red/yellow) and the lowest values are shown in cool colors (blue/green). The colors between these 2 are equally divided according to maximum and minimum stress values. Peak effective stresses increased within the 0.3 kPa to 0.75 kPa domain by 11.6% and 3.4% in the wet hypothetical and anisotropic multilayer dressings, respectively (see Figure 2). Consistent with these data, the rise in maximal tissue shear stresses for the same moisture contents was within the same domain for both dressing types, 0.2 kPa to 0.5 kPa; however, the peak shear stress was shifted more for the wet hypothetical dressing condition than for the anisotropic multilayer dressing, a difference of 10.2% and 3.4%, respectively (see Figure 3). 

Modeling calculations of cumulative volumetric exposures of the soft tissues under the sacrum to effective stress under combined compression and shear loading indicated the stress exposures within the entire 3D mass of soft tissues near the sacrum of the supine body were up to a peak of 1.2 kPa (see Figure 4a). However, the type of the dressing used affected the distribution of exposure to high versus low tissue stresses, predominantly for the wet conditions. Specifically, a comparison of the cumulative volumetric exposure of the soft tissues adjacent to the sacrum to effective stresses due to simultaneous compression and shear are shown in Figure 4a for both dressing types in dry and wet conditions (see Figure 4b). The wet hypothetical dressing caused a considerable rise in tissue stress levels, particularly within the 0.2 kPa to 1 kPa stress domain, whereas the anisotropic multilayer dressings did not (see Figure 4b). This is also evident and quantifiable by means of the PE values, following the algorithm of calculations specified in equations 2 through 4. These calculations show the PE of the anisotropic multilayer dressing is approximately 80%, compared to 22% for the hypothetical dressing. 

Discussion 

A modeling framework was used to investigate the relationship between moisture in prophylactic dressings and the biomechanical protection provided by such dressings, and specifically, to compare the mechanical stresses developing in the soft tissues near the sacrum due to bodyweight loads in dry versus wet conditions for 2 specific types of dressings. The hypothesis was that the sustainability of the anisotropic characteristic of the dressing in wet conditions is critical for the dressing to maintain its protective efficacy. The present modeling work supported this hypothesis.

This study builds upon the authors’ previously published work with regard to the biomechanical modes of action and function of prophylactic dressings in PI and DTI prevention.^10,11 The present study was conducted to further investigate biomechanical efficacy of dressings used prophylactically over the time of use after absorbing body fluids that accumulate in the dressing. 

Specifically, when comparing the tissue stress magnitudes developed at the different wetness levels, a difference in the transition from dry to a mildly wet dressing condition was observed, and stresses then approximately stabilized regardless of the additional increase in level of wetness. Importantly, this difference was considerably more pronounced for the hypothetical dressing, which underwent greater changes in mechanical properties with exposure to fluids. In contrast, the anisotropic multilayer dressing maintained its high modulus ratio, indicating strong anisotropy, which is a factor of its engineering design (see Table 2). 

The simulation data indicate that any absorption of fluids in the dressing, even to a small extent, could potentially influence the mechanical properties and behavior of the dressing and subsequently its biomechanical efficacy in prophylaxis. Accordingly, the capacity of the anisotropic multilayer dressing to preserve approximately 80% of its ideal function (determined in dry conditions) even when wet (see Figures 2 through 4 and the related PE data) is highly important in real-world clinical scenarios, where patients are sweating and/or may have incontinence issues.

An explanation for the above differences between the 2 types of dressings is that while the anisotropic multilayer dressing continues to function as an anisotropic dressing with a directional stiffness preference when wet, the hypothetical dressing functions as a nearly isotropic dressing; hence, it has limited ability to protect the soft tissues, as reported in prior research.¹¹ Specifically, the high modulus ratio (strong anisotropy) of the anisotropic multilayer dressing makes it much stiffer in the longitudinal direction of the dressing (the direction of the spine), which is also the direction of potential downward sliding of the body due to gravity (especially if the head of the bed is elevated). Because the anisotropic multilayer dressing is considerably stiffer along the line of the spine and given that it can maintain this property in wet conditions, the anisotropic multilayer dressing will act to preserve tissue shape and minimize tissue distortions in that longitudinal direction. By minimizing tissue distortions when wet, the anisotropic multilayer dressing effectively protects tissues of all patients, considering that normal perspiration always accumulates in the dressing, even if no other factors such as acute fever or incontinence caused (more substantial) fluid accumulation. The latter point is important, because a slightly wet dressing and a heavily wet (same) dressing behave similarly from a biomechanical perspective; thus, the dressing is able to provide a consistent, stable protective efficacy across the possible range of fluid accumulation, which makes a dressing reliably appropriate for PI prevention.  

This study introduced use of the PE index — an objective, quantitative, and standardized measure of the efficacy of prophylactic dressings subjected to altered conditions such as wetness accumulation. The PE is a straightforward method used for calculation once an adequate modeling framework is in place. Here, the PE was found to be distinctly greater for the anisotropic multilayer dressing when compared to the hypothetical dressing. This result remains consistent with the authors’ previous studies regarding the contribution of the anisotropy in the dressing structure to its biomechanical efficacy and highlights the importance of stable measures of efficacy in changing conditions such as exposure to perspiration or urine over the course of use.

In previously published work, the current authors compared the biomechanical PI prevention capacity of a hypothetical dry prophylactic dressing lacking directional stiffness preferences with that of the dry MBS anisotropic dressing.¹¹ By means of the FE method, it was demonstrated that the anisotropic dressing design reduced tissue loads, particularly when shear forces were present at the dressing-support surface interface. In such conditions, the hypothetical isotropic multilayer dressing yielded 52% and 39% reductions in exposure to the low and high SED domains in tissues, respectively; whereas, the anisotropic MBS dressing reduced tissue exposures by as much as 60% in both domains. These results revealed the benefits of the anisotropy design feature for prophylactic dressings; however, the durability of the biomechanical protective performances in wet dressing states has not been investigated before the present work.  

Limitations

Assumptions and limitations are inevitable in any computational modeling work. First, the MRI anatomy used is that of a healthy adult. Hence, the selected anatomy does not necessarily represent pediatric patients and all the possible anatomical variations and risk factors in adults, particularly with respect to bony, malnourished, or obese patients who are at a risk for developing PIs.^9,11 Likewise, pathophysiological changes in the mechanical stiffness of the tissues (eg, due to potentially existing scars or an evolving edema) were not considered. Moreover, the Poisson’s ratio of the dressing materials is an effective value for all layers (taken together), because it is technically problematic to measure Poisson’s ratios of very thin structures such as the individual layers of the dressing. Nevertheless, the authors believe these assumptions are reasonable, and they facilitated the systematic, standard and objective quantitative comparisons reported here. These data should be fundamental for computer-aided design of improved or new dressings and would help inform future methodological studies of efficacy of prophylactic dressings over time and use. 

Conclusion 

The purpose of this modeling study was to further investigate relationships between design features and biomechanical efficacy of sacral prophylactic dressings, particularly when exposed to moisture. The multilayer anisotropic prophylactic MBS dressing was found to exhibit superior PE, which was approximately 4 times that of the hypothetical dressing.  The present results are especially relevant to the common scenario of external shear loads applied to the sacral area that are caused by gravity pulling the body downward in bed, as well as the presence of moisture. A next step in research would be to optimize the extent of the anisotropy, particularly the property ratio of stiffnesses (elastic moduli). Although low anisotropy (toward an isotropic dressing) was shown to be less efficient in alleviating tissue loads in the model, an upper limit to the property ratio above which biomechanical effectiveness is not increased or even decreases should be considered. A second feature that interacts with the aforementioned stiffness property ratio is the ability of the dressing to evaporate or clear moisture, and hence maintain its anisotropy feature as well as its PE stability for hours and days, which requires laboratory studies of evaporation capacity of different dressing designs. 

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 May 23, 2018.

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

3. Vanderwee K, Clark M, Dealey C, Gunningberg L, Defloor T. Pressure ulcer prevalence in Europe: a pilot study. J Eval Clin Pract. 2007;13(2):227–235.

4. Gefen A. Why is the heel particularly vulnerable to pressure ulcers? Br J Nurs.  2017;26(suppl 20):S62–S74.

5. Santamaria N, Gerdtz M, Sage S, et al. A randomized controlled trial of the effectiveness of soft silicone foam multi-layer 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.

6. Kalowes P, Messina V, Li M. Five-layered soft silicone foam dressing to prevent pressure ulcers in the intensive care unit. Am J Crit Care. 2016;25(6):e108–e119.

7. 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.

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

9. 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.

10. Levy A, Gefen A. Assessment of the biomechanical effects of prophylactic sacral dressings on tissue loads: a computational modeling analysis. Ostomy Wound Manage. 2017;63(10):48–55.

11. Levy A, Schwartz D, Gefen A. The contribution of a directional preference of stiffness to the efficacy of prophylactic sacral dressings in protecting healthy and diabetic tissues from pressure injury: computational modelling studies. Int Wound J. 2017;14(6):1370–1377.

12. Kottner J, Lichterfeld A, Blume-Peytavi U. Transepidermal water loss in young and aged healthy humans: a systematic review and meta-analysis. Arch Dermatol Res. 2013;305(4):315–323.

13. Simpleware® Ltd. ScanIP, +FE, +NURBS and +CAD Reference Guide ver. 5.1, 2012. Available at: www.simpleware.com/software/. Accessed June 18, 2018. 

14. Maas SA, Ellis BJ, Ateshian GA, Weiss JA. FEBio: finite elements for biomechanics. J Biomech Eng. 2012;134(1):11005.

15. Linder-Ganz E, Shabshin N, Itzchak Y, Gefen A. Assessment of mechanical conditions in sub-dermal tissues during sitting: a combined experimental-MRI and finite element approach. J Biomech. 2007;40(7):1443–1454.

16. Palevski A, Glaich I, Portnoy S, Linder-Ganz E, Gefen A. Stress relaxation of porcine gluteus muscle subjected to sudden transverse deformation as related to pressure sore modeling. J Biomech Eng. 2006;128(5):782–787.

17. Gefen A, Haberman E. Viscoelastic properties of ovine adipose tissue covering the gluteus muscles. J Biomech Eng. 2007;129(6):924–930.

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

19. 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.

20. 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.

Abstract

Three-dimensional (3D) printing technology can generate objects in almost any shape and geometry. This technique also has clinical applications, such as the fabrication of specific devices based on a patient’s anatomy. A demonstration study is presented of a 54-year-old man who needed a thermoplastic splint to limit arm movement while a dehisced left shoulder wound healed.

The patient’s upper extremity was scanned using the appropriate noncontact scanner and 3D technology software, and the polylactic acid splint was printed over the course of 66 hours. This patient-specific splint was worn during the day, and after 2 weeks the wound was healed sufficiently to permit hospital discharge. Creation of an individualized splint is one of many potential medical uses of 3D technology. Although the lengthy printing time imposes limitations, the implications for practice are positive.

The digitization of manufacturing using cutting-edge software, materials, robots, new processes (notably 3-dimensional [3D] printing), and web-based services has revolutionized production methods.¹ Traditional production methods involve machining parts from blocks of material and then screwing or welding them together. Products now can be designed on a computer and printed on a 3D printer, which basically creates the object by building upon successive layers of material. Such printers can produce numerous objects that are too complex for a traditional factory to handle. The development of 3D printing has evolved in 4 successive stages: rapid prototyping in the early 1990s, rapid tooling in the late 1990s, direct manufacturing in the late 2000s, and home fabrication, with end-users manufacturing objects using 3D printing equipment at home, in the early 2010s.² 

The application of 3D printing in medical fields requires regulatory compliance; for example, a medical device should be approved by United States Food and Drug Administration (FDA) before marketing. The first 3D-printed item — a titanium skull implant — was created in 2006.³ This type of device has since been employed successfully in other scenarios where 3D printing has opened a world of potential medical applications.⁴ Similar to the first prototyping phase developed in industry, medical doctors use routine medical images, such as computerized tomography (CT) or magnetic resonance imaging (MRI), to construct 3D models. The 3D model then can be either manipulated in a computer or printed for treatment planning or surgical simulation.^5-7 

When they were first made, 3D-printed organs were created to train junior physicians. The 3D-image and printout could accurately represent the anatomy of the specific patient and the senior physician could explain the surgical planning to the patient and residents or interns. This use has evolved. Similar to the 3D printing rapid tooling developed in industry, surgeons have demonstrated that 3D printing is feasible and promising to use as a surgical guide for complex surgical procedures, such as surgical treatment of complex acetabular fractures⁸ and (as shown in a case study) improvement of joint function after reconstruction of a malignant bone tumor around the knee joint.⁹ In liver tumor surgery, for example, the 3D-image and printout can adequately show the hepatic and portal veins, enabling the surgeon to plan the surgical route to avoid bleeding. Using 3D technology in both treatment planning and surgical simulation has shown promising results.^8,9 

Patient-specific implants involve the direct manufacture and fabrication of end-use products with 3D printers that have been used to create shoulder, hip, and craniomaxillofacial implants.^10-12 Facilities may use bioprinters that utilize 3D printing techniques to combine cells, growth factors, and biomaterials to fabricate biomedical parts with natural tissue characteristics; this process is still in the very early stages.^13,14 Home fabrication (ie, end users manufacturing objects themselves using 3D equipment) is still under development in the industry.² 

In 2015, a Forbes report¹⁵ predicted “3D-printed hip and knee replacements, as well as other common internal and external medical devices, will be in mainstream use within 2 to 5 years.” Within the year, the US FDA approved 3D-printed oral medication (tablets)¹⁶ used to treat epilepsy, 3D-printed medical implants, 3D-printable material used as a denture base,¹⁷ and the first patient-specific cervical rod¹⁸ using 3D printing technology. 

To keep pace with the technological revolution and offer patients the newest options, the authors have been working on 3D printing at the Taipei Veterans General Hospital (Taipei, Taiwan) since October 2015. Taiwan FDA released 3D printing guidance in January 2018; thus far, 3D printing technologies are utilized mainly for modeling and surgical guides as previously described, because such use presents a low risk for patients. 

Because the authors could find no literature on the risks and benefits of creating 3D devices for medical application, the purpose of this case study was to describe the use of 3D printing technologies to generate a patient-specific splint device for wound care. 

Case Report

History. Mr. C was 54 years old when he was diagnosed with hepatocellular carcinoma for which he underwent a hepatectomy in 2011. Two (2) months later, he experienced persistent muscle soreness and tingling pain over his center trunk. A whole-body bone scan revealed bone metastasis over his left proximal humerus. Preoperative x-rays revealed an osteolytic lesion over his left proximal humerus with pending pathological fracture (see Figure 1). He subsequently underwent left hemishoulder arthroplasty in December 2011. The tumor was widely resected, as shown in the intraoperative photograph (see Figure 2). After tumor excision, the bone defect was reconstructed by long-stem hemiarthroplasty, and a titanium alloy artificial joint was implanted (see Figure 3). After reconstruction, Mr. C returned to normal daily life.

In December 2015, Mr. C noticed persistent, painful swelling of his left shoulder; infection was diagnosed based on routine clinical signs but without culture or biopsy. Orthopedic surgeons at the authors’ facility debrided and then closed the wound over his left shoulder with mesh and tape in April 2016. Wound discharge was noted 3 months later, and progressive shoulder pain and redness recurred in August 2016; septic arthritis was diagnosed. Due to deep infection, the artificial joint prosthesis was resected and high-dose vancomycin-impregnated polymethylmethacrylate was inserted to control the infection (see Figure 4). 

Plastic surgeons reconstructed the defect using a latissimus dorsi muscle flap and split-thickness skin graft on November 23, 2016; 5 months later, Mr. C visited the outpatient department with new wound dehiscence and was readmitted to the hospital for debridement and local flap repair in April 2017. During his hospital stay, Mr. C was asked to decrease movement of his left hand to facilitate wound healing. His physicians noticed that he constantly used his right hand to hold his left hand. They decided to use 3D technology to generate a patient-specific splint (PSS) to help immobilize the arm. Use of a readily available type of splint was avoided because Mr. C had just undergone debridement and local flap repair, and using a ready-made splint would involve the painful bending of his arm and potential added tension on the wound.

Modeling. The dimensions of the patient’s whole arm were captured using a handheld 3D scanner (Eva; Artec 3D, Luxembourg) that uses safe, structured, light-scanning technology to capture an object’s dimensions and shape. The scanner is equipped with post-processing software that can erase unneeded portions of an object. In this case, Mr. C’s upper extremity was scanned; the result is shown in Figure 5. Based on the 3D upper extremity model scanned, computer-aided design (CAD) software (Meshmixer; Autodesk, San Rafael, CA) was utilized to build the splint model. Clinicians marked the area on the computer model that required the splint and extracted the relevant dimensions, extending the surface area to 3-mm thickness to obtain the 3D splint model (see Figure 6). 

The 3D model was saved in an stereolithography (.stl) file format. Using this file, this printer technology creates an object by building up material layer by layer; logically, the bigger the object, the longer the printing time. Numerous professional 3D printing companies provide outsourcing worldwide.

3D printing. The authors’ 3D printing equipment center includes D-Force 500 (D-Force. Taiwan, Kaohsiung, Taiwan), Form 2 (Formlabs, Inc, Somerville, MA), UpBox (Tiertime, Beijing, China), and other home assembly components (users assemble the device). The D-Force 500 was selected for use because it has the capacity to print longer objects, and the arm splint needed to be approximately 400 mm long. Printing took approximately 66 hours and polylactic acid, a biodegradable thermoplastic derived from renewable resources such as corn starch or sugar cane, was used to create the splint. As shown in Figure 7, Velcro straps were attached to affix the splint on the patient. 

If any events interrupt the process, the printing must be repeated; for example, if the filament tangles, the printing process may fail. This occurred in the process of creating the splint, but ultimately printing was successful. 

Splint application. Once the splint was applied, the hospital course of care went smoothly. Mr. C wore the PSS during the day and rested his arm on a soft pillow at night. Because the PSS helped Mr. C hold and protect his left hand, the splint appeared to help expedite the wound healing process. The wound showed signs of healing, presumably because tension on the wound was reduced; no pain or swelling was noted and signs of infection no longer were present. Mr. C was discharged in stable condition <2 weeks after his admission for debridement and flap repair. The wound continued to appear to be healing at the postdischarge follow-up 1 week after discharge. Because Mr. C had terminal liver cancer, he decided not to have any artificial joint implant on his left shoulder, choosing instead to occasionally wear the splint for support. After returning to normal daily life, he wrote an appreciation letter to the Hospital Superintendent, noting that the PSS promoted his wound healing. 

Discussion

The digitization of the manufacturing process via 3D printing has dramatically changed production methods of items previously available only through standard production means.¹ According to a review article²⁰ and the authors’ experience using 3D applications in medical fields, the greatest advantage of 3D printing technology in medical applications is the ability to produce patient-specific devices. For example, news in medical field and reviews^12,15,21 note the application of 3D printing to customize prosthetics and implants represents significant value for both patients and physicians. 

To the best of the authors’ knowledge, no studies have reported the creation of a splint using 3D technology.^22,23 Although 3D technology can create a splint without the need to touch the wound (as would occur using traditional thermoplastic materials), the 66-hour production time represented a serious limitation of 3D printing a splint. However, the benefits of not coming in direct contact with the wound outweighed the disadvantages of the print time. Furthermore, given that the left artificial joint was removed, the patient required fixation that might not have been possible using a traditional immobilization device. The 3D-printed PSS also demonstrated the advantage of customization; in addition, material costs were almost the same as that of traditional thermoplastic material. 

Conclusion

To limit arm movement while a dehisced wound healed, 3D-printing technology was successfully used to create a PSS device. The main limitation of the using the 3D printing technology for this patient was the amount of time required (66 hours) to print the splint. With the utility and availability of 3D printing hardware progressing, the use of more precise and rapid 3D printers in the near future is expected.² n

References

1. The third industrial revolution. The Economist. 2012. Available at: www.economist.com/node/21553017. Accessed June 19, 2018.

2. Rayna T, Striukova L. From rapid prototyping to home fabrication: how 3D printing is changing business model innovation. Technological Forecasting Soc Change. 2016;102(1):214–224.

3. Silloc. About Xilloc: Brief history. Available at: www.xilloc.com/company/about-us/. Accessed June 4, 2018.

4. Jones N. Science in three dimensions: the print revolution. Nature. 2012;487(7405):22–23.

5. Cheung CL, Looi T, Lendvay TS, Drake JM, Farhat WA. Use of 3-dimensional printing technology and silicone modeling in surgical simulation: development and face validation in pediatric laparoscopic pyeloplasty. J Surg Educ. 2014;71(5):762–767.

6. Kurenov SN, Ionita C, Sammons D, Demmy TL. Three-dimensional printing to facilitate anatomic study, device development, simulation, and planning in thoracic surgery. J Thorac Cardiovasc Surg. 2015;149(4):973–979.

7. Rose AS, Kimbell JS, Webster CE, Harrysson OL, Formeister EJ, Buchman CA. Multi-material 3D models for temporal bone surgical simulation. Ann Otol Rhinol Laryngol. 2015;124(7):528–536.

8. Merema BJ, Kraeima J, Ten Duis K, et al. The design, production and clinical application of 3D patient-specific implants with drilling guides for acetabular surgery. Injury. 2017;48(11):2540–2547.

9. Wang FP, Zhu J, Peng XJ, Su J. The application of 3D printed surgical guides in resection and reconstruction of malignant bone tumor. Oncol Lett. 2017;14(4):4581–4584.

10. Lu MX, Min L, Xiao C, et al. Uncemented three-dimensional-printed prosthetic replacement for giant cell tumor of distal radius: a new design of prosthesis and surgical techniques. Cancer Manag Res. 2018;10:265-277.

11. Wang SS, Wang L, Liu Y, et al. 3D printing technology used in severe hip deformity. Exp Ther Med. 2017;14(3):2595–2599.

12. Hatamleh MM, Bhamrah G, Ryba F, Mack G, Huppa C. Simultaneous computer-aided design/computer-aided manufacture bimaxillary orthognathic surgery and mandibular reconstruction using selective-laser sintered titanium implant. J Craniofac Surg. 2016;27(7):1810-–1814.

13. Daly AC, Cunniffe GM, Sathy BN, Jeon O, Alsberg E, Kelly DJ. 3D bioprinting of developmentally inspired templates for whole bone organ engineering. Adv Healthc Mater. 2016;5(18):2353–2362.

14. Lee JM, Yeong WY. Design and printing strategies in 3D bioprinting of cell-hydrogels: a review. Adv Healthc Mater. 2016;5(22):2856–2865.

15. Columbus L. Gartner’s Hype Cycle For 3-D Printing, 2015: Medical Products Driving Market Growth. Forbes. 2015. Available at: www.forbes.com/sites/louiscolumbus/2015/08/28/gartners-hype-cycle-for-3-.... Accessed June 4, 2018.

16. Chai X, Chai H, Wang X, et al. Fused deposition modeling (FDM) 3D printed tablets for intragastric floating delivery of domperidone. Sci Rep. 2017;7(1):2829.

17. Krassenstein E. DENTCA Receives FDA Approval for World’s First Material for 3D Printed Denture Bases. 2015. Available at: https://3dprint.com/87913/dentca-fda-3d-print/. Accessed June 4, 2018.

18. Butler O’Neal B. 3D Technology Allows MEDICREA to Create New FDA-Approved Spinal Implants Giving Patients Dramatic Relief. 2016. Available at: https://3dprint.com/132030/medicrea-spinal-implants/. Accessed June 4, 2018.

19. Autodesk. Free software for making awesome stuff. 2017. Available at: www.meshmixer.com/. Accessed June 4, 2018.

20. Banks J. Adding value in additive manufacturing: researchers in the United Kingdom and Europe look to 3D printing for customization. IEEE Pulse. 2013;4(6):22–26.

21. Mertz L. Dream it, design it, print it in 3-D: what can 3-D printing do for you? IEEE Pulse. 2013;4(6):15–21.

22. Mikolajewska E, Macko M, Ziarnecki L, Stańczak S, Kawalec P, Mikołajewski D. 3D printing technologies in rehabilitation engineering. J Health Sci. 2014;4(12):78–83.

23. Lin HH, Lonic D, Lo LJ. 3D printing in orthognathic surgery — a literature review. J Formos Med Assoc. 2018;117(1):547-558.

Potential Conflicts of Interest: This work was supported in part by a Taipei Veterans General Hospital Research Grant (V106 E-003-1, V107 D39-001-MY2-1, and V107C-198), Taiwan.

Dr. Wu is the Division Chief, Therapeutical and Research Center, Musculoskeletal Tumor, Department of Orthopedic Surgery and Traumatology, Taipei Veterans General Hospital, Taipei, Taiwan; and an Assistant Professor, Institute of Clinical Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan. Dr. Shih is a visiting staff member, Division of Plastic and Reconstructive Surgery, Taipei Veterans General Hospital; and a lecturer, Department of Surgery, School of Medicine, National Yang-Ming University. Dr. CM Chen is a visiting staff member, Department of Orthopedic Surgery and Traumatology, Taipei Veterans General Hospital; and a lecturer, Institute of Clinical Medicine, National Yang-Ming University. Dr. G Chen is a resident, Division of Plastic and Reconstructive Surgery, Taipei Veterans General Hospital; and a lecturer, Department of Surgery, National Yang-Ming University. Dr. WM Chen is Vice Superintendent, Taipei Veterans General Hospital; and the Associate Dean, Institute of Clinical Medicine, School of Medicine, National Yang-Ming University. Ms. Huang is a physiotherapist, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Mr. Hung is a physiotherapist, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Mr. Wang is a research assistant, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Mr. Yu is a research assistant, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Dr. CK Chang is a visiting staff member, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Dr. BC Chang is a visiting staff member, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital; and an Assistant Professor, Department of Biomedical Engineering, Chung Yuan Christian University, Taoyuan City, Taiwan. Dr. Lin is the Divisional Chief of Rehabilitative Treatment for Physical Dysfunction, Rehabilitation and Technical Aids Center, Taipei Veterans General Hospital. Dr. Wang is a Researcher, Rehabilitation and Technical Aids Center and Division of Experimental Surgery; and a Professor, Institute of Hospital and Health Care Administration, National Yang-Ming University. Please address correspondence to: Shyh-Jen Wang, PhD; email: wangsj@vghtpe.gov.tw; or Pei-Hsin Lin, MD, PhD; email: phlin2@vghtpe.gov.tw.

Abstract

An ileal conduit is the most common urinary diversion following radical cystectomy for invasive bladder cancer. Unlike internal complications commonly described in urological literature, reports about the incidence of external complications are sparse.

A Medline database review (1996–2008) of English-language literature was conducted to: 1) describe and compare external stoma and peristomal complications and complication rates among outpatients with ileal conduit diversion following radical cystectomy, and 2) summarize commonly used prevention and management strategies. Fourteen publications (mostly retrospective, single-center studies) met inclusion criteria. The reported incidence of complications ranged from 15% to 65%. Divided according to pathogenesis, the most commonly reported complications are 1) stoma or abdominal wall-related changes — parastomal hernia, stoma prolapse, stenosis, and retraction; and 2) peristomal skin changes — chemical injury: irritant contact dermatitis, pseudoverrucous lesions, and alkaline crustations; mechanical injury: pressure ulcers, skin stripping injuries, mucocutaneous separation; infection: candidiasis, folliculitis; immunologic disorders: allergic contact dermatitis; and disease-related lesions: varices, pyoderma gangrenosum, malignancy. Peristomal complications also appear to be under-recognized and under-reported. Research to establish the validity and reliability of assessment tools and long-term follow-up studies are needed to improve the evidence-base of prevention and care.

Potential Conflicts of Interest: Dr. Kassouf, Dr. Szymanski, and Ms. St-Cyr have nothing to disclose. Mr. Alam is an employee of Hollister Ltd., Aurora, Ontario, Canada.

Please address correspondence to: Wassim Kassouf, MD, CM, FRCSC, Montreal General Hospital, 1650 Cedar Avenue, L8-315, Montreal, Quebec H3G 1A4 Canada; email: wassim.kassouf@muhc.mcgill.ca.  

   External stoma complications are the most frequent indication for reoperation after cystectomy.¹ They represent the most common reason for outpatient ostomy service visits and are important predictors of patient quality of life.² In addition, although the majority of peristomal skin disorders are mild and can be easily managed on an outpatient basis, they can progress in severity when unattended.³ Evidence-based approaches are sparse for primary and secondary prevention of complications.

     There appears to be a certain disconnect between the prevalence of cystectomy with ileal conduit creation and the knowledge regarding long-term stoma complications in the literature and among patients and urologists. In a cross-sectional study (N = 202),³ 62% of participants with a peristomal skin disorder did not believe they had a disorder and more than 80% of participants did not seek professional attention.

     Following radical cystectomy and ileal conduit creation at the authors’ institution, patients are followed-up by an interdisciplinary team, which includes experienced enterostomal therapy nurses (ETNs) and urologists. The high frequency of external stoma and peristomal complications observed in these patients, along with questions about evidence-based management principles, were motivating factors for conducting and synthesizing a literature review to describe and compare epidemiology, management, and assessment of long-term external stoma and peristomal complications among patients with ileal conduit diversion following radical cystectomy.

Methods

     A literature review of the Medline database (1966 to 2008) was conducted to find English-language epidemiological data on outpatient external stoma complications. Studies and reviews selected pertained to external complications among patients following ileal conduits after radical cystectomy. Articles that did not include this patient population and/or report external peristomal (involving the stoma or peristomal area) complication rates were excluded. Search terms included stoma, ileal conduit, urostomy, radical cystectomy, parastomal, peristomal, stoma complications, hernia, stenosis, retraction, dermatitis, and ulcer. Rate ranges were combined from different studies for reporting purposes. Studies about peristomal skin assessment tools also were identified. To illustrate review results, photographs were obtained with patient consent by an ETN.

Results

     Fourteen publications were found from which complication rates could be extracted^1,3-15 (see Table 1). Of these, five (36%) were published in nursing journals,^3,5,7,8,13 three were reviews,^7,9,13 and two were long-term retrospective studies of patients who had exclusively undergone radical cystectomy or exploration for bladder cancer with ileal conduit creation.^1,6 Two other publications (a review² and a retrospective single-center series of 319 patients with urinary diversions followed for 3 years¹⁶) were used for descriptive and risk factor data.^2,15,16

     The reported overall rate of external stoma complications was found to range from 15% to 65%.^{1,3-6,8-12,14} Complications were reported in the literature and categorized following an accepted pathogenesis-based classification²: 1) stoma, or abdominal wall-related changes — parastomal or peristomal hernia, stoma prolapse, stenosis, and retraction, and 2) peristomal skin changes — chemical injury (irritant contact dermatitis, pseudoverrucous lesions, alkaline encrustations), mechanical injury (pressure ulcers, skin stripping injuries, mucocutaneous separation), infection (candidiasis, folliculitis), immunologic disorders (allergic contact dermatitis), and disease-related lesions (varices, pyoderma gangrenosum, malignancy). Three articles describing peristomal skin assessment tools were identified.^4,17,18

Understanding “Normal” Peristomal Skin

     Skin care begins with an understanding of “normal” (intact and healthy) peristomal skin.² Even when covered with an adhesive skin barrier, this skin is similar to the other side of the abdomen. Chronic irritation is abnormal. Covering peristomal skin is the primary method used to protect it from stoma effluent. Results of one cross-sectional study³ suggest that contact with irritating effluent causes 75% of peristomal skin disorders. Appropriate stoma siting is also important — considerations include abdominal scars,¹⁴ contour, and clothing (ie, the stoma should not automatically be placed in the middle of an abdominal quadrant or below a low belt line).⁷ There must be ample flat area around the stoma (2 to 3 inches) for the pouching system to adhere adequately because a poorly located stoma also can lead to pouching system leakage.⁷ The stoma should be located at the crest of an abdominal bulge where it can be easily seen by the patient.⁷ The pouching system needs to be reassessed and refitted as stoma edema resolves postoperatively and patients gain weight.

Overall Complication Risk

     Despite the wide use of ileal conduits in urinary diversion and a high cumulative incidence of external complications involving the stoma (15% to 65%),^{1,3-6,8-12,14} literature addressing this issue remains scant.¹ This range of ileal conduit complications is comparable to the 10% to 70% risk for enterostomies.^3,5,19 In one study (see Table 1),³ peristomal skin disorders were noted in 48% of patients with ileal conduits, 57% with ileostomies, and 35% with colostomies. However, the true incidence of complications is difficult to assess. Estimates vary widely across studies and most do not include definitions or details of the complications assessed.² In two analyses of retrospective, single-center data of more than 1,600 patients with enterostomies, preoperative siting of an enterostomy and education by an ETN have been found to decrease overall postoperative enterostomal complications by 25% to 43%.^20,21

Need for Long-term Follow-up

     Studies suggest that external peristomal complications can occur at any time after surgery. In one long-term study⁶ of patients living with ileal conduits with a median follow-up of 98 months, the median time to stoma complications was 54 months, with almost 20% occurring 10 years after surgery (see Table 1).The one exception appears to be mucocutaneous separation, which usually occurs within 1 month following surgery.² For these reasons, follow-up with an ETN is recommended at 2 to 4 weeks after surgery, 3 months, 6 months, and then annually for the life of the patient.²

Stoma or Abdominal Wall-related Complications

     Abdominal wall-related complications (parastomal hernia, stoma prolapse, stenosis, and retraction) not only have a significant morbidity, but they also increase the risk of a concurrent peristomal skin disorder by altering the abdominal contour and pouching system fit, leading to urine leaks and pooling.^2,5 They remain the most common cause for reoperation after ileal conduit surgery.⁹

     Parastomal hernia. A parastomal, or peristomal, hernia is an incisional hernia secondary to a fascial defect surrounding the conduit.^9,22 A recent review¹ on parastomal hernias proposed two comprehensive definitions. Clinically, a parastomal hernia is any palpable defect or bulge adjacent to the stoma detected with the patient supine with legs elevated or with a standing patient coughing or straining²² (see Figure 1a). Radiologically, it is any intra-abdominal content protruding along the ileal conduit on a CT scan. With regard to ileal conduits, the 2-month, postoperative incidence is 12%5 and prevalence is 5% to 28%^1,6,9-12— by comparison, prevalence among enterostomies is 5% to 65%.²² Parastomal hernias can appear years after surgery; average time to herniation is 8 to 22.4 months.^1,10,11,13 In a single-surgeon case series¹ of 137 patients who had undergone ileal conduit diversion after radical cystectomy for bladder cancer, overweight (body mass index [BMI] 25 to 30 kg/m2) and obese (BMI >30 kg/m2) patients were found to be four to six times more likely than those with a normal BMI to develop parastomal hernias over 5 years. Other cited⁹ contributing factors include malnutrition, chronic cough, and use of steroids, although studies are often small, patient populations include all stomas, and risk ratios are unknown. In the enterostomal literature, emergency surgery has not been shown to be a risk factor for a parastomal hernia.²³

     Placing the stoma in, rather than lateral to, the rectus abdominis sheath is the gold standard; in a retrospective, single-center case series²⁴ of 130 patients with colostomies, this approach has been shown to decrease parastomal hernia risk from 22% to 3%. Before stoma creation, all facial layers should be aligned so the entire opening is within the sheath.⁹ A randomized study^22,25 of 47 persons with colostomies showed that placing a large-pore mesh during the primary operation reduced the parastomal herniation rate (50% versus 5% at 12 months). In this study, no wound or mesh infection, fistula formation, or pain associated with the stoma was recorded among the mostly overweight patients (mean BMI 27.5) followed for a mean of 24 months. However, no data are available on the role of mesh during primary operations in patients receiving an ileal conduit.

     Although most parastomal hernias can be managed nonoperatively, a retrospective, single-surgeon case series¹ of 137 patients with ileal conduits and a retrospective, single-center case series²⁴ of 130 patients with colostomies have shown approximately 30% require surgical intervention secondary to obstruction, pain, bleeding, poorly fitting pouching systems, or leakage. Surgical outcomes have been shown to be poor, with recurrence rates often >50%^1,27 and complication rates up to 88% for surgical bowel obstruction, stoma prolapse, wound infection, fistula, and mesh erosion.²⁶ In the general surgery literature,²² contralateral stoma resiting and primary fascial repair are reported to have recurrence rates of 24% to 86% and 50% to 76%, respectively; ipsilateral or second resitings have even higher risks of recurrence (71% to 86%). Given the poor surgical outcomes and the (albeit) small likelihood of life-threatening complications, many authors^16-27 propose avoiding repair and advocate primary prevention, which includes proper siting and surgical technique, weight loss, and management of other risk factors.

     Both open and laparoscopic repair of ileostomy and colostomy parastomal hernias with tension-free mesh are promising surgical approaches. In a review article²² and a retrospective, single-center case series²⁶ of 24 laparoscopically repaired parastomal hernias, recurrence rates have been reported at 5% to 11%, but long-term follow-up is lacking. Laparoscopy recently has been implemented to treat patients with ileal conduits.^1,26 The laparoscopic intraperitoneal onlay mesh technique carries risks of converting to open surgery (15%), bowel injury (22%), and mesh infection with subsequent mesh removal (9%).^22,26 In one case series²⁴ of laparoscopic intraperitoneal onlay mesh repairs that included nine patients with ileal conduits, one required laparoscopic reoperation for an obstructed conduit.

     Stoma prolapse. Although the clinical distinction between a parastomal hernia and stoma prolapse has been reported to not always be clear,²² in the authors’ experience the distinction is usually unmistakable. A parastomal hernia presents as a bulge of the peristomal skin, at times associated with stoma retraction. Stoma prolapse involves eversion of the stoma through the abdominal wall²⁸ and telescoping ileal mucosa⁷ (see Figure 1b). In one study,¹⁴ stoma prolapse was defined as stomal protrusion >30 mm.

     Stoma prolapse occurs most often in loop colostomies (2% to 46%); it is relatively rare in other types of stomas, affecting 1.5% to 8% of ileal conduits^7,11,14,19 at a median time of 2 years after surgery.¹¹ Nonsurgical management includes the use of a prolapse belt to reduce the prolapse, but carries the risk of stoma necrosis.⁷ A case of stoma prolapse with a parastomal hernia was successfully repaired with tension-free mesh.¹

     Stoma stenosis. Stoma stenosis is a narrowing of the ostomy lumen, either at the level of skin or fascia, leading to impaired drainage²⁹ (see Figure 1c). It is thought to occur secondary to ischemia, leading to retraction and scarring,⁷ particularly in the setting of circumferential mucocutaneous separation. Chronic local inflammation and hyperkeratosis, possibly due to an ill-fitting pouching system, are possible causes.⁹

     Historically, the incidence of stoma stenosis was cited as 20% to 25%⁹; more contemporary research^6,7,9-11 notes an incidence of 2.5% to 8.5% at a median of 10 years after surgery.¹¹ This is similar to rates observed among patients with ileostomies and colostomies.⁷

     Stenosis at the skin level can be managed by dilating the stoma opening, usually by inserting a lubricated digit down to the fascial layer for several minutes.^7,11 This technique, taught to select patients at the authors’ institution, may need to be frequently and regularly repeated¹² and carries a small risk of forming a false passage or opening. Stenotic bowel can be excised; fascial stenosis usually requires surgical revision or resiting.⁹

     Stoma retraction. Stoma retraction has been defined in one enterostomal study¹⁹ as a stoma surface >0.5 cm below the skin level (see Figure 1d). Information in ileal conduit literature with regard to this complication is sparse. Stoma retraction can result from persistent tension on the stoma due to short mesentery, inadequate bowel mobilization, or the presence of a thick abdominal wall.⁷ In relevant literature, it has been associated with obesity¹⁹ and Crohn’s disease.³⁰

     Stoma retraction occurs in 9% to 15% of ileal conduits^10,12 and 1% to 11% of all stomas.^7,8 Management is usually conservative and involves use of a convex pouching system and patient education.¹⁹

Chemical Injury

     Irritant contact dermatitis. Dermatitis presents as erythematous, moist, painful, shallow peristomal erosions in areas of substance contact with the skin² (see Figure 2a). Irritants include mucus, urine, and skin care products. Dermatitis can be related to poorly sited stomas, urine pooling in skin creases, or stoma pouching system openings that are too large.⁷ Errors in stoma care technique also can contribute and include inconsistent pouching system changes, reinforcing rather than changing a leaking pouching system, and inappropriate use of protective skin products. Prevention includes optimal stoma placement and creation, patient education, selecting a pouching system of optimal size and convexity, and facilitating patient and caregiver use (eg, a one- or two-piece pouching system).

     A 12% 2-month postoperative incidence rate⁵ and prevalence of 14% to 20%^7,11,12 have been reported. These rates are lower than among patients with a colostomy (29% to 31%) or an ileostomy (5% to 70%).⁷ Irritant contact dermatitis can be managed by resizing the stoma pouching system and possibly refitting with a convex adhesive surface. Peristomal skin creases can be filled with a skin barrier paste or strip. Eroded peristomal skin can be prepared by dusting a hydrocolloid powder to absorb exudate and provide a dry adhesion surface.⁷

    Pseudoverrucous lesions. This complication consists of benign, thickened epidermis with white, grey, brown, or dark red papules or nodules in areas chronically exposed to effluent and causes hemorrhage or pain² (see Figure 2b). The lesions are also known as chronic papillomatous dermatitis, hyperkeratosis, and pseudoepitheliomatous hyperplasia. Pathogenesis involves epidermal hyperplasia secondary to chronic chemical irritation and often occurs among patients lost to follow-up who wear a pouching system without an anti-reflux valve and too large an opening.²

     In one study,14 pseudoverrucous lesions affected 21% of 66 ileal conduits, were seen exclusively after 5 years of follow-up, and were associated with stomas protruding <10 mm. Another study⁴ noted a cumulative incidence of 23% of 57 patients at 7 years of follow-up.

     Management of pseudoverrucous lesions includes refitting the pouching system to cover the lesions and shortening the pouch change intervals to 3 to 4 days until lesions resolve.² Hydrocolloid powder is used to absorb moisture in the fissures of the lesion; its irregular surface can be covered with strips of extended-wear skin barrier. Although usually not necessary, silver nitrate may be helpful for lesions that are considerably raised and hemorrhaging.²

     Alkaline encrustation. Crystal deposition on exposed peristomal skin is a complication unique to urostomies² (see Figure 2c). Stoma bleeding can occur when crystals are manipulated. Encrustations are associated with pseudoverrucous lesions, alkaline, concentrated urine; renal calculi, and urinary tract infections. In a retrospective, single-center case series¹¹ of 123 patients with ileal conduits followed for a median of 3 years, 23.6% developed encrustation.

     Management includes increasing oral fluid intake and acidifying urine with a maintenance dose of 1g daily of ascorbic acid.² Vitamin C should be used with care in patients with glucose-6-phosphate dehydrogenase deficiency, recurrent oxalate renal calculi, and hemochromatosis.³¹ Patients at the authors’ institution are counselled to dissolve the encrustations with 33% to 50% vinegar-soaked pads applied to the stoma for 20 minutes when changing the pouching system every 3 to 4 days. The stoma can temporarily blanch when applying the pads.

Mechanical Injury

     Pressure ulcer. When the pouching system component or accessory delivers too much pressure, early stage pressure ulcers (Stage I) that present as nonblanching erythema that does not resolve in 1 to 2 minutes after removal of the device can occur.² With enough pressure, tissue ischemia and necrosis lead to further skin breakdown, including partial-thickness (Stage II), full-thickness ulceration (Stage II) (see Figure 3a), or exposure of underlying muscle (Stage IV).³² No incidence data about this complication is available.

     Management includes resizing and refitting the pouching system that may be too convex or too firm, as well as loosening or discontinuing the ostomy belt, hernia support binder, or prolapse belt causing the ulcer.²

     Stripping injury. Stripping injury can cause erythema with scattered areas lacking epidermis and often corresponds to the adhesive surface or its borders² (see Figure 3b). It is usually associated with too-frequent adhesive removal or poor technique. In a prospective, single-center series⁵ of 220 patients with stomas, 7% of patients were affected 2 months after surgery.

     Management includes skin support during gentle removal of the pouching system in the direction of hair growth. A liquid skin sealant sometimes is used and wear-time extended to the recommended period.²

     Mucocutaneous separation. This complication is an interruption of the suture line with skin separation at the mucocutaneous junction¹⁹ (see Figure 3c). It occurs in 12% of patients with enterostomies; no data are available for ileal conduits. Etiology includes compromised healing, infection, a large skin opening, poor surgical technique, and excessive tension at the mucocutaneous junction.^2,7

     Management involves irrigating and filling the defect with an absorptive powder or dressing (ie, alginate or hydrofiber) while the pouching system covers the packing material and the entire peristomal field.^2,7 If infection or an abscess is suspected, the defect is incorporated in the opening size of the pouching system, exposing the wound and allowing it to drain until it resolves. In this situation, the defect heals by secondary intention.³³

Infection

     Candidiasis. Fungal infection initially presents as pustules, often progressing to pruritus; burning; and confluent, erythematous plaques with satellite lesions² (see Figure 4a). It is associated with increased perspiration from activity or fevers, frequent leakage episodes of the pouching system, or recent antibiotic treatments. It has been observed in 2% of patients 2 months after surgery.⁵

     Treatment involves applying antifungal powder with each pouch change until the candidiasis resolves, as well as drying off the pouching system after exercise or swimming.² The application of a skin sealant may be useful during humid weather.

     Folliculitis. This bacterial infection most often involves Staphyloccocus aureus presenting as erythematous or pustular lesions originating at the hair follicles² (see Figure 4b). No prevalence or incidence data are available.

     Because this infection often is associated with shaving, management includes trimming hair with scissors or clippers to leave hair short and above skin level, washing with antimicrobial soap, and applying a skin sealant. Minimizing skin trauma by supporting the skin during gentle removal of the pouching system in the direction of hair growth is an additional preventive measure.

Immunologic Disorder

     Allergic contact dermatitis. This allergic reaction to skin care products applied with or composing the stoma pouching system adhesive manifests as erythema, pruritus, vesicles, papules, bullae, skin induration, and erosions² (see Figure 5). This type of complication should be suspected when the lesion corresponds exactly to an area covered by a specific product or component of the pouching system (eg, tape border or skin barrier). Dyes, perfumes, adhesives, soaps, lotions, and preservatives can be allergens. A retrospective, single-center study¹¹ of 123 patients reported a cumulative incidence of 1.6% over 3 years. The sensitizing product needs to be identified and removed from the ostomy care protocol. A patch test can be helpful to determine allergens; corticosteroid cream applied between appliance changes and antihistamines can relieve symptoms.²

Disease-related Lesions

     Varices. Varices occur secondary to portal hypertension and present as purple skin discoloration with dilated, tortuous veins on the stoma² (see Figure 6a). No incidence data are available. Although the skin usually remains intact, the veins are vulnerable to bleeding, requiring protection of the mucosa. Convex, rigid devices and belts should be used only when necessary and the pouching system should always be removed gently. Minor bleeding can be managed with local pressure and application of silver nitrate, ice packs, and a hemostatic dressing. Uncontrolled hemorrhage requires medical attention.²

     Pyoderma gangrenosum. This rare, painful, inflammatory ulceration of the skin often begins with pustules that break open and form full-thickness ulcers with red to purple edges^2,7 (see Figure 6b). Although its etiology is unknown, about 50% of cases are associated with underlying systemic disease (eg, inflammatory bowel disease, polyarthritis, and hematologic disorders).² Because this condition is diagnosed by exclusion, a dermatology referral may be helpful to rule out other diseases, especially skin malignancy. No incidence data are available.

     Management of the underlying systemic condition should be the initial focus of the intervention, especially in moderate and severe cases; topical or intralesional steroids may be effective for mild disease.³⁴ Although case reports show effective treatment of pyoderma gangrenosum lesions with topical immunosuppressors (eg, 0.1% tacrolimus³⁵), topical treatment should be considered an adjuvant to systemic therapy³⁶ and should include the application of an absorptive dressing to control excessive exudate (eg, alginate or hydrofiber) and topical or systemic agents to control pain.²

     Malignancy. Although sporadically reported for ileostomies and colostomies, malignancy has not been reported in ileal conduits. In the enterostomal literature,² malignancy can present with peristomal skin or stoma growth, pouch leakage, or a friable, brownish or grey mass. A history of gastrointestinal tumors should increase clinical suspicion. Confirmatory biopsy is required.

Standardized Peristomal Skin Assessment Tools

     Despite several decades of descriptive literature on peristomal skin complications among patients with ileostomies, colostomies, and urostomies, no standardized, clinically validated instrument to grade and classify these problems has gained international acceptance. The authors’ research identified three published classification tools.^4,17,18

     A Classification of Peristomal Skin,⁴ developed by an ETN and a dermatologist, was published in Sweden in 1988. It focused strictly on dermatologic changes beneath the ostomy appliance, dividing them into irritative lesions, erythematous/erosive lesions, and pseudoverrucous lesions. Severity was based on the area involved (severe erythematous lesions: >2 cm2, erosive: >1 cm2) and height of pseudoverrucous lesions (>3 mm to 5 mm).

     In 2007, Bosio et al¹⁷ (an Italian team of seven ETNs and four surgeons) proposed a system based on lesion severity and location. It included five lesion descriptions (hyperemic, erosive, ulcerative, necrotic, and proliferative) and five possible locations (four quadrants and total).

     The Ostomy Skin Tool,¹⁸ recently was developed by an international group of 12 expert ETNs working in collaboration with Coloplast (Minneapolis, MN) and a dermatologist. The tool is based on clinical observations of lesion area and severity in three domains: discoloration, erosion, and tissue overgrowth. Each of the six observations can be scored as 0, 1, or 2. The scores are added to calculate a composite score and implement a diagnosis algorithm. This tool can help guide investigations; allow reliable, quantitative monitoring of treatment effectiveness; and improve interdisciplinary communication. The tool is currently being validated in a large, multicenter international study.

Discussion

     A review of the literature revealed 14 published reports^1,3-15 of complication rates among patients living with ileal conduits. External peristomal complications after radical cystectomy are common; overall complication rate estimates vary widely between 15% and 65%.^{1,3-6,8-12,14} Studies typically include small populations and lack consistent definitions, making comparison between case series difficult. Causes of peristomal skin complications are multifactorial and include poor surgical technique, poorly fitting appliance, inappropriate use of the appliance and products, infection, poor healing, and patient risk factors such as obesity.

     Studying ileal conduit complications is difficult because conduits are usually a subset of all the stomas investigated and not all complications are stratified by stoma type. This is particularly important, given varying complication rates and complications unique to ileal conduits, such as alkaline encrustations. Study populations identified were heterogeneous in terms of time since surgery. Some case series spanned well over 20 years^6,10; five studies included patients operated in the last decade^1,3,5,8,10; and only two case series focused strictly on patients operated in the last 10 years.^1,5 In light of changing surgical techniques and stoma care standards, complication rates among patients operated decades ago may not apply to patients operated on today.

     The primary goal of the current endeavor was to study complication rates among patients with ileal conduits after radical cystectomy. All but two studies^1,6 reported rates for all ileal conduits, regardless of indication. Because rates of ileal conduit complications have been reported to be higher among women with urinary incontinence,^10,14 results of such studies might be biased.

     Three published assessment tools for stoma complications also were identified.^4,17,18 The most recently developed, the Ostomy Skin Tool, is currently being validated in a multicenter trial.¹⁸ The Coloplast Dialogue Study is ongoing and expected to end in June 2010 (see www.coloplast.com/ostomycare/topics/educationtools/the ostomyskintool/about/pages/validityofthetool.aspx). An objective, validated, comprehensive, and widely accepted classification system should facilitate documentation and comparisons, allow effective communications among physicians and ETNs responsible for the care of ostomy patients,⁴ and guide therapy. Current stoma care guidelines rely heavily on expert opinion rather than scientific evidence.^5,7 Standardized reporting of complications is a crucial step toward assessing the true incidence of peristomal complications using prospective, multicenter studies as well as toward studying the effectiveness of therapies by taking into account predisposing factors, clear interventions, and objective outcomes.

Conclusion

     A review of the literature found that external peristomal complications affect more than 50% of patients with ileal conduits after radical cystectomy and often go unrecognized. The few studies available have low enrollment and use inconsistent definitions. Evidence-based management approaches and long-term follow-up studies are needed.

Abstract

The urgent need to eliminate unnecessary use of antibiotics in wound patients has been hampered by diagnostic uncertainty and the time required to obtain culture results. The authors evaluated bedside use of a handheld bacterial fluorescence imaging device for real-time visualization of bacteria within and around wounds, used in addition to monitoring of clinical signs and symptoms of infection, in a series of 7 patients (5 women, 2 men; age range 57–93 years) with varying comorbidities who were referred to the wound ostomy continence clinician for wound assessment.

When excited by 405-nm violet light, tissues fluoresce green (collagens) and bacteria fluoresce red; specialized optical filters reveal these colored signals in real time on the device’s display screen. Wounds exhibiting red fluorescence were presumed to have moderate/heavy bacterial contamination (≥10⁴ CFU/g) and were subsequently swabbed. Swabs from the 5 wounds with regions of red fluorescence confirmed heavy growth of 1 or more pathogenic bacterial species. Images revealing pronounced bacterial fluorescence in 3 patients with pressure injuries about to be discharged led to prescription of systemic antibiotics and additional patient monitoring. In 2 patients (1 with a skin tear, 1 with a surgical wound), the absence of bacterial fluorescence prevented planned, unwarranted use of systemic antibiotics. Fluorescence images obtained bedside during routine wound assessments had a direct effect on antimicrobial stewardship practices. Follow-up images demonstrated antibiotic effectiveness and, in some instances, led to reduced antibiotic courses and duration. This case series demonstrates the potential use for real-time information on bacterial presence obtained via bacterial fluorescence imaging to guide evidence-based deployment of antibiotics and prevent unnecessary use. Additional studies to optimize the diagnostic potential and randomized controlled studies to examine the effect of this technique on antibiotic usage, antimicrobial stewardship practices, and wound outcomes are warranted.

Landmark reports on the rise and dangers of antibiotic resistance from the United States Centers for Disease Control¹ and the Chief Medical Officer for England² and 2016-2017 surveillance data from the World Health Organization’s Global Antimicrobial Surveillance System³ (data from 500 000 people with suspected bacterial infections across 22 countries) have reaffirmed that antibiotic resistance remains a growing public health crisis of global concern.⁴ A position paper from the European Wound Management Association⁵ (EWMA) on antimicrobial stewardship states that although multiple factors contribute to this global crisis, it is clear that antibiotic resistance is directly related to the level of antibiotic use. Treating a patient with commonly used antibiotics has been shown in cohort studies^5,6 to significantly increase risk for future infection by an organism resistant to antibiotics, which leads to increased morbidity, hospitalization, and health care cost.

Abstract

Many recent studies have focused on the potential role of topical agents in the wound healing process. To compare the time to healing of full-thickness wounds treated with topical estrogen, phenytoin, or silver sulfadiazine (SSD), an in vivo study was conducted using 32 male Wistar rats.

Animals were housed individually in standard cages in similar environmental conditions, and a single, circular (4 mm in diameter), full-thickness skin wound was created on the dorsum of each rat. Animals were randomly divided into 4 groups of 8 rats each and treated with topical phenytoin, SSD, estrogen cream, or no treatment/control. Each wound was measured and examined daily until healing, defined as complete reepithelialization and closure of the wound. Group mean healing times were calculated, and Tukey’s multiple comparison test was used to compare these data. Average times to healing were 11 days in estrogen group, 10 days in phenytoin group, 7.62 days in SSD group, and 11.87 days in control group. Wound healing was significantly faster in the SSD compared to control (P<.01) and the estrogen group (P<.01). No other differences were statistically significant. Further studies, especially randomized clinical trials on human beings with larger sample sizes, are recommended to elucidate if these topical agents affect wound outcomes.

Because the skin protects against dehydration, bleeding, and invasion of microorganisms, maintaining its integrity is important.¹ A wound, defined as the destruction of the epidermis and dermis, compromises the skin and prolonged healing time increases the risk of complications. Therefore, clinicians and researchers aim to decrease the healing time of wounds. 

Phenytoin was introduced as an antiepileptic drug in 1937; owing to the related complication of gingival hypertrophy, 2 in vivo studies,^2,3 a systematic review,⁴ and a comparison study⁵ investigated the probable effects of phenytoin on the wound healing process. These studies concluded phenytoin improves angiogenesis and increases pain tolerance during the healing process. In a comparative study by Hokkam et al,⁵ 54 patients with chronic venous ulcers received topical phenytoin once daily and 50 patients (the control group) received a dressing with normal saline. After 8 weeks, complete healing was observed in 64.8% of the patients in the study group and 52% of the patients in the control group (P = .04). The authors concluded topical phenytoin can be administered to improve chronic venous ulcer healing. In an experimental study,⁶ 24 Wistar rats with tibia fractures were divided into 2 groups; the study group was provided phenytoin 20 mg/kg, injected directly to the fracture site every 72 hours, while the control group had normal saline injected at the same intervals. After 28 days, histomorphometric assessment demonstrated the total periosteal callus was mineralized significantly more in the phenytoin group than the control group (P = .011), showing phenytoin had a positive effect in fracture healing. In a single-blind, placebo-controlled study (N = 100), Pereira et al⁷ excised 2 melanocytic nevi from each patient. One (1) of the injuries was provided a dressing with topical phenytoin 0.5% cream and the other a dressing with just cream (not specifically described in the study). Wounds treated with phenytoin demonstrated shorter healing time, more intense epithelialization, a smaller scar, and better cosmetic results. In a prospective, randomized controlled trial, Subbanna et al⁸ compared 28 patients with Stage 2 pressure ulcers, 14 randomly dressed with phenytoin and 14 with normal saline, for 15 days. Pressure ulcer healing scores were slightly higher and ulcer size slightly reduced with topical phenytoin treatment, but neither sets of data were significantly different statistically. However, measuring the serum levels of phenytoin in this study showed unremarkable systemic absorption and safety.

Silver sulfadiazine, a topical sulfonamide with bactericidal and bacteriostatic properties, has been traditionally used for burns. This drug has been reported effective in a systematic review⁹ on both Staphylococcus aureus and Pseudomonas and improves the wound healing process by inducing epithelialization and granulation tissue formation.¹⁰ Olawoye et al¹¹ included 144 patients with burn injuries of various thickness in their descriptive study and applied a layer of silver sulfadiazine over the entire wound. The mean duration from time of injury to wound healing was 21.5 days with a median of 17 days. The authors concluded open dressing with topical silver sulfadiazine is safe and efficient and should be regarded as a viable option for burn wound patients. 

In vivo study¹² has shown estrogen can affect neovascularization, proliferation of myofibroblasts, and secretion of growth factors. A significant difference in wound healing between men and women has been noted, as well as between women before and after menopause,^13-16 indicating sex hormones have an effect on the wound healing process. In vivo studies¹³ of estrogen and its derivatives have shown it can accelerate the wound healing process¹⁷ while androgens decelerate it. In an in vivo investigation by Gal et al,¹⁷ 16 rats were ovariectomized and 8 additional rats were sham operated. Two (2) parallel full-thickness skin incisions and 2 round full-thickness skin excisions were made on the dorsum of each rat. Eight (8) ovariectomized rats received estradiol benzoate for 6 days after the operation, while the other rats received a placebo. Histological examination of ovariectomized, estrogen-treated rats demonstrated a significant augmentation of neovascularization associated with enhancement of collagen deposition in their wounds. Systemic or topical administration of 17-beta-estradiol has been proposed to accelerate the wound healing process in postmenopausal women as well.^13-16 In these studies, different derivatives of estrogen were used, including conjugated estrogen, a topical derivate of estrogen. 

The aim of the present study was to compare the effects of topical phenytoin, silver sulfadiazine, and conjugated estrogen (the derivative available to the authors) on the healing of skin wounds in male rats.

Method

All experiments in this study were reviewed and approved by Arak University Animal Experiment Committee and performed in accordance with the Guidelines for the Care and Use of Laboratory Animals of Arak University of Medical Sciences, Arak, Iran. In the present experimental study, 32 10-week-old male Wistar rats weighing 275 g to 300 g were housed individually in standard cages under similar environmental conditions (temperature 18˚ C to 23˚ C, humidity 50% to 55%, 12-hour light/dark cycle using fluorescent light, and free access to food and water). Animals first were anesthetized in a glass vessel containing cotton wool soaked in chloroform; then their dorsal hair was shaved using a standard electric shaver, and the shaved area was rinsed with normal saline. Next, under sterile conditions, a single, circular (4 mm in diameter), full-thickness skin wound was made on the dorsum of each rat using a sterile disposable biopsy punch (Kai Industries Co. Ltd, Gifu, Japan). The depth of the induced wound was controlled by excising the epithelial tissue to the extent that the dorsal muscular fascia was exposed. Then, the animals were randomly divided into 4 groups (8 rats with 8 wounds in each group), and each sample was given a specific code and a checklist sheet. Wound surfaces were rinsed with normal saline and dried gently every day. In group 1, wounds were covered with 2-mm thick phenytoin 1% ointment; in group 2, silver sulfadiazine 1% ointment; in group 3, conjugated estrogen 0.625% ointment; and in group 4 (control) simple ointment (Eucerin cream, Beiersdorf AG, Wilton, CT) was applied daily, all without cover dressing. The base vehicles of these ointments (base vehicles were not the same but did not differ regarding wound adhesion) had no wound healing properties. Each wound was examined for possible infection every day, and its unepithelialized area was measured using a mm ruler. Results were recorded until complete healing, defined as complete reepithelialization and closure of wound surface. After completion of the experiment, rats were sacrificed by decapitation with a guillotine. The healing times in the 4 groups were compared using one-way variance analysis, and Tukey’s multiple comparison test was used to compare mean healing times. A P value <.05 was considered significant.

Results

The mean time to healing was 10 ± 1.7 days in the phenytoin group, 7.62 ± 0.72 days in the silver sulfadiazine group, 11 ± 1.81 days in the conjugated estrogen group, and 11.87 ± 2.01 days in the control group (see Table). In other words, the shortest healing time occurred in the silver sulfadiazine group and the longest in the control group. The difference in time to healing was statistically significant only between the silver sulfadiazine and conjugated estrogen cream groups (P≤.01). 

Discussion

The results of this study showed silver sulfadiazine is effective in wound healing and reduces the healing time in comparison with the control group and conjugated estrogen. In this study, the effects were approximately similar in phenytoin, estrogen, and control groups and these treatments had no advantage over one another. To the authors’ knowledge, this comparison has not been made in the literature; most studies investigated the effects of only 1 of these agents on the process of wound healing.

Phenytoin. The mechanism of action of topical phenytoin in wound healing remains a subject for debate. According to several clinical trials,^18-20 phenytoin promotes proliferation of myofibroblasts and fibroblasts, the production of the extracellular matrix and its proteins, and the activity of growth factors. Eventually, collagen synthesis is enhanced, resulting in increased wound strength. Phenytoin also decreases collagenase activity, edema, wound exudate, and bacterial load. In a study conducted by Hasamnis et al,² excisional wounds in 20 male Wistar rats were divided randomly to the control group (A) that received no drug and the treatment group (B) that received 1% phenytoin cream on their wounds for 16 days. This study showed the average number of days required for complete epithelialization of wounds in group B (20.60 ± 1.51) was significantly less than the period required for complete epithelialization in group A (23.00 ± 2.26) (P = .0120). The experimental study by Mathew et al⁶ demonstrated phenytoin had a positive effect in fracture healing. Beigom Taheri et al²¹ divided 60 rats into 4 groups: group 1 served as the control and the wounds in groups 2, 3, and 4 were treated with 1% phenytoin cream, diode laser, and both phenytoin cream and diode laser, respectively. Histopathologic features of reepithelialization of wounds in these groups were compared; reepithelialization was complete in all animals of the 4 groups and a keratin layer was generated, but in the phenytoin group the healing process was slower. The result for the phenytoin-treated group was not better than in the control group, which was similar to current study results.

Estrogen. The discovery of the crucial role of estrogen in skin physiology resulted in the hypothesis that it may have an important role in wound healing.^14-16 Several studies have demonstrated estrogen might be involved in wound healing in terms of altering the inflammatory response, enhancing reepithelialization, inducing granulation formation, modifying proteolysis, and balancing collagen biosynthesis and degradation.¹⁶ However, conflicting results were obtained in the research. In the review of histological process of wound healing in animals by Gal et al,¹⁷ significant augmentation of neovascularization associated with enhancement of collagen deposition was reported. In the clinical trial conducted by Ghazizadeh Hashemi et al,¹⁵ patients with traumatic wounds were divided to 2 groups of 15. The case group was treated with topical conjugated estrogen cream, while the control received Eucerin cream as a placebo. Wound area, healing rate, and required time for wound healing were compared, and no significant differences were found between the 2 groups for these factors. These findings are comparable with the current results. A clinical trial conducted by Asilian et al²² found topical estrogen resulted in slower wound healing in comparison with phenytoin and silver sulfadiazine, also similar to the results of the current study.

Silver sulfadiazine. Silver sulfadiazine is best known for its antibacterial properties. The application of silver sulfadiazine was associated with favorable results in surgical wounds, burns, and wound healing in systematic reviews⁹ and descriptive studies,¹⁰ albeit with conflicting results. A recent systematic review by Wasiak and Cleland²³ reported silver sulfadiazine may prolong healing time and increase pain, although the authors noted the existing evidence was limited by small sample sizes and the heterogeneity of the patient population. In a large systematic review, Miller et al¹⁰ concluded data are lacking to either confirm or disprove the routine use of silver sulfadiazine for patients with partial-thickness burns or stasis dermatitis ulcers.

In the current study, the average time to healing in the silver sulfadiazine group was shorter than in the phenytoin group, although the difference was not statistically significant. These 2 substances appeared to have almost similar effects, a finding comparable to results of the in vivo study by Shamseddini et al.²⁴ Furthermore, the authors of the current study found a significant decrease in the time to healing in the silver sulfadiazine group in comparison with the estrogen and control groups. Although the results of some studies^9,10,25-27 support these findings, other in vivo and review studies found increased rates of healing were obtained with other agents such as argan oil,²⁸ silver nanoparticles,²⁹Lithospermum officinale,³⁰ and honey³¹ in comparison with silver sulfadiazine.

Limitations

The current study was limited by the rather small sample size and the inherent limitations of in vivo research.

Conclusion

A study of wounds in rats that compared 3 topical products to each other and to a control group showed wound healing was significantly faster in the silver sulfadiazine compared to the control and estrogen groups. No other differences were statistically significant. However, conflicting data in the literature about these topical agents, as well as the limitations of animal research, infer that additional studies, especially randomized clinical trials on human beings involving larger samples, are recommended to elucidate the best therapeutic options for patients with wounds. 

References

1. Simpson NB, Gunliff WJ. Rook S. Textbook of Dermatology, 7th ed. Oxford, UK: Oxford Blackwell Science;2004:11–38.

2. Hasamnis A, Mohanty B, Muralikrishna, Patil S. Evaluation of wound healing effect of topical phenytoin on excisional wound in albino rats. J Young Pharm. 2010;2(1):59–62.

3. Chan FC, Kennedy C, Hanson RP, O’Sullivan B, Kelly J, Bouchier-Hayes D. Topical diphenylhydantoin sodium can improve healing in a diabetic incision animal wound model. J Wound Care. 2007;16(8):359–363.

4. Shaw J, Hughes GM, Langan KM, Bell PM. The clinical effect of topical phenytoin on wound healing: a systematic review. Br J Dermatol. 2007;157(5):997–1004.

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8. Subbanna PK, Margaret Shanti FX, George J, et al. Topical phenytoin solution for treating pressure ulcers: a prospective, randomized, double-blind clinical trial. Spinal Cord. 2007;45(11):739–743.

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Abstract

Care of the patient with an ostomy is included in the curriculum of prelicensure nursing programs, but no studies examining student nurses’ knowledge about stoma care have been published. The purpose of this project was to examine the ostomy knowledge, experiences, and confidence of nursing students in order to assess and improve the curriculum.

At the end of the fall 2016 semester, students enrolled in 3 separate nursing courses in an undergraduate program were asked to participate in a project to examine students’ ostomy knowledge, their experiences, and their confidence in providing care. This project was undertaken to explore the college’s ostomy curriculum. Participation was voluntary, and no student who was willing to participate was excluded. Students completed a 50-question knowledge test, answered questions about the frequency of performing ostomy-related skills, and rated their confidence in providing ostomy care. Responses were examined with descriptive and inferential statistics. Of 189 possible participants, 138 completed the questionnaires and included mostly women (113, 81.9%); participant mean age was 27.26 ± 6.22 years. The mean number of correct knowledge responses was 35.66 (71.32%); 66 participants (47.8%) reported no experience caring for a patient with an ostomy. The most common skills performed in clinical rotations were emptying (49) and changing (24) the pouch. A scale of 1 to 5 was used to evaluate 6 confidence items, with students having a mean confidence score of 19.54 ± 5.20. They had the most confidence in their ability to empty a pouch and to size and fit the pouching and the least confidence in teaching and community resources. Confidence was related to the number of skills performed in the lab (r = .32; P<.001), the number of skills performed in clinical practice (r = .38; P<.001), and ostomy knowledge scores (r = .23; P<.007). Total correct knowledge scores did not differ significantly by year in the educational program. Based on the results of this survey, it was concluded that students had a beginning knowledge about ostomy care and very limited clinical experience, yet confidence in providing ostomy care was high. Curriculum adjustments were implemented, including strategies for increasing ostomy knowledge, opportunities to provide care, and confidence; these need further investigation in prelicensure undergraduate nursing programs. The effect of curriculum adjustments remains to be evaluated.

Knowledge about the care of patients with an ostomy typically begins in undergraduate nursing educational programs. This foundational nursing education is critical; more than 750 000 Americans are living with an ostomy and more than 130 000 new ostomy surgeries occur in America yearly.¹ As many as 70% of persons with a stoma experience a stomal or peristomal complication.^2,3 The nursing care and teaching of patients with an ostomy require specific knowledge and skills.⁴ The Wound Ostomy Continence Nurses (WOCN) Society, the American Society of Colon and Rectal Surgeons, and the American Urological Association recommend preoperative and postoperative ostomy education be provided by a wound ostomy continence (WOC) nurse.^5-7 According to a number of studies done with surgical patients, pre- and postoperative teaching of persons with a stoma has been linked to a decrease in length of hospital stay, decrease in time to stoma care proficiency, a reduction in use of community resources postdischarge, and improvements in adjustment and quality of life.^8-10 However, due to a number of factors, including limited availability of WOC nurses and a decreasing length of stay secondary to improved surgical techniques and enhanced recovery after surgery programs, this may not always be possible.^11,12 Thus, nursing students, as future registered nurses, also need to have basic ostomy knowledge, be able to perform ostomy care/skills at a beginning level, and have confidence in their ability to perform ostomy care. Examining prelicensure undergraduate students’ ostomy knowledge, ostomy skill, and confidence in providing ostomy care is critical. The purpose of this assessment project was to examine prelicensure baccalaureate undergraduate nursing students’ knowledge about ostomy care, their ostomy skill experiences, and their confidence in providing ostomy care. This assessment project was conducted to examine ways to improve the curriculum regarding ostomy teaching in a prelicensure undergraduate baccalaureate nursing program. 

Literature

Research regarding prelicensure baccalaureate students’ ostomy knowledge, experiences with ostomy care, and confidence in providing ostomy care was not found. Therefore, literature about registered nurses’ knowledge, experiences, and confidence with patients with an ostomy was examined; even this research literature was scarce. 

Gemmill et al¹¹ explored acute care oncology nurses’ knowledge and attitudes in the care of patients with an ostomy; 21 nurses of varying educational backgrounds and levels of experience completed a questionnaire designed to assess their knowledge and attitudes. Nurses’ average score on the ostomy knowledge survey was 77%, and most nurses (80%) felt confident in their ability to assess patients with an ostomy well enough to care for the patient. However, only 30% of these same acute care oncology nurses felt they received adequate inservices/staff education to keep knowledge up-to-date, and most (70%) expressed concern about how prepared patients were to care for themselves at home. The authors¹¹ simultaneously surveyed patients who had undergone ostomy surgery and who were cared for on the same acute care units as the nurse participants; 12.5% of patients identified the education received from nurses postoperatively as being useful. Interestingly, 60% of these patients stated that most of the education they received did not occur in the hospital during the postoperative period but instead in the preoperative clinic setting. 

Duruk and Uçar¹³ examined staff nurses’ (N = 100) knowledge and perceived responsibility for providing ostomy care. Approximately 43% stated they cared for a patient with a stoma on a regular basis, and approximately 30% indicated they were willing to receive additional training required for specialization in this practice. Out of 54 items that measured knowledge of ostomy care, the mean score was only 24.9. Therefore, despite regularly caring for patients with a stoma, knowledge was inadequate. A majority of these nurses also indicated that either the physician or a company representative was primarily responsible for ostomy education, and 26% believed ostomy care and education were the responsibility of the clinic nurse or ostomy nurse.

Cross et al⁴ examined the staff nurses’ confidence in their skills, their knowledge of ostomy care, and barriers to care for the patient with an ostomy. The authors received completed questionnaires from 576 nurses with varied educational levels. Greater confidence in ostomy care knowledge was associated with more education, years of nursing experience, higher frequency of providing ostomy care, and knowing how to obtain and use supplies. Nurses’ had the most confidence in emptying an appliance and the least in teaching nutrition. Nurses’ greatest concern was the potential to hurt the patient. The authors concluded continuing education about ostomy care may increase nurses’ confidence in providing ostomy care. 

Purpose

The purpose of this project was to examine ostomy knowledge, ostomy skill experiences, and confidence in providing ostomy care among prelicensure baccalaureate undergraduate nursing students. This project was performed to identify gaps in the teaching of theoretical and clinical ostomy content in an undergraduate educational program with the goal to inform teaching and learning in the curriculum. Graduates of prelicensure programs need to have ostomy care knowledge to facilitate patient teaching and reinforce the teaching performed by WOC or other specialty nurses. 

 The following questions were asked:

1. What is the ostomy knowledge level of prelicensure undergraduate baccalaureate nursing students? What ostomy knowledge questions have a high correct response and which have a low correct response?

2. How many and what types of ostomy care experiences do prelicensure baccalaureate undergraduate nursing students have in the learning and/or simulation laboratory and clinical practice?

3. How confident are prelicensure undergraduate baccalaureate nursing students in providing ostomy care?

Methods

Participant enrollment and procedure. At the end of the fall 2016 semester, faculty told students across the 3 years of the prelicensure undergraduate baccalaureate educational program about the project during a clinical post-conference session for the students in fundamentals and medical-surgical nursing courses and after the lecture for the critical care course. Students were invited to participate in the assessment project and were told the purpose of the project, details of the survey, and that responses were anonymous. Students were informed the goal of the project was to improve the curriculum about the care of the person with an ostomy. They were free to respond or not respond to items on the survey. Because participation or nonparticipation was both voluntary and anonymous, students were assured their course grade would not be affected. Each student responded to the survey 1 time. All students in the selected courses were asked to participate; there were no exclusion criteria. The survey was paper/pencil and took approximately 30 minutes to complete. 

Design. This project was developed as a curricular assessment project, used a survey methodology, and was conducted by 2 faculty. Because this was not a human subjects research study, it was determined that Institutional Review Board approval was not required. The authors assessed a component of an internal educational program in terms of student knowledge, skill, and confidence in the care of a person with an ostomy. The faculty used the students’ responses to this project to examine course content and learning experiences to enhance stoma care teaching. 

Participants. Students in this project were enrolled in either a traditional or a second career/accelerated baccalaureate program. The content and experiences in both programs are the same; the second career program progresses at a faster pace. Potential clinical experiences with patients who have an ostomy occur across the curriculum in this baccalaureate prelicensure nursing program. 

Students in their first year of nursing take a fundamentals of nursing course. During this course, they receive a 1-hour basic lecture about the anatomy and functioning of fecal and urinary ostomies, pouch emptying and changing, diet, fluids, self-care, sexuality, and mental health. Because this is the first nursing course, ostomy complications and peristomal skin changes are not discussed. The lecture content follows the nursing fundamentals textbook,¹⁴ which has sections about meeting the needs of patients with bowel or urinary diversion. The textbook incorporates text and pictures about the person with an ostomy and the care required. During laboratory practice (3 hours), students handle ostomy pouching systems and measure and apply a pouch to a mannequin. Pouch selection is limited to either a 1- or 2-piece drainable appliance. Use of accessory products such as paste or barrier rings is not included. During the clinical experience, which takes place on a variety of medical-surgical units in a number of acute care hospitals (6.5 hours per week), students may be assigned patients who have an ostomy. However, patient assignments are dependent on the patient population at the assigned unit as well as faculty preference in the selection of patients.

Students in the second year of the program take 2 separate yet related medical-surgical nursing courses. Course content includes two 1- to 2-hour sessions during class time that focus on care of the patient with urinary and intestinal disorders. This includes discussion of the management of patients with urinary and fecal diversions but only in relation to specific disease processes. For example, colostomies are discussed as an outcome of treatment for colon cancer. Clinical experiences occur in an acute care setting for 6.5 hours per day, 1 day per week, on a variety of medical-surgical units. As with students in the first year of the program, hands-on experience with a patient with an ostomy is inconsistent. The course includes a simulation laboratory experience on the care of a patient who has both an ileostomy and heart failure. This simulation requires the student to change an ostomy pouching system as well as integrate the concepts of fluid and electrolyte balance; however, the focus of the simulation is on the cardiac condition, not ostomy management. As in the first year of the nursing program, ostomy complications and skin changes are not discussed and the focus is on the immediate physical care of the patient as opposed to psychosocial or discharge needs.

Students in the third year of the prelicensure program take a course focused on critical care. The critical care course contains lecture content about the critically ill patient but does not include content specific to the care of a patient with an ostomy or a clinical component. Students in this year also take 2 additional courses (leadership and immersion); these courses include clinical experiences but course content does not focus on the person with an ostomy.

Across all years, the clinical sites for courses vary in the types of patients that students encounter. For example, 1 clinical site might have primarily postoperative patients while another clinical site’s patient population may have a cardiac focus. Students’ assignments are based on a combination of course objectives, faculty preference, and available patients. Therefore, despite course objectives, there may not be a patient with a urinary or fecal diversion on the assigned unit or the faculty may not choose the patient with an ostomy for any number of reasons. 

Survey instruments. The study authors used questions based on established questionnaires and developed new survey instruments for this assessment. The first part included basic demographic questions (gender, age) and asked participants to state which nursing course they currently were enrolled in.

Zimnicki-Pieper Knowledge Test. The Zimnicki-Pieper Ostomy Knowledge Test (Z-POKT) was developed based on a review of the literature and professional experience to measure ostomy knowledge. The Z-POKT consists of 50 true-false-do not know items. This type of test format is quick for students to answer and easy to score. If study participants did not know an answer, they were asked to not guess but to check do not know. Questions with a do not know response or items left blank were considered wrong when tabulating scores. The total Z-POKT score was obtained by tabulating the number of correct answers. 

Before the Z-POKT was used for the study, 12 WOC nurses were asked to evaluate the appropriateness of the questions for ostomy knowledge for prelicensure students enrolled in a baccalaureate nursing program. These nurses did not give suggestions for items to be revised, added, or removed from the test. All gave a global response that the test was appropriate. The Z-POKT’s Cronbach’s alpha was 0.75 on this initial use.

 The Ostomy Skills section lists 5 skills: measure stoma, cut pouching system, change pouching system, empty pouching system, and apply paste or barrier ring. Students distinguished between the described tasks they performed in the learning and/or simulation laboratory and those tasks they performed in clinical practice with patients by placing a check mark in the box by the item. The checked items were tabulated for a total number of skills performed in each setting. 

In the Confidence with Ostomy Care section, students were asked to rate their confidence using an adaptation of 1 section of the City of Hope Staff Survey on Ostomy Care¹⁵ that included knowledge of different types of pouching systems, determining fit and size of a pouching system, applying an ostomy pouch, emptying an ostomy pouching system, teaching ostomy care for self-care at home, and advising the patient about community resources. They completed the thought, I feel confident in my… or I feel confident that I can…. Each was scored 1 (strongly disagree) to 5 (strongly agree). Total confidence scores could range from 6 (low) to 30 (high).

Statistical analysis. Responses to the survey were entered into an Excel file. The file was converted for analysis by the IBM Statistical Package for the Social Sciences (SPSS Statistics, (Armonk, NY). Responses were primarily examined using descriptive and correlational statistics; when appropriate, inferential statistics also were used for comparisons. The project intention was not to compare ostomy knowledge, skills, and confidence by year in the program. However, because information about this topic is so limited, some outcomes were compared by program year using analysis of variance. 

Results

Student participants. Of the 189 possible student participants, 138 students completed the surveys; the majority were women (113, 81.9%), and mean age of participants was 27.26 ± 6.22 years. Sixty-six (66) students (48.2%) reported they never cared for a patient with an ostomy, 51 (37.2%) reported caring for 1 to 2 patients with an ostomy, and 20 (14.6%) cared for 3 or more patients with an ostomy.

Students’ knowledge. The Z-POKT correct scores ranged from 12 to 45; the mean number of knowledge items answered correctly was 35.66 (71.32%). Items with the highest number of correct responses on the Z-POKT are presented in Table 1 and included conditions requiring ostomy surgery (96.4%), information related to emptying the pouch and removing and applying a pouching system (96.4%), foods causing gas (95.7%), and when to empty a pouching system (94.9%). Items with the lowest number of correct responses on the Z-POKT are presented in Table 2 and included moldable paste is like glue (8%), knowledge of neobladders (16.7%), knowledge of internal anal reservoir (18.1%), and whether a permanent colostomy is created during an abdominal perineal resection (27.5%). Total Z-POKT correct scores (mean ± standard deviation) by year included sophomores (36.54 ± 4.51), juniors (34.43 ± 6.33), and seniors (35.3 ± 4.68); these scores did not differ significantly by year in the baccalaureate educational program.

Prelicensure undergraduate students’ experiences performing ostomy care. The mean number of ostomy experiences performed in the learning and/or simulation laboratories was 3.06 ± 1.75. The most common learning and/or simulation experiences were measuring stoma size (102) and changing the pouching system (100). The mean number of ostomy care experiences performed during clinical practice was 0.99 ± 1.62. The most common clinical experiences were emptying the pouching system (49) and changing the pouching system (24). The number of students who performed ostomy care skills in either the learning and/or simulation laboratory or clinical practice is presented in Table 3. Neither the number of learning and/or simulation laboratory experiences nor direct patient ostomy care experiences was significantly related to Z-POKT scores. Skill laboratory and/or simulation laboratory experiences did not differ significantly by year in the program. Students in the second year (mean 1.63) performed significantly more ostomy skills in clinical practice than those in the first year/fundamentals course (mean 0.58) or third year (mean 0.95) (F[2, 137] = 6.36; P = .002). 

Prelicensure students’ confidence in performing ostomy care. Prelicensure undergraduate students’ confidence scores ranged from 6 to 30; the mean confidence score was 19.54 ± 5.20. Item confidence scores are shown in Table 4. Student confidence was highest in terms of ability to empty a pouch (mean 3.82 ± 1.07) and to size and fit a pouching system (mean 3.55 ± 0.99). Student confidence was lowest in ostomy teaching (mean 2.86 ± 1.11) and community resources (mean 2.64 ± 1.05). Higher confidence in ostomy care was significantly related to higher number of skills performed in the learning and/or simulation laboratories (r = 0.3; P <.001), higher number of ostomy skills performed in clinical practice (r = 0.38; P<.001), and higher knowledge scores on Z-POKT (r = 0.23; P = .007). Students in the first-year fundamentals course (mean 20.64) had significantly higher mean confidence scores than second-year (mean 18.76) or third-year (17.45) students (F[2, 134] = 3.86; P  = .024). 

Discussion

Prelicensure baccalaureate undergraduate nursing students’ ostomy knowledge, skill experiences, and confidence in providing ostomy care were examined. To the authors’ knowledge, this is the first project to examine these factors. Mean ostomy knowledge levels were low (71%). Almost 50% of students had no experience caring for a patient with an ostomy. Most experiences that students had were obtained in a skills or simulation laboratory. In clinical practice, students primarily emptied or changed the appliance. Confidence levels were at the midpoint of the scale. Students in the first course had significantly higher confidence, possibly due to the amount of content in that course in relation to ostomy care. 

 Cross et al⁴ noted the nursing care of patients with ostomies requires specific skills. Students in the current project had few opportunities to provide ostomy care for hospitalized patients. These findings with students are not much different from studies that included registered nurses. Even registered nurses had concerns about ostomy experiences. Gemmill et al¹¹ reported only 30% of oncology nurses (576) felt that they cared for enough patients with ostomies or received adequate in-services/staff education to maintain their skills. Due to the lack of opportunities to provide care, many nurses expressed concern that ostomy patients were poorly prepared for discharge. 

 Having confidence in their ability to provide ostomy care was approximately a midpoint score for nursing students in this project. In contrast, Gemmill et al¹¹ reported 80% of acute care oncology nurses felt confident in their abilities to provide ostomy care. Cross et al⁴ reported nurses’ greatest confidence was in emptying an appliance and the lowest was in teaching nutrition. Similarly, students in the current study also had the highest confidence in emptying an appliance and the lowest confidence in ostomy teaching and in the use of community resources. Cross et al⁴ concluded that continuing education about ostomy care may increase nurses’ confidence in providing ostomy care. The current authors also found higher student confidence in ostomy care was related to a higher number of skills performed in skills laboratory, higher number of ostomy skills performed in clinical practice, and higher knowledge scores. 

Knowledge about ostomy care is important for patient teaching and the provision of safe patient care. Because they did not have data linking students’ knowledge with patient teaching and safe care, the current authors looked at literature available about nurses. In its outcome criteria for discharging patients with a new ostomy from acute and home care, the WOCN Society¹⁶ states teaching the patient/caregiver is paramount; thus, nurses’ knowledge and confidence in that knowledge is critical. Because not all clinical facilities have access to a nurse certified in ostomy care, all nurses need to have knowledge of ostomy care to facilitate patient teaching and identify resources for patients to provide continued support. Such education is imperative because pre- and postoperative teaching for ostomates has been linked to positive health outcomes, including a decrease in length of stay, decrease in time to stoma care proficiency, a reduction in use of community resources postdischarge, and an improvement in adjustment and quality of life.^8-10 

Gemmill et al¹¹ explored acute care oncology nurses’ ostomy knowledge; their average knowledge score was 77%. This is not much different from the current study’s students’ average score of 71%. Cross et al⁴ reported only 12.5% of patients identified the education received from nurses postoperatively as being useful; this may be because nurses lacked knowledge and confidence. Cross et al⁴ also found higher confidence in ostomy care knowledge was associated with more education, years of nursing experience, higher frequency of providing ostomy care, and knowing how to obtain and use supplies.

Effect on curriculum. This assessment project had a positive effect on the authors’ curriculum. More ostomy equipment, such as appliances and stoma models, was added to the learning and simulation laboratories to allow students to better practice preparing and applying the pouching system. This encouraged all course faculty to refresh their own knowledge of ostomy management and to reinforce content taught in lecture about ostomy care. Due to time constraints in all courses, an effective way to incorporate content on peristomal skin and ostomy complications has yet to be found. This is despite the literature reporting that more than 75% of persons living with an ostomy develop peristomal skin problems.¹⁷ For example, Taneja et al¹⁸ reported 36.7% of their study participants had a peristomal skin complication in the 90-day period following the surgery, and the total health care costs were almost $80 000 higher for persons with peristomal complications.¹⁸ 

Given the amount of material that must be covered in nursing courses, prelicensure baccalaureate programs must explore educational strategies for incorporating ostomy content. For example, in addition to simulation experiences, wearing an ostomy appliance for a day has been used as a strategy to teach ostomy care to nursing students.^19-21 Some students used the experience to explore emotions and to blog the experiences²¹; others wrote a self-reflection of the experience.²⁰ Because not all ostomy-related education can take place in the prelicensure period, this study highlights the need for collaboration between prelicensure programs and their clinical partners in order to provide future and current nurses with the education and experiences needed to care for this unique patient population. 

Limitations 

This project had limitations. Students volunteered to participate; thus, they may not represent all students’ knowledge, experiences, and confidence. The sample size was small, especially for the third-year students. Because this was a 1-time project, it is not known whether changes to the learning experiences or knowledge occurred in a specific course or across the curriculum. A longitudinal project would provide additional information that may enhance curricular design, including how to best level the knowledge and experiences specific to ostomates across the curriculum. Finally, the project examined only factual knowledge and technical skills and did not examine students’ perceptions of the patient or the provision of care with dignity. Further research, such as replication of the study in other institutions/programs, is needed with nursing students in terms of ostomy care as well as the transition of the student to the registered nurse role.

Conclusion

Nursing students need knowledge to assess patients with ostomies, to educate patients/family members regarding ostomy care, and to develop strategies for effective self-care. The purpose of this project was to examine ostomy knowledge, experiences, and confidence of nursing students in order to assess and improve the curriculum. In this study, students, like many nurses, indicated they have few opportunities to provide care to patients with ostomies. This lack of experience may contribute to students having a low level of knowledge and a lack of confidence in their ability to provide care to the patient with an ostomy. Although the project helped inform the curriculum, more research is needed to examine nursing student knowledge at other institutions, integration of the new content into the curriculum, effective teaching strategies, and the impact of these changes as students’ transition to the role of the registered nurse.

References

1. United Ostomy Associations of America. Available at: www.ostomy.org/About_the_UOAA.html. Accessed August 2, 2017.

2. Beitz JM, Colwell JC. Management approaches to stomal and peristomal complications. J Wound Ostomy Continence Nurs. 2016;43(3):263–268. 

3. Salvadalena G. Incidence of complications of the stoma and peristomal skin among individuals with colostomy, ileostomy, and urostomy: a systematic review. J Wound Ostomy Continence Nurs. 2008;35(6):596–607.

4. Cross HH, Roe CA, Wang D. Staff nurse confidence in their skills and knowledge and barriers to caring for patients with ostomies. J Wound Ostomy Continence Nurs. 2014;41(6):560–565.

5. Goldberg M, Aukett LK, Carmel J, et al; Ostomy Guidelines Task Force. Management of the patient with fecal ostomy: best practice guideline for clinicians.J Wound Ostomy Continence Nurs. 2010;37(6):596-598.

6. American Society of Colon and Rectal Surgeons Committee Members, Wound Ostomy Continence Nurses Society Committee Members. ASCRS and WOCN joint position statement on the value of preoperative stoma marking for patients undergoing fecal ostomy surgery. Joint position statement on the value of preoperative stoma marking for patients undergoing fecal ostomy surgery. J Wound Ostomy Continence Nurs. 2007;34(6):627–628.

7. American Urological Association and Wound Ostomy Continence (WOC) Nurses Society. Joint position statement on the value of preoperative stoma marking for patients undergoing creation of an incontinent urostomy. J Wound Ostomy Continence Nurs. 2009;36(3):267–268.

8. Chaudri S, Brown L, Hassan I, Horgan AF. Preoperative intensive, community-based vs. traditional stoma education: a randomized, controlled trial. Dis Colon Rectum. 2005;48(3):504–509. 

9. 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.

10. Younis J, Salerno G, Fanto D, Hadjipavlou M, Chellar D, Trickett J. Focused preoperative patient stoma education, prior to ileostomy formation after anterior resection, contributes to a reduction in delayed discharge within the enhanced recovery programme. Int J Colorectal Dis. 2012;27(1):43–47.

11. Gemmill R, Kravits K, Ortiz M, Anderson C, Lai L, Grant M. What do surgical oncology staff nurses know about colorectal cancer ostomy care? J Contin Educ Nurs. 2011;42(2):81–88. 

12. Burch J. Stoma care and enhanced recovery. Gastrointestinal Nurs. 2012;10(7):26–32.

13. Duruk N, Uçar H. Staff nurses’ knowledge and perceived responsibilities for delivering care to patients with intestinal ostomies: a cross-sectional study. J Wound Ostomy Continence Nurs. 2013;40(6):618–622.

14. Bowel elimination. In: Taylor C, Lillis C, Lynn P, LeMone P. Fundamentals of Nursing:The Art and Science of Person-Centered Nursing Care. Philadelphia, PA: Wolters Kluwer;2015:1343–1394.

15. City of Hope Pain and Palliative Care Resource Center. Staff survey on ostomy care. Available at: http://prc.coh.org/res_inst_new.asp. Accessed July 9, 2018.

16. Colwell JC, Kupsick PT, McNichol LL. Outcome criteria for discharging the patient with a new ostomy from home health care: a WOCN Society Consensus Conference. J Wound Ostomy Continence Nurs. 2016;43(3):269–273.

17. Colwell JC, NcNichol L, Boarini J. North America wound, ostomy, and continence and enterostomal therapy nurses current ostomy care practice related to peristomal skin issues. J Wound Ostomy Continence Nurs. 2017;44(3):257–261.

18. Taneja C, Netsch D, Rolstad BS, Inglese G, Lamerato L, Oster G. Clinical and economic burden of peristomal skin complications in patients with recent ostomies. J Wound Ostomy Continence Nurs. 2017;44(4):350–357.

19. Kerr N. Ostomate-for-a day: a novel pedagogy for teaching ostomy care to baccalaureate nursing students. J Nurs Educ. 2015;54(8):445–449. 

20. Maruca AT, Diaz DA, Kuhnly JE, Jeffries PR. Enhancing empathy in undergraduate nursing students: an experiential ostomate simulation. Nurs Educ Perspect. 2015;36(6):367–371.

21. Reed KS. Bags and blogs: Creating an ostomy experience for nursing students. Rehabil Nurs. 2012;37(2):62–65.

Potential Conflicts of Interest: none disclosed

Dr. Zimnicki is an Assistant Professor, Clinical; and Dr. Pieper is a Professor/Nurse Practitioner, College of Nursing, Wayne State University, Detroit, MI. Please address correspondence to: Katherine Zimnicki, DNP, RN, CWOCN, College of Nursing, Wayne State University,5557 Cass Avenue, Detroit, MI 48202; email: av2284@wayne.edu.

Abstract

Pressure ulcers (PUs) are detected by visual skin assessment (VSA). Evidence suggests ultrasound (US) and subepidermal moisture (SEM) scanner technology can measure tissue damage before it is visible. Purpose: A pilot study was conducted to evaluate consistency between SEM and US examinations of suspected deep tissue injury (sDTI).

Method: Using an observational, prospective cohort study design, patients >55 years of age were recruited. VSA, SEM, and US assessments were performed daily for a minimum of 3 and maximum of 10 consecutive days following enrollment. US results were considered indicative of sDTI if hypoechoic lesions were present. SEM readings were considered abnormal when ∆ ≥0.6 was noted for at least 2 consecutive days. Boolean analysis was utilized to systematically determine consistency between US and SEM where sDTI was the clinical judgment. Results: Among the 15 participants (10 women, mean age 74 ± 10.9 years), there was consistent agreement between SEM and US when sDTIs existed. For 1 patient who developed a heel sDTI during the study, SEM readings were abnormal 2 days before VSA indicated tissue damage and 3 days before the appearance of a hypoechoic lesion in the US. Conclusion: US and SEM results were similar, and in an evolving sDTI case, SEM detected a lesion earlier than US. 

One of the greatest gaps in preventing pressure ulcers (PUs) is, in the authors’ opinion, the available and implemented technology. In nearly every field of modern medicine, clinician assessments are routinely supported by basic technological aids that effectively screen and diagnose (eg, electrocardiography and blood pressure measurements in cardiology). However, in wound prevention and care, clinicians traditionally depend mostly on visual assessment, because potentially helpful, high-end technologies such as bedside imaging examinations or immunoassays are not yet part of the regular diagnostic protocol. All currently used risk assessment tools include a visual skin assessment (VSA) or are conducted in conjunction with a VSA. Moreover, VSAs are conducted as part of the usual care if a patient has been determined to be at risk for PUs. 

In the last 2 decades, PU research has made considerable progress in understanding wound etiology and specifically revealed that PUs may develop internally under intact skin.¹ Clinical practice has evolved accordingly, redefining PU classifications and adding suspected deep tissue injury (sDTI) to American and international classification systems.¹ 

This new understanding and the global consensus reflected in the current literature that damage may occur in deep tissues and progress toward more superficial layers until eventually presenting on the skin create a difficult situation. In the case of an existing (or a progressing) sDTI, assuming clinical signs such as the typical red, maroon, or purple local discoloration of the skin (as per the definition of a sDTI) are in evidence, a clinician performing a VSA will document existing tissue death. In other words, even successful detection of these clinical signs via routine VSAs will, by definition (of a DTI), document existing subdermal tissue damage rather than prevent it. 

This dilemma originates from the lack of technology to effectively and cost-beneficially detect cell and tissue damage under intact skin in clinical practice. Much the way cardiologists need more than the naked eye to detect a cardiovascular disorder, nurses and other wound care professionals deserve and require bioengineering technologies to examine tissue viability under the skin. Therefore, the field warrants technological breakthroughs that will provide information on pathophysiological phenomena that occur in deep tissue and cannot be detected visually and timely. 

Since the identification of the inside-out damage evolution pathway and the subsequent inclusion of DTIs in international PU classification systems, ultrasound (US) has been the modality of choice to identify subdermal pathoanatomical changes that may point to tissue damage in PU care, as reported in multiple case series.^2-6 For example, in the case series by Aoi et al,² 12 patients (ages 16 to 92 years) who showed DTI-related abnormal findings on ultrasonography at the first examination, were analyzed and followed-up until the PU reached a final stage, which revealed the effectiveness of US in detecting and monitoring the injury. In a retrospective review of patient examinations, Higashino el al³ used US in conjunction with infrared thermography in 28 early-stage PUs (21 patients). The authors concluded heterogeneous hypoechoic area findings on the US assessment and high skin temperature pointed to an evolving DTI.³ In a prospective, descriptive pilot study, Scheiner et al⁵ studied a hospital convenience sample of 33 individuals determined by means of Braden score (<18) to be at risk for PUs; all the DTIs that later became purple skin DTIs were able to be detected using US before clinical signs were visible on the skin. 

No formal validity, reliability, or sensitivity studies have been conducted to assess US as a diagnostic tool for PUs. Despite that, the literature suggests US technology can help detect tissue integrity issues that are not apparent in a VSA.⁴ Furthermore, US technology is becoming less costly, is often available at the bedside, and recently has been miniaturized to operate on portable devices. For example, the Lumify system (Philips Medical Co, Amsterdam, the Netherlands) utilizes a tablet or cellular phone as its computer platform; a clinician connects a US probe and downloads the appropriate app in order to perform US scans. Nevertheless, interpretation of US images still requires substantial training and expertise and is not quantitative; hence, data may be subject to interrater differences. Because it is not feasible to train all nurses and other relevant health care professionals to read and decipher US data, a fundamentally different, clinically feasible approach is required for cost-effective subdermal tissue viability evaluations. Moreover, any pathology that is identifiable by means of US is, by definition, already at the stage of macroscopic damage and has already affected tissue structures. In other words, US is unable to detect damage while it is still microscopic and limited to small groups of cells, at which time the damage could still be repairable by the body systems and be fully or partially reversible, pending a timely and adequate intervention. 

An emerging technology that appears to successfully bridge the above gaps is the subepidermal moisture (SEM) scanner. The SEM scanner is a hand-held device that measures capacitance of tissues at a depth of several millimeters under the skin (depending upon the specific anatomical site, version of the device, and examination protocol).⁷ Briefly, tissue capacitance rises when the extracellular water content (called SEM) increases, because a localized inflammatory response is triggered when the first cells in a tissue die. The SEM scanner determines tissue health status at the subepidermal layers (per manufacturer guidelines, the skin needs to be dry and clean to eliminate the influence of perspiration or incontinence). Specifically, the pathophysiological mechanism for the increase in extracellular water content is activated by the death of these first cells, which triggers recruitment of immune system cells from the bloodstream through release of signaling molecules in order to dispose the cell debris.⁸ These signaling molecules also cause blood vessel walls to be more permeable, enabling immune cells in the blood to cross the walls (a process called extravasation) and reach the site of cell death.⁸ The elevated vessel wall permeability then causes leakage of plasma fluids into the extracellular space, which eventually builds up to the clinically evident edema. Noteworthy is the gradual formation of edema and its initiation as a localized, microscopic event (ie, an increase in SEM). Accordingly, the SEM scanner targets this early phase of cell death rather than exploring macroscopic signs of tissue destruction as occurs in US examinations. 

The SEM scanner has been rigorously evaluated in large-scale clinical trials conducted primarily by the Bates-Jensen group^9-13 in nursing home settings and in a prospective, observational study that was performed in a spinal cord injury care facility and a residential care facility.¹⁴ The Bates-Jensen group conducted VSAs of heel PUs among 417 nursing home residents in 19 United States’ facilities over 16 weeks.¹⁰ The elderly study population was ethnically diverse; the authors found abnormal SEM readings were associated with concurrent damage and damage 1 week later in generalized multinomial logistic models adjusting for age, diabetes, and function.¹⁰ It also was found that elevated SEM values co-occurred with skin damage at the sacral region in generalized multinomial logistic models, adjusting for age and risk.¹¹ Greater SEM values were associated with visual skin damage 1 week later using similar logistic models.¹¹ The aforementioned work was conducted based on earlier clinical studies from the same research group and indicated the SEM scanner was able to differentiate between erythema and Stage 1 PUs in nursing home residents (N = 31 in 2 centers)¹² as well as in an elderly population with dark skin tones (N = 66 in 4 centers).¹³ Additionally, the ability of the SEM scanner to differentiate between Stage 3/Stage 4 PU tissues and intact skin was demonstrated in a pilot study among persons with spinal cord injury.¹⁵ 

Overall, studies conducted to date show the SEM scanner to be effective in detecting DTIs before they present on the skin and differentiating those that resolve, remain, or deteriorate, as well as predicting the occurrence of visual skin damage approximately 1 week later.^9-13 However, the SEM scanner has never been directly compared with US and VSAs in the same cohort. 

Given the fundamentally different characteristics examined by US versus the SEM scanner, the current authors hypothesized that the SEM scanner would be able to detect damage earlier than US. Earlier detection of cell and tissue damage sets the stage for prevention of further tissue damage (either more widespread or deeper). The ability to detect tissue damage earlier using the SEM scanner, possibly before damage becomes irreversible, potentially alerts caregivers to prevent deterioration.

Accordingly, the aim of this pilot work was to determine, through an observational, prospective cohort study conducted among elderly persons in a postacute care setting, whether SEM scanner measurements are consistent with US examinations in assessing subdermal tissue damage, and, if possible, further test the hypothesis that SEM scanner measurements not only precede VSAs in alerting caregivers to the onset of PUs and sDTIs, as previously reported,^9-14 but also that SEM may precede US in doing so.

Methods

Patient recruitment. All patients at Kindred Healthcare (Virginia Beach, VA), a postacute care center with a high proportion of elderly patients, were recruited through an observational, prospective cohort study design, as follows. A nurse practitioner (NP) and the principal investigator, a board-certified physical medicine and rehabilitation physician, apprised the nursing staff of the study and helped identify potential participants (ie, participants who had a PU or sDTI). The physician met with each potential participant (and typically with a family member) and reviewed the study protocol. If the patient was interested in participating, informed consent was obtained. The patient was enrolled only after informed consent was obtained and he/she was deemed eligible to participate in the study. 

Study groups. Patients were recruited from December 2016 through February 2017 into 1 of 4 groups (inclusion/exclusion criteria varied per group): group 1 included patients at risk of developing PUs/sDTIs but with no evidence of these wounds at the time of recruitment; group 2 included patients with an existing, diagnosed sacral Stage 1 PU; group 3 included patients with sDTI; and group 4 included patients without wounds who were not at risk. Inclusion criteria were age >55 years and, for groups 1, 2 and 3, risk of developing PUs at the time of enrollment (as indicated by Braden score <13), poor mobility (Braden mobility and activity subscore ≤2 or clinically observed limited movement such as chair- or bedbound), or medical procedures involving inability to change position for >4 hours due to, for example, surgery or imaging exam. Group 4 (the control group) consisted of age-matched individuals who were not at risk for PUs as indicated by their Braden score. In the 2 groups of patients that did not have PUs (group 1 and group 4), recruitment was based on risk factors or lack thereof and a willingness to participate in the study. All participants were evaluated by the study team for a minimum of 3 and a maximum of 10 consecutive days, and all underwent the SEM and US scanning procedures (described as follows) daily. Patients with modesty concerns and physical, mental, or other limitations preventing performance or compliance with the US and/or SEM scanning assessments such as suspected or actual injury that might prevent turning, as well patients with active inflammatory skin diseases (eg, eczema, psoriasis), moisture lesions, incontinence-associated dermatitis at the sacrum, skin infection, open wounds or scarring over the scan areas, or broken skin at the sacrum and both heels (SEM scanner guidelines forbid use on broken skin) were excluded. However, possible assessment at only 1 or 2 locations was not grounds for exclusion. 

Ethical considerations. The study was approved by a medical-ethical review committee (Quorum IRB #QR32052/1) and informed consent was obtained from all participants. Classification of PUs into stages/categories was done according to the up-to-date International Pressure Ulcer Prevention and Treatment Guidelines 2014.¹ 

Procedure. Daily skin assessments were conducted by the NP from the day of enrollment until study exit. The NP conducted the VSAs to obtain data on tissue characteristics, the presence or absence of a PU, and characteristics of the PU if present. As per best practice, the NP examined the patient for changes in skin color (particularly redness/erythema), dry/flaky skin, bruising, callous, scab, cut/abrasion, cyst, rash, scar, texture change, and sensation of the skin surface through visual observation (see Table 1). In individuals with darkly pigmented skin, the NP observed and documented for persistent erythema, nonblanching hyperemia, blisters, discoloration (purple/blue localized areas), localized heat (replaced by coolness as tissue is damaged), localized edema, and localized induration. The physician took the SEM readings (photographs also were taken at the time when SEM readings were performed). In addition, the physician reviewed the inclusion/exclusion criteria and collected the demographic information and the relevant medical history data. The variables collected in the study and the respective assessment days are listed in Table 1. An US radiology specialist assessed the USs. 

The SEM readings began on the day of enrollment and on each subsequent day until exit from the study. Every day, 6 readings were obtained at the sacrum and 4 at the heels according to the study protocol. The US readings were performed by the US specialist on the same day but at a different time. The readings were obtained per the protocol; images were saved to the US machine as well as to an external data drive. 

The NP who conducted the VSAs and the physician were wound specialists, proficient in the up-to-date international guidelines, as specified in Table 1.¹ Group 1 (at-risk) patients were assessed once daily by the clinical study team for a minimum of 3 and maximum of 10 (consecutive) days. These clinicians then provided the standard care preventions (listed in Table 1) and recorded any interventions and notable observations of patient health status (including response to interventions). Group 2 and group 3 patients with confirmed PUs or sDTIs were similarly assessed by specialists daily and had daily photographs of the (suspected) damage sites taken; deterioration or healing of their wounds was digitally recorded. Group 4 (control) patients also underwent daily US and SEM assessments of their sacrum and heels, similar to the experimental groups, for 3 days to verify that all diagnostic means (SEM, US, VSA) consistently provided benign results. Following informed consent, the physician reviewed the health status of each patient and the NP reviewed the Braden score. 

Scanning instrumentation. All participants were assessed using a portable US system (M7; Mindray, Mahwah, NJ) that featured a 6–14 MHz linear array transducer allowing depth of field of 2 cm to 39 cm, as well as by using the SEM Scanner (Point of Care 200; Bruin Biometrics LLC, Los Angeles, CA). 

The SEM scanner directly measures the steady state capacitance (in Farads) of a volume of tissue. The sensor is fundamentally a 2-electrode capacitor that has been unwrapped so that the electrodes are coplanar. The electric field created between the electrodes projects into the tissue when the electrodes are placed in contact with a patient’s skin. The shape of the field is constant and based on the geometry of the electrodes^.16 With the excitation voltage used in the SEM scanner, the sensor is sensitive to a depth of approximately 0.15 inch (3.8 mm). The capacitance of this unwrapped capacitor is dependent upon the effective dielectric constant of the tissue within the field. Water has a high dielectric constant of 80 compared to a dielectric constant of 4 for the dry collagen, which is the major structural component of the extracellular matrix (ECM).¹⁷ As localized edema builds up due to the pathophysiology of inflammation, the effective dielectric constant of the tissue region affected by the PU rises toward that of water. Although the mixing rule for the effective dielectric constant for a 2-phase composite, such as a biological tissue, cannot be analytically predicted,¹⁸ testing with the SEM scanner indicates the effective capacitance is linearly related to the percentage of water in the tissue. Assuming, as an example, the ECM normally has a volumetric collagen content of 50% and the remaining content is water, the dielectric constant of normal ECM is (0.5 x 80) + (0.5 x 4) = 42. A change in the water content of the ECM from 50% to 55% in a small subsurface region of tissue may not be visually detectable on the skin surface, but it will change the effective dielectric constant of that region of tissue to (0.55 x 80) + (0.45 x 4) ≅ 46, a 9% increase that can be detected by the SEM scanner. 

The SEM scanner is CE-marked and pending United States Food and Drug Administration decision and not available for sale in that country. Participants were examined using US and the SEM scanner at the same anatomical locations (ie, the sacrum and left and right heels according to the study design as detailed above), with follow-up periods detailed in Table 1. 

Outcome measures. Generally, heterogeneous hypoechoic area findings on the US assessment are an indication for subdermal tissue damage.^2-5 An abnormal US exam exhibits inconsistent tissue structures (unclear layered structure, discontinuous fascia) or hypoechoic lesions. Hypoechoic lesions, in particular, were considered to be a typical finding for sDTI that may indicate localized tissue decomposition, as reported by Aoi et al.² 

An abnormal SEM reading was defined as SEM delta (Δ) ≥0.6 for at least 2 consecutive days (see Table 1) according to manufacturer guidelines. The SEM Δ, the parameter of primary clinical interest, is the difference in the SEM values between nonwounded tissue and a nearby region of tissue that may have subsurface damage that affected local tissue fluid content (ie, the inflammatory response had triggered microscale edema). For example, a set of 4 to 6 measurements may be taken at the sacral or heel regions. It is almost certain that at least 1 of these measurements at a certain anatomical site will be over healthy (undamaged) tissue. The SEM scanner compares the set of SEM values to each other and calculates the Δ value as the difference between the highest SEM value and the lowest SEM value in the set. A healthy body site will have fairly uniform distribution of SEM values, because all measurement points will reflect normal tissue resulting a low Δ value (typically 0.0 to 0.2) for that area. Larger Δ values are an indication of potential subsurface tissue damage in the examined area, reflected in nonuniform tissue fluid contents due to the localized build-up of edema (this threshold has been set as Δ ≥0.6 in the present study based on manufacturer guidelines). 

In this study, abnormal US and visual/photographic findings were compared to SEM Δ values to identify markers indicating PUs/DTIs and either declining or improving tissue status (also considering clinical judgment and outcome). This was done to reveal the value of SEM measurements in determining the risk for subdermal damage in PUs and in early detection of DTIs that later become apparent by means of US and/or VSA. Given the older age and fragility of the studied patient sample and the variety of underlying background conditions, comorbidities, and possible history of PUs, the focus in this study was clinically significant, consistent tissue pathologies. Hence, a lesion in skin or subdermal tissue was defined as an abnormal finding detected through VSA (as per the categories in Table 1) and confirmed by a hypoechoic US finding as listed above, which was detectable over at least 2 consecutive days. Abnormal findings in all measurable outcomes are defined in Table 1. 

Data collection. All study variables (see Table 1) were initially noted using paper and pencil and later entered to Excel spreadsheets (Microsoft Co, Seattle, WA) while maintaining patient anonymity. The heel and sacrum data were reported separately and entered into the case report form, which was available to the skin assessment NP until the end of the study. Importantly, the clinical principal investigator performing the SEM scanner readings was blinded from the US and VSA results of each participant until patients exited from the study. 

Data analysis. All quantitative results were reported as the mean ± 1 standard deviation (SD) from the mean. Boolean analysis and rule-based classifiers programmed in spreadsheets were utilized to systematically determine if a lesion (as defined above) was consistent with abnormal SEM readings across the diagnosed PU/DTI cases in the study. False positives were not considered because the focus of the pilot study was different and was not statistically powered for sensitivity and specificity, nor was it powered for validity and reliability. Rather, the focus was on consistency between SEM and US where there were apparent clinical signs of (suspected) tissue damage by means of VSA.

Accordingly, for the 3 patients recruited to group 3 who had sDTIs according to VSAs (patients 11, 12, and 13 [see Table 2]), examination of the subdermal tissue status was justified; hence, Boolean analysis and rule-based classifiers were used to determine agreement between US and SEM findings (see Table 3). The Boolean analysis is considered positive per patient, anatomical site, and visit day according to the following rule-based classifiers: 1) SEM Δ readings were normal (below 0.6) and US examination did not identify a hypoechoic lesion, or 2) SEM Δ readings were abnormal (0.6 or above) and US identified a hypoechoic lesion.

Results 

The demographics of the recruited patients are specified in Table 2. Consent was obtained from a convenience sample of 15 patients (10 women, 5 men, mean age 74 ± 10.9 years old). Eleven (11) were white/Caucasians with Fitzpatrick classification¹⁹ for human skin color of II–III; the other 4 were black/African Americans with Fitzpatrick scale of III and above. Patients from groups 2 and 3 in Table 2 where PUs or (suspected) DTIs existed were pooled for similarity in characteristics; the number of patients assigned to the different groups were 7, 6, and 2 for groups 1, 2-3, and 4, respectively. A variety of background and acute conditions typical to the facility setting were documented in the medical records of patients, including respiratory (eg, bronchitis, chronic obstructive pulmonary disease) and cardiovascular (eg, pulmonary edema, deep vein thrombosis, and peripheral vascular) conditions, type 2 diabetes, sepsis, and renal failure, all of which may be associated with known PU etiological and risk factors. None of the patients had undergone surgery during the study period. One (1) patient was incontinent for urine, and 2 had a history of sacral PUs. Mean Braden risk assessment scores for the pooled participant groups (2-3), excluding the controls, were 11.4 ± 2.8 (range 10–16), indicating an overall high risk for the study sample, with 4 individuals at very high risk (score ≤9). The at-risk group (group 1) had an even lower mean Braden risk score of 9.7 ± 2, pointing to a high to very high risk for PUs for this specific group. In every case, the daily score obtained by the NP was the same score the patient had in the chart previously recorded by the nursing staff (before the initiation of the study).

All at-risk patients received the usual care for PU prevention, including routine VSAs, repositioning every 2 hours, and use of repositioning aids such as pillows, wedges, and heel boots according to clinical judgment. One (1) patient from group 1 was prescribed a low-air-loss mattress; all others were positioned on standard hospital mattresses. All participants completed the study as per the protocol without adverse events. Patients were assessed for 7 ± 4 consecutive days of follow-up (across all groups). 

All participants in the at-risk group (1) exhibited elevated (Δ ≥0.6) SEM readings in at least 1 anatomical location for 2 or more consecutive days. All patients in group 1 had intact skin at all their examined anatomical locations over the study period, but 1 patient in the group developed a sDTI during the course of the study.

Four (4) of the 15 study participants (1 in the at-risk group and 3 in the confirmed/suspected PUs groups 2 and 3) already had or developed a visible sDTI within the timeframe of the study (ie, a period prevalence of 20%). All sDTI lesions developed at the heels. 

For the patient from at-risk group 1 (patient 2; see Table 2) who developed a left heel sDTI (described in the record as “soft mushy heel”) 3 days after the start of the study, SEM readings were abnormal from the first visit day onward. The VSA indicated sDTI on visit day 3. The US indicated mild structural inconsistencies (unclear, layered structures and discontinuous fascia) on the first day, but an additional hypoechoic lesion, which is a typical finding in a sDTI,² was formed and detected by the US on visit day 4. On visit day 4, the abnormal SEM Δ reading was in agreement with both the US and VSA assessments that indicated a tissue lesion. Interestingly, the sDTI appeared to resolve according to VSAs during the follow-up in visit days 9 and 10. This was likely aided by the early intervention to offload the left heel using a pillow/wedge, which was conducted immediately when the respective SEM reading was abnormal on the first day while the VSA was still normal. The abnormally elevated SEM  readings and US finding of hypoechoic lesion remained until the end of the 10-day follow-up. Thus, the initially high and increased SEM Δ reading from 1.3 to 1.7 between the first and second days, leading to the rapid, preventative intervention (heel elevation), appeared 2 days before the hypoechoic lesion US finding. The timeline of the above events for patient 2 is depicted in the Figure. 

In patients with existing DTI, an important agreement was observed between US and the SEM Δ reading in 5 different potential wounds appearing for at least 2 consecutive days. Focusing on the 3 patients comprising group 3 (patients 11, 12, and 13; see Table 2) and using a Boolean analysis and rule-based classifiers found SEM measurements always agreed with the US (see Table 3); agreement was observed both in positive and negative identification. In addition, although there always was agreement between SEM and US readings, they did not always agree with VSAs (eg, for both heels of patient 12; see Table 3), which points to the limited ability of VSAs to reveal the true status of subdermal tissues. 

Discussion

The Boolean analysis and rule-based classifiers (see Table 3) indicated that if a subdermal lesion existed (based on US), SEM measurements always agreed with the US-based identification of hypoechoic lesion (likely pointing to subdermal tissue composition).² In addition, for the single patient who developed a heel DTI during the study period, the SEM measurements were predictive of tissue damage 2 days before damage was detected via VSA and 3 days before the appearance of a hypoechoic lesion in the US (see Figure). A review of the outcomes of the Bates-Jensen series of large-scale studies in nursing home residents^9-13 concluded abnormal SEM readings may precede positive VSA findings by 3 to 10 days,²⁰ which concurs with the current observation. 

US has been evaluated against other technologies such as infrared thermography and has been identified as a successful means for early detection of PUs in multiple case series/retrospective studies. A systematic review²¹ suggests US and SEM measurements are promising in the early detection and prediction of PUs, but more studies are needed. Nevertheless, a fundamental difference exists between US and SEM, which is critically important to emphasize in the context of the present study: US detects macroscopic pockets of fluids (edema) that are visible to the radiologist, presented as hypoechoic lesions (as in the example of patient 2), whereas the SEM scanner has the sensitivity to detect the occurrence of edema while it is still microscopic and invisible to the eye. The present study is the first in the literature to directly compare US and SEM measurements within the same participant group in a clinical setting. Consistent with the above argument that SEM should detect PUs earlier, the current researchers found the SEM reading for the 1 patient who developed a DTI during the course of this study increased from the first to the second visit days, which was 2 days before the US exam clearly indicated tissue pathology through a hypoechoic lesion (macroscopic fluid pocket) finding. Although the authors did not conduct infrared thermography scans in this research, it is noteworthy that infrared thermography is limited to near-surface measurements of skin temperature and hence is unlikely to detect deep tissue damage through localized temperature changes.²¹ Accordingly, currently, it is most appropriate to compare the SEM scanner to US technology. 

Interpreting US images requires expertise and a months of training.²² According to a study analyzing 5 consecutive US courses with a total of 363 participants²³ and a systematic review,²⁴ the teacher-to-learner ratio should be 1:3 during hands-on, multiple-day US training in order to facilitate training the skills needed for even simple image acquisition. Additionally, there is the potential for interobserver disagreements in interpreting US results (which are neither objective nor quantitative); hence, sensitivity and specificity may vary among studies.²² 

Clendenin et al²⁵ conducted a study that focused on the interrater and interdevice agreement and reliability of the SEM scanner in a group of 31 volunteers who were free of PUs or broken skin at the sternum, sacrum, and heels. The authors analyzed more than 3000 SEM scanner readings and reported good interoperator agreement with mean differences ranging from -0.01 to 0.11. These researchers further reported interoperator and interdevice reliability (Pearson product correlation coefficient) exceeding 0.80 at all the above anatomical sites. Bates-Jensen et al¹¹ reported an even greater overall mean SEM reliability in their large cohort study of nursing home residents (N = 417), which was 0.92 for all skin conditions and locations. However, reliability by specific skin conditions was slightly lower and varied across conditions (normal, erythema, Stage 1 PU).¹¹ Both research groups concluded the SEM scanner is a reliable tool for assessing the presence or absence of PUs and that it shows great promise for clinical use. Overall, the aforementioned studies^11,25 demonstrate high reliability and good agreement of the SEM scanner across different operators and devices. Given the limitations of current methods to prevent and detect PUs, the above studies indicate the SEM scanner shows promise as an objective, quantitative, and reliable tool for assessing the presence of subdermal tissue damage. 

The SEM scanner has the potential to be a useful adjunct to clinical experience and judgment in early PU detection, particularly for wounds that develop under intact skin. In real life, risk assessment and early detection should be integrated on the continuum of care. Microscale tissue damage that is not yet clinically significant and can be, at a certain point in time, fully repairable and reversible by the body systems, may evolve into a macroscopic clinically significant tissue damage if the proper interventions or actions are not or cannot be taken. Hence, when damage is still microscopic — that is, if some cells in the tissue have died but the body may be able to replace them — according to clinical experience, a patient is said to be at risk (for the damage to deteriorate).²⁶ If damage then proceeds to accumulate and affect larger numbers of cells, the patient will have initial tissue damage (possibly under intact skin) that requires an early detection tool, and still the tissue damage can be self-repaired by the body if actions are adequate and timely. Hence, continuity exists between the state of being at risk and the state of being affected by early cell and tissue damage, which requires early detection. The SEM scanner has clinical potential because it detects the early phase of inflammation and can help the clinician modulate the response of the immune system and adjacent vasculature to the event of death of the first cells.²⁶ 

In order to describe the potential of the SEM scanner in early detection applications, it is necessary to understand its underlying physical mode of action and how that relates to the pathophysiology of PUs. Thus, to reiterate: the SEM scanner measures the localized edema (ie, subepidermal moisture) that precedes the macroscopic edema that involves swelling and increased firmness of the affected tissues.²⁶ At the early phase of PU damage when the damage is still microscopic and limited to small numbers of cells, the damaged or dying cells release chemokines (signaling/messenger molecules also called chemoattractant molecules) that act as inflammatory signals and attract immune system cells (eg, neutrophils, macrophages, and T-cells) to the affected site.^8,22 The release of chemokines also acts to increase the permeability of capillaries, which enables extravasation (ie, infiltration of the immune system cells to the damaged region).^8,26 A key consequence of this inflammatory process is that as gaps between endothelial cells increase to facilitate the extravasation, the walls of capillaries become leaky and fluids leave the vessels and build up at the extracellular space.²⁶ Eventually, the volume of blood plasma fluids escaping from the vasculature will cause visible tissue swelling, but one should recall that this process begins microscopically and progresses over time as the immune system is recruited to deliver a sufficient number of immune cells to the damaged site.²⁶ The practical implication for diagnosis of the beginning of formation of an injury is that there will be a small increase in extracellular fluid contents very soon after the death of the first few cells.²⁵ A device that is sensitive enough to capture such slight changes in water content within soft tissues will be able to detect these cell death events. The physical principles underlying the device, its specific technology, and the sensitivity parameters derived from its engineering design together will dictate the rapidness of early detection. 

The physical theory of electrical biocapacitance of tissues²⁶ points to the prospect of achieving sensitivity to small changes in water content by means of a handheld cost-effective device. The SEM scanner utilizes the principles of biocapacitance^16,27 to detect small changes in water content of examined tissue. The scanner directly measures the steady-state capacitance (in Farads) of a volume of tissue that is associated with the local fluid contents in the tissue. The ability to detect small, local changes in the water content of ECMs caused by the early stages of edema makes biocapacitance measurement a powerful tool in the detection of early tissue damage that is a precursor to PUs. 

Limitations 

This is a small cohort pilot study, which limits its external validity and the ability to draw firm conclusions. Other limitations of this work are associated with the general lack of gold standard technology in the clinical practice of prevention and early diagnosis of PUs. In that context, these are still early days for this technology. SEM thresholds for detecting an invisible tissue lesion need to be tested, optimized, adjusted, and fine-tuned. Specifically, with reference to DTIs, the pathophysiology is dynamic and so are the fluid contents in the affected tissues, which change from the stage of initial cell damage and the resulting localized edema to the state of massive tissue necrosis. For example, evidence that tissue stiffness changes along this time course²⁸ makes it likely that the SEM readings and Δs will change over the evolution of a DTI as well. It is also presently unknown whether chronic conditions such as peripheral vascular disease, diabetes, or cancer (which may locally affect the pattern of edema or leakiness of the vasculature) also influence SEM Δ values. Likewise, conditions that affect the inflammatory response such as obesity, spinal cord injury, cancer, and human immunodeficiency virus may influence the SEM Δ values, so related subgroups should be studied for their SEM Δ responses. 

Conclusion 

Using an observational, prospective cohort study design, this pilot study evaluated consistency between SEM and US examinations of PUs and sDTIs. Among the 15 participants, where lesions existed, SEM measurements always agreed with the US and VSA findings. For the 1 patient who was determined to be at risk at the beginning of the study and developed a heel sDTI during the course of the study, SEM readings were abnormal 2 days before VSA indicated tissue damage and 3 days before the appearance of a hypoechoic lesion in the US. Hence, the authors found US and SEM scanner results were similar but in the evolving sDTI case, the SEM scanner detected it earlier. Moreover, although SEM and US readings always agreed between themselves, they did not always agree with VSAs, which points to the limited capacity of VSAs to assess the status of subdermal (nonvisible) tissues. Further clinical, prospectively designed research is needed in other at-risk cohorts to evaluate the potential effect of other health conditions on the validity, reliability, sensitivity, and specificity of the SEM scanner. n

References

1. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. 2014. Available at: www.internationalguideline.com/. Accessed July 14, 2018.

2. Aoi N, Yoshimura K, Kadono T, et al. Ultrasound assessment of deep tissue injury in pressure ulcers: possible prediction of pressure ulcer progression. Plast Reconstr Surg. 2009;124(2):540–550. 

3. Higashino T, Nakagami G, Kadono T, et al. Combination of thermographic and ultrasonographic assessments for early detection of deep tissue injury. Int Wound J. 2014;11(5):509–516.

4. Osman B, Kernodle MH. Focus on caregiving. A new look at pressure ulcers: ultrasound technology can help detect skin integrity issues that are not apparent in a visual skin assessment. Provider. 2007;33(4):35–37.

5. Scheiner J, Farid K, Raden M, Demisse S. Ultrasound to detect pressure-related deep tissue injuries in adults admitted via the emergency department: a prospective, descriptive, pilot study. Ostomy Wound Manage. 2017;63(3):36–46.

6. Yabunaka K, Iizaka S, Nakagami G, et al. Can ultrasonographic evaluation of subcutaneous fat predict pressure ulceration? J Wound Care. 2009;18(5):192,194,196.

7. Tonar YC, Rhodes S, Clendenin, M, Burns M, Jaradeh K, inventors; Bruin Biometrics, LLC, assignee. Apparatus and methods for determining damaged tissue using sub-epidermal moisture measurements. 2017, US patent 9763596. September 29, 2016.

8. Turner MD, Nedjai B, Hurst T, Pennington DJ. Cytokines and chemokines: at the crossroads of cell signalling and inflammatory disease. Biochim Biophys Acta. 2014;1843(11):2563–2582.

9. Bates-Jensen BM, McCreath HE, Kono A, Apeles NC, Alessi C. Subepidermal moisture predicts erythema and stage 1 pressure ulcers in nursing home residents: a pilot study. J Am Geriatr Soc. 2007;55(8):1199–1205.

10. Bates-Jensen BM, McCreath HE, Nakagami G, Patlan A. Subepidermal moisture detection of heel pressure injury: the pressure ulcer detection study outcomes. Int Wound J. 2018;15(2):297–309.

11. Bates-Jensen BM, McCreath HE, Patlan A. Subepidermal moisture detection of pressure induced tissue damage on the trunk: the pressure ulcer detection study outcomes. Wound Repair Regen. 2017;25(3):502–511.

12. Bates-Jensen BM, McCreath HE, Pongquan V, Apeles NC. Subepidermal moisture differentiates erythema and stage I pressure ulcers in nursing home residents. Wound Repair Regen. 2008;16(2):189–197.

13. Bates-Jensen BM, McCreath HE, Pongquan V. Subepidermal moisture is associated with early pressure ulcer damage in nursing home residents with dark skin tones: pilot findings. J Wound Ostomy Continence Nurs. 2009;36(3):277–284.

14. Guihan M, Bates-Jensen BM, Chun S, Parachuri R, Chin AS, McCreath H. Assessing the feasibility of subepidermal moisture to predict erythema and stage 1 pressure ulcers in persons with spinal cord injury: a pilot study. J Spinal Cord Med. 2012;35(1):46–52.

15. Harrow JJ, Mayrovitz HN. Subepidermal moisture surrounding pressure ulcers in persons with a spinal cord injury: a pilot study. J Spinal Cord Med. 2014;37(6):719–728.

16. Mayrovitz HN. Assessing free and bound water in skin at 300 MHz using tissue dielectric constant measurements with the MoistureMeterD. In: Greene A, Slavin S, Brorson H, eds. Lymphedema. Cham, Switzerland: Springer International Publishing AG; 2015:133-148.

17. Tomaselli P, Shamos MH. Electrical properties of hydrated collagen. I. Dielectric properties. Biopolymers. 1973;12(2):353–366. 

18. Goncharenko AV, Lozovski VZ, Venger EF. Lichtenecker’s equation: applicability and limitations. Optics Communications. 2000;174(1-4):19–32. 

19. Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988;24(6):869–871.

20. Moore Z, Patton D, Rhodes SL, O’Connor T. Subepidermal moisture (SEM) and bioimpedance: a literature review of a novel method for early detection of pressure-induced tissue damage (pressure ulcers). Int Wound J. 2017;14(2):331–337.

21. Oliveira AL, Moore Z, O’Connor T, Patton D. Accuracy of ultrasound, thermography and subepidermal moisture in predicting pressure ulcers: a systematic review. J Wound Care. 2017;26(5):199–215.

22. Schoenherr JR, Waechter J, Millington SJ. Subjective awareness of ultrasound expertise development: individual experience as a determinant of overconfidence. Adv Health Sci Educ Theory Pract. 2018. doi: 10.1007/s10459-018-9826-1.

23. Greenstein YY, Littauer R, Narasimhan M, Mayo PH, Koenig SJ. Effectiveness of a critical care ultrasonography course. Chest. 2017;151(1):34–40.

24. Bøtker MT, Jacobsen L, Rudolph SS, Knudsen L. The role of point of care ultrasound in prehospital critical care: a systematic review. Scand J Trauma Resusc Emerg Med. 2018;26(1):51.

25. Clendenin M, Jaradeh K, Shamirian A, Rhodes SL. Inter-operator and inter-device agreement and reliability of the SEM scanner. J Tissue Viability. 2015;24(1):17–23.

26. Gefen A. Managing inflammation by means of polymeric membrane dressings in pressure ulcer prevention. Wounds Int. 2018;9(1):22–28.

27. Schwan HP, Kay CF. Capacitive properties of body tissues. Circ Res. 1957;5:439-443.

28. Gefen A. Deep tissue injury from a bioengineering point of view. Ostomy Wound Manage. 2009;55(4):26–36.

Potential Conflicts of Interest: This work was supported by an unrestricted educational grant from Bruin Biometrics LLC, Los Angeles, CA. 

Dr. Gefen is a Professor of Biomedical Engineering, Department of Biomedical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv, Israel. Dr. Gershon is the Medical Director, Gershon Pain Specialists, LLC, Virginia Beach, VA. Please address correspondence to: Prof. Amit Gefen, Department of Biomedical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv 69978, Israel; email: gefen@eng.tau.ac.il.

Abstract

Purpose: Because infection can thwart burn healing, microorganisms, their susceptibility patterns, and the effect of tangential excision timing on outcomes of burn patients were examined.

Methods: A prospective, observational study was conducted that involved 318 patients with deep second-degree burns from a gas explosion treated in Xinxiang, Henan, China between January 2009 and December 2016. Patient demographic data, culture and antimicrobial susceptibility test results, and outcome variables (resuscitation fluid volume, signs of shock, body temperature, heart rate, and time to wound healing) were analyzed. Outcomes were compared among patients who had early (<24 hours), middle (2 to 7 days), and late (> 7 days) post burn excision. Results: Bacterial culture and drug sensitivity data were available for 314 of the 318 persons with burns >10% of total body surface area (TBSA). Of the 486 bacterial isolates, 330 (67.9%) were gram-negative and 156 (32.1%) were gram-positive. The number of isolates and resistance to third-generation cephalosporins increased over time. Patients having early tangential excision had significantly lower heart rate (P<.05) and reduced time to healing (P<.01) than patients in the middle or late excision group. Conclusion: Early tangential excision was found to be safe and to facilitate healing. 

Burns are one of the most common emergency events and global public health problems.¹ Resistance from the disruption of mechanical epithelial integrity can render patients with burns susceptible to the complications of infection.² Lipový et al³ investigated the prevalence of infection complications in burn patients; among 134 patients, 92 had infection complications. A prevalence study by Abbasi-Montazeri et al² regarding Staphylococcus aureus infection in a burn center highlighted the need for antibiotic susceptibility monitoring of methicillin-resistant S aureus. A retrospective study⁴ found infection remains the greatest danger for burn patients despite great advances in antimicrobial therapy over past decades. A prospective study⁵ indicated that infections in burn patients may lead to delays in wound healing, graft losses, and the development of sepsis. For example, Acinetobacter baumannii is an important pathogen causing infections in burn patients; multiple factors contribute to the multidrug resistance of A baumannii.⁶ A combination of an early diagnosis of wound infection, appropriate antimicrobial treatment, surgical debridement, and early wound closure may be effective in infection management.^7,8 

A retrospective study⁹ investigated visceral injuries, wound infection, and sepsis in 226 patients who sustained electrical burns. Mortality following burn injuries was shown to be likely due to infection; although a gradual decrease in mortality rates was observed over the last 5 years, mortality rates due to sepsis showed a slower decline. To support crucial treatment decisions, it is important to determine the bacterial microorganisms responsible for the infection of burn wounds, their prevalence, and their drug resistance state. Glik et al¹⁰ retrospectively analyzed the hospital notes of 388 patients with thermal injuries and found patients with sepsis caused by gram-negative bacteria are at higher risk of death than patients with infections caused by gram-positive bacteria. 

In the case study by Ma et al,¹¹ eschar formation was noted in burn injuries, which may be either superficial or deep. The presence of nonviable eschar not only serves as a physical barrier to wound healing, but it also is known to support significant bacterial growth.¹² Hence, per their prospective  study, Lawrence and Carney¹³ recommended surgical debridement of eschar. A retrospective study¹⁴ (N = 71) showed burns from a gas explosion, in which serious internal and combined injuries occur, have a higher prevalence of disseminated infection and mortality than other types of burns.

In contrast to excising burned skin down to fat or deep fascia, tangential excision involves first removing the necrotic tissue from the burn wound followed by covering with heterogeneous skin (irradiated pigskin) after excision.¹³ The bacterial profile of burn wounds and the safety and effectiveness of early tangential excision is unclear. The purpose of this study was to assess microorganisms and their antimicrobial susceptibility patterns from burn wounds of patients injured by gas explosion and to determine the most beneficial timing of tangential excision for these patients.

Materials and Methods

Study design and participants. A prospective, observational study was conducted among patients injured by gas explosion between January 2009 and December 2016. All patients with burn wounds injured by gas explosion who were admitted to the Research Center of Trauma and Orthopedics, Xinxiang Medical University, Henan, China, were considered eligible for participation regardless of age or diagnosis. This study was conducted in accordance with the Declaration of Helsinki and the approval of the Ethics Committee of Xinxiang Medical University. Written informed consent was obtained from all participants’ and/or their guardians. If consent was granted, the patient was enrolled. 

Bacterial identification. Samples isolated from wound, sputum, and blood to identify bacterial species and perform antimicrobial susceptibility testing were analyzed. Bacteria were cultured in an enrichment broth medium at 35˚ C for 4 days. When the medium became cloudy, bacteria were transferred onto blood agar for another 24 hours. Isolation was performed by conventional methods according to the National Clinical Test Operation Regulation.¹⁵ The isolates were identified with the Sceptor bacterial identification instrument (Becton Dickinson, Franklin, NJ).

Antimicrobial susceptibility test. Bacterial culture and drug sensitivity experiments were performed on persons with burns covering >10% total body surface area (TBSA). The Kirby-Bauer test was performed according to National Committee for Clinical Laboratory Standards criteria to determine antimicrobial susceptibility. Paper discs with different antimicrobial drugs (Oxoid; Thermo Fisher Scientific, Waltham, MA) were utilized. The rate of drug resistance was calculated as a percentage of drug-resistant bacteria. The wound bacterial culture and drug sensitivity tests were performed 6 to 14 days after the patient was burned.

Tangential excision. 

Grouping. Participants were divided into 3 groups depending on when tangential excision was performed in accordance with previous observational studies^16,17: group A received tangential excision during the early stage (<24 hours postburn), group B during the middle stage (2 to 7 days postburn), and group C during the late stage (>7 days postburn). All patients who had not received previous treatment were provided routine debridement once admitted to the study.

Additional treatment. Silver sulfadiazine cream was used topically and fluid resuscitation was applied according to the Ruijin formula^18,19 as follows: during the first 24 hours after injury, electrolytes were supplemented at 1.0 mL/kg/% TBSA and colloids at 0.5 mL/kg/% TBSA, with 2000–4000 mL basic water. During the second 24 hours, the amount of supplemented electrolytes and colloids was halved, with no change to the volume of basic water. The electrolytes comprised Ringer’s lactate solution, physiological saline, 50 g/L sodium bicarbonate injection, plasma, and 50 g/L glucose injection. According to accepted principles of administering electrolytes followed by colloids, electrolytes were administered quickly, followed by the slow administration of colloids.

Tangential excision procedure. Tangential excision involves removing the necrotic tissue from the burn wound and covering the wound with heterogeneous skin after excision. Methylene blue dye (5 g/L) was used to discern the necrotic tissue to remove. All patients received autologous skin grafts 5 to 7 days postoperation.

Clinical parameters. Five (5) clinical parameters were measured.

Resuscitation fluid volume. Resuscitation fluid volume was the amount of balanced blood supplemented during the first 3 days postburn according to the Ruijin rehydration formula.^18,19 The criteria for rehydration was judged as follows: urine volume >1 mL/kg/h, mean arterial pressure >65 mm Hg (1 mm Hg = 0.133 kPa), heart rate <120 times/minute, and central venous pressure of 0.8 to 1.2 kPa.

Signs of shock. Shock was considered to have occurred if the following were noted: weak pulse of the dorsalis pedis artery, abnormal peripheral circulation, heart rate >120/minute, and urine output <30 mL/hour.

Additional signs. Body temperature and heart rate were noted during the shock and rehydration phases, urine output was assessed during shock phase, and wound healing time was determined. 

Statistical analysis. The data were presented as mean ± SD and entered into and analyzed by SPSS, version 18.0 software (SPSS Inc, Chicago, IL). Differences between groups were analyzed by single-factor analysis of variance, and the t test was used for pairwise comparisons. Differences with P values <.05 were considered statistically significant.

Results

Patient inclusion. Consent rate for participation was 91.0%. Of the 346 total cases, 318 patients (316 men, 2 women, age 31.1 + 2.1 years) were enrolled and underwent tangential excision at the General Hospital of Pingmerishenma Medical Group, which is affiliated with the Medical University of Xinxiang. The average burn area (% TBSA) was as follows: 136 patients <20%, 115 between 20% and 49%, and 16 with 80% to approximately 98%. The basic characteristics of patients are shown in Table 1. Bacterial culture and drug-sensitivity testing were performed on 314 patients with TBSA >10%. 

Identification of bacteria from wound samples. The culture from wound samples yielded 486 bacterial isolates, of which 330 (67.9%) were gram-negative and 156 (32.1%) were gram-positive. The top 10 isolates in each year are shown in Tables 2, 3, 4, and 5. Pseudomonas aeruginosa was the most common isolate followed by Klebsiella pneumoniae for gram-negative bacteria. S aureus was the most common isolate for gram-positive bacteria. A total of 38 fungal isolates was obtained from the burn wounds, most of which were of the Candida spp. These included 19 isolates of Candida albicans, 10 isolates of Candida tropicalis, 5 isolates of Torulopsis glabrata, and 4 isolates of other types.

Drug resistance. The rate of drug resistance was analyzed using the antimicrobial susceptibility test. The schedule was as follows: 83, 58, 39, 31, 29, 25, 20, 16, and 13 cases were cultured and tested at postburn days 6, 7, 8, 9, 10, 11, 12, 13, and 14, respectively. The drugs tested included ampicillin, amikacin, cefazolin, cefoperazone, ceftazidime, imipenem, piperacillin, vancomycin, and levofloxacin.

The most common isolated bacterial organisms with drug resistance included P aeruginosa, K pneumoniae, Enterobacter cloacae, Escherichia coli, A calcoaceticus, Proteus mirabilis, Citrobacter strains, S aureus, Enterococcus strains, and Streptococcus pyogenes. The drug exhibiting the highest drug resistance was cefazolin (1928 cases), followed by ampicillin (1784 cases) and amikacin (1269 cases). By contrast, the lowest number of cases of drug resistance was against imipenem, with 541 cases (see Table 6). 

Basic condition of postburn patients. Resuscitation fluid volume did not differ significantly at 1 to 3 days postburn among the 3 groups (P>.05). Urine output was higher in group A than in groups B and C, both at 1 day postburn (P<.05) and 3 days postburn (P<.01) (see Table 7). 

The incidence of shock was not significantly different among the 3 groups (21 cases in group A, 15 cases in group B, and 8 cases in group C; P>.05).

At 7, 10, and 14 days postburn, heart rate was significantly higher in groups B (116.4 ± 112.58, 104.52 ± 15.36, 100.33 ± 14.21, respectively) and C (119.6 ± 212.82, 110.38 ± 16.22, 104.67±13.58, respectively) than in group A (101.24 ± 12.36, 96.38 ± 14.66, 90.28 ± 8.92, respectively) (P<.05) (see Table 8). 

The wound healing time in group A was 19.08 ± 5.31 days, which was significantly shorter than that in groups B (29.36 ± 7.03 days; P<.01) and C (31.62 ± 7.18 days; P<.05).

Discussion

Infection with multidrug-resistant organisms remains the leading cause of morbidity and mortality in burn patients; these organisms have been reported in prospective studies^20,21 as the frequent cause of nosocomial outbreaks of infection in hospital burn units or as colonizers of the wounds of burn patients. Prospective studies^22,23 also have shown several factors, including the presence of coagulated proteins, the avascularity of the burn wound, and the resultant absence of blood-borne immune factors make burn wounds susceptible to opportunistic colonization by bacteria and fungi.

In the present study, contamination of burn wounds also occurred at a high rate. The results showed gram-negative bacteria predominated (67.9%) in burn wounds of patients, compared to gram-positive bacteria (32.1%), which is consistent with a previous retrospective report.²⁴S aureus, Enterococcus strains, and S pyogenes were the main isolates of gram-positive bacteria before 2002, with S aureus exhibiting a progressive rise over the subsequent 4 years. P aeruginosa, K pneumoniae, and E cloacae were the main isolates of gram-negative bacteria. P aeruginosa, K pneumoniae, and E  cloacae were the main isolates of gram-positive bacteria in this study. The detection rate of E cloacae and A calcoaceticus was increased and both these species exhibited multidrug resistance.

The types of isolated species increased over the 8 years of the study. This could be related to the wide use of broad-spectrum antibiotics, which resulted in the inhibition of predominant sensitive bacteria, allowing the propagation of resistant bacteria that were previously disadvantaged. The predominance of P aeruginosa, K pneumoniae, and S aureus did not necessarily indicate the improper use of antibiotics²⁵ but was probably correlated with the widespread distribution of bacteria and increase in drug resistance. Bacteria in sputum samples were detected at the same rate as in wound samples, suggesting severe lung infection of patients burned by gas explosion, as noted in a prospective study.²⁶ This could be caused by respiratory tract burn when the patients cried out. The present study found the distribution of organisms was consistent with that of a cross-sectional study²⁰ and a prospective study.²⁸ 

An in vitro study by Sasidharan et al²⁸ found a variety of bacteria became resistant to third-generation cephalosporins. Although many third-generation cephalosporins were applied, no fundamental improvement was achieved. The ubiquitous occurrence of multidrug resistance could be due to the empirical use of broad-spectrum antibiotics; a retrospective study²⁹ has shown the mechanisms were proven to be based on β-lactamases, suggesting the importance of determining the predominant microorganisms and their antimicrobial susceptibility pattern in patients burned by gas explosion.

According to retrospective analysis^30,31 over 10 years, active removal of necrotic tissue and wound closure are basic principles of treatment for deep burns. Prospective analysis²⁶ showed deep second-degree burn wounds could heal with the rapid growth of residual epithelial tissues. According to a prospective study,³² infection tends to occur in patients with extensive deep second-degree burns during the removal of eschar, which may endanger life. Therefore, the treatment of deep second-degree burns is a problem. A retrospective study³³ indicated that delayed tangential excision to increase local interleukin 8 levels deepens the necrotic wound, thus converting deep second-degree burns to deep third-degree burns and preventing the healing process. Early tangential excision has the potential to resolve local inflammation and increase the level of epidermal growth factor, basic fibroblast growth factor, and platelet-derived growth factor, which promote wound healing. A Cochrane review³⁴ recommended treatment with tangential excision 3 to 5 days after conventional dressing with pertrolatum-impregnated gauze. Early tangential excision has been recommended and adopted to retain viable deep dermis tissue.³⁵

In the current study, tangential excision was provided during the shock phase and shifted the excision time to 24 hours post-burn with no increase in complications noted. No significant difference was noted in the resuscitation fluid volume and the incidence of shock among the 3 groups. The patients who underwent early tangential excision exhibited better body temperature and heart rate, suggesting that tangential excision within 24 hours after burns was more beneficial than later excision. Urine output was higher in the early excision group than in the other groups; this could be because of the removal of necrotic tissue, reduction of wound exudate, and resolution of edema. The wound healing time was reduced by 10 days in the early tangential excision group.

Limitations

The present study is prospective in nature, and the data may have inherent flaws unknown to the current researcher. Tangential excision was performed by different surgeons, which may have had an effect on the complication rates.

Conclusion

This prospective study investigated microorganisms and their susceptibility patterns found in the burn wounds of patients injured by gas explosion. Results showed early tangential excision (within 24 hours after the burn) was a safe and effective treatment. The majority of pathogens were found to be gram-negative bacteria. In this study, early tangential excision within 24 hours after burns was safe and effective for promoting the wound healing process of deep second-degree burns caused by gas explosion. Bacteria-sensitive antibiotics should be used early in the clinical treatment of patients with gas explosion injuries. n 

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17. Gallagher JJ, Goldin IM, O’Sullivan GM, Silverman EL, Mitchell KB, Yurt RW. Simulation of tangential excision: a test for construct validity. J Burn Care Res. 2015;36(5):558–564. doi: 10.1097/BCR.0000000000000166.

18. Chen Z, Yuan K. Another important factor affecting fluid requirement after severe burn: a retrospective study of 166 burn patients in Shanghai. Burns. 2011;37(7):1145–1149. doi: 10.1016/j.burns.2011.05.003.

19. Huang Y, Yan B, Yang Z. Clinical study of a formula for delayed rapid fluid resuscitation for patients with burn shock. Burns. 2005;31(5):617–622. doi: 10.1016/j.burns.2005.02.002.

20. Leseva M, Arguirova M, Nashev D, Zamfirova E, Hadzhyiski O. Nosocomial infections in burn patients: etiology, antimicrobial resistance, means to control. Ann urns ire Disasters. 2013;26(1):5–11. 

21. Singh NP, Rani M, Gupta K, Sagar T, Kaur IR. Changing trends in antimicrobial susceptibility pattern of bacterial isolates in a burn unit. Burns. 2017;43(5):1083–1087. doi: 10.1016/j.burns.2017.01.016.

22. deMacedo JL, Santos JB. Bacterial and fungal colonization of burn wounds. Mem Inst Oswaldo Cruz. 2005;100(5):535–539. doi: 10.1590/S0074-02762005000500014.

23. Essayagh T, Zohoun A, Tourabi K, et al. Burn nit: olonization f urn ounds nd local environment. Ulus Travma Acil Cerrahi Derg. 2012;18(4):296–300. doi: 10.5505/tjtes.2012.26928.

24. Dokter J, Brusselaers N, Hendriks WD, Boxma H. Bacteriological cultures on admission of the urn atient: to do or not to do, that’s the question. Burns. 2016;42(2):421–427. doi: 10.1016/j.burns.2015.08.006.

25. Manyahi J, Matee MI, Majigo M, Moyo S, Mshana SE, Lyamuya EF. Predominance of multi-drug resistant bacterial pathogens causing surgical site infections in Muhimbili National Hospital, Tanzania. BMC Res Notes. 2014;7:500. doi: 10.1186/1756-0500-7-500.

26. Zhang Y, Meng WZ, Wang MJ, et al. The epidemiological features of blast injury of lungs caused by as xplosion. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2012;30(8):582–583.

27. Khaliq MF, Noorani MM, Siddiqui UA, Al Ibran E, Rao MH. Factors associated with duration of hospitalization and outcome in burns patients: a cross sectional study from Government Tertiary Care Hospital in Karachi, Pakistan. Burns. 2013;39(1):150–154. doi: 10.1016/j.burns.2012.04.002.

28. Taneja N, Chari P, Singh M, Singh G, Bidwal M, Sharma M. Evolution of bacterial flora in burn wounds: key role of environmental disinfection in control of infection. Int J Burns Trauma. 2013;3(2):102–107.

29. Sasidharan NK, Sreekala SR, Jacob J, Nambisan B. In vitro synergistic effect of curcumin in combination with third generation cephalosporins against bacteria associated with infectious diarrhea. Biomed Res Int. 2014;2014:561456. doi: 10.1155/2014/561456.

30. El Salabi A, Walsh TR, Chouchani C. Extended spectrum β-lactamases, carbapenemases and mobile genetic elements responsible for antibiotics resistance in gram-negative bacteria. Crit Rev Microbiol. 2013;39(2):113–122. doi: 10.3109/1040841X.2012.691870.

31. Leaper DJ, Schultz G, Carville K, Fletcher J, Swanson T, Drake R. Extending the TIME concept: what have we learned in the past 10 years?(*). Int Wound J. 2012;9(suppl 2):1–19. doi: 10.1111/j.1742-481X.2012.01097.x.

32. Liu Y, Zhou Q, Wang Y, et al. Negative pressure wound therapy decreases mortality in a murine model of burn-wound sepsis involving Pseudomonas aeruginosa nfection. PLoS One. 2014;9(2):e90494. doi: 10.1371/journal.pone.0090494.

33. Cao PF, Xu YB, Tang JM, Yang RH, Liu XS. HOXA9 regulates angiogenesis in human hypertrophic scars: induction of VEGF secretion by epidermal stem cells. Int J Clin Exp Pathol. 2014;7(6):2998–3007.

34. Jull AB, Rodgers A, Walker N. Honey as a topical treatment for wounds. Cochrane Database Syst Rev. 2008;(4):CD005083. doi: 10.1002/14651858.CD005083.pub3.

35. Mosier MJ, Gibran NS. Surgical excision of the burn wound. Clin Plast Surg. 2009;36(4):617–625. doi: 10.1016/j.cps.2009.05.006.

Potential Conflicts of Interest: none disclosed

Dr. Shao is a chief physician, Department of Cardiology, General Hospital of Pingmei Shenma Medical Group, Pingdingshan, China. Dr. Ren is a director, Research Center of Trauma and Orthopedic, Xinxiang Medical University, Xinxiang, Henan, China. Mr. Meng is an associate chief physician, Department of Cardiology, General Hospital of Pingmei Shenma Medical Group; and an associate professor, Research Center of Trauma and Orthopedic, Xinxiang Medical University. Ms. GZ Wang is an associate chief physician; and Dr. TY Wang is a professor, Research Center of Trauma and Orthopedic, Xinxiang Medical University. Please address correspondence to: Wen-Jie Ren, PhD, and Tian-Yun Wang, PhD, Research Center of Trauma and Orthopedic, Xinxiang Medical University, Xinxiang, Henan, China; email: wtianyuncn@126.com

Abstract

Management of diabetes-related foot ulcers often involves debridement of devitalized tissue, but evidence regarding the most effective debridement method is limited. Purpose: A systematic review was conducted to determine the effectiveness of nonsurgical sharp debridement (NSSD) versus low-frequency ultrasonic debridement (LFUD) for diabetes-related foot ulceration in adults.

Method: Published studies (earliest date available to April 2017) comparing healing outcomes of LFUD- and NSSD-treated foot ulcers in adults were considered. The quality of publications that met inclusion criteria were assessed using the PEDro scale, and a meta-analysis was undertaken to compare percentage healed and percentage of ulcer size reduction. Results: Of the 259 publications identified, 4 met the inclusion criteria but 2 of the 4 did not contain sufficient patient outcomes details for meta-analysis, leaving a sample size of 173 patients. Outcome data for the 2 studies included percentage of ulcers healed between the 2 debridement methods. This difference was not significant (RR = 0.92; 95% CI = 0.76-1.11). The risk of bias for both studies was low. Conclusion: No difference in healing outcomes between NSSD and LFUD debridement of diabetic foot ulcers was found. Well-designed, controlled clinical studies are needed to address the current paucity of studies examining the efficacy and comparative effectiveness of debridement methods.

Globally, diabetes is one of the most common noncommunicable diseases. The number of studies describing the epidemiology of diabetes has increased over the last 20 years, and over the past 15 years the global burden estimates of adults living with diabetes has exceeded predictions. In 2000, the International Diabetes Federation¹ estimated 151 million adults were living with diabetes; by 2010, this number was expected to increase to 285 million and estimated to reach 438 million by 2030.² The most recent report from the International Diabetes Federation³ shows the number of adults likely to have diabetes globally in 2015 was 415 million. 

According to the Australian Institute of Health and Welfare,⁴ people with diabetes may develop complications including peripheral neuropathy, peripheral arterial disease, and foot deformity, which can lead to ulceration, infection, and an increased risk of amputation. One (1) in every 6 people with diabetes in developed countries will have a diabetes-related foot ulcer during their lifetime.³ According to the International Working Group on the Diabetic Foot,⁵ people with diabetes also face a 25 times increased risk of amputation compared to persons without diabetes. Currently, a limb is lost every 20 seconds worldwide as a result of diabetes-related amputation.³ 

Optimal management of these ulcers is vital in preventing lower limb amputation. Treatment routinely involves offloading⁶ to redistribute pressure away from the area of ulceration and maintaining a moist wound bed environment⁷ to encourage new tissue growth. Additionally, treatment of diabetes-related foot ulcers often involves routine debridement to remove devitalized tissue from the ulcer base. According to guidelines⁸ and a systematic review,⁹ the process of debridement, regardless of the method applied, is believed to stimulate the inflammatory response and encourage healing. Debridement methods include autolytic debridement using dressings and biological debridement using sterile larvae and chemical enzymes. In addition to these topical agents, mechanical debridement via surgical excision or nonsurgical sharp debridement using either a scalpel or scissors is commonly utilized, according to a Cochrane review⁹ and systematic reviews.^10,11 

Contact and/or noncontact, low-frequency ultrasonic debridement (LFUD) offers an alternative to sharp debridement. LFUD generates sound waves ranging from 20 to 40 kHz (undetectable to human hearing), delivered to the ulcer through a liquid medium such as normal saline. According to systematic reviews,^12-14 ultrasound waves have the mechanical effects of cavitation and microstreaming, leading to an increase in cellular activity which, in turn, promotes healing. Specifically, systematic reviews^13,15 of ulcer healing studies also have determined an increase in protein synthesis and an increase in production of growth factors and endothelial cells occurs, all of which stimulate the ulcer toward healing. In vitro studies^14,16 have found both noncontact and contact LFUD lowers bacterial counts through the mechanical destruction of the bacterial cell wall. An in vitro study¹⁷ has shown direct-contact LFUD has the added benefit of enhanced fibrinolysis due to an increased intensity of ultrasound; this subsequently leads to ulcer angiogenesis without destroying healthy ulcer tissue.¹⁵ 

A Cochrane review⁹ on the debridement of diabetes-related foot ulcers included 6 randomized controlled trials; 5 evaluated the effectiveness of hydrogel as a method of debridement against a range of comparators such as combinations of saline dressings and pressure offloading, hydrogel with an additional bacteriostatic action, larval therapy, and 2 other hydrogel dressings. The sixth trial compared surgical debridement with nonsurgical sharp debridement (NSSD) in addition to relieving the pressure of weight-bearing and providing regular dressing changes. Conclusions from the Cochrane review⁹ suggest that although hydrogels increase diabetes-related foot ulcer healing compared with gauze or standard wound care, it is unclear if this effect is directly due to debridement. Additionally, it was noted that randomized controlled trials on debridement for diabetes-related foot ulcers are small in number and of poor methodological quality. The review concluded that while debridement is regarded as an effective intervention to assist healing, more research is needed to evaluate the effects of a wide range of debridement methods and of debridement per se. No subsequent Cochrane review was conducted since its publication, nor a protocol registered for update. 

The aim of this systematic review was to compare available evidence on the effectiveness of bedside NSSD via scalpel without using anesthesia versus contact or noncontact LFUD in terms of percentage of ulcers healed for diabetes-related foot ulceration.

Methods

Methodology. The clinical question for this systematic review was generated using the Population Intervention Comparison Outcome¹⁸ (PICO) model for clinical questioning. The question was: In adult patients with chronic diabetes-related foot ulcers, what effect does LFUD have on ulcer healing rates compared to NSSD?

This question was separated into terms to search electronic databases including Ovid, MEDLINE, EMBASE, the Cumulative Index of Nursing and Allied Health Literature Plus, and the Cochrane Database of Systematic Reviews from the earliest date publications were available in each index until April 2017. Table 1 shows the search terms used. Searches were restricted to human studies and English-language articles. 

Two (2) authors independently reviewed the title and abstract of all retrieved studies against the eligibility criteria (see Table 2), which specified chronic diabetes-related foot ulcers (>4 weeks’ duration) in adults >18 years of age. Publications were excluded if 1) the methods of debridement did not involve comparing LFUD to NSSD, 2) wounds demonstrated an etiology other than a diabetes-related foot ulceration, or 3) the study involved acute ulcers, ulcers that did not undergo debridement, and diagnostic or dental ultrasound. 

When the 2 authors disagreed regarding study inclusion, a third author helped resolve the issue through discussion. The full text of articles was obtained when the abstract seemed uncertain. Forward and backward searching strategies also utilized the reference lists and Google Scholar citations of articles included within the full text review. 

Data extraction. General demographics such as gender, country, age, diabetes type, and method of wound debridement of each participant group were extracted from each included study and tabulated and summarized in Table 3. The primary outcome of interest was healing rates of diabetes-related foot ulcers. The secondary outcome of interest was the percentage of ulcers healed. 

All articles included within the review underwent methodological assessment for risk of bias using the quality indicators as outlined by Physiotherapy Evidence Database (PEDro).¹⁹ This scale has 11 indicators to identify any risk of bias. Each indicator was given a score of - if not included, ? if not mentioned, or + if included. According to the PEDro guidelines, criteria 2 to 11 are used for scoring purposes, so a score out of 10 is calculated. 

Two (2) authors completed this assessment independently and resolved any disagreements. Articles also were classified into levels of evidence using criteria set out by the Oxford Centre for Evidence-based Medicine.²⁰ This provides advice on the most appropriate research to guide treatment. Systematic reviews of randomized controlled trials are the highest level of evidence (Level 1), followed by randomized controlled trials (Level 2), nonrandomized controlled cohort/follow-up studies (Level 3), cohort studies and/or case studies (Level 4), and mechanism-based reasoning (Level 5). 

Data collection. Primary outcome of percentage of ulcers healed were extracted into an Excel worksheet (Microsoft Excel, version 16.15, Redmond, WA). 

Data analysis. Analysis was performed using Stata 13 software (College Station, TX). Random effect meta-analysis was performed where data were available for similar outcomes evaluated in more than 1 study. Authors were contacted to request additional data for studies not reporting sufficient outcome data for inclusion in the meta-analysis; however, no responses were received, thus eliminating 2 of the 4 studies from analysis. 

Results

Of the 259 total publications identified using the review search terms after duplicates were removed, 204 titles were determined to be potentially relevant and their abstracts were reviewed. One hundred, ninety-three (193) articles were excluded after reading the abstracts, leaving 11 articles for full text screening. Only 4 articles met the criteria for inclusion in the review. The PRISMA statement lists the reasons for exclusion (see Figure 1). 

Description of studies. Table 3 provides a summary of the 4 articles included: 3 describe clinical trials involving randomization and 1 used historical data from the same clinic as the control with LFUD as the intervention group. Three (3) of the studies used the MIST® noncontact LFUD (Celularity, Inc, Warren, NJ) with varying debridement times and treatment provided either once or 3 times per week. The fourth study used Sonoca 180® noncontact LFUD (Söring GmbH, Quickborn, Germany) performed once per week with debridement duration calculated based on ulcer total area. The control treatments varied between studies, but all studies included NSSD where required and moist wound dressings. Offloading strategies and other treatment modalities varied between the studies, reflecting the complexity and variability of ulcer management and confounding the validity of pooling these studies. The pooled population included 227 patients ranging in age from 40 to 72 years. The included articles described are for the primary outcome (percentage of ulcers healed). 

Meta-analysis/pooling of data. Data extracted included patient demographics, study design and criteria, measurement tool, clinical outcome, and follow-up period. Results from the 2 studies included in the meta-analysis found 30% of the patients in the NSSD groups healed, and 33% in the LFUD groups healed. A meta-analysis was performed on only 2 of the 4 articles; 2 articles had insufficient outcome data, although the current authors attempted to secure the missing data from the original researcher^21,22 in a format that would allow for meta-analysis. Therefore, meta-analysis was performed with 2 articles^23,24 and a total sample size of 173; the analysis did not identify any relationships that suggested a greater effectiveness of either LFUD or NSSD in total healing diabetes-related foot ulcers (RR = 0.92; 95% CI = 0.76-1.11) (see Figure 2). 

Quality of evidence. Scores of the 4 articles indicated a risk of bias according to the PEDro scale (see Table 4). Three (3) of the studies were randomized controlled trials and the fourth used historical data from the same clinic as the control. Not all criteria on the PEDro scale could be satisfied in these studies (eg, the blinding of participants  and clinicians). In 2 of the publications, certain information was not documented and therefore led to a query if the criterion of participant allocation concealment and participants, therapists, and assessors blinding were met. In all 3 randomized controlled trials, participants were randomized to treatment groups and received the allocated treatment or control; these studies also noted between-group statistical comparisons reported for the primary outcome. The 2 studies included in the meta-analysis had a low risk of bias (PEDro score 9/20). 

Discussion 

This review identified that available evidence is insufficient to determine whether LFUD or NSSD provides better outcomes in the treatment of diabetes-related foot ulcers. A total of 110 participants that were provided LFUD was compared to 117 participants treated with NSSD within the same studies. Devices that deliver LFUD are available with varying applications (contact vs. noncontact) that influence the ultrasound intensity delivered to the ulcer. Much variation also was evident in the examined studies in the application time for LFUD as well as the frequency of debridement with treatments, ranging from 3 times per week to once per week. Interim therapy also was a confounding factor. 

It is important to establish whether LFUD is more effective than NSSD to justify its use in clinical practice. Without high-quality evidence supporting the use of LFUD in the treatment of diabetes-related foot ulcers, clinicians using this technology must rely on expert opinion and guidance from the manufacturer. In the current authors’ experience, the different application methods and settings are recommended based on limited research available; clinicians are faced with the potential to be under- or overutilizing this therapy. 

This review demonstrated a relative paucity of evidence supporting the use of LFUD as an alternative to NSSD. Use of NSSD for the management of diabetes-related foot ulcers is recommended in several guidelines,^5,8 which is why it was considered in this study an appropriate standard for comparison in this review. 

Limitations

It is a limitation of the scope of this review that the effectiveness of NSSD alone was not considered. In addition, the variety of outcome measures among the 4 studies included in this review (percentage of ulcers healed, reduction in ulcer size/volume) made comparisons across the studies difficult. Ideally, a uniform set of outcomes and time points of collection would be reported in the literature to enable pooling across studies. Also, no studies that investigated the use of contact LFUD were found; therefore, the effects of contact versus noncontact LFUD cannot be reported. This was variable outside the study question should other authors wish to undertake further research in this area. Finally, the control groups for all 4 studies were significantly varied. In 3 of the 4 studies, offloading with footwear, orthotics, or padding was not standardized, including the 2 studies in the meta-analysis. Mechanical offloading is known to be vital in managing diabetes-related foot ulcers and plays a large role in healing outcomes,³⁰ but in this research the variety of offloading approaches was a confounding factor. Finally, other important outcomes such as pain, cost, and provider variables were not considered. 

Conclusion

A diabetes-related foot ulcer is a common complication of diabetes that is often a primary cause of hospital admission. LFUD and NSSD are used to manage diabetic foot ulcers, whereby clinicians observe an immediate reduction in nonviable tissue which is believed to facilitate healing. The results of this study showed no difference in healing rates between LFUD and NSSD. More rigorous randomized controlled trials with long follow-up periods and an adequate sample size are needed to identify whether debridement aids the healing of diabetes-related foot ulcers and if so, which is the optimum method when used as an adjunct with best practice ulcer management. n

References 

1. International Diabetes Federation. IDF Diabetes Atlas. Brussels, Belgium: International Diabetes Federation; 2000.

2. International Diabetes Federation. IDF Diabetes Atlas. 4th ed. Brussels, Belgium: International Diabetes Federation; 2009.

3. International Diabetes Federation. IDF Diabetes Atlas. 7th ed. Brussels, Belgium: International Diabetes Federation; 2015.

4. Australian Institute of Health and Welfare (AIHW). Diabetes: Australian Facts 2008. Canberra, Autralia: AIHW;2008.

5. Apelqvist J, Bakker K, van Houtum WH, Nabuurs-Franssen MH, Schaper NC. International consensus and practical guidelines on the management and the prevention of the diabetic foot. International Working Group on the Diabetic Foot. Diabetes Metab Res Rev. 2000;16(Suppl 1):S84–S92.

6. Bus SA, van Deursen RW, Armstrong DG, Lewis JE, Caravaggi, CF, Cavanagh PR; International Working Group on the Diabetic Foot. Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review. Diabetes Metab Res Rev. 2016;32(Suppl 1):99–118.

7. Schultz GS, Sibbald RG, Falanga V, A et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003;11(suppl 1):1–28.

8. National Health and Medical Research Council. National Evidence-Based Guidelines on Prevention, Identification and Management of Foot Complications in Diabetes. Melbourne, Australia: NHMRC;2011.

9. Edwards J, Stapley S. Debridement of diabetic foot ulcers. Cochrane Database Syst Rev. 2010;(1):CD003556.

10. Bradley M, Cullum N, Sheldon T. The debridement of chronic wounds: a systematic review. Health Technol Assess. 1999;3(17 pt 1):iii–iv,1–78.

11. Falabella AF. Debridement and wound bed preparation. Dermatol Ther. 2006;19(6):317–325.

12. Hess CL, Howard MA, Attinger CE. A review of mechanical adjuncts in wound healing: hydrotherapy, ultrasound, negative pressure therapy, hyperbaric oxygen, and electrostimulation. Ann Plast Surg. 2003;51(2):210–218.

13. Voigt J, Wendelken M, Driver V, Alvarez OM. Low-frequency ultrasound (20-40 kHz) as an adjunctive therapy for chronic wound healing: a systematic review of the literature and meta-analysis of eight randomized controlled trials. Int J Low Extrem Wounds. 2011;10(4):190–199.

14. Breuing KH, Bayer L, Neuwalder J, Orgill DP. Early experience using low-frequency ultrasound in chronic wounds. Ann Plast Surg. 2005;55(2):183–187.

15. Driver VR, Yao M, Miller CJ. Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: a meta-analysis. Wound Repair Regen. 2011;19(4):475–480.

16. Pierson T, Niezgoda JA, Learmonth S, Blunt D, McNabb K. Effect of low-frequency ultrasound applied in vitro to highly antibiotic-resistant Acinetobacter isolates recovered from soldiers returning from Iraq. Wound Repair Regen. 2008;13(2):1–2.

17. Stanisic MM, Provo BJ, Larson DL, Kloth LC. Wound debridement with 25 kHz ultrasound. Adv Skin Wound Care. 2005;18(9):484–490.

18. Huang X, Lin J, Demner-Fusjman D. PICO as a knowledge representation for clinical questions. AMIA Annu Symp Proc. 2006;2006:359-363. 

19. Maher CS, Sherrington C, Herbert RD, Moseley AM, Elkins M. Reliability of the PEDro Scale for rating quality of randomized controlled trials. Phys Ther. 2003;83(8):713–721.

20. OCEBM Levels of Evidence Working Group. The Oxford Levels of Evidence 2. Oxford Centre for Evidence-Based Medicine. Available at: https://www.cebm.net/index.aspx?o=5653. Accessed April 2, 2017.

21. Ennis WJ, Valdes W, Gainer M, Meneses P. Evaluation of clinical effectiveness of MIST ultrasound therapy for the healing of chronic wounds. Adv Skin Wound Care. 2006;19(8):437–446.

22. Yao M, Hasturk H, Kantarci A, et al. A pilot study evaluating non-contact low-frequency ultrasound and underlying molecular mechanism on diabetic foot ulcers. Int Wound J. 2014;11(6):586–593.

23. Ennis WJ, Formann P, Mozen N, Massey J, Conner-Kerr T, Meneses P. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. 2005;51(8):24–39.

24. Amini S, ShojaeeFard A, Annabestani Z, et al. Low-frequency ultrasound debridement in patients with diabetic foot ulcers and osteomyelitis. Wounds. 2013;25(7):193–198.

25. Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care. 2001;24(6):1019–1022.

Potential Conflicts of Interest: Ms. Michailidis is supported through an Australian Government Research Training Program Scholarship. Dr. Williams is supported through a National Health and Medical Research Early Career Health Professional Fellowship.

Ms. Michailidis is a podiatrist, Monash Health, Podiatry Department, Monash Medical Centre, Clayton, VIC, Australia; and a post-graduate student, Monash University, School of Primary and Allied Health Care, Physiotherapy Department, Frankston, VIC, Australia. Dr. Bergin is a podiatrist, Monash Health, Podiatry Department, Monash Medical Centre. Professor Haines is the Head of School, Monash University, School of Primary and Allied Health Care, Physiotherapy Department. Dr. Williams is an academic, Monash University, School of Primary and Allied Health Care, Physiotherapy Department; and in Allied Health Research, Peninsula Health, Allied Health, Frankston, VIC, Australia. Please address correspondence to: Lucia Michailidis, B Pod, Monash Health, Podiatry Department, Monash Medical Centre, 246 Clayton Road, Clayton, VIC, 3168, Australia; email: lmichailidis@phcn.vic.gov.au

Abstract

Home care services are effective in many patient groups. Purpose: The authors examined the effect of specialized ostomy care in the home on peristomal skin complications and patient quality of life (QOL).

Method: A prospective, experimental study was conducted among 35 people >18 years old with a colostomy or ileostomy and peristomal skin complications who were listed in 2 ostomy supplier databases. Participants were alternatively allocated to 6 home care visits (intervention [IG], n = 18) or 2 outpatient/clinic care [CG] visits (control, n = 17).  Demographic and patient variables were assessed at the initial visit in both groups. The Ostomy Skin Tool (OST) and the Stoma-Quality of Life instrument were used to assess study characteristics; data were statistically analyzed. Results: The Discoloration, Erosion, Tissue Overgrowth scores of the OST of the 2 groups were similar in the first assessment (IG = 6.22 ± 1.47; CG= 6.11 ± 1.96; P = .776), but a statistically significant difference was noted between groups at the end of study (IG = 0.44 ± 0.85, CG = 4.76 ± 2.30; P = .00). At the first assessment, QOL scores of the IG and CG groups were 72.63 ± 11.48 and 66.73 ± 17.52, respectively (P = .197). At the final assessment, QOL scores were 78.12 ± 9.66 and 71.83 ± 18.37 for IG and CG, respectively (P = .390). Conclusion: Home nursing care was found to be effective in treating peristomal skin complications. The QOL scores achieved at the final assessment were significantly improved compared with the initial assessment. The results demonstrated the importance of follow-up after stoma surgery. 

Stoma complications can be designated early- and late-occurring. Early complications are defined as those occurring within 30 days following stoma creation and include ischemia/necrosis, retraction, mucocutaneous separation, and parastomal abscess; late complications include parastomal hernia, prolapse, retraction, and varices.¹ Peristomal skin complications can occur in either period and according to review and descriptive studies,^2-7 they are the most frequently observed stoma complications. Peristomal skin complications can be divided into 5 groups: irritant dermatitis, allergic dermatitis, mechanical trauma, complications caused by the underlying disease, and complications induced by infection.⁸ 

 In the literature, prevalence rates for both early and late peristomal skin complications vary greatly. Park et al⁵ performed a retrospective chart review of 1616 patients of all ages with an ileostomy or colostomy. According to their results, skin irritation was both the most common early (12%) and late complication (6%). A systematic review by Salvadelena⁹ of stoma complication prevalence (N = 21) also showed that both early (16%) and late (12%) peristomal skin complications were the most common stoma complications. Likewise, a retrospective study by Sung et al¹⁰ among 1170 patients with a colostomy or ileostomy found peristomal skin complications (at a rate of 15.5%) were most common. A prospective study by Ratliff¹¹ showed peristomal skin complications were the most common stoma complications among individuals with an ileostomy or colostomy, with a 47% prevalence. The latter rate was high in comparison with other studies, possibly because a standardized tool was used, yielding a more objective evaluation. Results of a prospective audit by Cottam et al¹² of 3970 colostomy and ileostomy patients 3 weeks after surgery found 1329 (34%) stomas were problematic, most commonly due to retraction.

In Turkey, a wound ostomy continence (WOC) nurse is not available in all hospitals and no standard protocol exists for patients with stoma complications. In the postoperative period after discharge from the hospital, patients can go to a physician or they can visit a WOC nurse (if available) when they have a stoma-related problem. WOC nurses typically schedule the patient for outpatient clinic follow-up of his/her stoma and peristomal area 2 weeks after hospital discharge, with subsequent visits according to the patient’s needs. 

According to an experimental study¹³ and a literature review,¹⁴ a stoma adversely affects quality of life (QOL). Gooszen et al¹⁵ performed a cross-sectional, descriptive study among 43 individuals with a colostomy or ileostomy at least 6 months post ostomy surgery using the Stoma Quality of Life (Stoma-QOL) scale to measure QOL. The authors found 70% of patients’ QOL scores were low. Kuzu et al¹⁶ conducted a retrospective study among 178 patients who had colorectal surgery. Patients were divided into 3 groups according to surgery type. Results showed stoma patients had the lowest QOL score compared with the patients that did not have stoma surgery. Prospective, descriptive studies by Ross et al¹⁷ (N = 249; 3, 6, 12, and 24 months after surgery) and Sideris et al¹⁸ (N = 132, with a cross-sectional component) show similar results. In the former,¹⁷ QOL scores for patients with a stoma were poorer than nonstoma patients; in the latter,¹⁸ QOL scores of stoma and nonstoma patients were not significantly different, but stoma patients had more complaints about body image.

 Prospective and retrospective follow-up studies^15-18 have shown stoma complications to be the cause of reduced sexual activity, sleep disturbances, fatigue, and deterioration in body image. Moreover, stoma complications have an adverse effect on social life, work satisfaction, and fiscal concerns,^15-18 issues that adversely affect QOL.

Home care services provided by health care systems often include rehabilitation, support, health promotion or disease-prevention, and technical nursing care for both chronic and acute conditions.¹⁹ Although descriptive and experimental studies^20-22 indicate home care services have been effective in the care of many patient groups, no studies have been published regarding the effectiveness of home health care specializing in peristomal skin complications and QOL of people with a stoma. In the United States, WOC nurses are employed in many home care facilities. However, the newly constructed home care services in Turkey have hired no nurse specialists on wound and ostomy care.

The aim of this research was to examine the effect of home health care on the healing of peristomal skin complications and QOL. The study question was: Does the provision of home health care affect peristomal skin complication healing and patient QOL?

Methods

Study design. This experimental study used a control group through a “time series” research model.²³ The research data were collected in the city of İzmir, Turkey, between July 1, 2012 and February 1, 2013.

Study participants. Stomatherapy units are not available in every hospital in Turkey; therefore, no formal record system (number, complication rates, and so on) exists for individuals with a stoma. The intent was to use patient records of the 3 companies that sell stoma supplies in the city of İzmir as the study population, but 1 of the companies did not allow the use of patient records for research purposes. Patient lists obtained from 2 companies were alphabetically ordered by initials, and patients were contacted by phone, given information about the research, screened, and invited to the stomatherapy unit. Persons who were at least 18 years old, had a colostomy or ileostomy, experienced peristomal complications, and were living in central İzmir were eligible to participate in the study. Persons who agreed to participate were examined by a WOC nurse for the purposes of this study, yielding the final number of participants. Participants were alternatively allocated to the intervention or control group based on consecutive stomatherapy unit visit order. The intervention group received 6 home care visits once every 5 days over 1 month and the control group had 1 outpatient clinic visit. Both groups had an initial assessment visit.

In order to determine the strength of the sample size, a power analysis was performed. The efficacy of home nursing care in healing peristomal skin complications could be expressed by 0.05 in terms of its level of significance (N1 = 18, N2 = 17) and determined to be at 100% power. Participant enrollment was discontinued when the target sample was reached in accordance with the result of the power analysis. 

Ethical considerations. Written permission was granted by Ege University (İzmir, Turkey) Faculty of Nursing Ethics Board and Dokuz Eylül University (İzmir, Turkey) Clinical Research Ethics Committee. Written informed consent was obtained from all individuals participating in the research. 

Patient confidentiality. Patient confidentially was maintained by separating the personal data page from the Diagnostic Form (the first 12 questions) and by using a coding system for the remaining questions. Only the investigators had access to these data. Patients were informed of the precautions that would be taken to protect the confidentiality of the data and who would or might have access.

Data collection instruments.

Diagnostic Form. This form was created by experienced researchers who had reviewed the corresponding literature. It included 4 sections and a total of 28 questions. Section 1 (12 questions) addressed personal information including the patient’s initials, address and telephone number, age, gender, educational status, marital status, income status, occupation, social health insurance plan, person living with the patient at home, height, weight, body mass index (BMI), and the presence of chronic disease. 

The second part of the diagnostic form consisted of 13 questions about the stoma, including date of stoma surgery; stoma duration, type (colostomy/ileostomy), and status (permanent/temporary); assumed stoma closure time for temporary stomas; the patient’s medical diagnosis; the person responsible for care of the stoma at home; the title of a person who provided the patient stoma care education; and whether the patient had a problem purchasing basic and accessory stoma materials. 

The third section included 2 questions on the duration and treatment history of peristomal skin complications, and the fourth part was designed to assess factors that may adversely affect wound healing including diabetes, anemia, immunodeficiency, immobility, vascular problems, chemotherapy and/or radiotherapy, or other conditions/circumstances.

The Ostomy Skin Tool (OST). The OST was developed in 2009 by an international group of 12 expert ostomy care nurses working in collaboration with Coloplast A/S (Humlebaek, Denmark) and with advice from a dermatologist. The OST provides a common language to describe the severity, extent, and likely cause of a peristomal skin disorder.²⁴ 

The OST consists of 2 parts:

1) The Discoloration, Erosion, Tissue Overgrowth (DET) Score Calculation Guide. The DET is the sum of the extent and severity scores given to discoloration, erosion, and uncontrolled tissue size (in terms of growth) in the peristomal area (minimum: 0, maximum: 15; high score shows worse peristomal skin condition). The guide for calculating the DET score yielded an intraobserver concordance coefficient of 0.84 and an interobserver concordance coefficient of 0.54.²⁴ To establish the reliability and validity of the DET, photographs of 30 peristomal skin complications with different levels were shown to 2 stoma care nurses twice at 1-hour intervals. The nurses were asked to evaluate the photographs and calculate the DET scores; the results of this exercise showed that intraobserver agreement was very good (K = 0.83–1) and interobserver concordance (K = 0.51–0.77) was adequate. In the current study, DET scores were calculated at every home visit and assessments and nursing interventions were implemented according to the Assessment, Intervention, Monitoring (AIM) guide by researcher. Additionally, at the last/sixth home visit, the Stoma QOL scale was administered again. 

2) AIM Guide. This guide includes the identification and classification of peristomal skin complications according to their causes as well as appropriate interventions. The AIM guide includes 22 factors (aimed at 5 categories) causing complications and 78 nursing interventions prepared to address these problems.²⁵ As a part of Turkish validity and reliability testing, 10 experts provided feedback on the content, language conformity for the Turkish society, clarity, and understandability and were asked to grade the AIM entries on a scale of 1 to 4. The AIM guide’s content validity index was found to be 0.99 among these experts, and it was concluded to have met the criteria for compliance (ie, content validity).²⁶ Necessary adjustments were made in accordance with the experts’ feedback. 

Permission for the use and translation of the Peristomal Skin Tool was obtained and language validity, content validity, intraobserver, and interobserver concordance coefficients of the Turkish OST were calculated before the data collection period. 

Quality of Life Scale for Stoma-QOL. The Stoma-QOL was created in 2003 to measure the QOL of patients with a stoma. The 20 items in the scale are assigned a value between 1 and 4. The overall QOL score is obtained by summing all values attached to each item.²⁷ The validity and reliability of the scale in terms of Turkish language compliance was studied by Harputlu et al²⁸; the Cronbach α coefficient was found to be 0.89 for the entire scale. The test/retest reliability coefficient of correlation between the 2 measurements was found to be 0.83.

Data collection procedures. The initial clinical assessment was conducted in the stomatherapy unit for both the intervention and control groups. At the initial assessment, the Diagnostic Form was completed; DET scores were calculated; assessments regarding the complications, causes, and necessary nursing interventions were implemented according to the AIM guide; and QOL scores were calculated for both groups. Patients could complete the questionnaires (diagnostic form and Stoma-QOL) by themselves; researchers read and filled in the answers when participants with difficulty reading and writing needed help. 

For the intervention group, research data were collected over the 7 visits (initial monitoring and 6 follow-up visits at home once every 5 days). For the control group, 2 follow-up visits (initial monitoring and an outpatient visit after 30 days) were provided. Because acute peristomal skin wound healing typically takes 2 to 3 weeks, the follow-up period was used for follow-up assessment.

For the control group (after initial assessment), owing to the fact no special home health care is available for the individual with stoma in Turkey, patients received outpatient nursing care. No formal protocol exists for provision of outpatient care control, so the WOC nurse decided care mostly based on his/her knowledge. Control group patients in this study received interventions according to the AIM guide. Treatment suggestions were given, and patients were provided proper stoma care information according to AIM guide and were invited to visit the stomatherapy unit if they needed further nursing care. Individuals in the control group cared for their complications on their own without having any home visits and were re-evaluated in the stomatherapy unit after 30 days, at which time the final DET and QOL questionnaires were completed. 

Statistical analysis. Data were collected using paper and pencil and entered directly into the Statistical Package for the Social Sciences (SPSS for Windows, version 15.0; Chicago, IL) by the researchers for data analysis. The hypothesis tests in the research were evaluated in accordance with an α = 0.05 level of significance. Frequency and percentage distribution, chi-squared analysis, 2-paired sample t tests, Linear Weighting Kappa analysis, Mann-Whitney U-test technique, Lawshe, Friedman’s chi-squared, and the Wilcoxon Signed Ranks tests were used to analyze data. 

Results

General participant characteristics. From the total manufacturer database population of 1269, 76 patients (5.99%) agreed to participate and were examined for peristomal complications. Thirty-five (35) patients met the inclusion criteria and were accepted for participation; 18 were enrolled in the intervention and 17 in the control group. The average age was 57.45 ± 14.70 years and the largest age group was 60–69 years (12, 34.3%) old. Twenty-two (22, 62.9%) were women, the most common highest educational level was elementary school (14, 40.0%), 25 (71.4%) were married, the largest employment portion was the working class (16, 45.7%), and most were retired (18, 51.4%). All 35 (100%) had a social health insurance plan, 32 (91.4%) lived with their families, and 19 (54.3%) defined themselves as being financially solvent in terms of income. The most prevalent medical diagnosis/reason for the stoma was rectal cancer (14, 40%); 20 (57.1%) had no chronic disease. Seventeen (17, 48.6%) study participants were overweight. Twenty-one (21, 60.0%) had an ileostomy, 18 (51.4%) had a permanent stoma, and 8 (22.9%) were 1 month postsurgery at the time the study was conducted. Nineteen (19) individuals (54.3%) reported that they performed their own stoma care, and 27 (77.1%) stated their first instruction regarding this self-care was provided by their stoma care nurse. No statistically significant difference was found between intervention and control groups in terms of sociodemographic characteristics (P >.05). 

The distribution of individuals according to their peristomal skin complications is shown in Table 1. The most common peristomal skin complication for the intervention group was irritant dermatitis (12, 66.7%). Three (3) individuals (16.7%) had mechanical trauma, 2 (11.1%) had allergic dermatitis, and 1 (5.6%) had both allergic and irritant dermatitis. Similar to the intervention group, the most common complication in the control group was irritant dermatitis (14, 82.4%), with 2 people (11.8%) experiencing mechanical trauma and 1 individual (5.9%) with allergic dermatitis. The groups were homogeneous in terms of factors that may adversely affect wound healing such as diabetes mellitus, immobility, and undergoing chemotherapy or/and radiotherapy. 

In the intervention group, 3 of 18 (16.7%) patients with a colostomy and 9 of 18 (50%) with an ileostomy had irritant dermatitis. Of those, 2 individuals with a colostomy and 3 with an ileostomy were in their early postoperative period (0 to 29 days). In the control group, 4 of 17 (23.5%) people with a colostomy and 10 of 17 (58.8%) people with an ileostomy had irritant dermatitis. Of those, 3 individuals with ileostomy were in their early postoperative period, but no one with a colostomy was in the early postop period. 

The effect of nursing care on healing peristomal skin complications. The mean DET score of the individuals in the intervention group at the first assessment was 6.22 ± 1.47 (range 4–9), and the mean DET score at the sixth home visit was 0.44 ± 0.85 (range 0–2). Further, it was found that mean DET scores decreased gradually with every home visit. The mean DET score of the individuals in the control group was 6.11 ± 1.96 (range 3–10) at the first assessment and 4.75 ± 2.30 (range 0–10) at the final assessment (DET = 6). The results from the initial assessment of both the intervention and control groups showed homogeneity in terms of DET scores (P  = .776, U = 144). However, in the final assessment, a statistically significant difference was noted between the intervention and control groups in terms of DET scores (P  = .00, U = 15000) (see Table 2). 

Irritant dermatitis and applied nursing interventions. At the initial assessment, 12 in the intervention group and 14 in the control group were diagnosed with irritant dermatitis. In the intervention group at the first assessment, 3 people had problem 1 (P1), 12 had P2, 4 had P3, and 11 had P4. For these problems, all the appropriate interventions noted in the AIM guide during the home visits were provided. At the last assessment, 3 had P4 and the other problems were healed. In the first assessment of control group, 4 people had P1, 9 had P2, 1 had P3, 12 had P4, and 1 person had P5. All necessary interventions described in the AIM guide were applied. In the last control group assessment, 2 people had P1, 6 had P2, 12 had P4, and 1 had P5 (see Table 3). 

Allergic dermatitis and applied nursing interventions. Two (2) participants from the intervention group and 1 participant from the control group were diagnosed with allergic dermatitis. At the first intervention group assessment, 1 person had P7 and 2 had P8. At the last assessment after the interventions, 1 person had P7. At the first and last control group assessments, 1 person had P7 (see Table 4). 

Mechanical trauma and applied nursing intervention. Three (3) participants from the intervention group and 2 from the control group were diagnosed with mechanical trauma. In the first assessment of intervention group, 1 person had P10, 2 had P11, and 1 had P13. All appropriate interventions were applied, and by the last assessment all problems were healed. In the first assessment of control group, 1 person had P11 and 1 had P12. At the last assessment after interventions were applied, 1 person in the control group had P12 (see Table 5). 

QOL in individuals with a stoma. At the first assessment, mean QOL scores for the intervention and control groups were 72.63 ± 11.48 (range 53.75–96.25) and 66.73 ± 17.52 (range 28.75–92.50), respectively (P = .197). At the final assessment, the QOL mean scores also were not significantly different between groups (78.12 ± 9.66 [range 58.75–96.25] and 71.83 ± 18.37 [range 25–95] for the intervention and control groups, respectively; P = .390). However, the difference between intervention group’s first and last QOL scores was statistically significantly different (first QOL score = 72.63 ± 11.48; last QOL score = 78.12 ± 9.66; t = -3.078; P = .007), as was the difference between the control group’s first and last QOL assessment scores (first QOL score = 66.73 ± 17.52; last QOL score = 71.83 ± 18.37; t = -2.252; P = .039).

Discussion

Peristomal irritant dermatitis. When experimental and systemic review studies^3,29,30 involving peristomal skin complications were examined, it was noted that skin contact with feces or urine leaking from the stoma was the most common factor involved in irritant contact dermatitis. The current research also shows that at the initial assessment of individuals with irritant dermatitis, the complication was caused by feces or mucous coming into contact with the skin as a result of the wafer being larger than the diameter of the stoma as well as poor adhesion of the wafer (see Table 3). Specifically, in the first 6 months following surgery, edema reduction causes the stoma to decrease in size, and measurement of the stoma diameter and the dimensions of the wafer often have to be recalibrated in order to accommodate the shape of the stoma.³¹ If this information is not shared with the patient or if the patient fails to understand its importance, the patient will cut the wafer according to the size of the stoma postoperatively in the hospital, increasing the risk of skin irritation. At the initial assessment, 12 people from the intervention group and 9 from the control group had their wafer fittings adjusted according to the appropriate stoma diameter measurement in each individual to avoid irritant dermatitis resulting from this problem. At the final assessment, this intervention was no longer needed in the intervention group. However, in the control group, 6 individuals were found to have an improperly fitting wafer and this intervention had to be applied again. Correct wafer application was performed in the control group at the initial assessment, and individuals were informed about the measurement of the stoma diameter; during later applications, the participants in the control group changed their own wafers. However, individuals were noted to have failed to cut their stoma wafer properly when they visited the stoma unit for research and peristomal skin controls. This demonstrates that individuals could not carry out proper application and were not aware of their improper application. At the same time, it also suggests that a single training session is not enough and that, if possible, home visits may be needed to reinforce proper application techniques. 

For individuals with complications resulting from poor adhesion of the wafer to the skin, 11 members of the intervention group and 12 members of the control group were treated with additional products such as stoma powder. In the final assessment, 3 members of the intervention group and 12 individuals from the control group continued to need additional product applications. The fact that 12 individuals in the control group still needed additional products may suggest that the recommendations were not followed (see Table 3). However, the control group may not have achieved the level of improvement of the intervention group for many reasons; for example, the stoma powder recommended for care is an additional product not covered by a social health insurance plan, stoma products are available for sale in only some parts of Turkey (they are not available in every pharmacy or drug store), and when the investigator conducted a home visit she brought basic and additional products that might be necessary so patients in the intervention group had no difficulty obtaining products. Also, persons in the control group who needed additional products in the final assessment could have difficulty obtaining them. 

Peristomal allergic dermatitis. Peristomal allergic dermatitis is a reaction to the product used on the individual’s skin.³¹ A case study by Martin et al²⁵ of a 63-year-old patient with an ileostomy sought to determine the cause of the patient’s dermatitis. The authors performed a patch test that showed the patient was allergic to the stoma paste. In a case study by Gallo et al,³² patch test results from a 76-year-old patient with an ileostomy also showed the allergen was stoma paste, as did another case study by Scalf and Fowler,³³ who found an allergy was caused by stoma paste and the substance gantrez. As part of a study on allergic dermatitis, Landis et al³⁴ conducted a retrospective review of medical records of patients with ostomies and peristomal dermatitis who underwent patch testing during a 10-year period in their hospital. Of the 10 patients with peristomal allergic dermatitis, 3 were allergic to stoma paste and the rest were allergic to several substances in stoma materials. In their case study, Lazarov and Trattner³⁵ reported on a patient with a colostomy and allergic dermatitis due to the adhesive remover.

In this sample, 3 participants from the intervention group and 1 participant from the control group were diagnosed with allergic dermatitis. One (1) individual in the intervention group and 1 individual in the control group had allergy-related complications presenting in the form of papules, plaques, edema, and/or discoloration (P7) despite proper use of products (see Table 4). The individual in the intervention group was found to be allergic to the stoma paste (initial DET = 6). Interventions for the individual included avoiding allergenic materials (I20) and the use of barrier products (I22). At the final home visit, the skin was almost completely healed (DET = 2). Patch test results of the individual with the same problem in the control group showed the allergen was the stoma wafer (initial DET = 7) and a nonallergenic stoma wafer was recommended. At the final assessment, the individual’s complication was not yet healed (DET = 5). Observed skin improvements suggested that the individual followed the recommendations. Although the individual from the control group and the individual from the intervention group at the initial assessment had similar complication scores, causes, and interventions, the individual from the intervention group experienced better recovery, suggesting that home care visits were effective in treating the complication. 

Peristomal mechanical trauma. Mechanical trauma is caused by the continuous application of stoma materials to the skin, removing the sticky edges from the skin, or damage caused by stoma materials related to peristomal entrapment, excoriation, friction, and tear.^8-36 Nybaek et al⁴ performed a systemic literature review on the complication of mechanical trauma. From the 98 studies they reviewed, they concluded the most common causes of mechanical trauma were pressure, friction, rubbing, stripping, and tearing.

In the current research, 3 participants from the intervention group and 2 from the control group were diagnosed with mechanical trauma (see Table 5). In the initial assessment that compared the DET scores of individuals with allergic dermatitis or irritant dermatitis, individuals with mechanical trauma had lower scores, suggesting they could recuperate more expediently. When the applied nursing interventions and problems of individuals with mechanical trauma from both the intervention and control groups were analyzed, all but 1 of the patients showed improvement in peristomal skin problems. 

QOL. Although definitions of the concept differ, QOL often is defined as “subjective well-being” or “an individual’s happiness with his/her life.”³⁷ Regardless of the reason it was created, the opening of a stoma is known to adversely affect QOL.^13,14 In both groups, the QOL scale scores of individuals in this study increased significantly between the first and last assessment. 

While some time passed between these 2 assessments, which may lessen the adverse impact of stoma creation on QOL,^15-18 it also is known that individuals with a stoma and peristomal skin problems have a lower QOL.⁴ In the current study, the intervention and control groups had differing levels of recovery from peristomal skin complications after 1 month. The factors involved in the improvement in QOL scores in both groups could have been related to healing of peristomal skin complication, the 1-month period between the initial and final assessments, and/or the nursing care and support provided. 

Limitations

Because stomatherapy units were not found in every hospital in Turkey, the records of 2 companies that sell stoma products were utilized in order to reach the individuals with stoma; the authors did not contact all the ostomates who live in İzmir, Turkey. Because the researchers live in city of İzmir, Turkey, the research was limited to persons who live in that city. Because of the small study population, observed rates and scores do not apply to general ostomate population. Also, some of the patients were unaware they had peristomal skin problems.

Conclusion

An experimental study was conducted among ostomates to examine the effect of home health care on the healing of peristomal skin complications and patient QOL. Home nursing care was found to be effective in treating peristomal skin complications, although it should be mentioned many control group patients also improved. In both groups, the QOL scores achieved at the final assessment were significantly improved compared with the initial assessment. The results of this study demonstrated the importance of follow-up after stoma surgery to address peristomal complications and help improve QOL. Additional research is needed to add to clinician knowledge of their role in follow-up care for persons with an ostomy. 

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Potential Conflicts of Interest: none disclosed

Dr. Harputlu is an Assistant Professor, Ankara University, Faculty of Health Sciences, Department of Nursing, Ankara, Turkey. Dr. Özsoy is a Professor, Ege University, Faculty of Nursing, İzmir, Turkey. Please address correspondence to: Deniz Harputlu, RN, PhD, Ankara University, Faculty of Health Sciences, Department of Nursing, Aktaş Mahallesi, Plevne Caddesi, No: 5, 06080 Altındağ/Ankara, Turkey; email: deniz9923@gmail.com