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Inferior Gluteal Artery Perforator Flap for Sacral Pressure Ulcer Reconstruction: A Retrospective Case Study of 11 Patients

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Ostomy Wound Management 2016;62(1):34–39
Chin-Ta Lin, MD; Kuang-Wen Ou, MD; Hao-Yu Chiao, MD; Chi-Yu Wang, MD; Chang-Yi Chou, MD; Shyi-Gen Chen, MD; and Tzu-Peng Lee, MD
Topics: 
case report
Pressure Ulcer
sacrum
perforator flap
wound closure techniques

Abstract

Despite advances in reconstruction techniques, sacral pressure ulcers continue to present a challenge to the plastic surgeon. The flap from the gluteal crease derives blood supply from the inferior gluteal artery perforator (IGAP) and reliably preserves the entire contralateral side as a donor site. To incorporate the IGAP in the reconstruction of sacral pressure ulcers, a skin paddle over the gluteal crease was created and implemented by the authors.

Data from 11 patients (8 men, 3 women; mean age 67 [range 44–85] years old) whose sacral ulcers were closed with an IGAP flap between June 2006 and May 2012 were retrieved and reviewed. All patients were bedridden; 1 patient in a vegetative state with a diagnosis of carbon monoxide intoxication was referred from a local clinic, 2 patients had Parkinson’s disease, and 8 patients had a history of stroke. The average defect size was 120 cm2 (range 88–144 cm2). The average flap size was 85.8 cm2 (range 56–121 cm2). Only 1 flap failure occurred during surgery and was converted into V-Y advancement flap; 10 of the 11 flaps survived. After surgery, the patients’ position was changed every 2 hours; patients remained prone or on their side for approximately 2 weeks until the flap was healed. After healing was confirmed, patients were discharged. Complications were relatively minor and included 1 donor site wound dehiscence that required wound reapproximation. No surgery-related mortality was noted; the longest follow-up period was 24 months. In this case series, flaps from the gluteal crease were successfully used for surgical closure of sacral pressure ulcers. This flap design should be used with caution in patients with hip contractures. Studies with larger sample sizes are needed to ascertain which type of flap is best suited to surgically manage extensive pressure ulcers in a variety of patient populations. 

 

 

Managing sacral pressure ulcers is a common problem for reconstructive surgeons. Local flaps created from the gluteal region are preferred when wound closure is needed due to their reliability and short learning curve for surgeons. Gluteal muscle perforator-based flaps have been used to cover sacral defects for more than 10 years. This flap construct has become increasingly popular because of its versatility and low incidence of donor site complications.1-3

Three types of flaps involving the gluteal crease based on different terminal branches of the inferior gluteal artery have been described in the literature: the infragluteal flap,4 the inferior gluteal artery perforator (IGAP) flap,5,6 and the inferior gluteal artery myocutaneous flap.7 Many clinicians harvest free flaps from the gluteal crease region for breast reconstruction because of its fatty composition.4-6 Gluteal crease flaps also provide positive aesthetic results for both the breast reconstruction and donor site scar without sacrificing muscle at a donor site. According to the case studies of Scheufler et al8 (N = 13) and Higgins et al’s case report,9 gluteal crease flaps also may be harvested for ischial pressure ulcer coverage.8,9

Two mechanisms contribute to pressure ulcer development: external pressure that compresses blood vessels and friction and shearing forces that tear and injure blood vessels. The sacral pressure ulcer is susceptible to recurrence if the underlying mechanisms are not addressed.

In the authors’ facility, a local, unilateral, gluteus maximus myocutaneous advancement flap is the usual choice for sacral defects. Gluteus maximus myocutaneous flap surgery is technically easy to perform. However, the gluteus maximus muscle should be partially split to allow for advancement of the flap and tension-free closure, which introduces the potential for gait instability in an ambulatory patient. The derived flap seldom crosses the midline of the gluteal region; a bilateral gluteus maximus myocutaneous advancement flap is needed for larger defects.1

The purpose of this case study is to describe the outcomes of patients in whom a gluteal crease flap was used for reconstruction of sacral pressure ulcers.

Patients and Methods

The authors treated 350 sacral pressure ulcers in 289 total patients with 332 flaps from June 2006 to May 2012 in the Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. From among these, they retrospectively analyzed the 11 patients (8 men, 3 women; mean age 67 [range 44–85] years old) whose sacral pressure ulcers had been reconstructed using IGAP flaps. The IRB committee of Tri-Service General Hospital approved all procedures for obtaining informed consent, reviewing records, and publishing data and photographs. All defects contained extensive destruction, tissue necrosis, and/or damage to muscle, bone, or supporting structures with or without full-thickness skin loss, a stage IV pressure ulcer according to the definition developed by Shea.10 All patients were bedridden; 1 patient was in a vegetative state following carbon monoxide poisoning, 2 patients had Parkinson’s disease, and the remaining 8 patients had a history of stroke. The patient summary is shown in Table 1. owm_0116_lin_table1

Surgical procedure. Surgical repair of the defect was performed with the patient in a prone position under general anesthesia. The surgical field was sterilized, the sacral pressure ulcer was debrided, and the bony prominence of the sacral bone was removed using an osteotome. The wound then was covered with epinephrine-soaked gauze, and the defect size was measured. An elliptical flap was created from the gluteal crease region; the authors’ preference is to harvest the flap from the side closest to the sacral pressure ulcer if the ulcer is not centrally located, according to the recommendations of Scheufler et al8 and Higgins et al.9 The axis of the flap was fashioned along the natural gluteal crease, the length of the flap was determined according to the vertical length of the defect, and the width of the flap was 3–5 cm less than the horizontal width of the defect so as not to interfere with flap inset as well as to facilitate donor site closure (see Figures 1, 2). The incision was made along the inferior flap margin to identify the inferior border of the gluteus maximus muscle. The length of the dissected pedicle was determined by the arc of movement of the flap.

owm_0116_lin_figure1owm_0116_lin_figure2

Care was taken to identify the cutaneous branch from the descending branch of the inferior gluteal artery at the inferior margin of the gluteus maximus muscle. If the descending branch was of suitable size (>12 mm), the cutaneous branch was isolated and traced along the descending branch toward the origin of the inferior gluteal artery. If the cutaneous branch was absent or too small, the superior margin of the flap was incised. The incision was carried down to the subfascial level, and subfascial dissection was performed caudally to identify the myocutaneous perforator of the inferior gluteal artery. If the perforator was of adequate size (>1–2 mm), intramuscular dissection of the perforator was performed, and the vessel was traced proximally. The flap then was elevated and transferred to the defect either through a subcutaneous tunnel or by incising the skin between the flap and the sacral defect. The flap was set into the defect without tension or twisting on the pedicle. Usually, the flap is rotated 90˚ using the horizontal length of the flap to approximate the vertical length of the defect.

After surgery, vital signs were monitored every 4 hours in unstable patients and every 8 hours in stable patients. The incision and dressing were monitored for signs of infection, and the amount of drainage was noted. Wet gauze dressing changes were performed using sterile technique throughout the hospitalization, and patients’ positions were changed every 2 hours. Some patients were placed on air-fluidized beds to decrease the frequency of patient repositioning. Patients were instructed to lay in the supine position during the day and to remain prone at night for approximately 2 weeks until the flap healed, after which they were discharged to a nursing facility or returned home. Patients were instructed to transition to full supine bed rest 4 weeks after surgery and continue this until wound healing without dehiscence was achieved.

Patients were reexamined and the wound photographed every week in the outpatient department; alternatively, telephone interviews were conducted by the authors’ medical staff if the patients did not return for follow-up.

Results

The average defect size was 120 cm2 (range 88–144 cm2). The average flap size was 85.8 cm2 (range 56–121 cm2). Seven (7) flaps were harvested from the left gluteal crease region and 4 from the right gluteal crease region. Although venous congestion commonly caused flaps to become purple and swollen immediately following surgery, 10 flaps survived completely and achieved wound healing without complications. One patient (patient 6) suffered a traction injury to the pedicle during the transfer of the flap through the subcutaneous tunnel; the flap was abandoned and immediately converted to a local gluteus maximus myocutaneous advancement flap. The skin between the sacral pressure ulcer and the donor site was incised for flap transfer in 3 patients; in 8 patients, the flaps were transferred through a subcutaneous tunnel. One wound dehiscence (patient 5) occurred over the donor site, requiring further wound reapproximation. No surgery-related mortality was noted. The longest follow-up was 24 months. No adverse outcomes were noted, but 1 pressure ulcer recurred (patient 2) 5 months after surgery (see Table 1).

Two case reports of the patients studied, exemplifying the use of IGAP flaps, are presented.

Case Reports

Patient 3. Mr. Q was an 85-year-old man who had been bedridden for 2 years due to a cerebrovascular accident. A grade IV sacral pressure ulcer developed 3 months before admission to the authors’ facility. Surgical debridement created an 11 cm x 10 cm defect, and a flap of corresponding size was designed from the left gluteal crease. During surgery, the cutaneous branch from the descending branch of inferior gluteal artery was identified, and the flap was harvested and transferred to the sacral region (see Figure 3). After surgery, the gauze dressing was changed daily to keep the wound clean; a single closed suction drain was used to monitor excessive bleeding from beneath the flap. Mr. Q was repositioned every 2 hours to prevent pressure ulcer development at other sites, pressure necrosis of the flap, or wound dehiscence. In addition, clinicians took steps to keep excess moisture and fecal contamination away from the wound by checking the wound dressings every 2 hours during repositioning. At 3 months post-surgery, the sacral defect was almost completely healed (ie, without wound dehiscence, discharge, and infection), and Mr. Q was left with an inconspicuous scar over the natural gluteal crease (see Figure 4). owm_0116_lin_figure4

Patient 10. Mr. K was a 69-year-old man who had been bedridden for 3 years before admission following an ischemic cerebrovascular accident. A grade IV pressure ulcer was present over his sacral region, resulting in a 10 cm x 10 cm defect after 2 debridements. A 10 cm x 7 cm flap was designed at the right gluteal crease to cover the defect (see Figures 5, 6, 7). After surgery, the gauze dressing was changed daily to keep the wound clean; a single closed suction drain was used to monitor excessive bleeding from beneath the flap. At his 5-month follow-up visit, both the sacral wound and gluteal wound were healing without ulcer recurrence.

owm_0116_lin_figure5owm_0116_lin_figure6owm_0116_lin_figure7

Discussion

Managing sacral pressure ulcers is a common task for reconstructive surgeons. Several types of flaps have been developed to cover sacral pressure ulcers.1,11-14 Coskunfirat et al13 presented the largest case series in the literature, with 32 gluteal artery perforator flaps for pressure ulcer reconstruction. The perforator flap provides a reliable fasciocutaneous flap for sacral pressure ulcer closure and spares the underlying muscle. However, according to Coskunfirat et al’s13 study, unlike other gluteal perforator flaps, the unpredictable perforator artery location often necessitates a change of flap design intraoperatively.

Harvesting the flap is technically demanding. Creating the IGAP flap involves a dissection of the perforator penetrating the gluteus maximus muscle underneath the piriformis muscle. By separating the dissected pedicle for an island flap, the defect site can be replaced without any tension on the flap. Using the flap from the gluteal crease has several advantages.5-9 First, the constant circulation always ensures successful flap harvesting from the gluteal crease despite having only tiny (<1–2 mm) perforators. Coskunfirat et al13 suggest this flap can be used as a primary choice in sacral pressure ulcer coverage; Doppler has been found to be unreliable in detecting perforators in the gluteal region, and the perforator is typically identified directly through subfascial dissection.13 Second, according to case-control studies,7,8 the infragluteal perforator flap minimizes donor-site morbidity by sparing the gluteal muscles and eliminating the need for primary closure of the donor site; the resulting scar avoids maximal pressure zones over bony prominences. This is beneficial for ambulatory patients for walking or sitting; however, most of the patients in the current study were bedridden. Third, the IGAP minimizes donor site morbidity by sparing the gluteal muscle and primary closure of the donor site, leaving a scar that avoids maximal pressure zones over bony prominences and allowing the scar to remain well hidden in the natural gluteal crease.8 Fourth, in the event of a recurrent ulcer or flap failure, the flap can be raised from an area other than the previous operative site; this technique provides a secondary option for salvage in such cases, as described in the case control study of Higgins et al.9

The major disadvantage of this flap is vascular variation. According to a large case series (N = 118),14 the descending branch of the inferior gluteal artery is present with variable prevalence.8,14 In the Windhofer et al14 study, the descending branch was present in 91.5% of patients. When the descending branch was absent, the cutaneous branch came from the medial or lateral circumflex femoral artery or as a perforator of the deep artery of the thigh.

Hip contracture occurs frequently in the long-term bedridden patient.15 This increases wound tension over the donor site and increases the chance of wound dehiscence. In the current patient series, wound dehiscence of 1 donor site occurred in a patient with hip contracture. In addition, hip flexion might cause undue tension on the flap pedicle, requiring caution in a patient with hip contracture. During the postoperative care period, the caregiver should prevent overflexion of the hip joint for at least 2 weeks. An added consideration is the relatively technical nature of flap creation owing to the demands of intramuscular dissection.

Using the gluteal perforator flap is controversial because published anatomical studies state the blood supply to the gluteal skin is inadequate. In their case control study, Ahmadzadeh et al16 performed a detailed dissection of the gluteal region and determined the vascular territory of a single perforator from the inferior gluteal artery is approximately 24 cm2. However, Koshima et al’s17 case-control study demonstrated a flap in the gluteal region can be nourished even by a single perforator; similarly, Nojima et al’s18 case-control study reported a vascular territory of mean size of 15 cm x 12 cm in the superior gluteal artery perforator flap can be nourished using single perforator with the dye injection method. Skin in the gluteal region also has been shown to be richly vascularized with perforators connected by long and voluminous subcutaneous anastomoses.18 In light of these factors, the authors of the current study concluded the determinant factor for flap size is whether the donor site can be primarily closed.

Limitations

As with all case studies, the outcomes described cannot be generalized to other patient populations. Although the IGAP flaps were found to be reliable and provided a viable option for primary sacral pressure ulcer reconstruction, the flaps should be used with caution in patients who may be at risk for an ischial pressure ulcer (eg, wheelchair users).

Conclusion

Sacral pressure ulcer management is challenging in plastic surgery, and patients and flaps both must be carefully selected. In this case series, the IGAP flap was found to be reliable and provided a viable option for primary sacral pressure ulcer reconstruction. Other advantages included minimal blood loss, mild donor site morbidity, and preservation of muscle function. Similar to other perforator flaps, pedicle dissection must be meticulous to avoid damaging the perforator vessels. The flap is raised from an area different from the previous operation site and can serve as a secondary option in difficult cases, such as a recurrent ulcer or flap failure. Studies with larger sample sizes are needed to ascertain which type of flap is best suited to surgically manage extensive pressure ulcers in a variety of patient populations. n

References

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

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

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

4.         Papp C, Windhofer C, Gruber S. Breast reconstruction with the fasciocutaneous infragluteal free flap (FCI). Ann Plast Surg. 2007;58(2):131–136.

5.         Beshlian KM, Paige KT. Inferior gluteal artery perforator flap breast reconstruction. Am J Surg. 2008;195(5):651–653.

6.         Allen RJ, Levine JL, Granzow JW. The in-the-crease inferior gluteal artery perforator flap for breast reconstruction. Plast Reconstr Surg. 2006;118(2):333–339.

7.         Hurwitz DJ. Closure of a large defect of the pelvic cavity by an extended compound myocutaneous flap based on the inferior gluteal artery. Br J Plast Surg. 1980;33(2):256–261.

8.         Scheufler O, Farhadi J, Kovach SJ, Kukies S, Pierer G, Levin LS, Erdmann D. Anatomical basis and clinical application of the infragluteal perforator flap. Plast Reconstr Surg. 2006;118(6):1389–1400.

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

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

11.       Heywood AJ, Quaba AA. Modified gluteus maximus V-Y advancement flaps. Br J Plast Surg. 1989;42(3):263–265.

12.       Lee HB, Kim SW, Lew DH, Skin KS. Unilateral multilayered musculocutaneous V-Y advancement flap for the treatment of pressure sore. Plast Reconstr Surg. 1997;100(2):340–345.

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

14.       Windhofer C, Brenner E, Moriggl B, Papp C. Relationship between the descending branch of the inferior gluteal artery and the posterior femoral cutaneous nerve applicable to flap surgery. Surg Radiol Anat. 2002;24(5):253–257.

15.       Vanwanseele B, Lucchinetti E, Stüssi E. The effects of immobilization on the characteristics of articular cartilage: current concepts and future directions. Osteoarthritis Cartilage. 2002;10(5):408–419.

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

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

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

 

Potential Conflicts of Interest: none disclosed. The Civilian Administration Division of Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan funded the project.

 

Dr. Lin and Dr. Ou are attending physicians; Dr. Chiao, Dr. Wang, and Dr. Chou are resident physicians; and Dr. Chen and Dr. Lee are attending physicians, Division of Plastic and Reconstructive Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. Please address correspondence to: Tzu-Peng Lee, MD, Division of Plastic and Reconstructive Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, No. 325, Section 2, Cheng-Gung Road, Taipei, 11490, Taiwan; email: aarondakimo@yahoo.com.tw.

Section: 

A Prospective, Descriptive Study to Determine the Rate and Characteristics of and Risk Factors for the Development of Medical Device-related Pressure Ulcers in Intensive Care Units

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Ostomy Wound Management 2016;62(2):12–22
Seval Hanonu, RN, MSN; and Ayise Karadag, RN, ET/WOCN, MsN, PhD, Prof. Dr.
Topics: 
clinical study
critical care
medical devices
Prevalence
pressure ulcers

Abstract

Pressure ulcers do not develop only in areas with bony prominences; they can develop in any tissue under pressure, including pressure exerted by medical devices. A prospective, descriptive study was conducted from December 15, 2013 to March 25, 2014 to determine the prevalence, risk factors, and characteristics of medical device-related hospital-acquired pressure ulcers (MDR HAPUs) among all patients  (N = 175) in 5 adult intensive care units (ICUs) in a university hospital in Turkey.

The previously established point prevalence of hospital-acquired pressure ulcers (HAPUs) in these ICUs was 15%. Patients were evaluated in the first 24 hours after admission and observed 6 times thereafter in intervals of 48 hours. Demographic (eg, age, gender, body mass index) and medical device-related pressure ulcer data (eg, location, device type, stage), and Braden Scale scores were collected and analyzed; frequencies and percentages were calculated and Mann-Whitney U Test, t-test, and odds ratios were applied. Twenty-seven (27) patients (15.4%) developed nonMDR HAPUs and 70 (40.0%) developed MDR HAPUs. MDR HAPUs occurred most frequently (45.0%) in patients with an endotracheal tube. The most frequent type (42.6%) was Stage II. The highest rates of MDR HAPUs were observed among internal medicine ICU patients (OR 7.041), patients who also had a nonMDR HAPU (OR 6.6), patients in the high Braden risk score group (OR 1.8), or patients who received enteral feeding (OR 2.12). Because of the high rate of MDR HAPUs noted, policies and procedures aimed at preventing medical device-related pressure ulcers are needed. 

 

Despite advancements in medical treatment, care, and technology, pressure ulcers (PUs) remain an important health problem worldwide.1,2 PUs commonly occur at bony prominences such as the sacrum or heels,3 but recent research shows PUs also occur in mucous membranes and skin lying over soft tissue. Because of external pressure on the tissue on which they are positioned, medical devices such as nasal cannulas, endotracheal tubes (ETs), and continuous positive airway pressure (CPAP) masks cause tissue damage, resulting in medical device-related pressure ulcers (MDR PUs).3,4 Despite numerous studies on PUs,1,5-8 studies on MDR hospital-acquired pressure ulcers (HAPUs) are limited in number.3,4,9 The proportion of MDR HAPUs to general PUs reported in these studies is high: a cross-sectional point prevalence study3 conducted on 2,178 patients in the United States to determine PU incidence and prevalence reported the overall prevalence of MDR HAPUs was 34.5%, one third of all PUs reported in this study.

A variety of medical devices can cause MDR HAPUs. In a prospective, clinical evaluation study (N = 166) by Davis et al10 among patients wearing a cervical collar <5 days, 33% developed MDR PUs; among patients whose wear time exceeded 5 days, 44% developed MDR PUs. A nonexperimental, descriptive study11 conducted on 148 trauma patients reported wearing a cervical collar for >2 days is the second most important cause of skin damage (23.7%) and the tracheostomy-related PU rate is 10.5%.

In a prospective, descriptive study by Wille et al12 involving 125 surgical intensive care unit (ICU) patients attached to pulse oximeter probes, 6 (5%) developed a device-related ulcer. In Jaul’s13 cohort study of patients treated at a psychogeriatric inpatient health care facility (N = 174), 166 atypical PUs were observed, of which 23 (35%) were related to medical devices.

Due to their immobility, sensory perception loss, and insufficient circulation, patients receiving care in an ICU are at high risk of developing PUs.3 ICU patients generally receive treatment involving multiple medical devices more than nonICU patients.2,14,15 ICU patient characteristics increase their vulnerability to the numerous medical devices used during treatment. The different degrees of pressure exerted by the medical device and the tolerance level of the patient’s skin also affect PUs occurrence.3 PUs reduce patient quality of life and increase treatment costs; upon discharge from ICU, recovery from PUs may take several months.6,16,17

Many medical devices such as nasal cannulas, oxygen masks, ETs, CPAP masks, nasogastric (NG) tubes, Foley catheters, peripheral oxygen saturation of hemoglobin (SpO2) probes, blood pressure (BP) cuffs, cervical collars, and splints are used for the treatment and monitoring of patients in ICUs.3,4 These devices exert pressure on the tissue on which they are positioned and cause changes  in  tissue humidity and temperature. The increase in temperature and moisture between the medical device and skin causes microchanges in the skin.3,4 Moreover, the moisture that occurs causes the skin to become more susceptible to compromise3; furthermore, a medical device attached to the skin may hinder assessment of the skin beneath it.3 The materials used to fasten the devices compress the tissue, can disturb the blood and lymph circulation, and cause edema. All of these factors are thought to increase the risk for MDR HAPUs.3,4,9

For effective treatment, a health problem needs to be diagnosed at an early stage and available preventive measures must be implemented.5 Nurses need to be vigilant in preventing MDR HAPUs in ICU patients. As with nonMDR HAPUs, nurses play an important role in MDR HAPU prevention. When MDR HAPUs are prevented, the prevalence and incidence rates of HAPUs will be reduced as well.3

As far as the authors could determine, no publication is available on the rate of MDR PUs in Turkey. The purpose of this prospective, descriptive study was to address the following research questions:

1.         What is the prevalence of MDR HAPUs in ICUs?

2.         What are the characteristics of MDR HAPUs?

3.         What are the risk factors for MDR HAPUs?

 

Methods

Ethical considerations. This study was conducted according to the ethical guidelines and principles of the International Declaration of Helsinki. Before the study, the approval of Gazi University Faculty of Medicine Ethics Board for Non-invasive Clinical Research was obtained. Written consent was obtained from the chairpersons of the departments of the relevant ICUs included in the study via the Gazi University Health Research and Application Center Directory. During the study, conscious patients were informed about the aim of the study and their oral consent to participate was obtained. Unconscious patients were consented via their guardians.

Study setting and sample. The research sample consisted of anesthesia reanimation, cardiovascular surgery, internal medicine, neurosurgery, and thoracic disease patients treated in the 5 ICUs. The literature reports patients treated in ICUs are at high risk of developing PUs2,3,14,15 and that ICUs are among the units with the highest PU rates.4,9,16,17 Moreover, more medical devices are used in the treatment and monitoring of patients in ICUs  than nonICUs,3,4 guiding the choice of patient sample.

To determine which ICUs should be included in the study sample, the hospital’s 2012 PU point prevalence records were examined; these records showed PU prevalence rates were 100% in the anesthesia-reanimation, 71.4% in the thoracic diseases and surgery, 43.9% in internal medicine, 42.9% in the neurosurgery, and 16.7% in the cardiovascular surgery ICUs.18 Following expert opinion, the other units, including neurology, general surgery, and coronary ICUs, with PU prevalence rates below 15% were excluded from the study.

The number of participants was determined using the following formula19:

owm_0216_hanonu_formula

 

where n = number of individuals to be sampled, p = frequency of incidence occurrence (probability), q = frequency of nonobservance of the phenomenon (1-p), t = theoretical value t from the table at a certain standard error and degree of freedom, and d = the standard deviation from incidence frequency. When numerical values were inserted, P = 0.11.

A review of the literature3,10-13  revealed MDR HAPU prevalence rates range between 5% and 44%. Based on these data, a statistician suggested setting the frequency of incidence occurrence at 11%: q = 0.78,  t = 1.96, d =0.05 (± 5% deviation was desired), (1.96)² x 0.11 x 0.89/(0.05)², n = 150. According to this formula, the sample size was calculated to be 150.

Data collection. Data were collected using the systematic observation method. To obtain the data, a Patient Characteristics Form, an MDR PU Form, the Braden Scale for Predicting Pressure Ulcer Risk, and the Pressure Ulcer Staging Form were used. Forms were completed by the researcher, a certified stoma and wound nurse.

Patient characteristics. The patient characteristics form was developed by the researchers based on the literature.1,3,20,21 The form consisted of 25 items regarding demographic information (eg, gender, age, body mass index [BMI]) and information on health conditions (eg, diagnosis, accompanying diseases, nutrition).

PU characteristics. The MDR PU form was developed based on the literature3,4,9,13,21,22 and included 5 questions regarding PU characteristics (eg, occurrence of nonMDR HAPU and MDR PU), as well as the observations and related information such as type of medical device, PU location on the body, and PU stage obtained at each observation. To facilitate the data recording, the form included codes to refer to medical device, body site, and ulcer stage. Both the patient characteristics and PU forms were developed specifically for and used for the first time in this study.

PU risk. The Braden Scale for Predicting Pressure Ulcer Risk was used to assess the risk of PUs. The total possible score on the scale ranges from 6 to 23. Accordingly, a score of 12 points or lower indicates very high risk, 13–14 points high risk, and 15–16 points low risk. For patients 75 years and older, 15–18 points is considered low risk for PU.23

PU staging. PU staging was based on the National Pressure Ulcer Advisory Panel/European Pressure Ulcer Advisory Panel24 (NPUAP-EPUAP) staging system standards of 2009. The stages include Stage I, Stage II, Stage III, Stage IV, unstageable, and suspected deep tissue injury.

Procedure. After obtaining the necessary approval and consent of the Hospital Directorate (IRB-equivalent), a pilot study was conducted with 15 patients from the cardiovascular surgery, internal medicine, neurosurgery, and thoracic surgery ICUs to determine the applicability and comprehensibility of the data collection forms. No changes were made to the forms after pilot study. In a prospective, cross-sectional study conducted in ICUs in the US and Australia, Coyer et al4 found MDR PUs developed within 3 to 13 days following admission to the unit; therefore, data for the study were collected from patients newly admitted (<24 hours) to the ICUs included in the study. Patients then were observed for PUs at 48-hour intervals. Data collection took place between November 15, 2013 and March 25, 2014.

Each study participant was examined at least once to a maximum of 6 times (2 weeks). Once a person was examined 6 times, data collection stopped, even if he/she was not discharged from the ICU. Assessment of MDR PUs was limited to only those body sites to which a medical device was attached at the first examination. Any information regarding any medical device attached to the patient after the initial examination was disregarded.

Examination. The patient’s skin was evaluated completely from head to toe, paying special attention to bony prominences, and the tissue under and around all attached medical devices was examined and palpated. Removing devices that can be unattached for a short period of time, such as oxygen masks, nasal cannulas, and SpO2 probes, allowed for examination of the tissue underneath. Using the Braden Scale, the patient’s PU risk was assessed; staging information was recorded for patients who had developed PUs. BMI data were grouped according to the World Health Organization25 (WHO) classification criteria. Accordingly, low BMI was considered <18.50, normal BMI 18.50–24.99, heavy BMI 25.00–29.99, and obese 30.00.

Data analysis. The data obtained from each patient were coded and entered into Statistical Packages for Social Sciences (SPSS) by the researcher. Data were stored according to research and publishing ethics and analyzed using SPSS for Windows, Version 20.0 (SPSS Inc, Chicago, IL, USA).The frequency and percentage distributions of the items pertaining to patient characteristics information were calculated. Group differences were evaluated using the normality test, and the Mann Whitney U test was used for paired group variables exhibiting nonnormal distribution. To evaluate the relationship among variables, the chi-square (2) and Fisher exact tests were used. The statistical significance level was determined to be 0.05, and significant differences among groups were observed when P <0.05. Data for risk factors were presented as crude or adjusted odds ratios (ORs) with 95% confidence intervals (95% CI).

 

Results

Patient demographics. From the 5 participating ICUs, 175 persons were assessed. Participant mean age was 62.50  ± 16.67 years, average BMI was 26.49 ± 5.26, and 57.1% of the patients were men. ICU breakout included internal medicine (26.2%), cardiovascular surgical (24.5%), and neurosurgical (23.4%). The most common primary patient diagnoses were cardiovascular (28.0%) and neurological (28.0%) system diseases. Prescribed medications included antibiotics (79.4%), steroids (56.0%), and anticoagulant medication (53.7%); 39.4% received oral feeding and 36.0% were attached to mechanical ventilation (see Table 1). owm_0216_hanonu_table1

Ulcer data. Of the 175 patients included in the study, 27 (15.4%) developed nonMDR HAPUs, 70 (40.0%) developed MDR HAPUs, 16 (9.1%) developed pre-ICU nonMDR PUs, and 14 (8.0%) developed pre-ICU MDR PUs (see Table 2). owm_0216_hanonu_table2

Of the 175 participants, 70 (40%) developed a total of 211 device-caused MDR HAPUs, which were caused by ETs (95, 45.0%), CPAP masks (22, 10.4 %), SpO2 probes (17, 8.0%), oxygen masks (15, 7.1 %), and nasal cannulas (14, 6.6%). No MDR HAPUs were observed in patients with orogastric tubes, cervical collars, splints, and percutaneous endoscopic gastrostomy tubes (see Table 3). owm_0216_hanonu_table3

The MDR HAPU stages encountered were assessed initially as Stage II (42.6%), Stage I (37.9%), unstageable (17.5%), and suspected deep tissue injury (1.9%) (see Figure 1). In terms of MDR HAPU rate, the difference in the observations between 11.8% and 60.2% was found to be statistically significant (P <0.05). The rate of MDR PUs at Stage I (1.2%), Stage II (3.3%), and unstageable (2.7%), determined at the first screening, increased to 60.0%, 67.7%, and 64.8%, respectively, at the sixth observation. owm_0216_hanonu_figure1

MDR PUs occurred on the lips (44.0%), nose (15.6%), fingers (7.5%), ears (6.1%), and other sites (17.6%) (see Figure 2). owm_0216_hanonu_figure2

Risk factors. Generally, patients that developed nonMDR HAPUs were 6.60 times more likely to develop MDR HAPUs; specifically, patients in the internal medicine, neurosurgery, and thoracic disease ICUs were, respectively, 7.04, 6.22, and 6.01 times more likely to increase MDR HAPUs risk, a statistically significant difference (P <0.05). Moreover, for enterally fed patients, PU risk increased 2.12 times and as the Braden risk score moved from low to high risk, MDR HAPU risk increased 1.81 times (P <0.5).

Although not statistically significant, MDR HAPUs occurred 1.23 times more often in male patients, 2.07 times more in patients attached to a mechanical ventilator, 2.07 times more in patients on anticoagulants, and 2.56 times more in patients receiving sedation. Although not statistically significant, MDR HAPU development was 1.02 higher as age increased and 1.17 higher as hemoglobin levels dropped (>0.05) (see Table 4). owm_0216_hanonu_table4

Length of stay. In this study, 340 (60.2%) of MDR HAPUs developed with a total of 211 devices. More MDR HAPUs developed as the number of days in hospital increased: 11.8% occurred during the first 24 hours (7/59 sites); on the fourth day, the number of occurrences rose to 48.0% (37/77 sites) and on the eleventh day to 82.3% (215/261 sites) (P <0.05)  (see Table 5). owm_0216_hanonu_table5

 

Discussion

Prevalence. The prevalence rate for MDR HAPUs in this study was 40.0% — approximately 1 in 2 patients admitted to an ICU developed a MDR HAPU. This rate was higher than nonMDR HAPUs prevalence (15.4%), which corresponds to the findings in the relevant literature. In a cross-sectional point prevalence study by Black et al3 conducted on 2,079 patients, nonMDR HAPU prevalence was 5.4% and MDR HAPU prevalence was 34.5%. In a cross-sectional study by Coyer et al4 conducted on 483 ICU patients in Australia and the US, the MDR PU rate was 12.8% (17/132) for Australian patients and 8.8% (3/351) for American patients. In a descriptive study by Apold and Rydrych22 among 255 cases of severe PUs, 74 (29%) were caused by medical devices. In a study by Jaul13 conducted among 174 patients in a geriatric ICU, 35 developed atypical PUs, of which 10 (28.5%) were medical device-related. In a cross-sectional study by van Gilder et al26 conducted in ICUs and other wards, 149 out of 1,631 PUs (9.1%) were caused by medical devices.

Location. MDR HAPU location varies depending on where a medical device is attached to a patient. In the present study, MDR HAPUs developed most commonly on the lips (44.0%), followed by nose (15.6%), fingers (7.5%), and ears (6.11%), whereas nonMDR HAPUs occurred in the sacrum, ischium-sacrum, and sacrum-ischium-trochanter regions. This is underscored in the literature; MDR PUs develop at sites of medical device use. In Black et al’s study,3 the locations of most MDR HAPUs were the ears (35%), lower leg (11%), and heels (8%). In the study by VanGilder et al,26 the most observed MDR PUs locations were the ears (20%), sacrum (17%), heels (12%), and buttocks (10%). In the studies by Watts et al11 and Apold and Rydrych,22  the most common location of PUs was the cervical collar region. These studies support that nonMDR HAPUs and MDR HAPUs occur in different locations from one another.

Stages. PU stages vary in the literature as well. In the current study, the most frequently observed PU stages of MDR HAPUs were Stage II, Stage I, and unstageable, respectively. In the study by Apold and Rydrych,22 the most observed MDR PUs stages were unstageable (52.7%), Stage II and Stage III (20.3%), and Stage I (5.4%). The MDR PU stages reported in Black et alare Stage I (35%), Stage II (32%), and unstageable (24%). The different frequencies in MDR HAPU stages reported is thought to be due to the differences in medical device use, differences and indefiniteness with respect to tissue examination scope and frequency, and the inability to determine the presence of MDR HAPUs until they have reached an advanced stage.22 Methodological differences in research also may account for these differences.3,4,22 In Apold and Rydrych,22 one fourth of MDR PUs (74%) was not identified until they reached Stage III, Stage IV, and unstageable, versus 54% for nonMDR HAPUs. The Stage I MDR PU identification rate is 5.0% and 20.0% for Stage I nonMDR HAPUs. In addition, the fact MDR PUs develop in relatively lean body sites with little fat tissue under the skin (eg, nostrils, behind the ears, neck, back of the head, nose bone) also allows the ulcers to reach Stage III, Stage IV, and unstageable faster than nonMDR HAPUs.22 Furthermore, in some cases, early-stage MDR PUs are mistakenly identified as dried exudate (oral, nasal, gastric) instead of PUs. These misidentifications tend to delay the timely and appropriate staging of PUs and thus their treatment.22 As with nonMDR HAPUs, the prevention and early diagnosis of MDR HAPUs greatly depends on nurses’ accurate staging and recording of ulcers forming on the skin on which medical devices are positioned.3,4,22

The MDR HAPU literature focuses mainly on skin ulcers.3,11,22,25 Coyer et al4 state to accurately determine the rate of MDR PUs, evaluations of mucous membrane ulcers as well as skin ulcers need be conducted in order to avoid classifying mucous ulcers as coagulum.

Devices. With advancements in medical technology, the number of available medical devices that may cause MDR PUs has increased. In the current study, more than 20 medical devices were used, among which ETs, CPAP masks, SpO2 probes, and oxygen masks caused the most MDR PUs. The device causing the most MDR PUs, the intubation tube is also a device widely used in ICUs, findings that correspond to those of Coyer et al.4

Risk factors. Although the literature includes studies on MDR HAPUs, no study to determine the impact of the relevant risk factors has been found. Therefore, the results of the present study provide important data for the literature. Advanced age, obesity, low hemoglobin, low albumin, lower Braden risk scores, chronic diseases, medications used, length of hospital stay, and the type of clinic are factors reported to influence the occurrence of nonMDR HAPUs.3,22,26 According to the literature, nonMDR HAPUs and MDR HAPUs share common risk factors, the most important of which is the use of a medical device. Studies3,4,22,26 report MDR PUs develop in high-risk patients whose risk evaluation score on the Braden Scale is low. The findings of the current study are supported by the literature: patients in internal medicine ICUs developed 7 times more MDR HAPUs, and those in neurosurgical and chest disease ICUs 6 times more than other ICUs. Moreover, in enterally fed patients, and as the Braden risk scores move from low risk to high risk, MDR HAPU rates doubled. Patients developed MDR HAPUs 7 times more than nonMDR HAPUs (P <0.05) (see Table 4). In addition, advanced age (67.4 ± 16.1 years); attachment to a mechanical ventilator; low hemoglobin and albumin values; and the use of steroid, anticoagulant, and sedative medications were found to be risk factors influencing MDR PU development (see Table 4).

NonMDR HAPU development risk is high in ICUs, where high-risk patients are treated.4,26 In this study, the highest MDR HAPU development rate was observed in patients admitted to the internal medicine ICU, followed by chest disease ICU and neurosurgical ICU. In the study by VanGilder et al,26 general ICU ranked first, followed by coronary ICU and surgical ICU. However, in these studies, ICU data are reported in terms of ulcers rather than patients, which limits the possibility of comparing studies with respect to MDR PU developing patient numbers. Yet in a study by Black et al,3 no difference was found between ICU and nonICU patients in terms of MDR PU development. Moreover, nonMDR HAPU development risk is higher in patients with medical devices.

Among the patients in the current study, fewer than half (63/175) were attached to a mechanical ventilator or received enteral feeding (43/175) (see Table 1). Although the number of mechanical ventilator-attached patients was smaller, a higher rate of MDR HAPU development was observed in these patients (see Table 4). The literature4 supports that ventilation devices cause more MDR PUs than other devices. Similarly, despite the small number of enteral feeding patients (see Table 1), MDR PUs were observed at high rates in these patients (see Table 4). In the study by Jaul,13 the incidence rate of MDR PUs was higher in enteral feeding  patients. This may be attributed to the fact that patients who receive enteral feeding and are attached to ventilation devices are usually also those at higher risk with respect to life functions, and thus more often exposed to treatments with more medical devices.

In the current study, patients at advanced ages (67.4 ± 16.1 years) developed MDR HAPUs at a high rate. This is supported by Coyer et al,4 where the average age of patients developing a MDR PU was 60.5 ± 20.6 years.

Low hemoglobin (9.7 ± 1.7) and albumin (2.8 ± 0.7) values, use of medication (eg, sedatives, steroids), and high PU risk scale score increase MDR PU risk.3,4,22,27  Low hemoglobin negatively affects circulation and thus leads to insufficient blood flow to tissues.6,28 Low albumin leads to interstitial leakage and thus to edema, which in turn results in increased pressure and deterioration in the nutrient exchange in tissues. This situation may facilitate the formation of MDR HAPUs in edematous tissue.28 The use of steroids prevents the formation of collagen fibers, and the use of sedatives impairs the patients’ sensory perception of pain. Therefore, patients on these medications do not feel the pain resulting from medical device-related tissue damage and thus do not adequately voice their discomfort. Because patients are usually prescribed anticoagulants to address circulation problems, MDR PUs may be more likely to develop in these patients.3,29

Patients in the high Braden Scale score risk group have low activity levels, nourishment problems, and weak stimulus perception and are mostly bedbound and attached to 1 or more medical devices. All these risk factors associated with nonMDR HAPUs occurrence are considered to be relevant for MDR HAPU occurrence as well.

Timing. In this study, MDR HAPUs occurred as early as 24 hours after admission to the ICU and continued to occur through to day 11. Within the first 24 hours, MDR HAPUs developed most commonly on persons using nasal cannulas and ETs. In Coyer et al,4 MDR PUs were found to develop between 3 and 13 days after admission.

Location as a factor of time. In the patients participating in the study, the rate of body sites where MDR HAPUs developed in the first 24 hours of hospitalization (11.8%) increased 7 times by the eleventh day. As the patients’ length of stay in the ICU increased, their days attached to medical devices increased as well, along with the risk of medical device pressure on the body site. As the pressure time increases, blood and lymph circulation in the compressed tissue decreases, resulting in inadequate tissue nourishment and thus increased PU risk.30-32 The same hypothesis appears to be valid for MDR PUs. As the time a medical device stays attached to the tissue increases, circulation under the tissue decreases. Moreover, factors related to the medical device such as the friction/shear and local temperature increase, the edema caused by tight attachment straps, skin softening, and maceration caused by excessive moisture accumulation are all considered to decrease skin tolerance and to contribute to MDR PU development.3,9,13,33

 

Limitations 

In this study, patients newly admitted to the ICU and examined within 24 hours were included. The evaluation of skin beneath medical devices was limited to the first examination — the skin beneath whichever medical device was present in the first examination was evaluated for MDR HAPU development in subsequent examinations. The skin sites of other medical devices attached to the patients after the first examination or later in their treatment and MDR HAPU due to these devices were excluded from the study. Due to the differences in the death, discharge from hospital, and transfer of patients to other departments, the observation periods of these patients were different. The observation period was limited to a maximum of 2 weeks. In addition, after completing the observation period  (a total of 6 examinations), patients were not evaluated again, even if their stay in the same ICU continued. Because this study was limited to patients in the internal medicine, cardiovascular surgery, neurosurgical, and anesthesia-resuscitation ICUs in an academic hospital with a MDR HAPU prevalence rate of 15%, the results cannot be generalized to other ICUs. Moreover, preventive measures taken by nurses to prevent MDR HAPUs were not evaluated.

 

Conclusion

The findings of this study, conducted to determine the prevalence of MDR HAPUs and to identify risk factors for and characteristics of MDR HAPUs development rate through systematic observation, showed MDR HAPUs occurred 3 times more often than nonMDR HAPUs. MDR HAPUs occurred most frequently due to ET, CPAP masks, and SpO2 probes and mostly on the lips, nose, and fingers. The stages of the MDR HAPUs observed were Stage II, Stage I, and unstageable, respectively.

In this study, the MDR HAPU development rate in patients treated in internal medicine, neurosurgical, and chest disease ICUs, who exhibited high Braden risk values, who were enterally fed, who developed nonMDR HAPUs, and who stayed in hospital for a greater number of days, were found to have a higher MDR PU development rate (P <0.05). Based on the findings, additional studies are needed to help develop evidence-based policies and procedures aimed at preventing MDR HAPUs. 

 

References

1.         Karadağ A. Basınç ülserleri: değerlendirme, önleme ve tedavi. C.Ü.Hemşirelik Yüksek Okulu Dergisi. 2003;7(2):41–46.

2.         Elliott R, McKinley S, Fox V. Quality improvement program to reduce the prevalence of pressure ulcers in an intensive care unit. Am J Crit Care. 2008;17(4):328–335.

3.         Black JM, Cuddigan JE, Walko MA, Didier LA, Lander MJ, Kelpe MR. Medical device related pressure ulcers in hospitalised patients. Int Wound J. 2010;7(5):358–365.

4.         Coyer FM, Stotts NA, Blackman VS. A prospective window into medical device related pressure ulcers in intensive care. Int Wound J. 2013;11(6):656–664.

5.         Lindgren M, Unosson M, Krantz MA. A risk assessment scale for the prediction of pressure sores development: reliability and validity. J Adv Nurs. 2002;38(2):190–199.

6.         Lindgren M, Unosson M, Fredrikson M, Ek AC. Immobility—a major risk factor for development of pressure ulcers among adult hospitalized patients: a prospective study. Scand J Caring Sci. 2004;18(1):57–64.

7.         Lahmann NA, Halfens RJG, Dassen T. Prevalence of pressure ulcer in Germany. J Clin Nurs. 2005;14(2):165–172.

8.         Schoonhoven L, Bousema MT, Buskens E. The prevalence and ıncidence of  pressure ulcers in hospitalised patients in the Netherlands: a prospective inception cohort study. Int J Nurs Stud. 2007;44(6):927–935.

9.         Black J, Alves P, Brindle CT, Dealey C, Santamaria N, Call E, Clark M. Use of wound dressings to enhance prevention of pressure ulcers caused by medical devices. Int Wound J. 2015;12(3):322–327.

10.       Davis JW, Parks SN. Detlefs CL, Williams GG, Williams JL, Smith RW. Clearing the cervical spine in obtunded patients: the use of dynamic fluoroscopy. J Trauma Nurs. 1995;39(3):435–438.

11.       Watts D, Abrahams E, MacMillan C, Sanat J, Silver R, Van Gorder S, et al. Insult after injury: pressure ulcers in trauma patients. Orthop Nurs J. 1998;17(4):84–91.

12.       Wille J, Braams R, van Harren W, van der Werken C. Pulse oximeter-induced digital injury: frequency rate and possible causative factors. Crit Care Med. 2000;28(10):3555–3557.

13.       Jaul E. Cohort study of atypical pressure ulcers development. Int Wound J. 2014;11(6):696–700.

14.       Strand T, Lindgren M. Knowledge, attitudes and barriers towards prevention of pressure ulcers in intensive care units: a descriptive cross-sectional study. Intensive Crit Care Nurs. 2010;26(6):335–342.

15.       Mattox E. Medical devices and patient safety. Crit Care Nurs. 2012;32(4):60–68.

16.       Tel H, Özden D. Güneş ÇP. Yatağa bağımlı hastalarda basınç yarası gelişme riski ve hemşirelerin bu hastalara uyguladıkları önleyici bakım. Hemşirelikte Araştırma Geliştirme Dergisi. 2006;1(2):35–45.

17.       Schoonhoven L, Defloor T, Grypdonck MH. Incidence of pressure ulcers due to surgery. J Clin Nurs. 2002;11(4):479-487.

18.       Karadağ A, Baykara ZG, Özaltan G. Bir üniversite hastanesinde nokta prevalans çalışması. In: 15 Ulusal İç Hastalıkları Kongresi 2013. Antalya, Turkey: MİKİ Matbaacılık; 2013:429.

19.       Karataş N. Araştırmada Örnekleme. In: Erefe İ (ed). Hemşirelikte Araştırma İlke, Süreç ve. Yöntemleri, Ankara, Turkey: Hemar Ge Yayınevi;2012:124–125

20.       Black J, Baharestani MM, Cuddigan J, Dorner  B, Edsberg L, Langemo D. National Pressure Ulcer Advisory Panel’s updated pressure ulcer staging system. Adv Skin Wound Care. 2007;20(5):269–274.

21.       Karadağ M, Gümüşkaya N. The incidence of pressure ulcers in surgical patients: a sample hospital in Turkey. J Clin Nurs. 2006;15(4):413–421.

22.       Apold J, Rydrych D. Preventing device-related pressure ulcers: using data to guide statewide change. J Nurs Care Qual. 2012;27(1):28–34.

23.       Pınar R, Oğuz S. Norton ve Braden Bası Yarası Değerlendirme Ölçeklerinin yatağa bağımlı aynı hasta grubunda güvenirlilik ve geçerliliklerinin sınanması. In: Uluslararsı katılımlı VI. Ulusal Hemşirelik Kongresi 1998. Kongre kitabı. Ankara, Turkey: Damla Matbaacılık;1998:172–175.

24.       National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel. Prevention and treatment of pressure ulcers: clinical practice guideline. Washington: National Pressure Ulcer Advisory Panel, 2009.  Available at: www.npuap.org/resources. Accessed October 10, 2014.

25.       World Health Organization. Global Data Base on Body Mass Index. Available at: http://apps.who.int/bmi/index.jsp?introPage=intro_3.html. Accessed October 7, 2014.

26.       VanGilder C, Amlung S, Harrison P, Meyer S. Results of the 2008–2009 International Pressure Ulcer Prevalence Survey and a 3-year, acute care, unit-specific  analysis. Ostomy Wound Manage. 2009;55(11):39–45.

27.       Karadağ A, Karabağ Aydın, A. Basınç Ülserlerinde Etiyoloji ve Fizyopataloji. In: Baktıroğlu S, Aktaş Ş (ed). Kronik yarada güncel yaklaşımlar. İstanbul, Turkey: İstanbul Üniversitesi Kronik Yara Konseyi;2013:120–125.

28.       Kozier B, Erb GL. Fundamentals of Nursing. Pearson International Edition, 2009. Sidney, Australia: Mosby Elsevier;2009:904–910.

29.       Wolverton CL, Hobbs LA, Beeson T, Benjamin M, Campbell K, Forbes C, et al. Nosocomial pressure ulcer rates in critical care. J Nurs Care Qual. 2004;20(1):56–62.

30.       Bryant RA, Shannon ML, Pieper B, Braden BJ and Morris DJ. Pressure ulcers. In: Bryant RA. Acute and Chronic Wounds – Nursing Management. St Louis, MO: Mosby;1992:105–163.

31.       Morison JM. The Prevention and Treatment of Pressure Ulcers. Toronto, Canada: Mosby;2001:20–32.

32.       Myers BA. Wound Management Principles and Practice. Upper Saddle River, NJ: Pearson Prentice Hall;2004:260–296.

33.       Jaul E. A prospective pilot study of a typical pressure ulcer presentation in skilled geriatric nursing unit. Ostomy Wound Manage. 2011;57(2):49–57.

 

Potential Conflicts of Interest: none disclosed

 

Ms. Hanonu is a research assistant, Gazi University Faculty of Health Sciences, Department of Nursing, Ankara, Turkey. Dr. Karadag is a Professor, Koç University School of Nursing, Istanbul, Turkey. Please address correspondence to: Seval Hanonu, RN, MSN, Emniyet Mah, Muammer Yasar Bostancı Sokak No:1606560 Besevler/Akara, Turkey; email:sevalhanonu@yahoo.com.

Section: 

Critical Evaluation of the Jackson/Cubbin Pressure Ulcer Risk Scale — A Secondary Analysis of a Retrospective Cohort Study Population of Intensive Care Patients

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Ostomy Wound Management 2016;62(2):24–33
Maarit H. Ahtiala, RN; Esa Soppi, MD, PhD; and Riku Kivimäki, MSc
Topics: 
retrospective studies
Risk Assessment
pressure ulcers
critical care
Risk Factors

Abstract

Although the Jackson/Cubbin pressure ulcer (PU) risk scale performs best among risk scales used in intensive care units (ICUs), its performance was not fully satisfactory. In 2010, a minimally modified Jackson/Cubbin (mJ/C) PU risk scale was introduced to formalize PU risk assessment in a large medical-surgical ICU in Finland. The purpose of this secondary analysis was to examine whether individual categories of the mJ/C scale have similar weight and whether the scores within each category (from 1 to 4; 1 equaling highest risk and 4 equaling lowest risk) are linear, as is assumed for the original and  modified scales.

Using data from a cohort of 1,616 consecutively admitted patients retrieved from the ICU database, a detailed secondary analysis of each of the 12 main scoring categories of the Jackson/Cubbin risk scale was performed using logistic regression and analysis of linearity and weight. Of the 1,616 admitted patients, 168 developed a PU during their ICU stay. Among the risk categories, body mass index, nutrition, respiration, age, and transportation during the 48 hours before scoring did not contribute significantly (P>0.05) to the total risk score or the actual development of a PU. The 7 other main categories — incontinence, mobility, medical history, oxygen requirement, need for assistance with hygiene, hemodynamics, and general skin condition — were the main risk contributors. Although only the linearity of the different categories correlated significantly with the predictive value of the categories, the linearity as well as the weights of the categories were at variance from what was assumed originally. The mJ/C scale needs refinement to be a more accurate instrument for PU risk assessment of ICU patients. Not all mJ/C categories were found to contribute to the risk and, when they do, their weight and linearity vary from what has been assumed. The categories respiration and oxygen requirement and the categories mental condition, mobility, and hygiene may overlap. The importance of the incontinence category depends on the frequency of urinary and fecal incontinence management system usage. A simpler, more valid and more sensitive risk assessment scale than the current Jackson/Cubbin scale is needed for ICU patients. 

 

Patients in intensive care units (ICUs) are at high risk of developing pressure ulcers (PUs).1-5 Several risk scales have been developed for general PU risk assessment.6,7 The Braden Scale often is used in ICUs.3,5,8 A survey by VanGilder et al5,8 comprising ~11,000 patients in more than 500 ICUs showed PU incidence varied between 8.8% and 12.3% and close to half of the patients had a Braden score above 14, indicating low to medium risk.

A specific risk scale for intensive care patients, the Jackson/Cubbin (J/C) pressure area risk calculator9 includes 4 out of the 5 Norton and 5 out of the 6 Braden categories (the missing Braden category involves friction and shear). The J/C pressure area risk calculator consists of 12 categories, each of which is graded linearly from 1 point (highest risk) to 4 points (lowest risk) to describe the clinical risk of PU for ICU patients9 (see Table 1). The lower the score, the higher the PU risk — a total score 29 signifies extremely high risk. Among the additional main categories in the J/C scale are age, weight, past medical history, and skin condition plus ICU-specific categories such as respiration, oxygen requirements, and hemodynamics. owm_0216_athiala_table1

The J/C scale has not gained wide acceptance, although its receiver operating characteristic (ROC), curve and sensitivity, and specificity have been the best of several scales proposed for ICU use.5,10-12 Specifically, the validation study by Seongsook et al10 comparing the J/C, Braden, and Douglas Scales included 112 ICU patients and found the specificity (61%) and positive predictive value (51%) of the J/C scale to be better than those of the Braden (26% and 37%, respectively) and Douglas scales (18%, 34% respectively). The review by Shanin et al11 compared the J/C, Braden, Douglas, Waterloo, and Norton scales and included 1,150 ICU patients in 7 studies; it concluded only the J/C scale was developed for assessment of PU risk in ICU patients, and the assessment of validity of different risk scales varied. The systematic review by García-Fernández et al12 presented 15 scales and 5,187 patients in 26 studies; the Braden scale was examined in 13 studies (1,458 patients) and J/C scale in 5 studies (629 patients). The authors recommended the Braden scale for use in PU risk assessment in ICUs. Both the Braden Scale and J/C risk scale are based on the Norton scale.13  

In 2010, a retrospective research program utilizing the ICU database was launched by the present study team to study the epidemiology and risk factors related to PUs in a large medical-surgical ICU. The program included introduction of a modified version of the J/C (mJ/C) risk scale in an attempt to formalize PU risk assessment14 based on previous studies.10,11 Briefly, the previous results implied the J/C risk scale and its predefined cut-off score of 29 do not sufficiently identify extremely high-risk patients because 55.8% of patients with PUs fell into the ≤29 score group, while 46.6% patients without PUs had a similar score.13 The sensitivity of the mJ/C scale was 55.8%, the specificity was 53.4%, the positive predictive value was 13.4%, and the negative predictive value was 90.3%. The total incidence of PUs was 11.1% (181/1,629); 13 patients with exclusively nasal PUs were excluded from the analysis.

Due to the limited mJ/C scale score separation of PU from nonPU patients and to the modest sensitivity and specificity, this retrospective secondary analysis was conducted to examine whether the individual categories of the mJ/C scale have similar weight (ie, each subcategory is scored from 1 to 4) and whether the scores within each category from 1 to 4 (1 meaning highest risk and 4 meaning lowest risk) are linear, as is assumed for the J/C scale. The hypothesis was not all factors contribute equally to PU development, as originally described by Jackson in 1999.9 A specific examination was conducted to determine more specifically what factors are related to the development of PUs in the ICU.

 

Methods

Patients. The Turku University Hospital serves a population of 700,000. The adult ICU has 24 beds. The hospital serves as a national center for hyperbaric oxygen therapy. All surgical and medical intensive care patients in the region are treated in this hospital, except patients with major burns and patients undergoing solid organ transplantation, who are treated elsewhere. Based on the treatment needs on admission, patients are classified as ICU-patients or as patients needing high-dependency (ie, step down) care.

Patient data from all 2010 ICU admissions (1,629 patients >18 years old, mean age 60.5 years [range 18–95 years], average length of stay 3.7 days) were retrospectively analyzed to study the occurrence of PUs and their risk factors in medical and surgical patients.14 Patients with nasal PUs only (n = 13) were excluded from the analysis, leaving 1,616 patients for the current secondary analysis.

The main categories of the J/C scale are presented in Table 1. In addition to these 12 main categories, 3 additional assessments are made that may lower the PU risk score (see Table 1, “deduct points”). The J/C risk scale9 from 1999 was back-translated and forward-translated into Finnish for validation purposes, and some of the categories were more precisely defined (mJ/C risk scale) to improve the clarity and reproducibility of the assessments (revised sections are marked as bolded in Table 1). The age and body mass index (BMI) values are automatically calculated by the clinical documentation and information system used by the ICU (Clinisoft, GE Healthcare, Buckinghamshire, UK). It takes 2 to 3 minutes for an ICU nurse to calculate risk and enter the information into the ICU database.

All data used in this study were retrieved from records, abstracted (ie, checked by computer for their correct format), and entered into a database for analysis.

The study plan was approved by the Ethics Committee of the Hospital District of Southwest Finland.

Statistical methods. Statistical evaluation of the main categories of the mJ/C risk scale was based on exploratory analysis and regression modeling. Linearity was scored from +4 (arbitrary unit) when linearity was as described in the J/C scale9 (see Table 1) to -4 if linearity was reversed. The relative weight of each individual J/C category was determined by multiplying each subcategory score point by the number of patients in that subcategory and then summing the 4 scores together and dividing the sum by the total number of patients in that category.

Logistic regression modeling was applied to evaluate the association between PUs and the categories of the J/C PU risk calculator. A proportional-odds cumulative logit model15 was used because all of the J/C PU risk categories are ordinal (1, 2, 3, 4) and the risk for PUs is expected to increase with lower scores (ie, 1 point represents the highest risk value of an individual risk category9). Separate analyses were performed for all risk categories to evaluate the marginal independence/association of PUs and individual risk categories. Odds ratio (OR) and the Wald chi-square (2) test, based on logistic regression modeling, were used to evaluate the association between PUs and the risk categories. Wald 2 is calculated as:

(MLE(PU)/standard error)2

MLE (PU) is the maximum likelihood estimated logistic odds of PUs effect. OR, the Wald 2-test, and the related P values (same for both) were used to evaluate the statistical null hypothesis, H0.  The distribution of mJ/C PU risk category values in a population with PUs was equal to the distribution in a population with no PUs. A P value <0.05 indicated sufficient evidence in favor of the alternative hypothesis, H:  values of a mJ/C PU risk category were statistically significantly higher in a population with PUs than in a population with no PUs. Fisher’s exact test16 and the 2 test were used to test statistical significance of the contingency tables. Both tests were used to determine whether the incidence rates of PUs were the same in 2 groups that were compared (ie, if the incidence of PUs was independent of the risk factor or of other predictive variables15,16).

Fisher’s exact test is designed to test the significance of contingency tables when the sample size is small or some cells of a contingency table number <5. This test is more conservative than the 2 test and may yield higher P values.16

 

Results

The results of the secondary analysis of each individual risk category of the mJ/C scale showed mobility, medical history, oxygen requirements, hygiene, hemodynamics (linearity score +2, relative weight 2.0; OR 2.232, P<0.001) and general skin condition (linearity score +4, relative weight 3.6; OR 3.272, P <0.001) significantly predicted PU development (see Tables 2 and 3). Incontinence (linearity score 0, relative weight 4.0; OR 3.910, P = 0.0126) and mental condition (linearity score +1, relative weight 2.2; OR 1.481, P = 0.0116) were significant predictors of PU, while BMI, nutrition, respiration, and age were not associated with the development of PUs (see Tables 2 and 3). owm_0216_athiala_table2

A trend was noted toward a linearity of the risk score point distribution of the categories that were significantly associated with the PU risk (see Table 2, Table 3, Figure 1a). The linearity of the incontinence category could not be determined due to too few patients in the score point groups 1 to 3 (see Table 3). Only general skin condition contributed linearly to PU risk, as defined in the J/C risk scale (see Table 1, Table 3, Figure 1a). Oxygen requirements and hygiene contributed almost linearly, and BMI, nutrition, and respiration were almost the opposite (ie, contralinear) (see Table 3, Figure 1a). A significant correlation was noted between linearity and the predictive value of the categories (OR): rs = 0.694 (P =  0.0123, Spearman’s rank correlation17). owm_0216_athiala_table3continuedowm_0216_hanonu_table3

The J/C risk scale assumes the relative weight of each J/C category is 2.5. The weights of the different risk categories that contributed to the PU risk differed from 2.5 and from each other (see Table 3, Figure1b). The relative weight of the hygiene category (1.6) was 3 times that of the nutrition (3.9) and incontinence (4.0) categories (see Figure 1b). The weight contribution of the other categories fell somewhere between these values. No correlation was noted between the relative weights of the categories and their predictive value (OR): rs = 0 (P = 1, Spearman’s rank correlation17). owm_0216_athiala_figure1

Two thirds of patients were transported within the hospital either to surgery or for examinations, but only a small number of patients (n = 20) qualified for the transportation group, because transportation had to have occurred within 48 hours of mJ/C scoring (see Table 4). All of the 20 patients who had been transported developed a PU (P<0.001, Fisher’s exact test) compared to the nontransport (PU n = 43, 8.5% of that group) and transport group (PU n = 105, 10% of that group). Of the patients who had been transported, 14 were in the high-risk group, as defined by the current J/C risk score (29), 3 patients were very close to the cut-off limit with a J/C score of 30–31, and 3 had scores of 34, 37, and 39 when transportation and other conditions requiring application of the deduction of points were considered (see Table 1). owm_0216_athiala_table4

 

Discussion

Because development of PUs is a multicausal problem, an adequate PU risk scale combined with clinical evaluation is important for overall PU risk assessment. The J/C risk scale is specifically designed for intensive care and has performed optimally for ICU patients.10,11 However, its performance in an unselected ICU population is satisfactory only to some extent, as shown by the previous study14: the separation of low-risk and high-risk patient groups and its sensitivity and specificity were suboptimal.14 Therefore, in this study, each of the scoring categories9 of the J/C risk scale were analyzed critically.

Among the general population and ICU patients, the prevalence of PUs increases with age.2,5,18 This observation is corroborated by the results of the present study among patients older than 70 years, but, as a whole, the importance of age as a predictor is negligible. In this study, low BMI values (<18 kg/m2) contributed to the PU risk and high BMI values did not, even though both are linked to PU development in the general population.19-21 A low BMI may be a PU risk factor (see Table 3) because it is associated with a minimal amount of subcutaneous fat, which may increase the deleterious effects of pressure from underlying osseous protuberances on the tissues.21,22 The mental condition, mobility, and hygiene categories contained definitions that are not sufficiently stringent; they are partly interchangeable or superfluous and this impairs their value.9,21,23 Still, it is understandable that mobility does contribute to PU risk because mobility is a crucial consideration in general risk assessment scales.20,23 ICU patients are rarely able to take care of themselves and need much assistance from staff due to their limited mobility and limited ability to independently maintain hygiene. Not surprising, most PUs develop in patients that need assistance when friction and shear on the skin can occur if the procedures to assist the recumbent patient are not performed correctly (see Table 3).

Moist skin, especially due to urine and feces, is a major risk factor for PUs.6,23,24 In the ICU of the Turku University Hospital, most patients have urinary catheters, and fecal catheters are used  when needed to keep the skin as dry as possible. This is represented in the point distribution in the incontinence category (see Table 3). Despite a wide confidence interval, the incontinence category reached significance (see Table 2).

The point distribution of the general skin condition category correctly reflects the PU risk: the risk is lowest when the skin is intact and highest when deep or secreting wounds are present9 (see Table 3). This is in accordance with what is known about the pathophysiology of PUs, because wounds are associated with an inflammatory reaction and often with infection and fever, release of free radicals, and pro-inflammatory cytokines.25-27 Wounds often produce high volumes of fluid, which keeps the skin moist and severely impairs positioning therapy because patients cannot be positioned on their large wounds.

Although definitions regarding respiration and oxygen are partly interchangeable or superfluous (see Table 1), both are related to tissue oxygenation, which has been examined only minimally as a risk factor for PU development.28 The contribution of respiration and oxygen requirements to PU risk differed significantly from each other (see Tables 2 and 3), probably because the respiration mode does not correlate with tissue oxygenation in practice. Oxygen requirements contributed to the risk of PU development in this study, especially the highest risk (1 point = >60% O2) (see Table 3). This probably reflects the situation where lower oxygen concentrations keep the tissue oxygen levels sufficiently stable, while patients needing a great deal of oxygen are so ill their tissue oxygen tension is insufficient to support tissue viability and prevent PUs. This assumption is supported by the findings in the hemodynamics category. Although the current scoring order was not optimal (see Table 3), the incidence of PUs is higher in patients who are unstable regardless of whether they are on or off inotropes (see Table 3).

With respect to PU risk score point deduction, anemia and hemoglobin concentration scoring may replace the need for blood products as an assessment category.6,29 Although 20 patients underwent transportation within 48 hours (see Table 4) before scoring, most of them also were otherwise classified as high risk based on their mJ/C score (29). Because, overall, two thirds of the patients were transported (most earlier than 48 hours before scoring), the contribution of this part of the mJ/C score seems to be insignificant relative to the overall score.

Although only the linearity of the mJ/C categories correlates significantly with the predictive values of PU development, the results show point order (1 as highest and 4 as lowest risk) is not correct in most categories. The J/C risk scale assumes the relative weight of each of the categories is 2.5, which was not the case, because the patients are distributed differently within each of the categories. A 3-fold difference was noted between the highest and lowest relative weight categories, and no correlation was found between the relative weights and predictive values of the mJ/C categories, meaning differences exist among the various categories of the mJ/C scale but this is not a reflection of the true weights of the different categories. This matter requires additional research.

 

Limitations

The retrospective retrieval of the data infers individual contributions of the nurses to the actual risk assessment could not be controlled. However, this is the largest single study of a consecutive ICU patient population. Also, the number of PUs was only 168, which leaves room for some chance effects in the results, because the number of both PU and nonPU patients is quite small in some of the mJ/C subcategories.

 

Conclusion

It is not an easy task to identify specific risk indicators for severely ill ICU patients with multiple disorders. The J/C risk scale is based on certain categories that have been assumed to be linear and of equal weight with regard to the risk of acquiring a PU. In this study, these assumptions were found to be invalid. Seven of the categories contribute substantially to the overall score and actual risk: incontinence, mobility, medical history, oxygen requirement, hygiene, hemodynamics, and general skin condition. This also indicates several risk categories of the J/C risk scale correlate and associate among each other, although this specific matter was not examined in this study. Because of this association, some categories measure the same pathophysiological phenomena. In addition, it was found the order of the risk points is suboptimal within the categories of the J/C risk scale. These results should prompt future research aimed at introducing an individualized order and weight of individual risk categories into the assessment of the risk of PUs with the mJ/C scale. Furthermore, numerous other PU risk factors30 such as admission diagnosis, body temperature, Sequential Organ Failure Assessment score, and hemoglobin concentration should be tested either by prospective cohort studies or retrospective analyses of existing large patient cohorts to identify the most important PU risk factors in the ICU setting. These variables were not examined in this study because they are not part of the risk evaluation scale.

There seems to be room for a simpler scale for PU risk assessment and risk prediction for ICU patients. Such a scale should include only those risk indicators that constitute separate, predictive risk categories. This study shows that, currently, the mJ/C risk scale in combination with clinical assessment is a feasible way to assess the risk of PU among ICU patients, but more research is needed to identify the most effective predictors.

 

References

1.         Takala J, Varmavuo S, Soppi E. Prevention of pressure sores in acute respiratory failure: a randomized, controlled trial. Clin Intensive Care. 1996;7(5):228–235.

2.         Bours GJ, De Laat E, Halfens RJ, Lubbers M. Prevalence, risk factors and prevention of pressure ulcers in Dutch intensive care units. Results of a cross-sectional survey. Intensive Care Med. 2001;27(10):1599–1605.

3.         Kottner J, Wilborn D, Dassen T, Lahmann N. The trend of pressure ulcer prevalence rates in German hospitals: results of seven cross sectional studies. J Tissue Viability. 2009;18(2):36–46.

4.         Terekeci H, Kucukardali J, Top C, Onem Y, Celik S, Öktenli C. Risk assessment study of the pressure ulcers in intensive care unit patients. Eur J Int Med. 2009;20(4):394–397.

5.         VanGilder C, Amlung S, Harrison P, Meyer S. Results of the 2008 – 2009 International Pressure Ulcer Prevalence Survey and a 3-year, acute care, unit-specific analysis. Ostomy Wound Manage. 2009;55(11):39–45.

6.         National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel. Pressure Ulcer Prevention and Treatment: Clinical Practice Guideline. Washington DC: National Pressure Ulcer Advisory Panel 2009.  Available at: www.epuap.org. Accessed January 15, 2016.

7.         García-Fernández FP, Soldevilla Agreda JJ, Verdú J, Pancorbo-Hidalgo PL. A new theoretical model for the development of pressure ulcers and other dependence-related lesions. J Nurs Scholar. 2014;46(1):28–38.

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

9.         Jackson C. The revised Jackson/Cubbin Pressure Area Risk Calculator. Intensive Crit Care Nurs. 1999;15(3):169–175.

10.       Seongsook J, Ihnsook J, Younghee L. Validity of pressure ulcer risk assessment scales; Cubbin and Jackson, Braden, and Douglas scale. Int  J Nurs Stud. 2004;41(2):199–204.

11.       Dassen T, Halfens RJ, Shanin ES. Predictive validity of pressure ulcer risk assessment tools in intensive care patients. World Crit Care Nurs. 2007;5(3):75–79.

12.       García-Fernández FP, Pancorbo-Hidalgo PL, Soldevilla Argeda JJ, Rodrigez Torres MC. Risk assessment scales for pressure ulcers in intensive care units: a systematic review with meta-analysis. EWMA J. 2013;13(2):7–13.

13.       Norton D, McLaren R, Exton-Smith AN. An Investigation of Geriatric Nursing Problems in Hospital. London, UK: National Corporation for the Care of Old People (now Centre for Policy on Ageing);1962. [Available as loan through special libraries.]

14.       Ahtiala M, Soppi E, Wiksten A, Koskela H, Grönlund J. Occurrence of pressure ulcers and their risk factors in mixed medical-surgical ICU — a cohort study. J Intensive Care Soc. 2014;15(4):2–4.

15.       McCullagh P. Regression models for ordinal data. J R Stat Soc. Series B (Methodological), 1980;42(2):109–142.

16.       Fisher R. A. On the interpretation of 2 from contingency tables, and the calculation of P. J R Stat Soc 1922;85(1): 87–94.

17.       Myers JL, Well AD. Research Design and Statistical Analysis, 2nd ed. London, UK: Lawrence Erlbaum Publisher;2003:508.

18.       Theaker C, Mannan M, Ives N, Soni N. Risk factors for pressure sores in the critically ill. Anaesthesia. 2000;55(3):221-224.

19.       VanGilder C, MacFarlane G, Meyer S, Lachenbruch C. Body mass index, weight, and pressure ulcer prevalence: an analysis of the 2006-2007 International Pressure Ulcer Prevalence Surveys. J Nurs Care Qual. 2009;24(2):127–135.

20.       Soppi E, Iivanainen A, Korhonen P. Concordance of Shape Risk Scale, a new pressure ulcer risk tool, with the Braden scale. Int Wound J. 2014;11(6):611–615.

21.       Kottner J, Gefen A, Lahmann N. Weight and pressure ulcer occurrence: a secondary data analysis. Int J Nurs Stud. 2011;48(11):1339–1348.

22. Cubbin B, Jackson C. Trial of a pressure area risk calculator for intensive therapy patients. Intensive Care Nurs. 1991;7(1):40–44.

23.       Braden B, Bergstrom N.  A conceptual schema for the study of the etiology of pressure sores. Rehabil Nurs. 1987;12(1):8–12.

24.       Bayón García C, Binks R, De Luca E, Dierke C, Franci A, Gallert E, et al. Expert recommendations for managing acute faecal incontinence with diarrhea in the intensive care unit. JICS. 2013;14(suppl 2):1–9.

25.       Friedland JS, Porter JC, Daryanani S, Bland JM, Screaton NJ, Vesely MJJ, et al. Plasma proinflammatory cytokine concentrations, Acute Physiology and Chronic Health Evaluation (APACHE) III scores and survival in patients in an intensive care unit. Crit Care Med. 1996;24(11):1775–1781.

26.       Vande Berg JS, Rose MA, Haywood-Reid PL, Rudolph R, Payne WG, Robson MC. Cultured pressure ulcer fibroblasts show replicative senescence with elevated production of plasmin, plasminogen activator inhibitor-1, and transforming growth factor-1. Wound Repair Regen. 2005;13(1):76–83.

27.       Bronneberg D. Biochemical markers for early detection of superficial pressure ulcers. Academic dissertation 2007, Technische Universiteit Eindhoven, Eindhoven, Holland.

28.       Manzano F, Navarro MJ, Roldán D, Moral MA, Leyva I, Guerrero C, et al. Pressure ulcer incidence and risk factors in ventilated intensive care patients. J Crit Care. 2010;25(3):469–476.

29.       Nixon J, Nelson EA, Cranny G, et al on behalf of the PRESSURE Trial Group. Pressure relieving support surfaces: a randomised evaluation. Health Technol Assess. 2006;10(22):1–179.

30.       García-Fernández FP, Soldevilla Agreda JJ, Verdú J, Pancorbo-Hidalgo PL. A new theoretical model for the development of pressure ulcers and other dependence-related lesions. J Nurs Scholar. 2014;46(1):28–38.

 

Potential Conflicts of Interest: Dr. Soppi is the chairman of the board of Carital Group, Helsinki, Finland, a group of companies manufacturing and marketing support surfaces.

 

Ms. Ahtiala is an intensive care unit RN and an authorized wound nurse, Turku University Hospital, Turku, Finland. Dr. Soppi is a consultant in internal medicine, Eira Hospital, Helsinki, Finland. Mr. Kivimäki is a statistician, StatFinn Ltd, Turku, Finalnd. Please address correspondence to: Maarit H. Ahtiala, RN, Intensive Care Unit, Turku University Hospital, Hämeentie 11, Turku 20520 Finland; email: maarit.ahtiala@tyks.fi.

Section: 

Turkish Nurses’ Opinions of the Braden and Waterlow Pressure Ulcer Risk Assessment Scales: A Descriptive Pilot Study

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Ostomy Wound Management 2016;62(2):34–40
Pınar Avsar, RN, MSN; and Ayise Karadag, RN, ET/WOCN, MSN, PhD, Prof. Dr.
Topics: 
Pressure Ulcer
Risk Assessment
pilot study
survey
nursing staff

Abstract

Risk evaluation scales are used as part of prevention strategies for pressure ulcers (PUs). Two of the more used scales, the Braden and Waterlow Pressure Ulcer Risk Assessment Scales (B-PURAS and W-PURAS, respectively) are used in Turkey and worldwide, and their validity in terms of sensitivity, specificity, and predictive validity have been examined in various studies. To determine nurses’ opinions of B-PURAS and W-PURAS in terms of administration time, practicality, clarity, and perceived ability to encompass PU risks and accurately predict PUs, a descriptive study was conducted from October 15, 2011 to November 20, 2011 at a university hospital among nurses who volunteered to participate.

Demographic information collected and assessed included age, highest degree of education completed, and practice area. Participants were trained to use both scales by researchers during a 1-hour session and asked to use them for 2 weeks in their daily practice. The nurses then completed a paper-and-pencil, 12-item questionnaire measuring agreement with general questions about PURAS with options to provide comments. In addition, the questionnaire contained 3 open-ended questions on scale preference, 1 question to rate perceived scale accuracy in predicting PUs, and the opportunity to recommend changes to the scales. Data were analyzed using SPSS 20.0. Frequencies, percentages, and Spearman’s rank correlations were calculated. Eighty-three (83) registered nurses (mean age 27.46 ± 3.73, mean nursing experience 6.53 ± 3.25 [range 0.5–16] years) participated; 18.1% of the nurses had prior experience using such scales, and none of the clinics in the study facility had used PU risk scales previously. Most participants (71, 85.5%) had a bachelor’s degree, 62 (74.7%) worked in a facility that admitted patients at high risk for developing PU, but 66 (almost 80%) saw fewer than 4 ulcers per week. Each nurse performed an average of 22 assessments during the study for a total of 1,826 assessments. Participants generally found both scales practical and appropriate; almost 75% thought the B-PURAS was acceptable for use in all clinics, compared to 51% for the W-PURAS; only 20 participants questioned the scales’ accuracy in predicting PUs. While 43% preferred the B-PURAS for precision, clarity, and practicability, 25% preferred the W-PURAS because it was more comprehensive. Also, the older the nurse, the more likely the preference for the B-PURAS (P <0.019). Some nurses (13%) suggested adding different risk factors such as serum albumin. Overall, 61.4% stated they would prefer to use the B-PURAS over the W-PURAS. Nurses’ recommendations should be considered for practice and new scale development and testing, ideally in different patient populations. 

 

Pressure ulcers (PUs) are frequently encountered in individuals with acute and chronic diseases.1-5 According to a bottom-up costing approach study by Bennett et al6 and a literature review by Ayello and Braden,7 the care and management of PUs are difficult, they are costly to treat, and they require extensive recovery time, prolonging the duration of hospitalization. In terms of quality, cost, and nursing care, preventing PUs is easier and cheaper than treating them.5-7

PU prevalence rates vary markedly among different countries. In the United States, the National Patient Care Safety Monitoring Study,8 which covered more than 51,000 patients, found 4.5% of Medicare beneficiaries developed a PU during their hospital stay and 5.8% had a PU on admission. In Canada, PU prevalence was estimated at 25% in acute care settings.9 In the UK, a point-prevalence study for estimating the prevalence of wounds in general (including surgical wounds, diabetic leg and foot ulcers, cancer, and PUs) found the prevalence of PUs alone was 17%.10 In descriptive PU prevalence studies11-15 in Turkey (N = 84), the prevalence of surgery-related PUs was 54.8%, and in intensive care units (ICUs) the rate was between 14.3% and 20.56%; point-prevalence studies revealed a prevalence between 8.1% and 8.3%. Although the literature overall (including descriptive and prospective studies and literature reviews7,16-26) suggests PUs are largely preventable, they remain a considerable problem. In the current authors’ opinion, the lack of a preventive approach and the much greater focus on the pathophysiology of PUs may be considered factors contributing to the overall failure to find a desirable solution to this problem.

The first preventive intervention involves assessment of the risk of developing a PU.7,16-22 According to a literature review by Ayello and Braden,7 if a risk assessment is performed systematically, PU occurrence can decrease by 60% commensurate with the risk level, and the cost of care also decreases markedly. According to various descriptive studies and literature reviews,3,6,20 identifying the risk of PU development decreases the immediate care costs and allows for higher quality and more effective patient care.

Many nurse investigators have developed various PU risk assessment scales (PURASs) to determine patient risk of developing PUs.21-24 The first PURAS was developed by Doreen Norton in 1962 for the selection of elderly participants for research on PUs.25,26 Numerous PURASs were developed in the 1980s; currently, at least 40 different PURASs are available.17 Hidalgo et al’s26 systematic review reported the most commonly known scales are the Braden (1987), Norton (1962), Gosnell (1973), and Waterlow Pressure Ulcer Risk Assessment Scales (1985); among these, the Norton and Braden scales are most commonly used throughout the world. However, although guidelines typically recommend the use of PURASs, these scales are not without critics. For instance, the scales do not include all risk factors associated with PUs, they sometimes are used as alternatives rather than to supplement clinical evaluations, and they have generally poor validity and reliability.25,26 As such, hospital guidelines nowadays recommend the use of clinical assessment and a PURAS together.27-30

Nurses can employ one of these scales while providing care or can develop one of their own. Developing a new scale and testing its reliability and validity requires expertise on the issue or the support of experts. Furthermore, the importance of the clinical decision-making of nurses themselves in risk evaluation cannot be overlooked, especially the clinical decision-making ability of experienced nurses who are experts in their fields. Thus, it may be easier to use scales already developed for nurses in clinical practice.19

Clinical and home care nurses who are certified in wound, ostomy, and continence nursing are legally responsible for the prevention and care of PUs in Turkey.31,32 Although the importance of using a PURAS and preventive care is frequently stressed in the literature, PURASs are not commonly used in acute care units or long-term care facilities in Turkey; furthermore, only limited care aimed at preventing PUs is generally provided because assessments are not frequently performed.2,13,19 In some countries, making a risk evaluation within the first 6 or 24 hours following admission may not be required. In Turkey, only the Braden, Norton, and Waterlow PURASs, which have undergone reliability and validity analyses in Turkey, are accepted for use.33-35

To the authors’ knowledge, around the world no studies have been conducted to examine nurses’ opinions regarding the use of these scales. The clinical observations and expertise of nurses are important for developing scales for PU risk evaluation, because nurse opinions are critical in determining the risk factors to be included in a scale. Nurse input is also necessary for determining the characteristics of the scale, such as the clarity and practicability of items that need to be included.7,17,19,20,25 Therefore, instead of merely asking nurses to accept the developed scales as wholly complete and accurate, researchers might obtain nurse opinions and allow them to contribute to scale development, which in turn may improve the buy-in and benefit of these scales to nursing care. In the authors’ opinion, PURASs based on nurses’ opinions tend to cover a more extensive range of relevant risk factors and are more applicable and responsive to nurses’ needs in planning patient care; furthermore, nurses’ opinions affect the use of evidence-based PU risk assessment.

The purpose of this descriptive pilot study was to determine the opinions and preferences of nurses regarding the Braden and Waterlow PURASs (B-PURAS and W-PURAS, respectively).

 

Methods and Procedures

The study was performed at a 1,100-bed university hospital. Written permission to conduct the study was obtained from the hospital directorate, which is also the hospital’s institutional review board. Study data were collected between October 15 and November 20, 2011 from participating nurses working in ICUs at the university hospital (including the anesthesia, neurosurgery, internal medicine, general surgery, chest diseases, cardiology, cardiovascular surgery, and neurology ICUs) as well as in the physical therapy, rehabilitation and orthopedics clinics. Nurses who worked in these areas  determined PU risk using their own professional knowledge and experience. Nurses were informed about the study and were invited to volunteer. Nurses who consented to participate in the study were given individual training by one of the researchers, who provided a 1-hour training session that addressed PUs, PU risk assessment, and use of the Braden and Waterlow PURASs. Following training, the nurses administered these 2 scales at the same time each day on the same patients for 2 weeks. Both scales were completed for each patient. After these 2 weeks, the questionnaires were completed by the participants and collected by the researchers.

Questionnaires.

Demographic data. The questionnaire on demographic characteristics comprised 12 items on nurses’ personal characteristics (eg, age, highest degree completed), their status in PURAS training, and their previous experience with using PURASs. The nurses completed the paper-and-pencil instrument independently (see Table 1). owm_0216_avsar_table1

Risk scale comparison. Researchers (experts interested in PUs and scale development) developed this questionnaire based on a review of the literature; it was not tested for validity or reliability. The survey instrument included 12 statements that allowed participants to compare the 2 scales/assessment on time to completion, practicality, clarity, coverage of PU risks, and perceived ability to predict PUs. Participants indicated their level of agreement with survey items (“I agree,” “I partly agree,” and “I do not agree”) and were asked to explain their answers when they selected “I partly agree” or “I do not agree” (see Table 2). Participants also indicated their level of agreement with the statement, “Risk assessment scales that have established validity and reliability should be used to prevent PUs.” The questionnaire also included 1 item that asked nurses how accurately they believed the scales predicted PUs; this item was rated using a visual analog scale ranging from 0 (worse at predicting) to 10 (better at predicting). Questions included, “Which PURAS do nurses prefer by area of practice?” “What are reasons for preferring one scale over the other?” “What are risk factors nurses believe should be included PURAS?” owm_0216_avsar_table2

The questionnaire initially was sent to 5 experts on PUs and scale development who evaluated the items in terms of comprehensibility, scientific content and criteria, ability to quantify the questions, and rating scale method. Necessary revisions were made according to the experts’ opinions. 

Data analysis. The data obtained in the study were analyzed using Statistical Packages for Social Sciences (SPSS) for Windows, Version 20.0 (SPSS Inc, Chicago, II, IL, USA). The frequency and percentages of nurses’ responses and Spearman’s rho were calculated to analyze the correlation between scale preference, work experience, and age. The open-ended questions were individually assessed and similar statements were grouped; data on the frequency and percentages were calculated  by SPSS.

 

Results           

Out of a total of 122 nurses in the participating departments, 83 (68%, mean age 27.46 ± 3.73, mean nursing experience 6.53 ± 3.25 [range 0.5–16] years) took part in the study. Nonparticipation was due to workload (27) or being on leave during the study period (12). None of these nurses used any kind of PURAS in their daily work, but 18.1% stated they had prior experience using such scales. Participants’ demographic characteristics are summarized in Table 1. Most nurses (71, 85.5%) had a bachelor’s degree in nursing, 62 (74.7%) had worked previously at clinics where patients with a high risk of PUs were admitted, and 40 (48.2%) provided care to an average of 1 to 2 patients with PUs weekly. Most had not received additional PU prevention/treatment (67, 80.7%) or training on risk assessment scales (81, 97.6%) after graduation. Each nurse performed an average of 22 assessments during the study for a total of 1,826 assessments. Most participants (80.7%) agreed with the statement, “Risk assessment scales that have established validity and reliability should be used to prevent PUs.”

B-PURAS. Most participants (66, 79.5%) thought the B-PURAS was easy to understand, 62 (74.7%) thought the B-PURAS was practical in terms of time consumption, and 56 (67.4%) thought it was practical to use. Only 8 (9.6%) of the participants thought the B-PURAS did not accurately identify patients at risk of PUs. The majority of participants (59, 71%) did not have difficulty choosing from among answer options while using the B-PURAS, and (19) 23% thought the B-PURAS was not suitable for all clinics (see Table 2).

W-PURAS. In assessing the W-PURAS, 53 (63.8%) thought it encompasses all risks associated with PUs, 22 (26.5%) had difficulty choosing from among the answer options, 36 (43.3%) thought it was important for identifying patients at risk but 12 (14.4%) thought it does not accurately identify which patients are at risk of PUs, and 42 (51.2%) found it suitable for use in all clinics (see Table 2).

More than half of the participants (51, 61.4 %) stated they would prefer to use the B-PURAS in their clinics. However, 7 participants (77.7%) working in the cardiovascular surgery ICU preferred the W-PURAS. All of the nurses working at the physiotherapy rehabilitation clinic, 87.5% of those working at the coronary ICU, and 83.3% of those working at the general surgery ICU preferred the B-PURAS (see Table 3). owm_0216_avsar_table3

Open-ended questions. Open-ended items regarding reasons for preferring one scale over the other were classified under the following categories: precision, clarity, and practicability.

 Among all participants, 43% preferred the B-PURAS for its precision, clarity, and practicability, while 25% reported their reason for preferring the W-PURAS was its elaborateness and comprehensiveness (see Table 3). The mean score on the visual analog scale regarding the B-PURAS’s perceived ability to predict PUs was 7.4 ± 1.7, while for W-PURAS it was 6.8 ± 1.8 (see Table 3). Twelve (12) nurses recommended that in addition to the risk factors found in the 2 scales, factors such as serum albumin value, arterial blood pressure, infection, connection with respirator, amputation, and dehydration should be added.

A significant correlation was found between participant preference for the B-PURAS and age (P<0.05) (see Table 4). Although a significant correlation between years of service and scale preference was not found (P>0.05), a significant negative correlation was found between age and B-PURAS preference (P<0.05); namely, with increasing age, nurses expressed a stronger preference for the B-PURAS (see Table 4). owm_0216_avsar_table4

 

Discussion

Although they had limited experience using risk assessment scales, the majority of the participants thought PURASs should be employed in the prevention of PUs. The importance of PURASs and preventive care practices has been frequently emphasized in the literature. The Agency for Health Care Policy Research27 issued the first guidelines on PU prevention, which stated PURASs with established validity and reliability should be used for the prevention of PUs. Guidelines27-30 also recommended the use of PURASs to identify and manage the risk factors of PUs. According to a systematic review by Walsh and Demsey,36 offering care commensurate with risk level by using a PURAS decreases the risk of PUs and improves the cost-effectiveness of care. Furthermore, recording and performing regular evaluations of a patients’ care requirements facilitates quantification of the patient’s improvement.26,37 Notably, a correlational study38 of critically ill patients indicated nurses’ subjective global risk estimates and total scores on risk assessment scales shared a 60% variance, suggesting nurses’ subjective assessments of risk exposure differ markedly from their risk estimates derived using standardized risk assessment tools. One explanation for this may be nurses draw on factors other than those captured by the standardized tools when making clinical decisions or they weigh certain patient conditions differently.38 It should be noted that recommending the use of scales does not necessarily mean that nurses’ identification and classification of patients’ risk according to their own knowledge and experiences is unimportant.

One third of participants thought the B-PURAS covered PU risks better than the W-PURAS. A possible explanation for this result is the B-PURAS is based upon risk factors for patients who are cared for at home,39 although with proven validity and reliability, the scale now is used widely in acute and long-term care settings. Braden and Bergstrom39 regarded the intensity of the pressure and the tolerance of the tissue to pressure as the main etiological factors, and thereby developed the B-PURAS with 6 subscales. B-PURAS has been found to have the highest validity and reliability of all PURASs.40 Specifically, the B-PURAS has satisfactory reliability and validity and appears to be effective for assessing risk of PUs.33,34,41-45 According to Hidalgo et al’s26 review, 22 studies have been performed to assess the validity and reliability of the B-PURAS. In these studies, the coefficient of consistency between observers was found to be between 0.83 and 0.99; the sensitivity was between 38.9% and 100%; the specificity was between 26% and 100%; the positive predictive value was 4%–100%; and the negative predictive value was 50%–100%.

In this study, most participants (79.5%) stated B-PURAS was easy to understand, while only 38.5% of them thought the same about the W-PURAS. For a PURAS to be easily comprehended, the statements should be clear and the scale itself should yield consistent results. The results of numerous studies33,34,40-44 on B-PURAS with varying sample sizes have indicated the scale can consistently assess the risk of PUs successfully. In contrast, fewer validity and reliability studies have been performed on the W-PURAS; it has commonly been criticized for having a low level of reliability.36 Based on the results of their methodological review, Papanikolaou et al44 stated varying interpretations can evolve from the W-PURAS results because its subscales are not clear. In the current study, nurses’ opinions were compatible with these criticisms of the scale.

No true agreement was reached as to whether either scale was more practical. In this study, nurses thought the scales took an approximately equal amount of time to complete. Practicality and time for completion are interrelated — PURASs that can be quickly completed may be considered more practical. These results may be attributed to the fact the B-PURAS is easier to understand because it has fewer subscales than the W-PURAS, where “neurological deficits” and “medication” subscales require more nurse interpretation and the “skin type/visual risk areas” and “tissue malnutrition” subscales contain items for which multiple answers can be given. The majority of the participants stated they had difficulty choosing answer options when using the W-PURAS; some subscales require nurses’ interpretations and more than one option must be scored for a given item, which may have been influenced nurses’ answers.

Arguably, the most important findings of the present study are that nurses rated both scales as 7 (out of 10) on perceived predictive ability for PUs and that the items of these scales are not best prediction (10) for determining the risk of PUs in the patients they care for at the clinics. Nevertheless, more than half of the nurses believed PURASs that have established validity and reliability through empirical study should be used in the prevention of PUs. Nurses also recommended (with similar frequency for all items) that risk factors such as serum albumin level, blood pressure, amputation, infection status, and connection with ventilator should be added to these scales. Based on these findings, further studies aiming to develop new PURASs that include other risk factors in accordance with nurses’ recommendations should be performed to determine if additional independent risk factors should be considered.

More than half of the participants preferred the B-PURAS, with the remainder preferring the W-PURAS. Nurses who favored the B-PURAS ascribed their preference to its greater clarity and practicality, while those who favored the W-PURAS cited its comprehensiveness. The nurses working at the cardiovascular surgery ICU preferred the W-PURAS. In a literature review by Feuchtinger et al45 on the risk of PUs in patients undergoing cardiovascular surgery, factors such as age; time spent on the operating table; having diabetes mellitus, multiple organ failure, anemia, or neurological conditions; and smoking status — all of which are subscales of the W-PURAS — were deemed significant. Hence, these nurses’ preferences may be associated with the fact there are more risk factors for PUs in cardiovascular surgery patients. Additionally, the W-PURAS layout includes a scoring system to determine risk level on its front side, while on the back side, items on the prevention of PUs, nursing practices, and classifications of PUs are presented. This arrangement provides guidance on nursing care, types of preventative aids associated with the 3 levels of risk status, wound assessment, and dressings.

 

Limitations

The nurses whose opinions were solicited were limited to those working in ICUs and orthopedics and physiotherapy-rehabilitation clinics of a single university hospital. As such, the views of nurses working at other clinics or in state and private hospitals were not included, which makes generalization of the results more difficult.

Another limitation is the small sample size and number of assessments. However, despite this, the general results were similar to those reported in national statistics.

Future research to determine whether nurses are able to score these scales accurately and then act according to patients’ results would be beneficial.

 

Conclusion

The findings of this descriptive pilot study indicated the majority of nurses working at clinics where the risk of PUs was high believed use of a PURAS is necessary, and as they became  familiar with the 2 PURAS utilized during the study, most of them preferred using the B-PURAS over the W-PURAS. The opinions of a larger sample of nurses who have used PURASs in clinics should be obtained and the findings of this study should be verified in a larger study population. 

 

References

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12.       Sayar S, Turgut S, Doğan H, et al. Incidence of pressure ulcers in intensive care unit patients at risk according to the Waterlow scale and factors influencing the development of pressure ulcers. J Clin Nurs. 2008;18(5):765–774.

13.       Katran HB. Pressure Sore Observation Frequency in a Surgical Intensive Care Unit and Addressing Risk Factors Effective on Pressure Sore Development [postgraduate thesis]. Istanbul, Turkey: Haliç University;2008.

14.       Akıl Y, Kabukçu N, Karadag A. Pressure Ulcer Point Prevalence Example: Çukurova University Balcalı Hospital, III. Presented at the National Wound Care Congress. Çesme, Turkey. November 26–29, 2008.

15.       Karadağ A, Gocmen Baykara Z, Özden G. Pressure Ulcers Point Prevalence Study in a University Hospital. Presented at the 15th National Internal Diseases Congress (Nursing program). Antalya, Turkey. October 2-6, 2013.

16.       Waterlow J. Prevention is cheaper than cure. Nurs. Times. 1988;2284(25):69–70.

17.       Keast DH, Parslow N, Houghton PE, Norton L, Fraser C. Best practice recommendations for the prevention and treatment of pressure ulcers: update 2006. Adv Skin Wound Care. 2007;20(8):447–460.

18.       Schoonhoven L, Defloor T, Grypdonck, MHF. Incidence of pressure ulcers due to surgery. J Clin Nurs. 2002;11(4):479–487.

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20.       Brandeis GH, Berlowitz DR, Katz P. Are pressure ulcers preventable? A survey of experts. Adv Skin Wound Care. 2001;14(5):244–248.

21.       Bergstrom N, Braden B, Laguzza A, Holman V. The Braden Scale for predicting pressure sore risk. Nursing Research. 1987;36(4):205–210.

22.       Defloor T, Grypdonck M. Pressure ulcers: validation of two risk assessment scales. J Clin Nurs. 2005;14(3):373–382.

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24.       Lindgren M, Unosson M, Krantz AM, Ek AC. A risk assessment scale for the prediction of pressure sore development: reliability and validity. J Adv Nurs. 2002;38(2):190–199.

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

27.       Agency for Health Care Policy and Research (AHCPR) Supported Clinical Practice Guidelines. Pressure Ulcers in Adults: Prediction and Prevention. Available at: www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat2.section.4521. Accessed May 22, 2011.

28.       European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel. Treatment of Pressure Ulcers: Quick Reference Guide 2009. Available at: www.epuap.org/guidelines/Final_Quick_Treatment.pdf. Accessed May 27, 2011.

29.       Murray LD, Magazinovic N, Stacey MC. Clinical Practice Guidelines for the Prediction and Prevention of Pressure Ulcers. Available at: www.awma.com.au/journal/0903_01.pdf. Accessed May 27, 2011.

30.       Wound, Ostomy and Continence Nurses Society. Guideline for Prevention and Management of Pressure Ulcers. Glenview, IL: Wound, Ostomy and Continence Nurses Society;2003. Available at: www.guideline.gov/summary/summary.aspx?doc_id=3860&nbr=003071&string=pre.... Accessed May 27, 2011.

31.       Nursing Regulation. Available at: www.turkhemsirelerdernegi.org.tr/menu/yonetmelikler/hemsirelik-yonetmeligi. Accessed July 22, 2012.

32.       Regulation on Home Care Services 2005. Available at: www.saglik.gov.tr/TR/belge/1-337/yonetmelikler.html. Accessed July 22, 2012.

33.       Oğuz S, Olgun N. Determination of patient risks by Braden Scale and determination of effectiveness of planned nursing care for prevention of pressure sore. Hemşirelik Forumu Dergisi. 1998;1(2):131–135.

34.       Pınar R, Oğuz S. Reliability and Validity Testing of Norton and Braden Pressure Sore Evaluation Scales in the Same Patient Group Confined to Bed. VI. National Nursing Congress. Ankara, Turkey: Damla typography; 1998:172-175. 

35.       Avşar P, Karadağ A, Alaca R. Waterlow Validity and reliability study of pressure ulcer risk evaluation. VI. Wound Care Congress Book. Antalya, Turkey; 2011:13.

36.       Walsh B, Demsey L. Investigating the reliability and validity of the Waterlow Risk Assessment Scale: a literature review. Clin Nurs Res. 2011;20(2):197–208.

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

38.       Balzer K, Kremer L, Junghans A, et al. What patient characteristics guide nurses’ clinical judgement on pressure ulcer risk? A mixed methods study. Int J Nurs Stud. 2014;51(5):703–716.

39.       Braden B, Bergstrom B. A conceptual schema for the study of the etiology of pressure sores. Rehabil Nurs. 1987;12(1):8–12.

40.       Seongsook J, Ihnsook J, Younghee L. Validity of pressure ulcer risk assessment scales; Cubbin and Jackson, Braden and Douglas Scale. Int J Nurs Stud. 2004;4(2):199–204.

41.       Pang SM, Wong TK. Predicting pressure sore risk with the Norton, Braden and Waterlow scales in a Hong Kong rehabilitation hospital. Nurs Res. 1998;47(3):147–153.

42.       Jalali R, Rezaie M. Predicting pressure ulcer risk: comparing the predictive validity of 4 scales. Adv Skin Wound Care. 2005;18(2):92–97.

43.       Serpa LF, Santos V, Peres G, Cavicchioli M, Hermida M. Validity of the Braden and Waterlow subscales in predicting pressure ulcer risk in hospitalized patients. Appl Nurs Res. 2010;24(4):6–12.

44.       Papanikolaou P, Lyne P, Anthony D. Risk assessment scales for pressure ulcers: a methodological review. Int J Nurs Stud. 2007;44(2):285–296.

45.       Feuchtinger J, Halfens JG, Dassen T. Pressure ulcer risk factors in cardiac surgery: a review of the research literature. Heart Lung. 2005;34(6):375–385.

 

Potential Conflicts of Interest: This research was supported by Scientific Research Projects of Gazi University, Ankara, Turkey. (Project No.47/2011-0).

 

Ms. Avsar is a research assistant, Yıldırım Beyazıt University Faculty of Health Sciences, Department of Nursing, Ankara, Turkey. Dr. Karadag is a Professor, Koç University School of Nursing, Istanbul, Turkey. Please address correspondence to: Pinar Avsar, RN, MSN, Faculty of Health Science, Yıldırım Beyazıt University, Bilkent Yolu 3.Km Bilkent/Çankaya, Ankara 06010 Turkey; email: p.avsar.ank@gmail.com.

Section: 

Silver-Collagen Dressing and High-voltage, Pulsed-current Therapy for the Treatment of Chronic Full-thickness Wounds: A Case Series

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Ostomy Wound Management 2016;62(3):36-44
Kehua Zhou, MD, DPT, LAc; Kenneth Krug, DPT, CWS; John Stachura, DPT, MBA; Paulette Niewczyk, PhD, MPH; Michael Ross, PT, DHSc, OCS; Justine Tutuska, MPH; and Gregory Ford, DPT, PhD, OCS
Topics: 
Case Study
Wounds
electrical stimulation therapy
silver
Collagen
dressing

Abstract

Research suggests high-voltage, pulsed-current electric therapy (HVPC) is safe and effective for treating chronic wounds, and some data suggest silver- and collagen-based dressings may facilitate healing. A combination therapy utilizing both HVPC and silver-collagen dressing may present clinical advantages. To explore the effect of the combined therapy for chronic full-thickness wounds, a prospective, consecutive case series study was conducted. All participants were adults with wounds of at least 6 weeks’ duration.

After obtaining informed consent, patient and wound characteristics were obtained, wounds were assessed and measured, and patients received 2 to 3 HVPC treatments per week followed by application of the silver- and collagen-based dressing for a period of 2 weeks. Data were analyzed descriptively, and changes in wound size and volume from baseline were analyzed using Wilcoxon Signed Rank Test. The dressings were saturated with normal saline, used simultaneously during the 45-minute HVPC treatment, and left on top of the wound after treatment. The HVPC electro pads (stainless steel electrodes with a sponge interface) also were moistened with normal saline and the cathode placed on top of the wound. If the patient had more than 1 wound on the same leg, the anode was placed on the additional wound (otherwise over the intact skin nearby). Secondary dressings (eg, foam and/or gauze) were used as clinically appropriate, and a 4-layer compression wrap was used, if indicated, for patients with venous ulcers. Ten (10) patients (3 women, 7 men, 57.30 ± 9.70 years old with 14 wounds of 273.10 ± 292.03 days’ duration before study) completed the study and were included in the final analyses. Average wound surface area decreased from 13.78 ± 21.35 cm2 to 9.07 ± 16.81 cm2 (42.52% ± 34.16% decrease, P = 0.002) and wound volume decreased from 3.39 ± 4.31 cm3 to 1.28 ± 2.25 cm3 (66.84% ± 25.07% decrease, P = 0.001). One (1) patient was discharged with complete wound closure. No serious adverse events were noted, but a diagnosis of osteomyelitis in 1 patient and increased pain in a patient with significant Reynaud’s syndrome suggest clinicians should be cautious using HVPC in these instances. The combined intervention utilizing both HVPC and silver-collagen dressing was effective in the treatment of chronic full-thickness wounds in this patient population. Controlled clinical studies of longer duration are needed to further explore the safety, effectiveness, and efficacy of this treatment. 

 

A wound that fails to heal properly in optimal conditions within 4 to 6 weeks is considered chronic.1,2 Chronic wounds can impair an individual’s functional status, restrict participation in employment and activities of daily living, and significantly decrease patient quality of life.3 Additionally, chronic wounds may lead to a number of costly complications including infection, amputation, and death.3 The healing of chronic wounds is often unpredictable. As a review4 indicates, healing processes can be interrupted or stalled in the sequence of biochemical and cellular events, and the risk of interruptions within the typical healing process becomes more common as the age of the patient increases and as the health condition of the patient decreases. In order to prompt transition of the chronic wound from a disrupted healing process, appropriate interventions are necessary. Currently, in clinical practice topical treatments constitute the mainstay of interventions in chronic wound care.5

Commonly used methods for the topical treatment of chronic wounds include various types of dressings, negative pressure wound therapy, debridement, local antibiotic therapy, and electric therapy.5 A review of the literature6 has shown high-voltage, pulsed-current electric therapy (HVPC) is effective in treating chronic wounds. In vivo animal experiments and in vitro study7-9 found HVPC can induce cellular electrotaxis, increase the production of vascular endothelial growth factor (VEGF) and fibroblastic growth factor (FGF), and activate VEGF receptors via VEGF and FGF (both stimulate angiogenesis and facilitate wound healing). Randomized, controlled trials (RCTs)10-12 also have found the use of HVPC in wound care to be promising. In a prospective, controlled trial (N = 16), Kloth and Feedar10 found HVPC accelerated the healing rate of Stage IV pressure ulcers compared to no treatment. In a similar prospective, controlled study (N = 17), Griffin et al11 reported HVPC induced significantly greater decrease in wound size than the placebo control in patients with a pelvic pressure ulcer. In a RCT, Franek et al12 found HVPC therapy provided to 33 patients produced better results than topical medication in 32 patients or Unna boot in 14 patients for healing venous leg ulcers.

Silver- and collagen-based dressings also are commonly used in chronic wound care. Silver is a toxic heavy metal that may cause protein denaturalization; however, silver-containing dressings are deemed safe based on a review of clinical trials13 because they allow only limited concentrations of silver ions to be present in the wound/dressing interface. According to a literature review,14 silver-based dressings have been found to possess antimicrobial activities and facilitate chronic wound healing. 

According to a narrative review,15 the human body contains various types of collagen, which comprises 70% to 80% of the dermis (dry weight). Collagen provides structural support for cellular mitogenesis, differentiation and migration via synthesis, and release of inflammatory cytokines and growth factors.15 Because of these benefits,13-15 dressings containing silver, collagen, or both are widely used in chronic wound care.1 

Various dressing brands with components of silver, collagen, or both are marketed. Reviews of the literature13-16 have found them effective. Additionally, in a recent case series study of recalcitrant wounds of various etiologies, Shah and Chakravarthy17 reported complete wound closure over 68 days of treatment in 15 out of 18 patients using a bovine-derived 100% native, type I collagen. In a prospective, comparative study of patients with venous leg ulcers or diabetic foot ulcers (N = 10), Manizate et al18 reported wound closure rates were 1.38 ± 1.44 cm2/week with bovine native collagen/ionic silver dressing and 0.79 ± 0.74 cm2/week with carboxymethylcellulose/1.2% ionic silver. 

The use of HVPC and silver and/or collagen dressings has both a theoretical foundation and clinical research evidence.6-18 Thus, the combination therapy utilizing both HVPC and silver-collagen dressing is logical and may hold additional advantages in facilitating wound healing. However, little research evidence on the safety, efficacy and effectiveness of this combined therapy is available. The purpose of this case series was to explore the effect and safety of the combined therapy utilizing both HVPC and silver-collagen dressing in the treatment of chronic, refractory, full-thickness wounds.  

 

Study Design and Methodology

A prospective, consecutive case series study was performed at the Daemen College Physical Therapy Wound Care Clinic, a subsidiary of the Daemen College Physical Therapy Department (Daemen College, Amherst, NY). Established in 2012 as a result of a grant secured from a private philanthropic organization, this clinic has been operating as an outpatient physical therapy clinic specializing in wound care and serving the Western New York community by offering treatment free-of-charge to patients for a 2-year period. In addition to providing patient care, clinical research on patient outcomes, effectiveness of treatment modalities, and patient response to dressings is ongoing. Patient participation in research is completely voluntary and is not a condition of receiving care. The study protocol was approved by the Daemen College Institutional Review Board; all participants provided written informed consent before study inclusion. 

Participants. Inclusion criteria stipulated patients must be 21 years of age or older with a full- thickness wound of any type present for at least 6 weeks before study inclusion and nonresponsive to previous wound treatments (no improvement in wound surface area and depth of wound for 1 week or longer). Patients with vasculitis, hypergranulation tissue, unstable vital signs, or a known hypersensitivity to collagen and/or silver were excluded from participating in the study. Additionally, patients with visually identifiable redness and new onset of pain related to the wound (possible active infection) and patients who were taking antibiotics at assessment for study participation also were excluded.  

Treatment protocol. Silver-collagen dressing (Puracol® Plus Ag+ MicroScaffold Collagen, Medline Industries, Inc, Mundelein, IL) that was saturated with normal saline was used simultaneously during 45 minutes of HVPC (RichMar Winner EVO ST4, Chattanooga, TN) treatment and was left on top of the wound after treatment. Electro pads (stainless steel electrodes with a sponge interface) were moistened using normal saline with the cathode on top of the wound; if the patient had more than 1 wound on the same leg, the anode was placed on the additional wound (otherwise over the intact skin nearby). Secondary dressings, which mainly include foams and gauzes, were used as adjuncts as clinically appropriate. An additional 4-layer compression wrap system was applied on patients with venous ulcers if the leg was compressible as judged from the ankle brachial index value and additional laser Doppler when needed. The same treatment protocol was applied to all patients during each visit. Participants were treated 2 to 3 times per week for 2 weeks. 

Outcome measurement. During the study, the following data were collected at each patient visit: wound size (length and width) and depth were measured with regular paper ruler and Q-tip. Wound surface area was calculated (wound length times wound width); wound volume was calculated as wound surface area times wound depth. Photographs of the wound were taken during each visit to assess other characteristics (eg, color change and border); wound exudate and odor were noted if applicable. Additionally, patient age; gender; wound location, etiology, and duration before study participation; previous wound treatments; and medical history were documented.

Data collection and statistical analysis. Patient demographics and wound-related history data were collected and stored in the electronic medical record system at the clinic. Additional hardcopy documents related to the study were stored in the locked drawer at the clinic. Patient demographic data were summarized descriptively. Statistical analysis was performed using SPSS 19.0 software (SPSS Inc, Chicago, IL, USA) for Windows. Percentages, means, standard deviations (SD), and quantitative ranges were provided. Two-tailed significance testing at the <0.05 probability level was considered statistically significant for all analyses. Differences in wound surface areas and volumes were compared at study enrollment and at the end of the study using Wilcoxon Signed Rank Test. Wound surface area and volume reductions were described in percentages.

 

Results

Flow of study participation is presented in Figure 1. At the beginning of the study (July 18, 2013), 3 patients whose wound healing did not progress for more than 1 week at the clinic were directly included in the present study (cohort A). From July 18, 2013 to September 17, 2013, new patients with unhealed wounds who had not made clinical improvements at their treating physician’s office, wound clinics, or other health care facilities were referred to the present clinic for evaluation; among these patients, 9 were included in the present study (cohort B). Eleven (11) other potential patients were excluded from the present study for the following reasons: 2 patients with a full-thickness venous ulcer declined participation; 2 patients with a diabetic foot ulcer had unstable vital signs and were subsequently admitted to the hospital; 6 patients had a partial-thickness wound; and 1 patient had tissue hypergranulation. owm_0316_zhou_figure1

In total, 12 patients participated in the study; none of the 12 patients showed signs and symptoms related to infection or were taking antibiotics at study inclusion. However, 2 patients were discontinued from the study after 2 treatments: 1 patient in cohort A developed excessive exudate and a strong foul odor as well as significant redness upon dressing removal; the wound under treatment had a 50+-year history and was caused by a motor vehicle accident. After study discontinuation, the patient was referred to a specialist and was diagnosed with chronic osteomyelitis. The other discontinued patient in cohort B experienced increased pain after 2 treatments; this patient had significant Reynaud’s syndrome. The remaining 10 patients who completed the 2-week study had 19 wounds in total; however, 5 wounds on 5 patients did not meet the inclusion criteria of wound duration of at least 6 weeks or full-thickness; these wounds were excluded from the present study. Consequently, 2-week outcomes data from 14 wounds (10 patients) were available. 

The 10 participating patients had an average age of 57.30 ± 9.70 (range 41–67 years) and a wound history of 273.10 ± 292.03 (range 45–892) days before study participation (see Table 1). At baseline, the average wound surface area was 13.78 ± 21.35 cm2; after 2 weeks, the average was 9.07 ± 16.81 cm2 (a decrease of 4.71 ± 6.51 cm2, P = 0.002) (see Table 2). Wound volume also decreased significantly from 3.39 ± 4.31 cm3 to 1.28 ± 2.25 cm3 (a decrease of 2.09 ± 2.43cm3, P = 0.001). One patient was discharged after complete wound closure at study conclusion. One wound exhibited decreased wound volume but not wound surface; the other 13 wounds showed a decrease in both surface area and volume. Overall, wound surface area decreased by 42.52% ± 34.16% and volume decreased by 66.84% ± 25.07% in these 14 wounds. Thus, the combined intervention utilizing both HVPC and silver-collagen dressing was effective in the treatment of all of the 10 (100%) patients with 14 chronic refractory full-thickness wounds. owm_0316_zhou_table1

In addition to the adverse events in the 2 patients mentioned previously, other adverse events noted among the participants included the following: 2 patients had a local infection per physician diagnosis, confirmed with wound culture and treated with antibiotics during study; 1 patient was briefly hospitalized due to recurrent deep vein thrombosis (DVT); and 1 patient reported increased foul odor after application of the dressing. These patients resumed/continued their participation in the study without additional events. No other side effects were reported. owm_0316_zhou_table2

 

Discussion

Despite extensive use of silver-based dressings in chronic wound care, research evidence using robust controlled models are not common, although a preponderance of in vitro antimicrobial studies has been conducted.13,14 In 1 of only a few RCTs (N = 34), Woo et al19 reported silver alginate powder could facilitate wound healing by decreasing bacterial burden using a foam dressing control. A review15 concluded a collagen-based dressing could facilitate wound healing; although high-quality clinical trials of collagen-based wound dressings are limited, collagen is widely considered safe and effective for wound healing15-18 and has no known side effects, according to a prospective, comparative study by Manizate et al.18 Results from the present study utilizing treatments containing both silver and collagen are consistent with these findings and demonstrated universal decrease in wound volume of all 14 wounds with minimal to no apparent treatment-related side effects. Nonetheless, it’s worth noting 2 patients withdrew from the study due to foul odor, drainage, or pain after 2 treatments; data on these 2 patients were not included in the final analyses. 

The use of HVPC in the current study is well supported by research.6-9 Electric stimulation was reported in a narrative review6 to facilitate the production of collagen by fibroblasts and increase blood flow and capillary density. Both collagen production and blood supply are of great importance for the enhancement of granulation tissue growth in chronic wounds. Through RCTs,10-12,20 researchers found 45–60 minutes of HVPC more than 5 times a week is an effective therapy for pressure ulcers, nonhealing venous wounds, and diabetic foot ulcers. Nonetheless, more research is needed regarding wound healing using HVPC because wound healing plateaued in 2 patients from cohort A (they were managed with HVPC and other dressings before enrollment in this study) and various patients did not show continuous improvement with HVPC treatment in the previous studies.10-12,20

If wound healing has plateaued, whether to continue the use of the same treatment is a question for debate. In addition to efficacy concerns, it may be unethical from a human subject perspective. In the present study, the same treatment protocol was applied for 2 weeks and patients could be provided other dressings or treatments after the study if no responses were observed. Additionally, to optimize treatment outcomes, this combined therapy utilizing both HVPC and silver-collagen dressing was applied for the treatment of full-thickness wounds. The results of the present study demonstrated an average 42.52% decrease in wound surface area and a 66.84% decrease in wound volume during a 2-week study period, which suggests this combined treatment protocol may be effective. 

With regard to side effects of the intervention, the etiology of the local infection in the 2 included patients remained unknown, most likely due to compromised immune function as a result of drug therapy or comorbidities. The patient who was hospitalized during the study due to DVT had transplantation of both a kidney and pancreas and had a long-term history of recurrent thrombosis, events not likely caused by the study intervention. Nonetheless, the foul odor may be caused by the breakdown of the silver/collagen-based dressing of the intervention. 

Additionally, the discontinuation of treatment for the 2 patients from the study is worth noting; 1 was later diagnosed with chronic osteomyelitis, which may be a contraindication for electric therapy.21 Although the supporting research evidence for chronic osteomyelitis as one of the contraindications for electric therapy is still insufficient,21 clinicians should be cautious when applying HVPC to patients with chronic osteomyelitis. The other patient had uncontrolled Reynaud’s syndrome; clinicians may need to be vigilant regarding the use of silver/collagen-based dressing and/or HVPC in patients with simultaneous chronic wounds and Reynaud’s.  

Although the majority of chronic wounds may stall in the inflammatory phase,1 the actual wound environment changes daily to weekly if not by hours or minutes. Thus, continuous monitoring of wound environment is needed. When wound healing plateaus, combined therapy using HVPC and silver-collagen dressing may facilitate the wound healing process.  

 

Limitations

The case series study design with a small sample size limits the generalizability of the study results. The effect of treatment for patients in cohort B who were newly examined and treated at the clinic may be due to a change in treatment clinics. Additionally, wound size and depth were measured with a regular paper ruler and Q-tip, which may not be reliable. Finally, patients were followed for only 2 weeks; thus, it is not known if ongoing treatment would have resulted in complete healing. Further investigation is warranted to better understand the treatment response and clinical utility of this combined intervention. 

 

Conclusion

A combined intervention utilizing both HVPC and silver-collagen dressing was effective in the treatment of 14 chronic full-thickness wounds in 10 patients. After 2 weeks of treatment, a universal reduction in wound volume was observed in all of the 14 wounds. Although the results from this case series cannot be generalized to a larger population, these results are encouraging. Two potential limitations of using HVPC also should be noted. Specifically, clinicians should be cautious when applying HVPC to patients with chronic osteomyelitis or Reynaud’s syndrome. Controlled clinical studies are needed to evaluate the safety, efficacy, and effectiveness of this combined treatment modality. n

 

Acknowledgments

The authors thank the John R. Oishei Foundation and James H. Cummings Foundation for funding the Daemen College Physical Therapy Wound Care Clinic, Amherst, NY; Medline Industries Inc (Mundelein, IL) and Derma Sciences Inc (Princeton, NJ) for the wound care dressings; Corstiaan Brass, MD for his generous donation to the clinic and guidance in the management of patients; Michael Brogan, DPT, PhD for his leadership in the management and administration of the clinic; and Laura E. Edsberg, PhD for her kind suggestions during the draft of the manuscript. 

 

References

1. Wound care. Clinical guidelines (nursing). Available at: www.rch.org.au/rchcpg/hospital_clinical_guideline_index/Wound_care/. Accessed October 3, 2014.

2. Sharma RK, John JR. Role of stem cells in the management of chronic wounds. Indian J Plast Surg. 2012;45(2):237–243.

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

4. Guo S, Dipietro LA. Factors affecting wound healing. J Dent Res. 2010;89(3):219–229.

5. Werdin F, Tennenhaus M, Schaller HE, Renne Kampff HO. Evidence-based management strategies for treatment of chronic wounds. Eplasty. 2009;9:e19.

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

7. Asadi MR, Torkaman G, Hedayati M, Mofid M. Role of sensory and motor intensity of electrical stimulation on fibroblastic growth factor-2 expression, inflammation, vascularization, and mechanical strength of full-thickness wounds. J Rehabil Res Dev. 2013;50(4):489–498.

8. Callaghan MJ, Chang EI, Seiser N, Aarabi S, Ghali S, Kinnucan ER, et al. Pulsed electromagnetic fields accelerate normal and diabetic wound healing by increasing endogenous FGF-2 release. Plast Reconstr Surg. 2008;121(1):130–141. 

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

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

11. Griffin JW, Tooms RE, Mendius RA, et al. Efficacy of high voltage pulsed current for healing of pressure ulcers in patients with spinal cord injury. Phys Ther. 1991;71(6):433–442.

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

13. Bergin SM, Wraight P. Silver based wound dressings and topical agents for treating diabetic foot ulcers. Cochrane Database Syst Rev. 2006;(1):CD005082.

14. Dowsett C. The use of silver-based dressings in wound care. Nurs Stand. 2004;19(7):56–60.

15. Rangaraj A, Harding K, Leaper D. Role of collagen in wound management. Wounds. 2011;7(2):54–63.

16. Fleck CA, Simman R. Modern collagen wound dressings: function and purpose. J Am Col Certif Wound Spec. 2011;2(3):50–54.

17. Shah SV, Chakravarthy D. Evaluation of a bovine 100% native collagen for the treatment of chronic wounds: a case series. J Wound Ostomy Continence Nurs. 2015;42(3):226–234.

18. Manizate F, Fuller A, Gendics C, Lantis JC 2nd. A prospective, single-center, nonblinded, comparative, postmarket clinical evaluation of a bovine-derived collagen with ionic silver dressing versus a carboxymethylcellulose and ionic silver dressing for the reduction of bioburden in variable-etiology, bilateral lower-extremity wounds. Adv Skin Wound Care. 2012;25(5):220–225.

19. Woo KY, Coutts PM, Sibbald RG. A randomized controlled trial to evaluate an antimicrobial dressing with silver alginate powder for the management of chronic wounds exhibiting signs of critical colonization. Adv Skin Wound Care. 2012;25(11):503–508.

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

21. Rennie S. Electrophysical agents — contraindications and precautions: an evidence-based approach to clinical decision making in physical therapy. Physiother Can. 2010;62(5):1–80.

 

Potential Conflicts of Interest: The Medline Industries Corporation (Mundelein, IL) was 1 of the contributing entities supporting the free clinic over a 2-year period of time. The collagen product was donated to the clinic.  

 

Dr. Zhou is a physical therapist, Daemen College Physical Therapy Wound Care Clinic and a clinical assistant professor, Department of Health Care Studies; Dr. Krug is a physical therapist, Daemen College Physical Therapy Wound Care Clinic; Dr. Stachura is a clinical assistant professor, Department of Physical Therapy; Dr. Niewczyk is an associate professor, Department of Health Care Studies; Dr. Ross is an assistant professor, Department of Physical Therapy; Ms. Tutuska is an assistant professor, Department of Health Care Studies; and Dr. Ford is an associate professor, Department of Physical Therapy, Daemen College, Amherst, NY. Please address correspondence to: Kehua Zhou, MD, DPT, LAc, Department of Health Care Studies, Daemen College, MailBox 144, 4380 Main Street, Amherst, NY 14226; email: kzhou@daemen.edu.

Section: 

A Prospective, Descriptive Study to Assess the Clinical Benefits of Using Calendula officinalis Hydroglycolic Extract for the Topical Treatment of Diabetic Foot Ulcers

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Ostomy Wound Management 2016;62(3):8–24
Marcelo Buzzi, PhD; Franciele de Freitas, NP; and Marcos Winter, MD
Topics: 
clinical study
diabetes complications
Calendula
diabetic foot
wound healing

Abstract

Diabetic foot ulcers (DFUs) have a significant impact on patient quality of life. A prospective, descriptive pilot study was conducted between May 2012 and December 2013 through the dermatology outpatient unit in a Brazilian hospital to evaluate the clinical benefits of using Calendula officinalis hydroglycolic extract in the treatment of DFUs.

Patients diagnosed with a stable neuropathic ulcer of  >3 months’ duration; ranging in size from 0.5–40 cm2; without osteomyelitis, gangrene, bone exposure, cancer, or deep tissue infection; ages 18–90 years; with adequate glycemic control and no history of an allergy to C. officinalis were enrolled. Patients provided demographic and diabetes-related information and were evaluated biweekly for 30 weeks or until healing (ie, full epithelialization with no wound drainage). DFUs were measured and clinically examined for microbiological flora and presence of odor, tissue type (eg, granulation, fibrin sloth, necrosis), exudate, and retraction rate using planimetry images. Patients’ blood tests and neuropathic pain assessment (the latter by clinician-directed questionnaire) were performed at baseline and the end of treatment; pain also was assessed during dressing changes using a 10-point rating scale. Patients’ ulcers were treated twice daily with C. officinalis hydroglycolic extract spray solution and covered with saline-moistened, sterile, nonadherent gauze and bandages followed by foot offloading with adequate protective footwear. Patients received their first treatment in the clinic then performed care at home. From a potential population of 109 patients, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled, 43 withdrew before study completion; cited reasons included lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), protocol violation (5), and death (3). Forty-one (41) — 17 women, average age 62 years (range 44–82 years), average glycemic level 153 mg/dL (range 82–395 mg/dL), most (34) with Wagner type 1 ulcers — completed the study. The proportions of patients who achieved complete wound closure after 11, 20, and 30 weeks of treatment was 54%, 68%, and 78%, respectively; mean healing time was 15.5 ± 6.7 weeks. When individual weekly healing rates (the percentage reduction in wound area per week) were corrected for variability in initial DFU area, the values were nearly 6-fold higher for complete wound closure (7.8% ± 3.6%) than for incomplete wound closure (1.4% ± 0.7%) (Student t-test; P = 0.001). After 30 weeks of treatment, the number of colonized wounds decreased from 29 at baseline to 5, and the number of odorous wounds decreased from 19 to 1. Ulcer bed planimetry data showed a significant reduction in the amount of exudate, fibrin slough, and necrotic tissue after the treatment with C. officinalis hydroglycolic extract (χ2 test; P = 0.001). No adverse events were observed during treatment. The study findings suggest C. officinalis extract is safe and has a beneficial effect on DFU healing. Randomized, controlled studies using C. officinalis hydroglycolic extract are warranted to confirm its safety and establish its clinical efficacy and effectiveness for the topical treatment of DFUs.

 

Diabetic foot syndrome is a common and severe complication worldwide with a cumulative lifetime incidence of up to 25%. The rapidly increasing rates of diabetes make diabetic foot ulcers (DFUs) a major public health issue. These ulcers have been shown to reduce patient quality of life and may ultimately lead to severe pain, prolonged hospitalization, and/or amputation of the lower extremities.1 

Chronic DFUs are complicated by delayed wound healing processes related to impaired glucose metabolism and neurovascular complications.2 The standard treatment plan for DFUs is designed to eliminate infection; maintain a moist wound bed; and offload pressure with protective footwear such as custom cushioned shoes, diabetic boots, and forefoot- and heel-relief shoes, as well as orthotic walkers, wheelchairs, and crutches. Periodic debridement to facilitate healing and topical medication such as preparations made of recombinant human platelet-derived growth factor are also important.3 According to a meta-analysis,4 many patients with persistent DFUs do not respond to commonly provided care. In such patients, a prospective, randomized controlled study5 reports the only available option to prevent amputation is skin replacement therapies. Because skin replacement therapy is expensive and not widely available, more effective treatments for chronic DFUs are desperately needed for patients with diabetes. 

A systematic review6 that included 60 studies (N = 24,747 patients) suggested topical medications and dressings such as cadexomer iodine, zinc oxide, hydrocolloids, alginates, and hydrogels provide no additional benefit to interventions used to treat DFUs such as sharp debridement, larvae therapy, hyperbaric oxygen, skin grafts, electrical and magnetic stimulations, and ultrasound. However, most topical pharmacological agents that are currently available or in development generally address a single aspect of DFU pathology. Examples of research include a randomized, double-blind, placebo-controlled (RDBPC) study7 (N = 87) of abnormal coagulation involving dalteparin, a case series8 (N = 21) using homologous platelet gel, a RDBPC study9 (N = 62) in which infection was treated using a photo-activated gel containing the antimicrobial agent RLP068, and a RDBPC study10 (N = 40) among patients with xerosis treated with a urea-lactic acid moisturizer. 

An emerging trend involves identifying natural extracts with healing properties that address all aspects of DFUs, especially with the new extraction methods designed to optimize their yield, purity, and bioactivity (eg, anti-inflammatory, wound healing, and antitumor properties).11–15 A prospective, randomized controlled trial16 with 37 patients with diabetes demonstrated topical kiwifruit extract reduced the size of DFUs by ~50% in 3 weeks compared to patients who received the standard treatment of surgical debridement, blood sugar control, and oral antibiotic therapy. Additionally, in a prospective, randomized controlled study,17 oak bark extract (QRB7) was found to be more efficient than polyherbal silver sulfadiazine cream for reducing the size of DFUs in 40 patients with diabetes, with 72.5% and 54.7% reduction in wound size after a 6-week treatment. However, none of these agents was proven to support complete wound closure (the duration of the study was not long enough).

The genus Calendula has been recognized for decades as a rich source of medicinal plants with strong healing potencies.16 Among them, Calendulaofficinalis flowers are used in numerous over-the-counter botanical preparations for external use as an anti-inflammatory wound healing agent and indicated for the treatment of herpes, solar erythemas, burns, and dermatitis. The phytopreparation Plenusdermax® (Phytoplenus Bioativos S.A., Pinhais, Paraná, Brazil) from C. officinalis is rich in various bioactive compounds with wound healing and anti-inflammatory properties, including terpene alcohols, monoester triterpenoids (ie, faradiol and arnidiol calenduladiol), and antioxidant flavonoids (ie, quercetin, rutin, kaempferol, and narcissine). According to animal studies,18–22 the monoesters triterpenoids (ie, isopropyl myristate, palmitate, and laurate) are considered the most effective topical agents in terms of anti-inflammation and wound healing capacity. However, the effects of hydroglycolic extract have not been tested on chronic diabetic ulcers.

 

Study Purpose

A prospective, descriptive clinical study was conducted to evaluate the effect of C. officinalis hydroglycolic extract on the healing rate of DFUs in patients with diabetes until complete wound closure and during a 30-week follow-up period to monitor the long-term effects of the treatment.

 

Methods and Procedures

Participants. The study was conducted between May 2012 and December 2013 in the outpatient unit of the Department of Dermatology, Hospital da Santa Casa de Misericórdia de Curitiba, Pontifícia Universidade Católica do Paraná (PUC-PR), Brazil. One hundred, nine (109) patients with diabetes and foot ulcers from the Curitiba metropolitan region were screened according to the inclusion and exclusion criteria presented in Table 1. The study was approved by the Institutional Research Ethics Committee of the PUC-PR (protocol no. 22.670) and was registered in Plataforma Brazil with the National Commission of Ethics in Research (no. 0.1051212.0.0000.0020). Written informed consent was obtained from all patients before screening. owm_0316_buzzi_table1

At the initial visit, a full medical history and assessment of the patients’ present condition were recorded. Study variables were collected on a paper/pencil instrument and evaluated; information included sociodemographic data, clinical history, and clinical evaluation of the wounds and amputations. The diabetic status of patients (ie, type, duration, glycemic management, including the determination of plasma glucose and glycated hemoglobin levels, current activity level, nutritional status, neuropathic pain assessment,23 and blood tests) also was recorded. Blood test results included glucose levels, glycated hemoglobin, serum albumin, blood count, erythrocyte sedimentation rate, and ulcer bacterioscopy and culture were obtained at baseline and at the study conclusion.

Treatment with C. officinalis hydroglycolic extract. All enrolled patients were treated with the C. officinalis hydroglycolic 4% extract. The extract composition included C. officinalis L. 4% and excipients (butylated hydroxytoluene, parabens, ethanol, polyethylene glycol, and purified water). The spray solution was prepared by authorized compounding pharmacies using commercial ingredients. The certificated analysis of the C. officinalis hydroglycolic extract included the following compounds from dichloromethane fraction: β-amyrin (6.7%), lupeol (4.7%), ψ-taraxasterol (8.1%), calenduladiol monoesters (5.5%), arnidiol monoesters (15.7%), faradiol monoesters (35.2%), others (24.1%), and from aqueous fraction: total flavonoids content of 120 mg/mL. Bioactivity was previously demonstrated using high-performance liquid chromatography.19,20 The DFU was cleaned twice daily with 25 mL of sterile physiological saline solution, after which 0.018 mL/cm2 of wound area of C. officinalis extract was sprayed on the wound. After allowing the solution to dry in the wound bed for 5 minutes, sterile, nonadherent, saline-moistened gauze and bandages were applied. Patients were provided cushioned footwear, diabetic boots, crutches, and wheelchairs to offload the affected areas. None of the patients used additional wound healing medication, phytopreparation, hydrogels, hydrocolloids, or supportive therapy (ie, electrotherapy, vacuum therapy, laser therapy, phototherapy). The nursing team instructed patients or their caregivers to use sterile gauze dressings after each C. officinalis extract application and to avoid bearing weight on the affected limb by using adequate footwear. Patients received their first treatment in clinic then performed care at home. The nursing team monitored whether the instructions for treatment were adequately followed through weekly phone calls to patients or their caregivers. Footwear such as cushioned shoes and diabetic boots was distributed by the local public health system and customized for the study patients. 

Assessment of C. officinalis hydroglycolic extract on DFU healing. DFUs were assessed at baseline and then twice a week during visits by the nursing staff. At each visit, the DFUs were clinically assessed for appearance, size, and size reduction rate using photographs analyzed by computerized planimetry, according to a methodology described previously.24 Photographs of each ulcer were taken with a Sony DSC-H1 digital camera (Sony USA, New York, NY, USA) at every nurse visit. Image capture was standardized using a tripod frame to support the camera fixed perpendicularly to the ulcer. A circular self-adhesive label with a known area was placed close to the ulcer as a calibrator used by the software for area quantification. Digital images obtained were analyzed using Image J® software (National Institutes of Health, Bethesda, MD, USA). The software delineates the margin of each ulcer and uses different shades of color to define and calculate areas with different types of tissue.

The clinical appearance of the ulcers was assessed for different tissue types such as granulation, epithelialization, fibrin slough, and necrosis. The presence of a specific tissue type was confirmed if computerized planimetry showed a relative area >20% of the total ulcer area. The presence of exudate was confirmed by the appearance of moist gauze during dressing changes. The presence of odor was noted. The ulcer was classified according to the Wagner Grading System,25 which was used to establish DFU depth and presence of infection. Microbiological flora of the DFUs was identified using a biogram/antibiogram of a swab from the wound bed. A validated quantitative swab technique was performed to assess wound contamination and infection.26 A wound was considered infected if a high level of bacteria (1 × 106 CFU) and signs of increased erythema, exudate, odor, warmth, edema, and/or pain were present. Patients with infected wounds were treated with systemic antimicrobials; patients who had a fever and other complications from wound infections during the treatment were discontinued during the study.

Complete wound closure (ie, healing) was defined as full epithelialization of the ulcer with the absence of drainage. Patients were monitored biweekly by the study physician and trained nursing staff for 30 weeks or until healing. Healing was confirmed 1 week following closure, and the patient was monitored for another 2 weeks.

If a patient experienced an allergic reaction to the C. officinalis hydroglycolic extract, an evaluation by the principal investigator was conducted, and the patient was removed from the clinical test. 

Pain assessment. Pain was assessed in 2 ways. Patients were asked to complete the paper/pencil Neuropathic Pain Scale Questionnaire (NPSQ) on the first visit (baseline) and after completion of the 30-week treatment under the guidance of the nursing staff for evaluation and discrimination of neuropathic pain, according to the methodology described previously.23 Briefly, patients were rated for numbness (no numbness sensation = 0, worst numbness imaginable = 100), tingling pain (no tingling pain = 0, worst tingling pain imaginable = 100), and increased pain due to touch (no increase at all = 0, greatest increase imaginable = 100). The NPSQ scores for these symptoms were multiplied by its specific coefficients, summed, and then subtracted by a constant to obtain the discriminant function score (DFS). DFS <0 predicted no neuropathic pain, whereas DFS ≥0 indicated neuropathic pain.

For pain related to DFU dressing changes, patients were asked to rate their pain using a numerical rating scale (NRS) that ranged from no pain (0) to the worst possible pain (10).27 The NRS questionnaire was completed at baseline and then once a month during the nursing visits.

Statistical analysis. Descriptive and analytical data were collected and stored using a Microsoft Office Access 2010 database, drawn from documents used in medical evaluations and nursing. Data were analyzed by importing Access files to the database to the Statistical Package for Social Sciences (SPSS) version 20 (SPSS, Inc, Chicago, IL, USA). All data were verified by double key entry as entered and stored in the Access database. The Access database was stored in a computer with an Intel Core 2 Duo processor, 2.2 GHz, and 2G of RAM.

Quantitative variables were analyzed using descriptive statistics. Unless otherwise indicated, data are presented as mean ± standard deviation. Qualitative variables were described as frequencies and percentages.

To evaluate the association between gender and outcomes of healing at 30 weeks, Fisher’s exact test was used. The wound contraction per week (WCw) was calculated as the baseline wound area (Ai) − final wound area (Af) ÷ the number of weeks.28

owm_0316_buzzi_equation

The percentage reduction in wound area per week (%RWAw) was calculated as follows:

owm_0316_buzzi_equation2

To compare the groups defined by healing within 30 weeks, the quantitative variables were analyzed using Student’s t-test, and the nonparametric variables were analyzed using the Mann-Whitney U test. Time to complete ulcer healing was measured as the number of days from the start of treatment to the date a patient achieved complete wound closure. Wound healing was observed on a weekly basis, and the time until complete healing was estimated by calculating a cumulative frequency chart. P<0.05 was considered to be statistically significant.

 

Results

The participants’ flow through the study is presented in Figure 1. Of the 109 subjects enrolled, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled into the treatment phase, 43 withdrew before study completion. The main reasons for withdrawal were lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), violation of the protocol (5), and death (3). Three (3) patients died from complications due to diabetes (eg, DFU, acute myocardial infarction, kidney failure, and stroke). Forty-one (41) patients completed the trial and were included in the analysis.

Baseline characteristics. Patient demographics and ulcer characteristics at baseline and after the 30-week treatment are presented in Table 2. Of 41 patients treated with C. officinalis hydroglycolic extract, 17 (41%) were female and 24 (59%) were male. The average age of the patients was 62 (range 44–82) years. Laboratory clinical tests showed 35 (80.5%) were hyperglycemic with an average blood glucose level of 152.9 ± 76.01 mg/dL (range 82–395 mg/dL). Glycated hemoglobin was in the range of 6.4%. Serum albumin and hemoglobin levels at baseline of the patients who achieved total wound closure were 4.03 ± 0.49 g/dL and 12.9 ± 1.37 g/dL, respectively, which were not statistically different (P = 0.509, Student’s t-test) from those that did not achieve complete wound healing (albumin = 4.24 ± 0.32, hemoglobin = 12.7 ± 1.75 g/dL). medium_owm_0316_buzzi_table2

Most patients (34) exhibited Wagner type 1 ulcers (82.9%), which were generally located in the plantar, lateral face, and malleolus regions. All DFUs were characterized as chronic lesions because they were present an average of 71.1 ± 41.7 (range 17–156) weeks before the onset of this study. The baseline wound area was 8.68 ± 8.55 cm2 (range 1.2–43.1 cm2). The biogram/antibiogram tests from the swabs collected from the wound beds showed 31 (76%) of the ulcers were either colonized or infected. Twenty (20) DFUs (48.8%) showed high levels of bacteria ( >1 × 106 CFU) and were considered infected. The predominant clinical signs of the infected wounds were odor, exudate, erythema, and edema. Eleven (11) DFUs (26.8%) were colonized with low bacteria level and were not considered infected. Staphylococcus aureus was the predominant pathogen (11, 27%), followed by Pseudomonas sp. (4, 10%), Klebsiella sp. and Escherichia coli (3, 8% each). Of the 33 patients with colonized DFUs at the beginning of the study, 21 were treated with ciprofloxacin 500 mg twice daily for 30 days and 12 with gentamycin 80 mg intramuscularly once a day for 10 days. Two (2) patients did not satisfactorily respond to antibiotics, so they were excluded from the study.

Ulcer area reduction and healing rate. The time-course analysis indicated a linear increase in the proportion of patients achieving complete would closure after 11–30 weeks of treatment (see Figure 2). Thus, a minimum treatment period of 10 weeks was required for complete wound closure, and the average healing time was approximately 15.5 ± 6.7 weeks. After 11 weeks of treatment, 22 (54%) of the wounds were completely healed, with an average reduction in the wound area of 64% and noticeable improvements in the ulcer appearance from the baseline, including an increase in epithelialization and reduction of exudate, fibrin slough, necrosis, edema, erythema, and odor. After 20 weeks, 28 wounds (68%) were completely healed; after 30 weeks, 32 patients (78%) achieved complete healing and the remaining 9 (22%) achieved an overall reduction in the wound area of 75%. Figure 3 illustrates the process of diabetic ulcer healing in 3 patients treated with C. officinalis hydroglycolic extract. Photographs of patients’ DFUs showed complete epithelialization without apparent excess of anomalous tissue such as keloids and hypertrophic scars. owm_0316_buzzi_figure2

Patients were separated into complete DFU closure (coDFU group) and incomplete DFU closure (inDFU group) after 30 weeks of treatment. The inDFU group had mean baseline DFU areas (mean 10.28 ± 6.91 cm2; median: 8.43 cm2) similar to those of the coDFU group (mean 8.23 ± 9.02 cm2; median 5.72 cm2) (P = 0.105, Mann-Whitney U test) (see Table 3). In contrast, the wound contraction rate for the coDFU group was 3-fold higher (54.4 mm2/week; range, 5.2–168.7 mm2/week) than for the inDFU group (16.1 mm2/week; range 2.3–64.3 mm2/week) (Mann-Whitney U test; P = 0.001) (see Table 3). When the individual healing rates were corrected for baseline DFU area, the rates were nearly 6-fold higher in the coDFU group (7.75 ± 3.37%) than in the DFU group (1.38 ± 0.69%) (Mann-Whitney U test; P = 0.001). owm_0316_buzzi_figure3

Ulcer infection and inflammation. After 30 weeks of treatment with C. officinalis hydroglycolic extract, the total number of colonized DFUs significantly decreased from 29 (70.7%) to 5 (12.1%) (χ2 test; P = 0.012; see Table 2). C. officinalis extract was equally effective against all pathogens identified in the DFUs. Accordingly, the proportion of wounds presenting with unpleasant odor at baseline (19, 46.3%) was considerably lower after 2 weeks and ultimately decreased to1 (2.4%) after completion of the treatment. Ulcer bed planimetry data showed a significant reduction of exudate, fibrin slough, and necrotic tissue after the treatment with C. officinalis hydroglycolic extract (χ2 test; P = 0.001) (see Table 2). 

owm_0316_buzzi_table3

Pain assessment. Data from the NPSQ showed patients had a positive DFS for neuropathic pain of 0.543 ± 0.213 at baseline. All patients had a positive score for tingling pain, numbness, and increased pain due to touch. After 30 weeks of treatment, the average score for neuropathic pain was positive (0.552 ± 0.200) with no significant differences from the baseline score. The average patient pain score at baseline was 6.953 ± 2.160; at the end of 30 weeks of treatment, this was significantly reduced to 0.767 ± 0.477 (χ2 test; P = 0.001).

No adverse events with the C. officinalis hydroglycolic extract were observed during the treatment.

 

Discussion

C. officinalis hydroglycolic extract for the treatment of DFUs was assessed by having patients use it in their regular life at home with minimal influence from hospital/outpatient interventions. All patients received their first treatment in clinic then performed care at home. 

A systematic review of the literature4 that included 10 clinical trials on the performance of standard DFU treatments reported completely healed wounds in an average of 24% of patients at 12 weeks and in 30% of patients at 20 weeks; these data are used to benchmark DFU wound treatment therapies. The current study demonstrated 54% of DFUs were completely healed at 11 weeks and 68% at 20 weeks using C. officinalis extract. The average healing time to complete reepithelialization was approximately 16 weeks. At the study’s conclusion (30 weeks), 78% of all wounds had achieved complete closure. However, it should be noted that most studies utilized an intent-to-treat analysis method and the current study did not, which limits the ability to compare the results.

Several therapies are currently used to treat DFUs, including topical active solutions and ointments, silver, alginate- and cellulose-containing dressings, acellular protein dressings, autologous platelet-rich plasma, and bioengineered cell-based tissue grafts.29 Table 4 shows the percentage of healed DFUs in several previous prospective studies with different treatments.4,5,30-37 A direct comparison of the healing rates between the studies conducted with different therapies is not possible because of the differences in the demographics, comorbidities, wound complexities, study endpoints, and data analysis methods used. In general, prospective, randomized controlled and retrospective studies involving advanced therapies such as acellular protein dressings, autologous platelet-rich plasma, and bioengineered cell-based tissue grafts for treating DFUs achieve complete healing in 45% to 68% of wounds in 12 weeks29; however, with commonly used methods of care, this rate is roughly 30%.4 The average percentage of completely healed wounds in the present study is comparable to these other effective therapies.owm_0316_buzzi_table4

The anti-inflammatory and healing properties of C. officinalis are associated with a greater diversity of bioactives, specifically triterpene alcohols, triterpene oligoglycosides, monoesters, triterpenoids, and flavonoids.18–22,38–41 Chromatographic analysis from the dichloromethane fraction of C. officinalis flowers demonstrated 9 anti-inflammatory bioactive triterpenoids (ie, faradiol-3-O-palmitate, faradiol-3-O-myristate, faradiol-3-O-laurate, arnidiol-3-O-palmitate, arnidiol-3-O-myristate, arnidiol-3-O-laurate, calenduladiol-3-O-palmitate, calenduladiol-3-O-myristate, and calenduladiol-3-O-laurate) are commonly found in many varieties of Calendula flowers.19,20,41 The hydroglycolic extract of C. officinalis used in the present study was rich in these compounds.

Generating new blood vessels in the wound is an essential component of the wound healing process. Observational cohort studies42,43 of diabetic neuropathic foot ulcers indicated angiogenic activity may be insufficient for promoting expansion of new blood vessels into the wound site and restricting the entry of inflammatory cells and oxygen supply. The wound healing properties of C. officinalis may be associated with the activation of angiogenesis in the injured tissue. In addition to the known anti-inflammatory and antiseptic activity of the C. officinalis extract, the authors of the current study suggest the components present in C. officinalis extract, such as the monoesters triterpenoids, are able to stimulate vascular growth in DFUs through the release of angiogenic factors, particularly the vascular endothelial growth factor (VEGF), thus promoting granulation, tissue growth, and epithelialization. Although the presence and activity of VEGF in the wound bed through sampling and analysis of ulcer fluids and tissues was not possible in this study, evidence from animal studies44,45 supports angiogenesis is stimulated in the presence of C. officinalis extract: one study44 used aqueous extract from C. officinalis flowers to show an induction of vascularization in the chick chorioallantoic membrane and one study45 used C. officinalis extract to demonstrate accentuated angiogenic activity in both chicken chorioallantoic membranes and rat cutaneous wound models.

The importance of matrix metalloproteinases (MMPs) and tissue inhibitors of MMPs (TIMPs) to the integrity of the extracellular matrix (ECM), which tightly control its metabolism in the normal healing process, has been shown in cell culture study.46 These proteolytic enzymes have been shown in animal studies42 to act on ECM, enabling migration of cells into the wound site and penetration of new blood vessels, which results in the deposition of new ECMs and the formation of new tissue, facilitating reepithelialization and wound contraction. In diabetic ulcers, an excessive activity of MMPs on ECM and deficiency of TIMPs result in the destruction of new ECMs, which consequently always delays wound healing. In a preclinical study, C. officinalis extract was used to prevent ultraviolet irradiation-induced oxidative stress in rat skin and was observed to increase the activity and secretion of MMPs 2 and 9, which may be associated with procollagen synthesis, regulation of inflammatory responses, and rearrangement of damaged skin.47 Studies39,48 using cultures of human and mouse fibroblasts demonstrated extracts of C. officinalis stimulated fibroblast proliferation and cellular metabolism through an increase in mitochondrial dehydrogenase activity, suggesting that several compounds of C. officinalis, particularly monoesters and triterpenoids, possess synergistic action in the reepithelialization process. In the present study, the observed removal of necrotic tissue in favor of granulation tissue, significant reduction in bacterial counts, and rate of epithelialization suggest bioactive components of C. officinalis extract can stimulate the entire tissue repair process.

The observed reduction in unpleasant odor, edema, erythema, exudate, bacterial colonization, and necrotic tissue may be due to the anti-inflammatory and bacteriostatic properties of the C. officinalis extract. Extracts of C. officinalis have been shown in in vitro microbiology study49 to have bactericidal and fungicidal effects against microorganisms isolated from hospital patients. The extract used in the present study showed anti-inflammatory, antimicrobial, and wound healing properties, which corroborate with previous clinical and experimental studies using C. officinalis phytopreparations.49–52 The clinical benefits of C. officinalis hydroglycolic extract in healing DFUs may be due to its chemical constituents such as monoesters, triterpenoids, triterpene alcohols, triterpene oligoglycosides, and flavonoids, which may act synergistically to promote wound healing.

It also may be advantageous that C. officinalis hydroglycolic extract is an aqueous preparation that leaves no adherent solid residue on the wound bed. This facilitates the process of cleaning and dressing changes and minimizes friction and potential small trauma to the emergent granulation tissue. 

 

Limitations

This study was limited by the small number of patients meeting the inclusion/exclusion criteria, which prevented the adequate fractionation of subgroups with a more regular baseline wound size. The intent-to-treat method of analysis was unsuitable for this study because a large majority of dropouts and noncompliant events (n = 33) occurred in the early phase of the research (first 3 weeks), which may have drastically diluted the treatment effect observed over 30 weeks. However, not using the intent-to-treat analysis method increases the risk of overestimating the effect of treatment. 

 

Conclusion

In this patient population, the use of extract of C. officinalis hydroglycolic extract was associated with a high percentage (78%) of DFUs healed. Although not a direct comparison, the proportion of healed DFUs was 2 to 3 times higher than the reported benchmark for assessing topical treatments for DFUs. No adverse events occurred, and the percentage of wounds with an unpleasant wound odor and wound pain ratings were significantly reduced at the end of the treatment period. No adverse events occurred. A randomized, controlled trial with a greater number of patients is needed to confirm the clinical efficacy of C. officinalis extract for the treatment of DFUs. Although pain at baseline and final assessment was reported, it is not known whether reduced average pain scores were the result of treatment or from the wound being healed. 

 

Acknowledgments

The authors acknowledge Alvaro Quintas, MD from PUC-PR for his help on the project; Marcia Olandoski, PhD for the statistical analysis; and Luiz Carlos Pereira, MD, Ney Alencar, MD, and Sergio Tarlet, MD from the Department of Dermatology at the Hospital, Santa Casa de Misericórdia of Curitiba, for their expert dermatology advice. The authors also thank Maurício Centa, MD from Hospital São Lucas and the nurse team, especially Flavia Pontes, NA for helping with the patients.

 

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27. Hawker GA, Mian S, Kendzerska T, Franch M. Measures of adult pain. Arthritis Care Res. 2011;63(11 suppl):s240–s252.

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29. Richmond NA, Vivas AC, Kirsner RS. Topical and biologic therapies for diabetic foot ulcers. Med Clin North Am. 2013;97(5):883–898.

30. Reyzelman A, Crews RT, Moore JC, Mukker JS, Offutt S, Tallis A, et al. Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study. Int Wound J. 2009;6(3):196–208. 

31. Marston W, Hanft J, Norwood P, Pollak R. The efficacy and safety of dermagraft in improving the healing of chronic diabetic foot ulcers. Diabetes Care. 2003;26(6):1701–1705.

32. Wieman TJ, Smiell J, Yachin S. Efficacy and safely of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. Diabetes Care. 1998;21(5):822–827.

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35. Caravaggi C, De Giglio R, Pritelli C, Sommaria M, Dalla Noce S, Faglia E, et al. HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal. Diabetes Care. 2003;26(10):2853–2859.

36. Uccioli L, Giurato L, Ruotolo V, Ciavarella A, Grimaldi MS, Piaggesi A, et al. Two-step autologous grafting using HYAFF scaffolds in treating difficult diabetic foot ulcers: results of a multicenter, randomized controlled clinical trial with long-term follow-up. Int J Low Extrem Wounds. 2011;10(2):80–85.

37. Veves A, Sheehan P, Pham HT. A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. Arch Surg. 2002;137(7):822–827. 

38. Akihisa T, Yasukawa K, Oinuma H, Kasahara Y, Yamanouchi S, Takido M, et al. Triterpene alcohols from the flowers of compositae and their anti-inflammatory effects. Phytochemistry. 1996;43(6):1255–1260.

39. Matysik G, Wójciak-Kosior M, Paduch R. The influence of Calendulae officinalis flos extracts on cell cultures, and the chromatographic analysis of extracts. J Pharm Biomed Anal. 2005;38(2):285–292.

40. Yoshikawa M, Murakami T, Kishi A, Kageura T, Matsuda H. Medicinal flowers. III. Marigold. (1): hypoglycemic, gastric emptying inhibitory, and gastroprotective principles and new oleanane-type triterpene oligoglycosides, calendasaponins A, B, C, and D, from Egyptian Calendula officinalis. Chem Pharm Bull (Tokyo). 2001;49(7):863–870. 

41. Zitterl-Eglseer K, Reznicek G, Jurenitsch J, Novak J, Zitterl W, Franz C. Morphogenetic variability of faradiol monoesters in marigold Calendula officinalis L. Phytochem Anal. 2001;12(3):199–201.

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46. Armstrong DG, Jude EB. The role of matrix metalloproteinases in wound healing. J Am Podiatr Med Assoc. 2002;92(1):12–18.

47. Fonseca YM, Catini CD, Vicentini FTMC, Nomizo A, Gerlach RF, Fonseca MJV. Protective effect of Calendula officinalis extract against UVB-induced oxidative stress in skin: evaluation of reduced glutathione levels and matrix metalloproteinase secretion. J Ethnopharmacol. 2010;127(3):596–601.

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49. Efstratiou E, Hussain AI, Nigam PS, Moore JE, Ayub MA, Rao JR. Antimicrobial activity of Calendula officinalis petal extracts against fungi, as well as Gram-negative and Gram-positive clinical pathogens. Complement Ther Clin Pract. 2012;18(3):173–176. 

50. Babaee N, Moslemi D, Khalilpour M, Vejdani F, Moghadamnia Y, Bijani A, et al. Antioxidant capacity of Calendula officinalis flowers extract and prevention of radiation induced oropharyngeal mucositis in patients with head and neck cancers: a randomized controlled clinical study. Daru. 2013;21(1):18. 

51. Duran V, Matic M, Jovanovć M, Mimica N, Gajinov Z, Poljacki M, Boza P. Results of the clinical examination of an ointment with marigold (Calendula officinalis) extract in the treatment of venous leg ulcers. Int J Tissue React. 2005;27(3):101–106.

52. Lavagna SM, Secci D, Chimenti P, Bonsignore L, Ottaviani A, Bizzarri B. Efficacy of Hypericum and Calendula oils in the epithelial reconstruction of surgical wounds in childbirth with caesarean section. Farmaco. 2001;56(5-7):451–453.

 

Potential Conflicts of Interest: Franciele de Freitas, NP provided consultancy services to Phytoplenus Bioativos

 

Dr. Buzzi is Research Director, Proamplus Clinical Research Advisory LTD, Pinhais, Paraná, Brazil. Ms. de Freitas is a nurse practitioner, Phytoplenus Bioativos S.A., Pinhais, Paraná, Brazil. Dr. Winter is a physician affiliated with Hospital da Santa Casa de Misericórdia de Curitiba, Department of Dermatology, Curitiba, Paraná, Brazil. Please address correspondence to: Marcelo Buzzi, PhD, Proamplus Assessoria Clínica Ltd, Pinhais, Paraná; email: marcelo.buzzi@gmail.com.

Section: 

Salmonella Abscess of the Anterior Chest Wall in a Patient With Type 2 Diabetes and Poor Glycemic Control: A Case Report

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Ostomy Wound Management 2016;62(3):46–49
Hao-Yu Chiao, MD; Chi-Yu Wang, MD; and Chih-Hsin Wang, MD
Topics: 
Case Study
salmonella
chest wall
abscess
diabetes mellitus type 2

Abstract

Salmonella can cause extra-intestinal focal infections as well as gastrointestinal problems. A few cases of Salmonella skin and soft tissue infection have been documented in immunocompromised patients such as persons with type 2 diabetes and poor glycemic control.

A case study is presented of a 30-year-old man with a 10-year history of poorly controlled (HbA1C 11.7%) diabetes mellitus who presented with a ruptured nodule resulting in a wound with signs of infection over his anterior chest region of 1-month duration. He had been taking amoxycillin/clavulanate for the week previous to presentation at the authors’ facility. Following sharp debridement, the ulcerative wound deteriorated and a chest wall abscess developed. Bacterial culture results were positive for Salmonella group D, resistant to ampicillin and susceptible to ceftriaxone and ciprofloxacin. The patient underwent surgical debridement, resulting in a wound 7 cm x 4 cm, and was provided ceftriaxone 2.0 g intravenously daily along with insulin therapy. After surgical debridement, a local rotational flap was created for wound closure and reconstruction. The patient was discharged 1 week later on oral antibiotic therapy for 1 week. His wound was completely healed without recurrence at his 4-month follow-up. For this patient, addressing glycemic issues, identifying the infectious organism, and providing appropriate therapy, radical debridement, and flap surgery helped heal an advanced soft tissue infection. In immunocompromised patients with skin or soft tissue infections, the presence of Salmonella should be considered. 

 

Skin and soft tissue infections within the dermis and deeper skin tissues can be due to 1 or more pathogens and may include skin flora as well as organisms from adjacent mucous membranes. A retrospective study1 that analyzed the specimens of cutaneous or subcutaneous abscesses (N = 86) revealed Staphylococcus aureus monoinfection (either methicillin-susceptible or methicillin-resistant) occurred in up to 50% of cases; more than 96% of the pathogens were Staphylococcus and Streptococcus species. However, a comprehensive review2 of Salmonella infection found nontyphoid Salmonella (NTS) can cause not only self-limited acute gastrointestinal infections, but also bacteremia with or without extra-intestinal focal infections. These hardy bacteria are especially problematic in a wide variety of immunocompromised individuals, including patients with malignancy, human immunodeficiency virus, or diabetes and those receiving immunotherapy agents. A retrospective study3 found that among 129 NTS patients, 39.5% had extra-intestinal focal infections, including endovascular infection (14.7%), pneumonia (10.1%), osteomyelitis (5.4%), intra-abdominal abscess (5.5%), and soft tissue infection (0.8%). Extra-intestinal focal infections often require prolonged antimicrobial therapy and hospital stays. A review of in vitro and in vivo research4 analyzed impaired immune responses and increased susceptibility in patients with diabetes to specific infections. A case report of a Salmonella abscess in the anterior chest wall of a patient with type 2 diabetes and poor glycemic control is herein presented.

Case Report

Mr. D, a 30-year-old with a 10-year history of diabetes treated with 500 mg metformin twice a day, presented to the plastic and reconstructive surgery department of Tri-Service General Hospital (Taipei, Taiwan) with a painful nodule of 1 month’s duration over his anterior chest region. Two (2) weeks before his hospital admission, the nodule ruptured and the surrounding tissue revealed erythema and warmth. He received sharp debridement and bacterial culture for pathogen identification by a physician in the outpatient department. Oral antibiotics (amoxycillin/clavulanate) were prescribed for high suspicion of multispecies skin and soft tissue infections. One week later, culture of wound discharge revealed Salmonella group D resistant to ampicillin and susceptible to ceftriaxone and ciprofloxacin. The ulcerative wound continued to exhibit purulent discharge and tenderness. 

Mr. D was admitted to the authors’ plastic surgery department on December 31, 2013. He denied any recent diarrhea, vomiting, abdominal pain, or fever. His physical examination was unremarkable except for a 2-cm, ulcerative chest wound above the sternum about the fifth intercostal space that exhibited purulent discharge (see Figure 1a). Blood tests revealed elevated C-reactive protein (112 mg/L) and hyperglycemia (318 mg/dL). His glycosylated hemoglobin A1c (HbA1c) — a serologic marker for average glucose over a 2- to 3-month period — was 11.7% (16.0 mmoL/moL). Blood and stool cultures were negative for Salmonella. His chest x-ray revealed normal distribution without local infiltration. Ceftriaxone 2.0 g was administered intravenously daily for 10 days; the oral antidiabetic agent was discontinued and he was started on insulin therapy. The insulin dose was adjusted based on blood sugar pattern to reach optimal blood glucose control (premeal target of <140 mg/dL with all random glucoses <180 mg/dL). On hospital day 2, he underwent surgical debridement, which revealed abscess formation in the subcutaneous layer of approximately 7 cm x 4 cm below the ulcerative wound (see Figure 1b). After radical debridement, a wet dressing (wet aqueous betadine gauze without topical antibiotic ointment) was provided to keep the wound clean; it was changed twice a day. No pus was noted in the open wound. owm_0316_wang_figure1

Owing to the large and deep open wound defect over the anterior chest wall, negative pressure wound therapy for secondary intention healing was not indicated — Mr. D’s physician believed in the presence of a deep and wide wound, secondary intention requires a great deal of time for healing and a skin graft will cause scar contracture and limited mobility and not fulfill functional and cosmetic goals. A local flap for anterior chest wall wound reconstruction is known to be an accepted option. Therefore, 2 days post radical debridement, the authors performed rotational fasciocutaneous flap surgery for wound reconstruction (see Figure 2a). This type of rotation flap starts with an incision at the top of the circular defect. The length of the circular cut to create the flap depends on the degree of wound edge firmness (ie, laxity) of the donor site as determined subjectively by the surgeon. In this case, the flap was 3 times the area of the defect. The wound edge was undermined deep to the fascia layer to decrease tension for wound closure. After the rotation flap was applied, a Jackson-Pratt drain was placed until drainage was <10 mL/day; in Mr. D’s case, this occurred 1 week after surgery. owm_0316_wang_figure2

Mr. D was discharged 1 week after his surgery and antibiotic therapy was changed to oral ciprofloxacin for 1 week. His wound remained completely healed without local recurrence at his 4-month follow-up (see Figure 2b).

 

Discussion

Salmonellosis may present in different clinical forms, ranging from asymptomatic chronic carrier to gastroenteritis, bacteriemia, and extra-intestinal focal infections. In recent years, several retrospective studies3,5 reported NTS infection with extra-intestinal focal infections, such as urinary tract infection, endovascular infection, meningitis, osteomyelitis, pneumonia, and soft tissue infection. To the best of the authors’ knowledge, chest wall abscesses caused by NTS have been reported in the literature in only 7 patients between 1990 and 2014: 4 had no underlying disease, 2 had autoimmune deficiency syndrome (AIDS), and 1 had diabetes.6 A recent review of the clinical literature7 reported most extra-intestinal focal infections of NTS develop in patients with underlying diseases or predisposing conditions, such as malignancies, diabetes mellitus, immunosuppressive therapies, liver cirrhosis, renal insufficiency, or AIDS.

Poorly controlled type 2 diabetes mellitus is associated with major complications, such as cardiovascular disease, atherosclerosis, retinopathy, nephropathy, and neuropathy. Infections are also much more prevalent in individuals with diabetes; this increased susceptibility to infection has been attributed to neutrophil dysfunction, dehydration, malnutrition, vascular insufficiency, and neuropathy.4 A prospective, randomized study8 involving 245 patients has shown hyperglycemia interferes with wound healing in patients with ulcers and contributes to increased rates of infection. A retrospective study9 reported poor glycemic control also has been associated with increased rates of wound infection and other complications in patients after colectomy. The role of HbA1c has expanded in the diagnosis and treatment of diabetes. A retrospective study10 that analyzed a prospectively collected database of 79 patients reported postoperative blood glucose and preoperative HbA1c levels are associated with wound infection, wound dehiscence, and wound reoperation.

According to the practice guidelines for the diagnosis and management of skin and soft tissue infection from the Infectious Diseases Society of America,11 the first step in treating purulent skin and soft tissue infections is incision and drainage with wound culture, followed by empiric antibiotic therapy. For skin and soft tissue infections due to NTS, ciprofloxacin or ceftriaxone are reasonable options.3 The current case study suggested NTS should be considered as a possible cause of chest wall abscess in individuals with a history of diabetes under poor glycemic control. A high level of HbA1c indicated poor glycemic control before the acute wound developed. During hospitalization, the oral antidiabetic agent was discontinued in favor of insulin therapy. According to the consensus statement by the American Diabetes Association and the American Association of Clinical Endocrinologists10 and the clinical practice guideline of the Endocrine Society,12 the insulin dose should be adjusted based on blood sugar pattern to reach optimal blood glucose control (premeal target of <140 mg/dL with all random glucoses <180 mg/dL) and to reduce postoperative wound complications. The surgical options include incision and drainage, curettage, and debridement. The type of surgical procedure depends on the radiological findings, clinical presentation, severity of the infection, and intraoperative findings. In this case, early incision and drainage (ie, immediately upon noting redness and tenderness surrounding the wound and poor response to oral antibiotics; for Mr. D, this occurred 1 week after presentation), culturing the wound, and providing appropriate antibiotic therapy, wound care, and radical debridement proved to be an effective treatment option for a patient with an advanced soft tissue infection, type 2 diabetes mellitus, and poor glycemic control.

 

Conclusion

Successful wound reconstruction was achieved after surgical debridement, appropriate antibiotic therapy, and good glycemic control in a patient with an infected anterior chest wound. In immunocompromised patients such as persons with type 2 diabetes with poor glycemic control, clinicians should remain vigilant for the presence of Salmonella species as a cause of skin and soft tissue infections. Screening for HbA1c levels will elucidate the effectiveness of recent glycemic control. Oral antihyperglycemic drugs or insulin can be administered to obtain optimal blood glucose control. n

 

References 

1. Summanen PH, Talan DA, Strong C, et al. Bacteriology of skin and soft-tissue infections: comparison of infections in intravenous drug users and individuals with no history of intravenous drug use. Clin Infect Dis. 1995;20(2 suppl):S279–282.

2. Hohmann EL. Nontyphoidal salmonellosis. Clin Infect Dis. 2001;32(2):263–269.

3. Chen PL, Chang CM, Wu CJ, Lee CC, Wang RR, Ko WC. Extraintestinal focal infections in adults with nontyphoid Salmonella bacteraemia: predisposing factors and clinical outcome. J Intern Med. 2007;261(1):91–100.

4. Moutschen MP, Scheen AJ, Lefebvre PJ. Impaired immune responses in diabetes mellitus: analysis of the factors and mechanisms involved. Relevance to the increased susceptibility of diabetic patients to specific infections. Diabet Metab. 1992;18(3):187–201.

5. Rodríguez M, de Diego I, Martínez N, Rosario Rocicio M, Carmen Mendoza M. Nontyphoidal Salmonella causing focal infections in patients admitted at a Spanish general hospital during an 11-year period (1991–2001). Int J Med Microbiol. 2006;296(4-5):211–222. 

6. Tonziello G, Valentinotti R, Arbore E, Cassetti P, Luzzati R. Salmonella typhimurium abscess of the chest wall. Am J Case Rep. 2013;25(14):502–506.

7. Asseva G, Petrov P, Ivanova K, Kantardjiev T. Systemic and extra-intestinal forms of human infection due to nontyphoid salmonellae in Bulgaria, 2005–2010. Eur J Clin Microbiol Infect Dis. 2012;31(11):3217–3221. 

8. Marston WA, Dermagraft Diabetic Foot Ulcer Study Group. Risk factors associated with healing chronic diabetic foot ulcers: the importance of hyperglycemia. Ostomy Wound Manage. 2006;52(3):26–32.

9. Jackson RS, Amdur RL, White JC, Macsata RA. Hyperglycemia is associated with increased risk of morbidity and mortality after colectomy for cancer. J Am Coll Surg. 2012;214(1):68–80.

10. Endara M, Masden D, Goldstein J, Gondek S, Steinberg J, Attinger C. The role of chronic and perioperative glucose management in high-risk surgical closures: a case for tighter glycemic control. Plast Reconstr Surg. 2013;132(4):996–1004.

11. Stevens DL, Bisno AL, Chambers HF, Everett ED, Dellinger P, Goldstein EJ, et al; Infectious Disease Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005;41(10):1373–1406.

12. Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, et al; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists; American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009;32(6):1119–1131. 

 

Potential Conflicts of Interest: none disclosed 

 

Dr. Chiao and Dr. Chi-Yu Wang  are residents; and Dr. Chih-Hsin Wang is an attending physician, Plastic and Reconstructive Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. Please address correspondence to: Chih-Hsin Wang, National Defense Medical Center, 5F, No.161-15, Sec. 6, Minquan E. Rd., Neihu Dist, Taipei, Taiwan; email: super-derrick@yahoo.com.tw

Section: 

Using Noncontact Infrared Thermography for Long-term Monitoring of Foot Temperatures in a Patient with Diabetes Mellitus

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Ostomy Wound Management 2016;62(4):54–61
Erik Staffa, MSc; Vladan Bernard, PhD; Luboš Kubíček, MD; Robert Vlachovský, PhD; Daniel Vlk, PhD; Vojtěch Mornstein, PhD, Prof; and Robert Staffa, PhD, Prof
Topics: 
Case Study
diabetic foot
thermography
angioplasty
Pressure Ulcer

Abstract

Foot complications in persons with diabetes mellitus (DM) are associated with substantial costs and loss of quality of life. Increasing evidence suggests changes in skin temperature, measured using an infrared thermographic system (IRT), may be a predictor of foot ulcer development in patients with DM. The purpose of this case study is to describe the long-term IRT findings and overall clinical outcomes of a patient with DM and peripheral vascular disease.

Foot temperature measurements using IRT were obtained slightly more than 1 year before and immediately following endovascular treatment of a 76-year-old man, a nonsmoker with type 2 DM, hypertension, and ischemic heart disease with cardiac arrhythmia. Although he was otherwise asymptomatic, the infrared measurement showed an average temperature difference of 2.3˚ C between the left and right foot until he developed a small, trauma-induced wound on the left foot, at which time left foot temperature increased. He was diagnosed with rectosigmoid adenocarcinoma, underwent surgery and chemotherapy, and subsequently was evaluated for peripheral vascular disease. Before undergoing peripheral angiography and percutaneous transluminal angioplasty, IRT evaluation showed a hot spot on the left heel. Immediately following endovascular treatment, the mean temperature difference between the right and left foot was low (0.2˚ C), but a Stage I pressure ulcer was visible on the left heel. Skin breakdown in that area was observed 2 months later, and the wound continued to increase in size and depth. The patient died shortly thereafter due to complications of cancer. In this case study, a series of infrared images of foot skin temperatures appeared to show a relationship with blood circulation and wound/ulcer development and presentation. IRT has the ability to instantaneously measure the absolute temperature of the skin surface over a large area without direct skin contact. However, the devices are very sensitive and prospective clinical studies to determine the validity, reliability, sensitivity, and specificity of these measurements for routine use in patients who are at risk for vascular disease and/or foot ulcers are needed.  

 

 

Early diagnosis of disease complications associated with diabetes mellitus (DM) is the first prerequisite for saving the lower limb. According to an analysis by Al-Maskari and El-Sadig,1 which was part of a general cross-sectional survey conducted to assess the prevalence of DM, great attention must be paid to risk factors such as a diabetic neuropathy and diabetic angiopathy. Predictors of ulceration include the presence of peripheral neuropathy, peripheral vascular disease, and a history of ulceration.2 In a cross-sectional study, Pound et al3 showed ulcers often recur after a median duration of 126 days in 40% of patients with a history of ulceration. Other risk factors for diabetic foot ulcers are foot infection, foot deformity, high plantar pressures during walking, male gender, and HbA1c >9%.4-6 These factors are considered to be the leading causes of diabetic foot syndrome. 

Accurate diagnosis is the foundation of ulcer care. Patients with DM should be tested for neuropathy; in addition, proper vascular assessment is critical to the evaluation of the diabetic foot.7 A simple test to diagnose patients at risk for ulcer formation due to peripheral sensory neuropathy is the nylon monofilament test; an inability to detect the monofilament when applied under the metatarsal heads or digits is indicative of neuropathy.8 During vascular examination, the dorsalis pedis and posterior tibial pulses should be palpated, and a general inspection of the extremities should be performed. Noninvasive vascular tests include the ankle-brachial index, which is determined by dividing the higher systolic pressure of the anterior tibial or posterior tibial vessels by the highest systolic brachial pressure.9-11 

Skin temperature is one of the most reliable indicators of body and foot blood perfusion. The systematic analysis of the literature by Houghton et al12 suggests the use of skin temperature monitoring is an effective way to predict, and possibly prevent, diabetic foot ulceration. In their systematic review, Bharara et al13 compared various thermal measurement techniques in the assessment of the diabetic neuropathic foot and showed thermal measurement is a useful technique in the clinical management of the diabetic foot. In a descriptive review, Ring14 focused on the medical use of an infrared thermographic system (IRT) and its general relevance to DM as a useful tool in the assessment of tissue viability and peripheral circulation. Ring concluded IRT is especially suitable for serial measurements used in the follow-up of response to treatment. In a preliminary study, Brånemark et al15 used IRT to study 16 persons with DM with or without vascular complications, together with the action of a vasodilator. The authors showed characteristic abnormalities exhibited by the patients in the thermal patterns over the hands and feet that deviated from those of healthy subjects.

Recently, IRT has been widely used in DM-related diagnostics. In an observational study of 60 patients, Sivanandam et al16 applied IRT to measure skin temperature from the various body regions (ie, the contralateral regions of the inner canthus of the eye; tympanic region of the ear; and the forehead, neck, and upper and lower extremities) and noted the device can be used as a mass screening tool for the accurate estimation of HbA1c by which a sensitivity of 90% and negative predictive value of 85% could be achieved. Clinical studies regarding the role of IRT in the diagnostics of diabetic foot include Liu et al’s case study,17 which indicated dermal thermography can be a screening modality to detect presigns of ulceration in a timely manner. The pilot study by Van Netten et al18 examined 15 patients with DM and diffuse complications using IRT and demonstrated differences in mean temperature of >3˚ C between the ipsilateral and contralateral foot.

The clinical studies of Lavery et al19,20 have shown thermometry is a useful monitoring tool for preventing diabetic foot ulcers and amputations. In a physician-blinded, 18-month randomized controlled trial study, Armstrong et al21 monitored 225 persons with DM and found in patients who developed an ulcer, foot skin temperature was 4.8 times higher at the site of ulceration in the week before ulceration than the temperature of patients who did not develop an ulcer. In their physician-blinded, randomized, 15-month, multicenter trial, Lavery et al20 quantified data from 173 patients with a history of diabetic foot ulceration. An infrared skin thermometer was used by the enhanced therapy group of patients to measure temperatures on 6 foot sites each day. Temperature differences (>2.2˚ C) observed between left and right corresponding sites triggered patients to reduce activity until temperatures normalized. The enhanced therapy group had fewer foot ulcers than the standard therapy group without temperature monitoring.

According to the studies mentioned, thermal symmetry is normal in healthy study groups; temperature gradients between feet may predict the formation of ischemic changes. 

IRT, unlike many other imaging techniques used in medicine, is not an internal imaging system for anatomical information; infrared imaging provides information on skin temperature distribution. The great advantage of IRT is that it is both noncontact and noninvasive and a real-time temperature measurement. Any object at a temperature above absolute zero (ie, T >0 K) emits infrared radiation. By remote temperature sensing, the camera is merely receiving the natural thermal energy emitted by the body and transforming it into an electronic signal.22 In their critical review, Lahiri et al23 focused on the basics of medical IRT, the procedures adopted for various measurements, and successful applications of IRT diagnosis in various medical fields. However, IRT can provide only an image of skin temperature distribution; it does not provide data at a specific depth inside the body. 

The purpose of this case study is to describe the long-term IRT findings and overall clinical outcomes of a patient with DM and peripheral vascular disease. The patient was chosen due to his willingness to cooperate with the study duration. 

Case Report

Mr. D, a 76-year-old nonsmoker with DM type 2, hypertension, and ischemic heart disease with cardiac arrhythmia, was monitored several times at home over a period of 1 year (from March 2012 until February 2013) using IRT before he was examined in the outpatient vascular surgery department. Intervals of monitoring were based on the patient’s availability. He received no treatment on his lower limbs before the February 2013 examination. Mr. D had no visible defects on the foot; his only complaint was that his feet felt cold. During home visits, the soles and the forefoot were scanned by IRT. Thermograms were recorded with an FLIR B200 infrared camera (Flir Systems, Danderyd, Sweden). The thermal images obtained were processed using QuickReport 1.2 software (Flir Systems, Danderyd, Sweden). All images were standardized to the same temperature range (20˚ C – 35˚ C). Temperature measurement points were selected along a line connecting the first toe and the heel or from the square area as is shown in Figure 1. The mean temperatures along the line and from the area of interest were calculated by the software. The same value of emissivity (ie, the measure of an object’s ability to emit infrared energy, ε = 0.98) was used for all thermograms. Standard conditions in IRT imaging have been documented by Vollmer and Möllman24 and Ring and Ammer25; according to these conditions, the thermal images were captured at a distance of 1 m from the body region in a restricted, temperature-controlled environment. The thermal equilibration of the patient was 15 minutes. owm_0416_staffa_figure1

IRT home monitoring. The infrared images (see Figure 2) show a temperature map of the feet. The first and second IRT assessments were obtained in March and May 2012 (see Figure 2a,b). The highest mean temperature difference between the left and right foot was 2.3˚ C (see Table 1), but no difference was noted during the next assessment in October (see Figure 2c). At that time, a small wound was noted on the nail of the first left toe after the patient injured himself in September 2012. Figures 2a–f show a colder upper part of the left foot. Lower limb ischemic, vascular, or wound complications were not present during this period of time. The highest temperature difference between the right and left foot toes was 4.6˚ C (see Figure 2e and Table 2). In February 2013, the temperature of the left foot increased (see Figure 2f); specifically, the mean temperature in the square area on the heel was 25.3˚ C for the right foot and 29.2˚ C for the left foot.

owm_0416_staffa_table1owm_0416_staffa_figure2owm_0416_staffa_table2

Clinical examination, treatment, and follow-up. Mr. D was first examined in the outpatient department in February 2013 for an ischemic defect on the first left toe with a diameter of ~1-cm necrotic base and phlegmon around the defect. According to Mr. D, the defect had appeared 4 months earlier (October 2012) when he injured himself and gradually worsened. In December 2012, Mr. D underwent a rectosigmoid resection for adenocarcinoma (T3N1bM1, diagnosed in December 2012) with metastatic liver disease. Overall, he was in good condition, without claudication; he received chemotherapy treatment (5-fluorouracil and leucovorin; FU/FA de Gramont) (see Table 3).

owm_0416_staffa_table3

Left leg pulses were palpable in the groin on the superficial femoral artery (SFA) and on the popliteal artery (PA). Peripheral arteries were not palpable. An audible pulse was detected in the posterior tibial artery (PTA) by ultrasonic Doppler probe. The right leg dorsalis pedal artery (DPA) was palpable. CT angiographic examination warranted the need for peripheral angiography of the left limb and a percutaneous transluminal angioplasty was performed in April 2013. Specifically, CT angiography showed evidence of patent SFA with PA and significant atherosclerotic disease of the tibial arteries (eg, stenotic anterior tibial artery with closure of the middle part) to the farther PTA with distal closure. The middle of the peroneal artery was stenotic with distal closure (see Figure 3). The plantaris communis artery (PCA) and DAP were not noted in CT angiographic images — that is, the distal parts of the lower leg and foot were perfused only by minor collateral vessels, mostly dilated muscular branches forming a collateral pathway around both ankles (see Figure 4). A percutaneous transluminal angioplasty of the anterior tibial artery (ATA) and peroneal artery was performed (see Figure 5). The control angiography showed good results after endovascular treatment at the site of dilatation, with slightly better collateral supplied peripherals — the dilated branches from revascularized parts of tibial arteries supplying peripheral parts of tibial and foot vascular system showed a hint of efflux in the common plantar artery (see Figure 6). A palpable pulse was clinically detected on the SFA/PA at the time of hospital discharge. Audible flows in the PTA and the peroneal artery were detected by ultrasound Doppler probe; lower limb mobility and sensitivity were not compromised.

owm_0416_staffa_figure3owm_0416_staffa_figure4owm_0416_staffa_figure5owm_0416_staffa_figure6

One (1) month after the endovascular surgery, an extensive pseudo-aneurysm in the tibial area overlying the left ATA was detected by ultrasound duplex. This observation was confirmed by control CT angiographic examination (see Figure 7). An asymptomatic pseudo-aneurysm in this area is not a medical emergency requiring immediate surgery and due to the serious overall condition of the patient (cancer with metastases), conservative therapy was continued. owm_0416_staffa_figure7

Infrared images were taken before (see Figure 8a) and 1 day after revascularization (see Figure 8b). The mean temperatures of the right and left foot were 32.3˚ C and 32.1˚ C, respectively, before and 33.6˚ C and 33.2˚ C 1 day after the procedure (see Figure 8b). Thirteen (13) days following angioplasty, an area of warmth on the left foot heel was apparent (see Figure 8c). The highest temperature was 33.6˚ C on the left heel and 32.3˚ C on the right heel. The left heel hot point area affected the mean temperature, which was up to 0.6˚ C higher in the treated limb (see Table 4). At the time of discharge following endovascular treatment, the wound on the left foot toe was dry with a diameter of ~1 cm with no signs of active infection, and the wound base showed granulation tissue without any signs of wound widening. A discoloration of the skin was visible on the left foot heel, and intermittent pain occurred at rest. Local treatment of the wound on the left toe continued twice a week in the outpatient department. The condition of the wound gradually improved, its size decreased, and by May 2013 it was reduced to its original size. The wound was dry with no signs of suppuration or inflammation (aggressive infection, phlegmon). Although the toe wound was healing well, by the end of May/beginning of June 2013 a nonblanchable erythema pressure ulcer (Stage I) had developed on the left heel. Clinically palpable pulsation in the limbs remained unchanged after the initial treatment. owm_0416_staffa_figure8

Mr. D’s overall condition gradually deteriorated while he was being monitored due to the cancer. The condition of his limbs also worsened in July. The defect on the toe was small with no signs of active infection, granulation tissue was noted in the wound base, and there were no signs of increasing wound size, but the heel pressure ulcer became necrotic and was 6 cm in diameter. The ulcer on the heel was treated using moist wound therapy twice a week. During the treatment, necrotic tissue was removed. By September 2013, the lesion progressed to Stage II; it was 2 cm deep with no signs of infection or inflammation around the ulcer. 

Mr. D’s overall condition worsened in September and October 2013. He developed ascites and died at the end of October due to cancer-related complications (see Table 3). owm_0416_staffa_table4

 

Discussion

This is the first case study describing clinical outcomes and IRT scanning results over an extended period of time and provides observations that suggest a relationship among vascular supply, skin temperature changes, and the development of wounds. Before developing any symptoms, a mean temperature difference of 1.8˚ C between the left and right foot was detected at the first (March 2012) and second (May 2012) IRT assessments (see Figure 2a,b). According to the pilot study of van Netten et al18 and the randomized multicenter study of Lavery et al,20 a difference in temperature contralaterally of the feet of patients with diabetes often was observed. No temperature difference was observed for Mr. D in October 2012 (see Figure 2c). At that time, Mr. D had a small wound on the nail of the first left toe after he injured himself. A mean temperature difference between feet showed a gradual increase of 2.1˚C (see Figure 2e). During the last IRT measurement, the hot point area of heel on the left foot was observed with a mean temperature difference 4.7˚ C between the left and right heels (see Figure 2f). This increase in temperature could have been the first indicator of heel pressure; a heel pressure ulcer was diagnosed 2 months later (May 2013). Evidence from Gatt’s26 single-center, randomized, prospective study among 63 healthy adults suggests the normal temperature difference between plantar feet is no greater than 0.84˚ C. 

IRT may be a useful tool for monitoring skin temperature changes influenced by blood circulation. This point was observed before and after Mr. D’s endovascular treatment. Foot skin temperature was affected by revascularization. Despite the 15-minute acclimatization period of thermal equilibration of the foot, an increased temperature in both limbs was detected. This increase could have been affected by the fact the image was taken early in the morning, immediately after Mr. D awakened when more time for acclimatization might be necessary. The warmer bearing on the left heel was where the pressure ulcer formed.

 

Limitations of Thermography

IRT is a very sensitive device for measuring variations in heat patterns; however, thermograms can be influenced by many ambient factors, as proposed in the review by Fernández-Cuevas et al.27 Thus, thermography images should be obtained under controlled environmental conditions, per the observational study of Zaproudina et al.28 The recommended option is to report data from scanned images as a difference between affected and healthy contralateral anatomical structures to define the consistency of abnormality. 

Another important consideration of IRT measurement is the preparation of patients. Fifteen (15) minutes of acclimatization are needed for thermal equilibration of the patient, and the skin surface has to be dry and free of any artifacts (ie, topical ointments, solutions, bandages or dressings). Ignoring these factors has a negative impact on the evaluation of resulting infrared images, because these artifacts can affect the characteristics of the skin (ie, emissivity and reflexivity).29,30 Based on authors experience and Gatt et al’s study,26 a nonreflective plate can be placed behind the area of interest, which leads to better evaluation of the infrared images due to the patient´s temperature filtration in the background.

 

Conclusion

In this case study, infrared images of foot skin temperatures appeared to show a relationship between blood circulation and wound/ulcer presentation. IRT has the ability to instantaneously measure the absolute temperature of the skin surface over a large area without direct skin contact. In this and other studies, IRT has been found to reveal physiological changes before they are clinically apparent. The infrared images can be used to monitor temperature differences between the lower limbs of patients over a long time period and have the potential to be used as an indicator of vascular disease or predictor of foot ulcer formation. However, IRT devices are very sensitive, and prospective clinical studies to determine the validity, reliability, sensitivity, and specificity of these measurements for routine use in specific populations are needed. 

 

References

1. Al-Maskari F, El-Sadig M. Prevalence of risk factors for diabetic foot complications. BMC Family Pract. 2007;8(1):59.

2. Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation. Basis for prevention. Diabetes Care. 1990;13(5):513–521.

3. Pound N, Chipchase S, Treece K, Game F, Jeffcoate W. Ulcer-free survival following management of foot ulcers in diabetes. Diabetes Med. 2005;22(10):1306–1309.

4. Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Predictive value of foot pressure assessment as part of a population based diabetes disease management program. Diabetes Care. 2003;26(4):1069–1073.

5. Veves A, Murray HJ, Young MJ, Boulton AJ. The risk of foot ulceration in diabetic patients with high foot pressure: a prospective study. Diabetologia. 1992;35(7):660–663.

6. Lavery LA, Armstrong DG, Vela SA, Quebedeaux TL, Fleischli JG. Practical criteria for screening patients at high risk for diabetic foot ulceration. Arch Internal Med. 1998;158(2):157–162.

7. Wu SC, Driver VR, Wrobel JS, Armstrong DG. Foot ulcers in the diabetic patient, prevention and treatment. Vasc Health Risk Manage. 2007;3(1):65–76.

8. Armstrong DG, Lavery LA. Diabetic foot ulcers: prevention, diagnosis and classification. Am Family Phys. 1998;57(6):1325–1358.

9. Hiatt WR, Goldstone J, Smith SC, et al; American Heart Association Writing Group !. Atherosclerotic Peripheral Vascular Disease Symposium II Nomenclature for Vascular Diseases. Circulation. 2008;118(25):2826–2829.

10. Orchard TJ, Strandness DE Jr. Assessment of peripheral vascular disease in diabetes. Report and recommendation of an international workshop sponsored by the American Heart Association and the American Diabetes Association. Diabetes Care. 1993;16(8):1199–1209.

11. Kunimoto B, Cooling M, Gulliver W, Houghton P, Orsted H, Sibbald RG. Best practices for the prevention and treatment of venous leg ulcers. Ostomy Wound Manage. 2001;47(2):34–51.

12. Houghton VJ, Bower VM, Chant DC. Is an increase in skin temperature predictive of neuropathic foot ulceration in people with diabetes? A systematic review and meta-analysis. J Foot Ankle Res. 2013;6(1):31.

13. Bharara M, Cobb JE, Claremont DJ. Thermography and thermometry in the assessment of diabetic neuropathic foot: a case for furthering the role of thermal techniques. Int J Lower Extremity Wounds. 2006;5(4):250–260.

14. Ring F. Thermal imaging today and its relevance to diabetes. J Diabetes Sci Technol. 2010;4(4):857–862. 

15. Brånemark PI, Fagerberg SE, Langer L, Säve-Söderbergh J. Infrared thermography in diabetes mellitus. A preliminary study. Diabetologia. 1967;3(6):529–532.

16. Sivanandam S, Anburajan M, Venkatraman B, Menaka M, Sharath D. Estimation of blood glucose by non-invasive infrared thermography for diagnosis of type 2 diabetes: an alternative for blood sample extraction. Molecular  Cellular Endocrinol. 2013;367(12):57–63.

17. Liu C, Heijden F, Klein ME, van Baal JG, Bus SA, van Netten JJ. Infrared dermal thermography on diabetic feet soles to predict ulcerations: a case study. Presented at: the Conference of Advanced Biomedical and Clinical Diagnostic Systems XI. San Francisco, CA. January 2–7, 2013.

18. van Netten JJ, van Baal JG, Liu C, van der Heijden F, Bus SA. Infrared thermal imaging for automated detection of diabetic foot complications. J Diabetes Sci Technol. 2013;(7):1122–1129.

19. Lavery LA, Higgins KR, Lanctot DR, et al. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004;27(11):2642–2647.

20. Lavery LA, Higgins KR, Lanctot DR, et al. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007;30(1):14–20.

21. Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007;120(12):1042–1046.

22. Modest MF. Fundamentals of thermal radiation. In: Waltham MA (ed). Radiative Heat Transfer. Amsterdam, The Netherlands: Academic Press;2013.

23. Lahiri BB, Bagavathiappan S, Jayakumar T, Philip J. Medical applications of infrared thermography: a review. Infrared Phys Technol. 2012;55(4):221–235.

24. Vollmer M, Möllmann KP. Selected applications in other fields. In: Vollmer M, Möllmann KP. Infrared Thermal Imaging: Fundamentals, Research and Applications. Weinheim, Germany: John Wiley & Sons;2010.

25. Ring EFJ, Ammer K. The technique of infrared imaging in medicine. In: Ring EFJ, Ammer K. Infrared Imaging. A Casebook in Clinical Medicine. London, UK: IOP Publishing;2015.

26. Gatt A, Formosa C, Cassar K, et al. Thermographic patterns of the upper and lower limbs: baseline data. Int J Vasc Med. 2015; doi: 1155/2015/831369. 

27. Fernández-Cuevas I, Marins JCB, Lastras JA, et al. Classification of factors influencing the use of infrared thermography in humans: a review. Infrared Physics Technol. 2015;71(7):28–55.

28. Zaproudina N, Varmavuo V, Airaksinen O, Narhi M. Reproducibility of infrared thermography measurements in healthy individuals. Physiol Measure. 2008;29(4):515–524.

29. Bagavathiappan S, Saravanan T, Philip J, et al. Investigation of peripheral vascular disorders using thermal imaging. Br J Diabetes Vasc Dis. 2008;8(2):102–104.

30. Bernard V, Staffa E, Mornstein V, Bourek A. Infrared camera assessment of skin surface temperature — effect of emissivity. Physica Medica-European J Med Physics. 2013;29(6):583–591.

 

 

Potential Conflicts of Interest: This research was supported by a specific grant from Masaryk University, Brno, Czech Republic (MUNI/A/1449/2014 and MUNI/A/0894/2015). 

 

Mr. Erik Staffa is a researcher and specialist, and Dr. Bernard is assistant professor and researcher, Department of Biophysics, Faculty of Medicine, Masaryk University; Dr. Kubíček is an assistant and vascular surgeon, and Dr. Vlachovský is an assistant professor and vascular surgeon, 2nd Department of Surgery, St. Anne’s University Hospital, Faculty of Medicine; Dr. Vlk is assistant professor and researcher, and Dr. Mornstein is a professor and head of the department, Department of Biophysics, Faculty of Medicine; and Dr. Robert Staffa is a professor and head of the department, 2nd Department of Surgery, St. Anne’s University Hospital, Faculty of Medicine, Masaryk University, Brno, Czech Republic. Please address correspondence to: Erik Staffa, Department of Biophysics, Faculty of Medicine, Masaryk University, Kamenice 5, Brno, 62500 Czech Republic; email: staffa@mail.muni.cz.

Section: 

A Cross-sectional, Descriptive, Quality Improvement Project to Assess Undergraduate Nursing Students’ Clinical Exposure to Patients With Wounds in an Introductory Nursing Course

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Ostomy Wound Management 2016;62(4):20–29
Barbara Pieper, PhD, RN, CWOCN, ACNS-BC, FAAN; Mary Kathryn Keves-Foster, MSN, RN; JoAnn Ashare, MSN, RN, ACNS-BC; Mary Zugcic, MS, RN, ACNS-BC; Maha Albdour, RN, APHN-BC; and Dalia Alhasanat, BSN, RN
Topics: 
nursing education
Wounds
clinical skills
Dressings
Irrigation

Abstract

Because nurses frequently participate in decisions related to wound care, learning about wounds and their care during undergraduate education is critical. A cross-sectional, descriptive, quality improvement project was conducted in an introductory baccalaureate nursing course to identify: 1) the types of patients with wounds assigned to beginning students, 2) patient wound care procedures and dressings, and 3) student level of participation in wound care.

Data were collected from the weekly notes recorded about students’ (N = 49) patient care experiences in 3 acute care hospitals for 9 clinical days during 1 semester. Data were recorded on a paper-and-pencil form by instructors at the end of the clinical day and included type of wound, wound irrigation, dressing, technique of care, and student’s participation. Descriptive statistics were used to examine the frequency and distribution of the wound characteristics and care assessed. Of the 284 patients assigned to students, 75 (26.4%) had a wound. The most common wound was a surgical incision (49, 65%) and was closed (36, 73.5%). Twenty-six (26) patients had a pressure ulcer, most commonly Stage II. The most common dressing was dry gauze (29). Damp gauze was used on 18 wounds. Wound irrigation was recorded for 24 wound protocols and performed with a bulb syringe or by pouring the solution from a container. Generally, nonsterile wound care was performed. Twenty-five (25) students performed wound care with the instructor, 16 watched the care performed by another clinician, and 10 participated with another nurse in the wound care. For 22 patients, the wound care was neither observed nor performed because either it was not time for the dressing to be changed or it was only to be changed by a medical team. From these data, it was concluded beginning nursing students had some, but limited, clinical experience with patients with wounds. Students’ wound care experiences need further examination, especially across multiple educational courses. 

 

Individuals with wounds are an increasing concern in health care, and nurses typically participate in the interdisciplinary care of these patients. The Centers for Disease Control and Prevention1 identified 51.4 million inpatient surgical procedures performed in the United States each year; operative procedures may include an incision requiring care. In addition, 6.5 million patients in the US have chronic wounds.2 Patients with wounds also reside outside of a facility and are seen in outpatient clinics. The incidence and burden of wounds disproportionately afflict older adults and impose substantial morbidity and mortality on aging Americans.2,3 Besides the burden of illness, wounds and their care have a great impact on quality of life, socioeconomic living status, and the economics of health care, to name but a few considerations.3,4 

Wound management involves scientific-based knowledge as well as clinical experience.5 Receiving theoretical information and participating in the clinical care of patients with wounds are important in undergraduate nursing education. The Essentials for Baccalaureate Education for Professional Practice6 stresses the importance of learning safe care, knowledge, and skills. Education and the clinical experience of caring for patients with wounds may begin at a basic level in the student’s first clinical course. The purposes of this quality improvement project performed in an introductory baccalaureate nursing course were to identify: 1) the types of patients with wounds assigned to beginning students, 2) these patients’ wound care procedures and dressings, and 3) the students’ level of participation in wound care.

 

Literature Review

Nursing education and wound care. Undergraduate nursing education includes a broad array of theoretical and clinical topics. Faculty must make tough curricular decisions as to what is taught and what is left out.7 Nursing students generally obtain theoretical and clinical content about wounds in the classroom and through varied clinical placements. The clinical setting is the least controlled of the learning environments because of the patients’ changing health status.7 Thus, nursing students may see wound management performed by other practitioners, may not see it at all, or sometimes be allowed to perform wound care.7 The limited research regarding undergraduate nursing education in terms of wounds and their care is summarized to follow.

Huff8 conducted a quantitative, quasi-experimental nonrandomized study of undergraduate nursing students’ knowledge of wound care. She compared 65 undergraduate nursing students in their second year of a baccalaureate nursing program (intervention group) with 55 first-year nursing students in a 2-year community college program (control group). All students received basic instruction on wound care and read a chapter about wound care in their textbook. Huff used a 10-item questionnaire to measure wound care knowledge before and after an intervention. The intervention was a 2-hour lecture and clinical laboratory experience delivered by a wound care specialist. The students who received the intervention had significantly higher test scores compared to the control group; the knowledge persisted for 2 months. Huff concluded a modest increase in curricular time may help fill a void in wound care education.

Romero-Collado et al9 examined course content regarding chronic wounds in 114 centers in Spain that offered a nursing degree; 95 programs posted their course content online and were the basis for the analysis. No center offered a course dedicated to chronic wounds or presented content about wound pain and its management. The concept/content of pressure ulcer prevention was lacking in 60 of the centers; 36 centers did not mention pressure ulcer treatment. Twenty-one (21) centers included content on wound dressing selection. Only 4 courses in 4 centers presented content about care of the diabetic foot; in contrast, venous and arterial disorders of the lower extremities were presented in 55 centers. Only 1 course presented wound bed assessment. The study authors concluded course content related to chronic wounds was deficient and nursing degree programs need to guarantee the acquisition of minimum basic skills in the prevention and treatment of chronic wounds and thus reduce theory-practice gaps.

Ousey et al10 examined final year nursing students’ (N = 217) formal teaching about skin integrity during their clinical placement at 2 educational institutions in England. Students were invited to complete a questionnaire. A majority of all respondents (67.9%) reported receiving <10 hours of formal teaching on skin integrity across their 3-year nursing education at the university. Most (70.3%) participants stated the teaching had developed their knowledge and skills to maintain skin integrity for all patients. Formal teaching also occurred during clinical experiences. The authors concluded it was essential for mentors and clinical staff to understand the importance of actively contributing to nursing students’ learning about skin integrity.

Ribu et al11 explored home care nurses’ (n = 31) and nursing students’ (n = 30) knowledge of the treatment of patients with leg and foot ulcers in the community in Norway. The authors used a structured observation form. They did not compare nurses with nursing students or separate the care by the nurse’s educational level. They reported some patients (16/32) lacked an ulcer diagnosis; most (79.9%) of the patients had other chronic diseases. The authors observed 35 wound care treatments on 32 patients. The most common ulcers were venous (7), diabetes-related foot/leg ulcers (5), and mixed cause ulcers (4). Nurses performed poorly in several aspects of wound care: lack of clinical assessment of the wound, poor use of wound care protocols, lack of hand washing, poor pain management, and poor documentation. The authors concluded nurses in the community needed more education about wound care and more time to provide wound treatments and documentation.

Day et al12 presented a 2-hour session about basic wound management to mental health nursing students (N = 20) in England. Wound types included trauma, leg ulcers, pressure ulcers, burns, and melanoma. Students raised questions about dressing selection, application of dressings, and documentation. Mental health nursing students acknowledged a deficit in skill acquisition, especially wound care, within the practice setting related to a lack of physical resources, support, mentor time, and knowledge. The authors concluded mental health nursing students need to be exposed to clinical skill teaching preregistration; one of the key areas was wounds.

Ayello et al13 conducted a survey of nurses’ wound care knowledge through a questionnaire placed in 2 journals; 692 nurses from 48 states, 5 Canadian provinces, and 7 other countries returned the survey. Of the 23 survey questions and statements regarding wound care knowledge and practice, 1 question was about chronic wound education in basic nursing education programs. Only 30% of respondents believed they received sufficient education about chronic wounds in their basic nursing education program. Younger, less experienced nurses compared to older, more experienced nurses felt better about their level of wound care education. The authors concluded the difference between less and more experienced nurses may reflect improved education about wound care, forgetting what they learned, or not knowing what they do not know until they have some experience. Only 20% of nurses who work with the most vulnerable populations (ie, home care, long-term care/subacute care, and the like) believed they had received sufficient wound care education. When nurses were asked how comfortable they were about making recommendations to practitioners on appropriate wound dressings, the most common response was sometimes (41%).

Medical education and wound care. Collaboration among health care providers is a means to improve patient outcomes. Nurses work collaboratively with other clinicians in determining interventions for wound care; thus, they need to be cognizant of what other practitioners offer in terms of knowledge and skill. The lack of education in medical schools about wounds and their care has been identified. Patel and Granick4 examined the time devoted to physiology of tissue injury, physiology of wound healing, and clinical wound healing at 50 medical schools in the US. Data were obtained from the American Association of Medical Colleges database. The mean hours of education in physiology of tissue injury were 0.05 in year 1, 0.2 in year 2, and none in years 3 and 4. The mean hours of education about physiology of wound healing were 2.1 in year 1, 1.9 in year 2, and <1 hour in years 3 and 4. The clinical education about wound management was highest at 2.1 hours in year 2 compared to 0.4 hours in years 1 and 4. Total hours of wound education across the 3 topics (physiology of tissue injury, physiology of wound healing, and clinical wound healing) for 4 years were 9.2. The study authors concluded there was a lack of direct education about wound topics in American medical schools.4 

Fourie5 examined themes about wound management and treatment that medical professionals (N = 30) considered during their studies. The author interviewed 9 medical practitioners and had 21 others complete a questionnaire. During their training, 88% stated they received none to minimal formal wound management education. For specific wounds, 77% of participants were uncertain about what the best wound care treatment would be. Five themes were identified as challenges in wound management within their practice/setting: lack of resources (23%), uncertainty of what products to use and when (44%), patient factors of sepsis and complications (13%), poor continuity of nursing care and failure to follow instructions (15%), and lack of team work (5%). Most participants (75%) stated no formal policy was available on wound management best practice in their practice or institution. Most (97%) medical practitioners said wound care education was very important and more training should be provided about it.5

Summary. Theoretical knowledge about wounds and their care and clinical experience with patients with wounds are important components in undergraduate nursing education. Studies about wound care in nursing education are scant. Two (2) studies from the US8,13 and 4 from Europe9-12 examined wound care education in nursing, and 2 studies looked at wound care education in medicine.4,5 All studies identified deficiencies in wound care education. In the US, the number of individuals with wounds is increasing with the aging population and the number of persons with chronic health conditions. 

The literature lacks information about the exposure and experiences of students in an introductory baccalaureate nursing course to patients who have wounds. The current study authors had the following questions: 1) What types of patients with wounds are assigned to beginning students? 2) What wound care procedures and dressings are ordered for patients with wounds? 3) What experiences do students have providing wound care?

 

Methods

Design. A quality improvement project was conducted by a faculty team at an urban, research-intensive university using a cross-sectional, descriptive design. The data were collected from faculty’s notes about the students’ clinical experience during a Fundamentals of Nursing course presented in the Winter 2015 semester. The clinical component of the course was taught by 6 instructors who offered 8 clinical sections. One instructor of a clinical section did not participate; thus, data were collected from 5 instructors who supervised 7 clinical sections, each with 7 to 8 students. Students’ (N = 49) clinical placements were in 3 acute care hospitals, all of which were part of major health care systems. Two (2) surgical and 4 medical/surgical units were included. Excluding clinical orientation and final examination week, the clinical experience comprised 1 day a week for 9 weeks. Because the goal of the project was to examine the wound care experiences students were provided, a patient care experience was not eliminated if that patient had been cared for by more than 1 student. Hence, the data include 2 patients that were recorded twice.

In addition to the clinical experience, students had 3 lecture hours in the theoretical component of the course devoted to wounds (pressure ulcer prevention and treatment and the surgical incision as prototypes), wound treatment, and care products. The lecture content included many pictures of wounds, attributes of wound assessment, and wound care products. Content in the Skills Laboratory experience included 2 hours about sterile gloving and 3.5 hours about incision dressing change, drains, irrigating wounds, and packing wounds. The Skills Laboratory experience provided time to view and discuss videos and practice clinical skills on a manikin under the supervision of the clinical instructors. Although a Simulation Laboratory was available, in this course it was used to teach nasogastric-tube nutrition and oxygen therapy.

Procedure and instrument. Clinical instructors completed a form each time a student cared for a patient who had a wound. The form included the type of wound(s), presence/type of drains, wound irrigation and method, dressing type, wound care technique (sterile or not sterile), and whether the student performed the dressing change with the faculty or with a staff nurse, watched the nurse or another provider, or was not able to do the dressing change. The reasons for not performing the wound care included 1) it was not time to change the dressing or 2) the medical team wanted to do all dressing changes. The patient’s age, gender, and race also were recorded as part of the notes faculty kept about students’ clinical experiences. 

Because this was a quality project, not a human subjects research study, it was not necessary to request Institutional Review Board approval. The authors assessed a component of an internal educational program in terms of beginning nursing students’ exposure to patients with wounds in order to determine ways to enhance the students’ clinical experience. Knowledge sought directly benefitted the Fundamentals of Nursing course; by sharing this information with other persons involved in educational programs, other nursing programs may benefit. 

Data analysis. Descriptive statistics were used to examine the frequency and distribution of types of wounds and their care. Data were analyzed using SPSS (Chicago, IL).

 

Results

Patients with wounds. Forty-nine (49) students provided care to 284 patients, including 75 patients with wounds (26.4% of the students’ experiences). Among the patients with wounds, 49 (65.3%) were men, 50 (66.7%) were African American, and the mean age was 56 years (SD 18.25 years). The most common wound was a surgical incision (49, 65%) located on the abdomen (37, 75.5%) and closed (36, 73.5%) (see Table 1). Twenty-six (26) patients had a pressure ulcer, most commonly Stage II. The 7 patients with more than 1 wound had a surgical incision and a pressure ulcer. owm_0416_pieper_table1

Wound care procedures and dressings. Wound care procedures and dressings are described in Table 2. Nine (9) patients had no dressing listed. The most common dressing was dry gauze (29), which was used on closed surgical incisions. Moist gauze was used on 18 patients who had an open incision (10), pressure ulcer (7, Stage II, Stage IV, or nonstageable), or an abscess (1). Other products used for wound care were barrier ointment (8), foam (6), and gel (4). A drain was present in 25 patients (33.3%). Wound irrigation was recorded for 24 wound protocols and included bulb syringe (11) or pouring solution from a container (7). The most common solution was normal saline (20). Nonsterile dressing care was performed for 45 of the 59 of dressing changes. Clinical instructors allowed students to perform 14 dressing changes as sterile for the experience of handling sterile equipment. owm_0416_pieper_table2

Students’ participation in wound care. A clinical instructor observed 25 students perform wound care, 16 students watched the care being done by another health care provider, and 10 students participated with another nurse performing the wound care. For 22 patients, the wound care was neither observed nor performed either because it was too soon to change the dressing or the medical team requested to do all dressing changes. 

 

Discussion

This project examined introductory baccalaureate nursing students’ clinical experiences providing care to patients with wounds, the types of wounds, and wound care procedures and dressings. Across the total potential clinical days, 26.4% of the assigned patients had wounds. The most common wound categories were surgical incisions followed by pressure ulcers. Gauze, either moist (18) or dry (29), was the most common dressing used. Students had little experience with other dressing products. Students were limited, in part, in wound care experiences because the dressings were not scheduled to be changed or another practitioner had desired to do all wound care. Ousey et al10 stated clinical practice and teaching help facilitate wound care skill acquisition and knowledge about maintaining skin integrity. Romero-Collado et al9 noted nursing faculty need to design courses so students achieve essential clinical competencies along with theoretical knowledge. Knowledge gained in the theory portion of the students’ learning experiences should correlate with simulation and clinical practice. 

Although the number of wound care experiences appears low, these students were in their first clinical nursing course; thus, the data represent a starting point with regard to wound care. In addition, faculty who teach introductory nursing are challenged to give students varied and numerous clinical skill experiences in order to meet multiple objectives in varied content areas (ie, hygiene, transfer and ambulation, nutrition, urinary and fecal elimination, to name a few). A patient who has a wound may not be assigned to a student because of other learning requirements. Selecting clinical experiences means balancing types of patients available with experiences that students need. In an exploratory qualitative study, Haraldseid et al14 (N = 19) explored student perceptions of their learning environment in a clinical skills laboratory via a focus group. They found creating an authentic environment, facilitating motivation, and providing methods of skill training in the clinical skills laboratory are important because the mastery of clinical skills may be limited due to lack of opportunities for varied skills in clinical practice. 

The role, nature, and timing of clinical skills teaching is a global issue.15 Ousey et al10 reported that over the 3 years of university education students generally spend <10 hours of formal instructional time on skin integrity, yet 56% of respondents reported they had sufficient exposure to wound care. This is similar to medical school curriculum where the total number of hours of direct wound education across 4 years was 9.2 hours.4 This is in contrast to Haraldseid et al’s14 research that found skills acquisition is a complex process of incorporating practical performance with knowledge and critical thinking.14

Surgical incisions are a common occurrence in acute care. Although these wounds were generally closed (73.5%) and covered with dry gauze, they provided learning for beginning student in terms of postoperative wound assessment for healing and infection as well as patient mobility, nutrition, and preparation and teaching for discharge. Twenty-six (26) patients had pressure ulcers; 2 also had a surgical incision. 

Patients with complex chronic wounds such as venous ulcers and diabetic neuropathic foot ulcers were seen infrequently by these students. Chronic wounds are most commonly treated in the community.2,16 In addition, students receive theoretical content about complex wounds in advanced courses and would lack an understanding of these conditions in an introductory nursing course. Nursing wound care education should occur sequentially across all academic years and in many clinical settings.

Sometimes nursing students observed wound care that did not align with current best practice. Wound irrigation or wound cleansing was performed with a bulb syringe or pouring the solution from a container. In contrast, the recommended method uses normal saline administered with a 19-guage angiocatheter and a 35-mL syringe to deliver 4 to 15 psi of pressure to remove debris without harming healthy tissue; bulb syringes do not provide enough pressure.17 The most common primary dressing used was gauze. Although dry gauze dressings may have been correctly used on closed surgical incisions or moist gauze applied over an open area, issues with the frequency of dressing changes, patient comfort, infection, and lower healing rates were possible.17 Nurses need knowledge about varied dressings, not just gauze, in terms of dressing properties, use, frequency of change, and evaluation. Very few students in this project saw “modern” longer-wear dressings such as foam, hydrocolloid, and alginate. Because these products decrease the occurrence of dressing changes, students may not have participated in their removal and re-application as part of the wound care experience. These products should be discussed in terms of their use in the clinical setting. By comparison, physicians often stated receiving little information about wound care treatment during their medical education; as such, their lack of knowledge of wound products and how to manage wound care correctly were concerns.5 

 

Clinical Implications

To enhance students’ learning about wound care, education on wound assessment and treatment should begin in the students’ introductory clinical course. This allows the student time to obtain clinical experience with patients with wounds across all courses. When a student is assigned a patient with a wound, the clinical instructor should consider multiple areas of critical thinking, including wound assessment, type of dressing, dressing selection, protocol for changing the dressing, pain, nutrition, and long-term care. In addition to teaching sterile technique, nursing programs should consider protocols for teaching nonsterile dressing change. Clinical instructors need to continuously examine the clinical units used for education and decide what settings provide experiences that meet the objectives of the course. Clinical instructors should be aware of what is current in wound care. This may facilitate discussion with staff nurses in terms of the appropriate use of varied dressings and wound care procedures. 

Knowledge about wounds and their care has undergone significant changes and these changes need to be reflected in undergraduate curricula.7 Romero-Collado et al9 noted the need to address theory-practice gaps; courses must be designed to achieve essential competencies along with knowledge of theory. Educational programs should combine textbook content with a variety of learning methods, including hands-on experiences.

Houghton et al’s18 qualitative, multiple case study reported clinical skills laboratories can provide a pathway to practice; they can be realistic and authentic. Qualitative, descriptive design, clinical skills laboratories can be a bridge between theoretical content and practice.19 The current authors support the availability of varied dressing supplies for students to see and use in the Skills Laboratory or Simulation Laboratory. According to Hope et al,20 simulation learning encouraged active transition of theory to practice, was a safe environment, and provided confidence.20 During all types of experience, students should be encouraged to link theoretical content about wound assessment and dressing selection to the experience. Photographs also may be used for teaching; for example, in a questionnaire study,21 burn photographs were rated as useful for teaching patient management and improving patient care.21

 

Limitations

The project had limitations. It represents data collected during 1 semester in an introductory clinical nursing course. Students were not followed sequentially throughout their other nursing courses. Faculty who provided wound care information did so voluntarily. The types of experiences were dependent upon the unit/hospital; for example, some surgical settings delayed dressing changes for 48 hours or required dressing changes be performed by the surgical team. These data did not identify the number of patients with wounds each student had or how many students had no opportunity to provide wound care during the semester. Possibly having students keep a list of their experiences will help identify clinical learning needs during their progression throughout the program. 

 

Conclusion

Nursing students in an introductory nursing class received basic clinical experiences with patients with wounds. The wounds they saw were the most common ones in acute care — that is, surgical incisions and pressure ulcers. The use of a variety of wound care products by classification was limited, but students were provided information about them in the theoretical component of the course. Clinicians should understand the function of dressings and treatment modalities and where and how to apply them.5 Wound education should occur across the curriculum. Wound management and treatment is vested in the knowledge, skill, and understanding of providers about the complexity of wound healing.5 

 

References

1. Centers for Disease Control and Prevention. Inpatient surgery. Available at: www.cdc.gov/nchs/fastats/inpatient-surgery.htm. Accessed May 12, 2015.

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

3. Gould L, Abadir P, Brem H, et al. Chronic wound repair and healing in older adults: current status and future research. Wound Repair Regen. 2015;23(1):1–13.

4. Patel NP, Granick MS. Wound education: American medical students are inadequately trained in wound care. Ann Plast Surg. 2007;59(1):53–55.

5. Fourie A. The inadequacy of wound management training for medical practice. Wound Healing Southern Africa. 2013;6(1):21–24.

6. American Associations of Colleges of Nursing. The Essentials of Baccalaureate Education for Professional Practice. Washington, DC: American Associations of Colleges of Nursing;2008:30–33.

7. Madsen W, Reid-Searl K. Overcoming tradition: teaching wound management into the twenty-first century. Collegian. 2007;14(4):7–10.

8. Huff JM. Adequacy of wound education in undergraduate nursing curriculum. J Wound Ostomy Continence Nurs. 2011;38(2):160–164.

9. Romero-Collado A, Raurell-Torreda M, Zabaleta-del-Olmo E, Horns-Romero E, Bertran-Noguer C. Course content related to chronic wounds in nursing degree programs in Spain. J Nurs Scholarsh. 2015;47(1):51–61.

10. Ousey K, Stephenson J, Cook L, Kinsey L, Batt S. Final year student nurses’ experiences of wound care: an evaluation. Wound Care. 2013;2013:S7–S16.

11. Ribu E, Haram R, Rustoen T. Observations of nurses’ treatment of leg and foot ulcers in community health care. J Wound Ostomy Continence Nurs. 2003;30(6):342–350.

12. Day J, Moriarty A, Tremayne P. Addressing a deficit: wound care and mental health nursing. Br J Nurs. 2007;16(3 suppl):S32–S37.

13. Ayello EA, Baranoski S, Salati DS. A survey of nurses’ wound care knowledge. Adv Skin Wound Care. 2005;18:268–275.

14. Haraldseid C, Friberg F, Aase K. Nursing students’ perceptions of factors influencing their learning environment in a clinical skills laboratory: a qualitative study. Nurse Edu Today. 2015;doi: 10.1016/j.nedt.2015.03.015.

15. Borneuf A-M, Haigh C. The who and where of clinical skill teaching: a review from the UK perspective. Nurse Ed Today. 2010;30(2010):197–201.

16. Wellborn J, Moceri JT. The lived experience of persons with chronic venous insufficiency and lower extremity ulcers. J Wound Ostomy Continence Nurs. 2014;41(2):122–126.

17. Rolstad BS, Bryant RA, Nix DP. Topical management. In: Bryant RA, Nix DP (eds). Acute & Chronic Wounds Current Management Concepts. St. Louis, MO: Elsevier Mosby;2012:289–306.

18. Houghton CE, Casey D, Shaw D, Murphy K. Staff and students’ perceptions and experiences of teaching and assessment in Clinical Skills Laboratories: Interview findings from a multiple case study. Nurse Ed Today. 2012;32(2012):e29–e34.

19. Ewertsson M, Allvin R, Holmstrom IK, Blomberg K. Walking the bridge: nursing students’ learning in clinical skill laboratories. Nurse Ed Pract. 2015; doi: 10.1016/j.nepr.2015.03.006.

20. Hope A, Garside J, Prescott S. Rethinking theory and practice: pre-registration student nurse experiences of simulation teaching and learning in the acquisition of clinical skills in preparation for practice. Nurse Ed Today. 2011;31(2011):711–715.

21. Nelson L, Boyle M, Taggart S, Watson S. Are burn photographs useful? Burns. 2006;32(2006):876–879.

 
 

Dr. Pieper is a Professor/Nurse Practitioner; Ms. Keves-Foster, Ms. Ashare, and Ms. Zugcic are clinical instructors; and Ms. Albdour and Ms. Alhasanat are teaching assistants, College of Nursing, Wayne State University, Detroit, MI. Please address correspondence to: Barbara Pieper, PhD, RN, CWOCN, ACNS-BC, FAAN, 1356 Yorkshire, Grosse Point, MI  48202; email: bapieper@comcast.net.

 

Potential Conflicts of Interest: none disclosed 

Section: 

A Quasi-experimental Study to Assess an Interactive Educational Intervention on Nurses’ Knowledge of Pressure Ulcer Prevention in Nigeria

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Ostomy Wound Management 2016;62(4):30–40
Rose Ekama Ilesanmi, RN, PhD, IIWCC (Stellenbosch); and Odunayo Morohunfoluwa Oluwatosin, Professor
Topics: 
comparative study
education
nursing
professional competence
pressure ulcers

Abstract

Educational intervention programs are an important element to improve nurses’ knowledge of pressure ulcer (PU) prevention. Various teaching methods have been used with diverse results but none have been analyzed in Nigeria. A quasi-experimental study using a pretest/post test design was conducted among 193 registered nurses with >6 months experience who worked in purposefully selected wards (neuroscience, orthopedics, renal, and cardiac) in 3 teaching hospitals to examine the level of knowledge retention after interactive instruction.

Participants were randomized to intervention (IG, n = 127 from 2 hospitals) and control (CG, n = 66 from 1 hospital) groups; the IG was provided a 5-day, face-to-face interactive lecture, and the CG engaged in a 1-day, 4-hour discussion of PU prevention practices. The Pressure Ulcer Knowledge Tool, a 47-item questionnaire in which a correct answer = 1 point and an incorrect/“I don’t know” answer = 0 (maximum score 47), was used to assess and compare knowledge retention at 3 time points: baseline (T1), immediately after instruction (T2), and after 3 months (T3). Three trained research assistants assisted with registration of participants and distribution and collection of the questionnaires. All questionnaires were retrieved at T1 before the intervention began. Respondents were encouraged to respond to all questions. Data were analyzed using t-test and ANOVA (P = 0.05). At T1, knowledge scores were comparable between the IG and CG (32.5 ± 4.2 and 30.8  ± 5.0 for IG and CG, respectively). At T2, knowledge scores increased significantly only in the IG to 40.7 ± 3.4 (d = 1.94, P<0.05). The mean difference between T1 and T2 was  -8.2 ± 5.4, t = -17.0, P = 0.000. Similarly, mean scores increased significantly from T2 to T3 in the IG (mean= -2.0 ± 5.5, t = -4.1, P = 0.000); scores in the CG were -6.2 ± 7.2, t = -6.3 (P = 0.000). A face-to-face interactive lecture was shown to be an effective method of program delivery for nurses; other educational methods should be assessed and their effects on PU prevention practices and outcomes evaluated.  

 

Pressure ulcers (PUs) are a significant threat to the safety of patients and have a major negative impact on patients, their families, and the health care system.1,2 Findings from a cross-sectional observational study1 conducted among 2,000 patients in a tertiary care hospital in Australia confirm PUs were responsible for prolonged hospital stay and increased economic cost. According to a systematic review and meta-synthesis,3 PUs have a substantial impact on health-related quality of life among older patients. A prevalence study by Mclnerney4 showed the risk of mortality is 2 to 6 times greater in patients with PUs as opposed to persons without PUs.3,4 The negative effects may be even greater in the poorer nations of the world, particularly among patients with spinal cord injury. According to Zakrasek et al’s review of the literature5 on risk factors and cost of PU in low- and middle-income countries, the prevalence of PUs is high and comes with increasing complications.  

Various strategies regarding education and training for nurses have been shown to be factors in PU prevention.6-8 For example, Tweed and Tweed6 conducted an educational intervention study among critical care nurses (N = 62) and reported an increase in knowledge for PU prevention post intervention. Using a pretest/post test design, Cox et al7 compared the effectiveness of 2 methods of instruction on PU prevention among critical care and medical surgical nurses and found knowledge retention can be maintained by a quarterly educational program. These educational programs have produced good outcomes, such as reduced PU incidence,6,9 effective risk assessment, successful  planning, and implementation of interventions.10-12 

Despite these findings, evidence from the literature suggests nurses’ level of PU knowledge is not yet optimal.13,14 For example, although a systematic review13 of the effectiveness of educational programs in promoting knowledge among nurses for PU prevention showed educational programs have positive effects on nurses’ knowledge of PU prevention, similar reports of descriptive studies15,16 in Nigeria suggested inadequate knowledge of PU prevention among nurses in Nigeria. Such reports point to a need for repeated education and training as new information on PUs emerges for Nigerian nurses. 

 

Literature Review

The joint international organization for PUs17 asserts a number of contributing or confounding factors, yet to be fully elucidated, are associated with PU development, underscoring a need for consistent attention to issues regarding PUs. Patient quality care and safety organizations have focused on PU prevention issues. For example, the American Nurses Association Quality Forum18 recognized PUs as largely preventable, nursing-sensitive adverse events. The Joint Commission on Accreditation of Healthcare Organization19 included PU prevention as one of the National Patient Safety Goals. The strong position on PU prevention taken by these organizations commends programs that provide PU updates for nurses because nurses play significant roles in PU prevention. Quasi-experimental, pretest/post test and descriptive studies20,21 confirm that inadequate knowledge and skills for PU prevention among nurses working in acute care facilities can significantly influence PU rates13 and patients’ clinical outcomes. This is evident in Nigeria, where hospital-based surveys22-25 reported increased PU incidence rates are attributed partly to inadequate knowledge of evidence-based preventive interventions among care providers, particularly nurses. This conclusion was corroborated by other authors,15,16 who reported knowledge about PU prevention among nurses was less than optimal. 

Continuing education is vital to consistent, safe, and effective care delivery and also a prerequisite for reconfirmation of practice licenses in most countries.26,27 Specifically, continuing education comprises activities that increase the knowledge of workers toward improved performance.28 Different strategies including face-to-face lectures are employed in continuing education programs. Traditional lectures are typically teacher-focused, one-way communication, which leaves the learners inactive and passive.29,30 According to quasi-experimental studies involving nurses,28,31,32 the duration of knowledge retention by learners participating in the lecture method is short, usually no longer than 8 weeks, even with the use of PowerPoint® delivery. Based on this limitation, educational experts33 suggest integrating diverse or blended methods in any one teaching session for better outcomes.

Teaching theories. Adult, professional learners such as nurses would benefit from blended strategies, because these learners are self-directed and need to have control over their learning needs.34 Nursing professionals need to incorporate learning into their busy schedules to effectively  understand and be current with increasing research evidence in health care, which also drives health care improvements. Some descriptive studies35,36 involving medical students suggest when professionals are engaged in learning, they reflect on previous experiences to bring meaning to the new knowledge, enhancing the learning experience. To facilitate reflection and better understanding of new knowledge, particular delivery strategies should be incorporated into a professional continuing education program. According to Sandars’37 review on the concept of reflection,37 reflection is a metacognitive process that creates better understanding of both the self and the situation to inform future actions. As such, reflection is a major component of life-long learning and believed to improve professional competence. Experience is significant in professional learning, but it is not a stand-alone phenomenon. Drawing from Kolb’s38 theory of experiential learning, experience must be integrated into an existing knowledge structure to become new and expanded knowledge. This process requires the skill of reflection for a higher level of personal learning, such as when an individual learns about the side effects of a drug by observing reactions (experience) from a patient on the drug or when the clinician becomes more adept at a clinical skill after an experience demonstrating ineffective application of the skill. 

Interactive lecture is a form of inquiry learning that allows active learner participation and reduces the monotony of passive learning that occurs with the traditional lecture.39 Interactive lecture is implemented using methods such as brainstorming, small group discussion, role play, and simulations,40 enhancing student engagement with their course materials. Interactive lectures also may take the form of questioning the audience or using engagement triggers to stimulate interest and arouse the learner’s attention and serve as ice breakers.41 In his review of the literature describing the indicators of interactive learning, Steinert and Snell41 noted active participation of learners is a prerequisite for learning beyond the recall of facts. On a broader perspective, Lee42 acknowledged interactive learning  encompasses every method except traditional lecture. The effectiveness of the interactive mode of learning has been well documented as a preferred method to the traditional lecture. However, to the best of the authors’ knowledge, its effectiveness in delivering PU prevention education in Nigeria has not been documented. 

The aim of this study was to examine the effectiveness of a face-to-face, interactive lecture approach to education on knowledge retention among nurses in selected teaching hospitals in southwest Nigeria.

Four (4) research questions were raised: 

1. What is the knowledge of PU prevention strategies of the intervention and control groups at baseline?

2. What is the effect of interactive lecture on post test knowledge score in intervention and control groups?

3. What is the difference in post test scores immediately (T2) and 3 months (T3) post intervention in the intervention group?

4. What is the effect of selected demographic characteristics (years of experience, professional cadre based on profession, previous exposure to PU lecture) on knowledge score in the 2 groups before and after educational intervention?

 

Methods and Procedures 

The study adopted a nonequivalent control group, pretest/post test design and was conducted in 3 selected teaching hospitals in 3 (Oyo, Osun, and Lagos) of the 6 states in the southwest geopolitical zone in Nigeria. The hospitals included the University College Hospital (UCH) and Lagos State University Teaching Hospital (LASUTH), Ibadan; and Obafemi Awolowo University Teaching Hospital Complex (OAUTHC), Ile Ife. The hospitals were under 2 main clusters based on proprietorship: state government-owned and federal government-owned, publicly funded institutions. All of  the hospitals are large tertiary institutions, with a minimum of 300 beds each. Ethical approval was sought and obtained from the Health Research and Ethics Boards of each institution. 

A purposive sampling of the hospital was conducted based on inclusion criterion of providing care for patients with complex health problems. Balloting was done to determine which hospitals served as intervention and control groups. The intervention group (IG) included nurses from LASUTH and UCH, and the control group (CG) included nurses from OAUTHC. To limit inadvertent influence of treatment condition on the CG, the IG was completely separate from the CG. 

Participating wards also were selected purposively to reflect patients with health problems that would likely place them at risk for PUs; as such, all nurses from the surgical (orthopedics), medical, and neurological wards (except nurses on vacation) were invited to participate. 

Testing instrument. The Pressure Ulcer Knowledge Test (PUKT)43 was used to assess knowledge and information acquisition at the 3 testing time points. The tool is composed of 47 items that measure respondents’ knowledge of risk factors, preventive strategies, and PU staging. Correct Yes/No responses are scored 1 and incorrect responses of Yes, No, or I don’t know are scored 0. The maximum score is 47 (100%).  

The PUKT has been used in other countries9,44 with reported good reliability levels. A pilot survey was conducted in a different state teaching hospital (Ogun state) among 111 nurses 6 months before the main study to examine the feasibility of the study and to test the reliability of the testing tool.16 Findings from the pilot study led to the revision and rewording of some items in the instrument for clarity and in relation to the care environment. For example, in the local hospital, nurses use water-filled gloves to elevate the heels. Therefore, the item in  the original document that reads Heel protectors relieve pressure on the heels  was reworded to read A heel protector such as water-filled glove effectively relieves pressure on the heels. In addition, the item that relates to the appointment of a governmental panel to study PU risk, prevention, and treatment were removed because it was not applicable to Nigeria. This was the first time the PUKT was validated in Nigeria. The reliability coefficient was found to be 0.82. 

General procedure. In each setting, with the support of the Director of Nursing services, the pretest (paper-and-pencil PUKT) was administered to all participants at the same time. This was to ensure the uniformity of nurses’ entry behavior and to establish their level of PU knowledge at baseline (T1) to accurately examine the effect of the program. Each participant signed a register to document attendance. The researcher recruited and trained 3 research assistants (RAs) to assist with participant registration and to monitor and retrieve completed questionnaires. 

Study group procedure. The nature, purpose, and procedure of the study were explained to nurses who provided written consent for participation. The IG participants  (UCH and LASUTH) were invited to attend the educational workshop organized in the respective hospitals. 

The program was structured to accommodate various nursing schedules because it was not possible to take all nurses off the wards at the same time to attend the 4-hour workshop. In UCH, the nurses were divided into 2 groups. Each group attended the workshop for 5 consecutive days. In LASUTH, all participants attended the same 5-day workshop facilitated by a labor conflict that decreased patient load.

Intervention fidelity was maintained because the module curriculum was followed strictly by the principal investigator, who also delivered all the sessions. 

The interactive educational program. Participants were provided the program of events for each day. They were encouraged to choose an identification number to facilitate analysis in matching each participant’s pretest with post test scores, to assess full participation, and to easily identify missing questionnaires. The intervention was an interactive lecture that involved small group discussions and brainstorming. Participants were grouped based on the wards where they work to facilitate continual cooperative work on the wards. During the first 15 minutes of each module, participants brainstormed on specific questions and answers and shared experiences and practical ideas on PU prevention. The remaining period was used for lectures and discussion on current trends regarding PU prevention and related clinical correlations. For example, the researcher projected pictures of different stages of PUs and participants were asked to determine the stages. This helped actively involve participants in the sessions. Lectures were projected using PowerPoint® slides. The principles of adult learning34 guided the interaction with the participants (ie, learners connect learning with past experience). To facilitate this connection, the researcher also displayed different skin care products (eg, dimethicone-based barrier creams and sprays, dressings, foams, and corn starch) to stimulate discussions on nurses’ practices. At the end of the sessions, paper versions of the PowerPoint® slides were provided to participants. The level of each respondent’s participation was not documented or measured.

All modules were presented by the principal investigator in the 2 hospitals. Each session lasted for 4 hours per day. The curriculum consisted of 5 modules as shown in Table 1. owm_0416_illesanmi_table1

Assessment. A pencil-and-paper PUKT was readministered on day 5 as an immediate post test (T2). The test was completed under supervision, and participants did not refer to the paper versions of the slides. Completed tests were retrieved on the spot. Participants were informed they would be invited to a third round of testing after 12 weeks (T3).  owm_0416_illesanmi_table2

Participants returned to their respective wards but maintained the groupings to facilitate cooperative problem-solving while providing care. Over the 12-week between-test period, the researcher reinforced what was covered in the module with hands-on demonstrations. At the end of 12 weeks, participants were contacted by telephone, Short Message Services, and email for the second post test. The same test (PUKT) was administered at all 3 time points. owm_0416_illesanmi_table3

Control group procedure. The CG also was provided study details. The PUKT questionnaire was distributed to the participants to examine their baseline knowledge. The participants engaged in a general 1-day, 4-hour discussion on their usual practices for PU prevention. The session was facilitated by the RAs under the supervision of the principal investigator. This was followed by a second test (T2). Participants were contacted for the second post test at 3 months (T3). 

At the end of the third data collection (which marked the end of the study), the CG was provided the same package of educational materials as the IG on PU prevention for ethical reasons. owm_0416_illesanmi_table4

Data analysis. Data from the PUKT instrument were collected and entered into a database, the Statistical Package for Social Sciences (SPSS) (Version 17.0, Chicago, IL), for analysis. Data were checked to ensure consistency and to determine where information was missing. A complete case-wise analysis was performed for missing data because the proportion of missing data categorized as Missing Completely at Random (MCAR) was <10% and  was observed only at the 3-month post test (T3). Descriptive statistics using absolute number and relative frequencies (percentages) to describe the sample characteristics were used. Means and standard deviations were computed to ascertain nurses’ PU knowledge scores. A paired sample t-test was used to compare the differences in knowledge between IG and CG pre- and post intervention. Cohen’s d was calculated to determine the strength of the intervention effect. The effect of selected demographic variables on participants’ knowledge scores was examined using ANOVA, and the effect size (eta squared) also was computed. The level of significance was set at α = 0.05% owm_0416_illesanmi_table5

Results

Demographic characteristics. The sample consisted of 193 registered nurses, 127 in the IG and 66 in the CG. The level of education and areas of practice are described in Table 2. The majority of the respondents were basic diploma-certified registered nurses (RN) (133, 68%) and degreed nurses (BNSc) (26, 13.5%); a statistically significant difference was noted in both the IG (36.8 ± 10.3, P = 0.03) and CG (35.2 ± 11.9, P = 0.04). A similar trend was found with years of experience between IG and CG (14.5 ± 13.7, P = 0.04 and 12.6 ± 12.0, P = 0.03, respectively).

Baseline knowledge. The mean knowledge score at baseline was comparable in both IG (32.5, SD = 4.2) and CG (30.8, SD = 5.0), as shown in Table 3. 

Knowledge retention. The score at T2 significantly increased only in the IG from 32.5 ± 4.2 to 40.7 ± 3.4. In the CG, the T2 score did not increase significantly (31.2 ± 5.2, effect size, Cohen d = 1.94). At 3 months (T3), a further increase in knowledge score was observed in the IG from 40.7 ± 3.4 to 42.7 ± 4.0, P<0.001) and in the CG from 31.2 ± 5.2 to 37.8 ± -6.3 (P<0.001) (see Table 3).

Using a paired sample t-test to compare results between the IG and CG from T1 to T2 and T3, the increased mean difference in knowledge scores was noted to be significantly higher in the IG than in the CG (-8.2  ± 5.4, t = -17.0, P<0.001, d = 0.385) (see Table 4), suggesting the intervention accounted for 38.5% of the change in knowledge scores. 

Effect of selected demographic characteristic. The effect of selected demographic characteristics (eg, years of experience, professional cadre, and previous exposure to a PU lecture) on respondents’ scores pre- and post intervention was determined using one-way ANOVA. Findings were not significant (see Table 5). An examination45 of the combined effect (interaction) of selected respondents’ factors (eg, years of experience, previous exposure to PU lecture) on the post test scores using a one-way ANOVA showed a significant interaction effect with previous exposure to PU education (F[1,192] = 2.781, P<0.05). However, the interaction effect with both years of experience and professional cadre was not significant (P>0.05).

 

Discussion  

The aim of this study was to examine the effectiveness of a face-to-face, interactive PU lecture approach to education on knowledge retention among nurses by comparing pretest and post test knowledge scores. The major hypothesis was that nurses will be able to retain knowledge for 3 months post intervention better than nurses who were not exposed to a similar learning method. The intervention was carried out in the same manner by the researcher in all the settings using the modules designed for the program. Participants were selected from neurology, orthopedic surgery, and medical inpatients units because reports from previous studies indicated the risk of PU was higher in patients admitted to these units as a consequence of impaired physical mobility.45 Results of Niederhauser et al’s46 systematic review of literature underscored the importance of PU educational programs in successful implementation of preventive protocols.  

The current study showed nurses had some basic knowledge about PU prevention because they were experienced practitioners. However, after the interactive lecture, the knowledge level increased significantly in the IG as compared to what was observed in the CG.   In addition, participants were able to retain the knowledge acquired as indicated by the mean scores at the 3-month follow-up. This suggests the intervention was effective. In contrast to these findings, reports from previous quasi-experimental studies30,31 involving nursing and medical science students showed students tend to forget ~80% of presented education within 8 weeks of a lecture. The current findings showed knowledge of PU prevention was sustained for 12 weeks (3 months) post intervention among the study cohort, as well as in the CG. This sustained knowledge retention may be linked to the fact respondents in both groups were adult learners, with varied previous experiences and learning they brought to the fore. In addition, hands-on experience and reinforcement of what was learned during the follow-up period in the IG could have contributed to the sustained knowledge 

Khatoni et al’s47 pretest/post test study among nurses (N = 140) suggested both lecture and elearning methods are effective in increasing students’ knowledge. Although opinions tend to differ regarding the most effective method of teaching, evidence supports the effectiveness of interactive lectures, which enhance active student engagement and participation and demonstrate more positive learning gains than traditional lecture methods. For example, from results of their study, Prince and Felder39 proposed inductive learning methods, including cooperative or team learning, active learning, case studies, projects, or presentations, are more effective than the traditional lecture. 

In this study, sustained knowledge retention may be explained using the principles of cooperative learning as proposed by Johnson et al.48 Accordingly, the authors described cooperative learning as the instructional use of small groups to facilitate students’ working together to maximize their learning through mutual dependence rather than competition. It is proposed such learning strategy promotes deep understanding of the subject matter and enhances knowledge retention. It follows that within the small groups, participants can easily exchange views and develop self-confidence. Johnson and Johnson49 also believed working/learning in small groups works among health care professionals to help develop communication skills essential for building stronger communication with patients.  

In the current study, participants worked in small groups based on their respective wards. During the 3-month follow-up period, the researcher visited the nurse participants on the wards weekly, and teaching was reinforced at the bedside to promote evidence-based practice. The practice component is not part of this current report. The authors strongly believe the small group discussions and the supplemental printed materials (ie, PowerPoint® slides) sustained the interactive learning and also enhanced self-instruction and knowledge retention. Additionally, participants were experienced practitioners. Goldberg et al’s50 pretest/post test study (N = 130) noted interactive lecture increased students’ self-efficacy, which is  associated with academic achievement. Similarly, Knight and Wood’s51 pretest post test study (N = 700) to compare the learning gains between traditionally taught lecture and interactive classroom format concluded collaborative work in student groupings and discussions significantly increased learning gains and conceptual understanding. Furthermore, Prince and Felder39 noted a strong motivation to learn when learners clearly perceive a need to know. It follows that learners’ perception of their specific learning needs influences the motivation to learn. The findings in the current study also can be explained by Kolb’s38 model of experiential learning, which hypothesized that concrete experience allows for reflection (ie, incorporation of experience with teaching). The current study authors assert such reflection was demonstrated by study participants, which possibly also strengthened their ability to recall new knowledge, as observed only in the IG. 

Adult learners have previous experiences that help illuminate a new learning situation. As such, the current study examined the interaction effect of treatment, years of experience, and exposure to previous PU lectures on post test scores in the IG and CG. The findings indicated a significant difference, suggesting the educational intervention accounted for the difference in post test scores and was not independently determined by demographic characteristics. This finding is consistent with Hulsenboom et al,52 whose cross-sectional, comparative study among nurses (N = 522) concluded demographics, including age and nurse experience, had no significant influence on knowledge of PU preventive interventions. 

Nurses play a significant role in PU prevention, requiring ongoing acquisition of knowledge. Because the interactive lecture contributed significantly to knowledge retention, a more consistent use of interactive methods of teaching, such as case presentations, brainstorming, and small group discussions, is suggested for continuing nurse education.  

 

Limitations 

The present study was conducted among nurses in 3 tertiary institutions. A study with a wider scope that may include nurses in secondary care facilities is warranted. In addition, comparison of the effectiveness of lecture with other methods of program delivery also should be considered. 

Limitations also include the fact the interactive face-to-face lecture method was compared with only 1 other method of program delivery (discussion group), so the findings should be interpreted with caution. Additionally, the pretest/post test design of this study limits the degree to which the results may be attributed to the effects of the intervention (ie, the authors had no control over natural events in the comparison group hospital). Therefore the effects of history may be a threat to internal validity. In this vein, history describes events that occur concurrently with the treatment, which the researcher may not have control over, thereby influencing the results obtained. In the current study, the possibility of another educational program in the CG institution during the period of this study that could provide information on the subject matter to respondents cannot be ruled out. To the best of the authors’ knowledge, the CG participants were not exposed to another learning situation except that the intervention package was provided at the end of the study to the CG participants. Finally, knowledge retention was monitored for only 3 months post intervention.

 

Conclusion 

A pretest/post test study was conducted to measure gains in knowledge retention for nurses following an interactive lecture on PU prevention. The results demonstrate an interactive lecture using small groups can effectively facilitate knowledge retention among nurses in a continuing education program. The effect of intervention was significantly higher in the IG than in the CG. Interactive engagement of nurses and inductive methods of instruction for program delivery appear to be successful approaches in continuing education programs for nurses. Future studies are needed to examine how acquired knowledge translates into effective PU prevention practices and influences clinical outcomes. 

                                 

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Dr. Ilesanmi is a lecturer and a certified wound care nurse, Department of Nursing; and Prof Oluwatosin is a Professor of Plastic and Reconstructive Surgery, Department of Surgery, College of Medicine, University of Ibadan, Ibadan, Nigeria. Please address correspondence to: Dr. Rose Ekama Ilesanmi, Department of Nursing, University of Ibadan, Ibadan, Nigeria; email: ekamailesanmi@yahoo.com.

 

Potential Conflicts of Interest: none disclosed 

Section: 

Computer Modeling Studies to Assess Whether a Prophylactic Dressing Reduces the Risk for Deep Tissue Injury in the Heels of Supine Patients with Diabetes

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Ostomy Wound Management 2016;62(4):42–52
Ayelet Levy, MSc; and Amit Gefen, PhD
Topics: 
preclinical
study
pressure ulcers
dressing
computational modeling

Abstract

Heels are susceptible to pressure ulcer (PU) development. Some evidence suggests dressings may provide mechanical cushioning, reduce friction with support, and lower localized internal tissue loading, which together may minimize the risk for heel ulcers (HUs). To examine the effect of dressing application on pressure ulcer prevention, 20 computer simulations were performed.

Volumetric exposure of soft tissues to effective and shear strains and stresses, with and without a multilayered foam dressing, were assessed, with the extent of tissue exposure considered as measures of the theoretical risk for PUs. The simulations, conducted using the finite element method, provided the mechanical strain and stress magnitudes and distributions in the weight-bearing tissues of the heel, which were visualized and analyzed post-hoc for comparing diabetic to healthy tissue loads with/without prophylactic dressings and at different foot (plantar flexion) postures. The volumetric exposure of the soft tissues of the heel to elevated strains and stresses was considerably reduced by the presence of the dressing, whether diabetic or nondiabetic tissue conditions existed, and for the entire range of the simulated plantar flexion positions. Further, greater plantar flexion, which occurs with elevation of the head of the bed, reduced the volumetric exposure of subcutaneous fat to increased effective strains and stresses, again, particularly when the dressing was on. Specifically, peak (maximum of raw data) effective strains in the soft tissues of the heel decreased by 14.8% and 13.5% with the use of the dressing for healthy persons and persons with diabetes, respectively. Additionally, volumetric exposures of the soft tissues to large effective strains, defined as exposures to >50% strain, decreased substantially, by at least a factor of 2, with the angle of plantar flexion and with respect to a neutral foot posture. Volumetric exposures to midrange (<50%) strains were more mildly affected by the foot posture (ie, <10% difference was noted across plantar flexion angles). The differences in tissue exposures to strains and stresses between the dressing and nondressing models suggest this dressing provides an important biomechanical protective effect, specifically when diabetic tissue conditions exist. In addition, the data suggest alleviating shear by repositioning the heels after elevating the head of the bed may be critical in order to limit the increase in tissue stress and subsequent PU risk. Randomized, controlled clinical studies to examine the efficacy of dressings for the prevention of heel PUs are warranted. 

 

Surveys1-4 show heel ulcers (HUs) are the most common type of facility-acquired pressure ulcers (PUs), and the heels are the most common site for deep tissue injury (DTI).Clinical trials have identified PUs as generally being associated with a number of contributing or confounding factors, such as impaired mobility and sensory capacities, compromised perfusion, increased body mass index, and type 2 diabetes, to name a few.5,6 During prolonged supine bed rest, the weight of the foot and ankle is transferred through the calcaneus bone to the support surface, subjecting subcutaneous fat and skin near the heel-support contact site to sustained mechanical loads, as demonstrated theoretically and in computer simulations.7 In lack of mobility or sensitivity or both, the sustained tissue loads may exceed tissue tolerance levels, increasing the risk for HUs.7 In persons with type 2 diabetes, in particular, peripheral sensory neuropathy may prevent patients from detecting the onset and progression of tissue damage, which has been documented in numerous clinical cases.8 

Finite element (FE) computational modeling is a powerful tool in PU research (see Sidebar: Finite Element Computational Modeling). FE modeling facilitates quantification of internal tissue strains and stresses in weight-bearing body parts such as the heels and buttocks.6,9-12 This method is further able to isolate the influence of specific intrinsic and extrinsic biomechanical factors on the resulting risk for PUs and DTIs, as demonstrated in various previous computational modeling studies.10-13 Briefly, the 3-dimensional (3D) anatomical model, usually derived from medical imaging such as magnetic resonance imaging (MRI), is divided into hundreds of thousands of small elements in the computer. The material properties and loading configuration is defined for each simulation; the computer then is able to calculate the mechanical reaction of the model for each element with respect to its neighboring elements, ultimately constructing the solution of the biomechanical problem for the entire structure. For example, in a previous study from the authors’ group, Sopher et al12 employed FE computational modeling to investigate how variation of tissue stiffness properties and degree of external rotation of the foot may affect the internal state of fat and skin strains and stresses in the resting heel for supine body postures. The authors demonstrated how lateral inclination of the foot might jeopardize tissue integrity by exerting higher strains and stresses on the soft tissues of the lateral aspect of the heel; however, their study did not include representation of the anatomical site of insertion of the Achilles tendon into the calcaneus bone nor did it examine the effect of diabetic tissue conditions or shearing forces acting on the foot.

Type 2 diabetes has been experimentally associated with stiffening of collagen-rich soft tissues, an effect demonstrated in both animal models and testing of human tissue specimens, as reviewed in detail in the modeling study of Gefen,8 which was focused on the influence of such connective tissue stiffening on the function of the foot. Mechanical testing8,14-16 consistently demonstrated stiffening of fat and skin; however, Connizzo et al17 reported reduced stiffness of the tendon tissue at the insertion site of the Achilles tendon into the calcaneus of mice. Because this insertion site is compositionally and structurally different from the midsubstance of the tendon, diabetes-related alterations at the insertion region may be expressed differently than at other parts of the tendon.

Given that PUs (and HUs in particular) are a major burden for health care facilities and that apart from their devastating impact on the quality of life of sufferers these wounds are known to be difficult and costly to treat, all of which has been documented extensively in patient safety, quality-of-life and health-economy human studies,18-20 great efforts are focused on prevention. Although complete offloading of the heels still is considered the most effective method for preventing HUs,7 it is not always feasible in the long-term, especially when considering patient movement. An illustrative example is a patient who can be immobile for hours but from time to time suffers seizures that cause his legs to move and change position. 

A prevention concept that is attracting the attention of several research groups around the world is the prophylactic use of dressings in order to protect the heels from HUs.7,21,22 In the past few years, the efficacy of such dressings in preventing HUs has been confirmed by more than 20 different clinical studies summarized in a recent systematic review22 that included randomized controlled trials (RCTs), cohort, and case series studies. In addition, positive reports have been published of contact pressure and shear measurements in experimental (laboratory) models.23-26  Recently, the development was reported of a 3D, MRI-based FE computational model for investigating the internal mechanical strains and stresses in the soft tissues of the supported heel and how these are influenced by the use of a prophylactic dressing.27 Although this research did not consider diabetic tissue conditions, clinicians often consider diabetes as a risk factor for HUs6 more because of the patient’s impaired sensation and perfusion and less because the biomechanics of the soft tissues are altered. Nevertheless, theory and computer modeling show abnormal biomechanical properties of diabetic connective soft tissues, where the tissues cannot adequately deform to dissipate the body loads, play a role in the overall risk of injury.8

In addition to prophylactic dressing use, another consideration is the posture of the ankle relative to bed elevation. A case-control study by Singer et al28 suggested the relaxed posture of the ankle in supine lying is external rotation with relative plantar flexion, but elevation of the head of the bed may increase the angle of plantar flexion in the relaxed ankle joint. Furthermore, in a review of relevant case series studies, guidelines, observational studies, and expert opinions, Fowler et al29 concluded elevating the head of the bed may induce additional shearing forces on the weight-bearing soft tissues of the heels, which should be examined in combination with diabetic tissue conditions given the fragility of the diabetic heel. 

Mepilex® Border Heel (Mölnlycke Health Care, Gothenburg, Sweden) is a 5-layer dressing consisting of 1) a backing film which faces the support, 2) an airlaid layer, 3) a nonwoven layer, 4) a polyurethane foam layer, and 5) a Safetac® layer that adheres to the skin.27 This specific dressing is indicated for both prevention and treatment of pressure ulcers and has already been used in randomized clinical trials5,24 where it was shown to be effective as a prophylactic intervention. 

The purpose of this study is to expand the authors’ previously published work27 that demonstrated the biomechanical efficacy of a prophylactic dressing in protecting the heels in order to account for diabetic tissue conditions. For this purpose, sets of computational model variants of the heel in supine lying were developed to represent patients with diabetes with their heels resting in a range of plantar flexion positions, as well as corresponding simulations of healthy tissue conditions.  

 

Methods 

Geometry. A set of 20 FE computational model variants was developed, representing diabetic tissue conditions and comparable healthy tissue cases at different foot postures, as specified in Table 1. Each model variant captured the anatomy of the posterior aspect of the heel, including the calcaneus bone, distal Achilles tendon, fat, and skin (see Figure 1a). Flat elastic foam was modeled as the support surface (see Figure 1a). Ten (10) of the model variants did not include the multilayered dressing and were used as reference cases, which then could be compared to cases where the foam dressing was incorporated (see Table 1). Variants 1–4 were set to a neutral foot position (0˚ plantar flexion) and variants 5–8, 9–12, and 13–20 were set to 10˚, 20˚, and 30˚ of plantar flexion, respectively (see Table 1, Figure 1). For each position of the foot tested, either diabetic or healthy soft tissues properties were assigned. owm_0416_gefen_table1

The anatomical structures of the posterior heel from the MRI dataset, as well as geometrical modeling of the dressing, were segmented as described in the authors’ previous work.27 Briefly, 56 T1-weighted axial MRI slices from the suspended left heel of a healthy man were used to develop an anatomically realistic, 3D, undeformed model geometry, using the ScanIP® module of the Simpleware® software package30,31(Simpleware, Exeter, United Kingdom). For clinical relevance, the study dressing was modeled (the specific considerations regarding the geometrical and material modeling of the dressing have been published previously27). The innermost and outermost layers of the dressing were modeled as contact conditions and used according to the manufacturer’s specifications to describe the airlaid (layer 2), nonwoven (layer 3), and polyurethane foam (layer 4) as physical layers in the modeling. The flat foam support (10-mm thickness) was added to all the heel model variants at the preprocessing stage in the PreView module of the FEBio software package.32 /files/owm/owm_0416_gefen_table1.jpg

Mechanical properties of the tissues and dressing. Constitutive laws and mechanical properties of all the tissues included in the heel model were adopted from the literature (see Table 2). Specifically, the healthy Achilles tendon and calcaneus bone were assumed to be linear-elastic isotropic materials (ie, having a constant stiffness that does not depend on the extent of deformation nor does it depend on the direction of the deformation) with instantaneous elastic moduli of 205 kPa and 7 GPa, and Poisson’s ratios (indicating a material’s deformation at a direction perpendicular to the loading direction) of 0.49 and 0.3, respectively33,34 (see Table 2). Skin and fat tissues were assumed to be nearly incompressible (Poisson’s ratio of 0.495), nonlinear isotropic materials. The large deformation mechanical behavior of skin and fat was described by an uncoupled Neo-Hookean material model35 with instantaneous shear moduli33,36 (see Table 2). Based on the literature, the instantaneous shear moduli of diabetic skin and fat tissues were assumed to be 40% stiffer than the corresponding healthy tissue14; likewise, the diabetic Achilles tendon was assigned a 40% softer instantaneous elastic modulus17 (see Table 2). The flat foam support was assumed to be isotropic linear elastic with a Poisson’s ratio of 0.3 and an elastic modulus of 45 kPa, which are within the range of hospital mattress properties.37 Layers 2, 3, and 4 were assigned instantaneous elastic moduli of 15.3, 75, and 12 kPa, respectively, according to the measurements described previously27 (see Table 2). The Poisson’s ratios of all dressing materials38 were set as 0.258 (see Table 2). owm_0416_gefen_table2

Body loads applied to the model, shear, and friction conditions. The loads applied to the model were chosen to simulate the descent of the calcaneus bone against a flat foam support during supine weight-bearing. For calibration, tissue deformations were measured from a weight-bearing MRI of the heel of the same subject to find the weight force the heel applied on the support. Because the total reaction force should be equal to the weight of the foot/ankle in the supine position, this datum was used to produce the same heel-support reaction forces in all the model variants. The resulting compressive (downward) displacements after imposing the same foot/ankle weight value in all the model variants were in the 4.7-mm to 5.2-mm range. Additionally, in order to represent shearing forces acting on the foot when the head of the bed is elevated, and by doing so to evaluate the importance of subsequent heel repositioning in patients with and without diabetes, model variants 17–20 were used. In these specific variants, a combination of compression and shear loading was employed, where shear displacements were taken as equal to the compressive ones27 (see Table 1). The bottom surface of the elastic foam support was fixed for all motions. Tied (fixed) interfaces were defined between all tissue components as well as between the skin and the polyurethane foam layer of the dressing (layer 4) to account for the adherence properties of the innermost Safetac® layer of the dressing that interfaces the skin (layer 5). Frictional contact between the support and either the skin of the bare heel or the outer surface of the dressing was defined, with the coefficients of friction set as 0.43 and 0.35 for the skin-support and dressing-support contacts, respectively.27,38,39 

Creating the computational simulations. The tissues and dressing were meshed using the ScanIP® module of Simpleware®,30 with mesh refinements that were applied in the skin and dressing materials near the contact area with the support (see Figure 1a). Meshing the support was performed in the Preview module of FEBio.32 All of the above FE simulations were set up using the PreView module of FEBio (Version 1.14), analyzed using the Pardiso linear solver of FEBio (http://mrl.sci.utah.edu/software/febio) (Version 1.7.1) and post-processed using the PostView tool of FEBio (Version 1.4).32 

Biomechanical outcome measures. The volumetric exposures of the soft tissues to mechanical strains were systematically compared using the effective Green-Lagrange strain as the strain measure.35 The effective Green-Lagrange strain is an adequate measure of large tissue deformations and the consequent risk for HUs because it is simultaneously considering tissue deformations in all loading modes (ie, compression, tension and shear) using a single weighed (scalar) measure. The strain data were pooled together from tendon, fat, and skin tissues for all elements in a consistent volume of interest in the meshes, which was defined by the circumference of the calcaneus and its projection at the retrocalcaneal region, as illustrated in Figure 1b. Additionally, peak effective and maximal shear stresses (shear stresses arise from shape distortion of the tissues due to forces parallel to the cross-sections of the tissues) in fat and skin tissues were compared separately as a second measure of the risk for HUs. For clarification, effective strain and stress measures consider compression, tension, and shear loads altogether, as opposed to just the aforementioned (maximal) shear measures, which do not consider tension and compression loads. The stress data were pooled from all the elements of skin or separately from those of fat. Converged time steps for data collection were chosen so the resulting reaction forces acting back from the support were within <3% difference from the predefined target reaction force (as explained previously). Hence, the biomechanical efficacy of the dressing was evaluated in diabetic and healthy tissue conditions based on the criteria of reduction in volumetric exposures of the soft tissues to critical effective and shear strains and stresses. The verification of the reference model variant based on the calculated interface pressures under the heel and corresponding compressive strains in the support, which have been compared to published experimental data, is described in a previous paper by the authors that fully validates the present modeling framework.27 

Data collection and analyses. Excel software (Microsoft Co, Spokane, WA) was used for the post-hoc analyses of the finite element simulations and for plotting and quantitatively comparing the results of all simulations. It should be mentioned that means and standard deviations are not provided because no variability in the modeling outcomes exists when the parameters of the models are set at a certain way (see Sidebar). Accordingly, no variance around the mean and no average values are reported — just a single value of each parameter that is calculated from a predefined set of simulation parameters (eg, peak tissue strain is calculated based on a simulated set of specific tissue mechanical properties and whether a dressing is present or not). The standard deviations are zero; each time the same simulation is run, the same outcome is obtained. 

 

Results

Effective strain distributions in the soft tissues of the heel in a neutral position and in 10˚, 20˚, and 30˚ plantar flexion, without and with the protection of the dressing, are shown in Figure 2 and Figure 3, respectively. Consistent with the authors’ previous work,27 peak effective strains were found at the bone-fat interface in all the model variants and these were shifted distally with an increase in plantar flexion (see Figures 2, 3). Specifically, peak (maximum of raw data) effective strains in the soft tissues of the heel decreased in presence of the dressing by 14.8% and 13.5% for the healthy persons and persons with diabetes, respectively. Additionally, volumetric exposures of the soft tissues to large effective strains, defined as exposures to >50% strain, decreased by at least a factor of 2 with the angle of plantar flexion and with respect to the neutral position of the foot. Volumetric exposures to midrange (<50%) strains were more mildly affected by the foot posture (ie, <10% was noted difference across plantar flexion angles) (see Figure 4).

owm_0416_gefen_figure2owm_0416_gefen_figure3owm_0416_gefen_figure4

Substantial alleviation of internal peak effective tissue stresses when the dressing was on, with respect to corresponding conditions when it was off, was evident in all foot positions for both the diabetic and healthy tissue conditions (see Figure 5); the most pronounced effect occurred in skin tissue that was subjected to less intense deformation exposures (see Figure 5 – dressing on versus dressing off). Specifically, peak effective stresses in the soft tissues of the heel decreased by 25.5% and 22.2% in the presence of the dressing for healthy and diabetic cases, respectively. Overall, diabetic tissue conditions yielded greater effective and shear stresses in skin and fat tissues and lower stresses in the Achilles tendon with respect to healthy corresponding tissues (see Figure 5). owm_0416_gefen_figure5

Effective stress distributions on the exterior skin surface in a neutral foot position after simulated elevation of the head of the bed and following subsequent repositioning of the heel are shown in Figure 6. The substantial increases in effective and shear stresses on the skin with the elevation of the head of the bed are considerably restrained by the use of the dressing; exposure to skin stresses is reduced by a factor of 2 to 3, and exposure to fat stresses is reduced by a factor of ~1.5 with application of the dressing, in either nondiabetic or diabetic tissue conditions (see Figures 6, 7). Furthermore, shear alleviation through repositioning of the heel was able to reduce the effective and shear stresses developing in skin tissues in diabetic and healthy cases between 20% and 40% across the different cases (see Figure 7), which is substantial. This occurred either with or without the presence of the dressing (see Figures 6, 7a,b), which points to the importance of offloading (elevating) the heels whenever shear in tissues is suspected (eg, immediately after the head of the bed is elevated). owm_0416_gefen_figure6

In general, volumetric exposure of fat tissue to effective stresses decreased with the angle of plantar flexion with respect to a neutral foot position and with elevation of the head of the bed. Nevertheless, alleviating shear by repositioning the heels was able to further reduce the volumetric exposures of fat tissues to effective stresses exceeding critical levels12 with regard to a state where no offloading has been performed (see Figure 7c). This again points to the importance of repositioning the heels — elevating and then gently resting them on the mattress again whenever internal tissue shear is suspected, such as in cases where the head of the bed has been lifted or where a patient appeared to have slipped down in the bed. Doing so is still important even if prophylactic dressings are being used (see Figure 7). owm_0416_gefen_figure7

Discussion

This study employed 20 MRI-based FE model variants of the heel in a supine posture for a range of plantar flexion positions in order to investigate the biomechanical efficacy of a prophylactic heel dressing in preventing HUs if diabetic tissue conditions exist. In accordance with the authors’ previous work,27 the heel dressing was found to consistently and considerably reduce the volumetric exposure of the soft tissues of the heel to elevated strains and stresses with respect to a bare heel condition (see Figures 2–7), whether diabetic or nondiabetic tissue conditions existed, and for the entire range of the simulated plantar flexion positions. Further, greater plantar flexion reduced the volumetric exposure of subcutaneous fat to increased effective strains and stresses. This finding can be explained by the thicker subcutaneous fat layer facing the support surface and the growing distance of the heel-support contact site from the insertion area of the (stiffer) Achilles tendon as the degree of plantar flexion increases.12,31 However, skin tissues seem to be conversely affected. As the angle of plantar flexion increases and subcutaneous fat deformations decrease, greater effective and shear stresses occur in skin tissues (see Figure 7a,b). Nevertheless, the dressing was able to considerably limit that increase in effective and shear stresses in the skin with respect to a bare heel condition to the point where the use of the dressing in plantar flexion of 30˚ resulted in lower skin stresses than for a neutral position without the dressing. This result was consistently observed for both diabetic and nondiabetic tissue conditions, which may suggest the use of bed footrests to maintain the foot in minimal plantar flexion is redundant if the dressing is placed for protection. However, this is subject to additional clinical studies. 

Elevating the head of the bed, some spontaneous movements of the patient, or repositioning that has not been carefully performed all can result in an increased plantar flexion angle of the foot and the addition of shear forces acting on the supported posterior heel. As expected, such additional shear forces were shown in this study to substantially exacerbate the states of effective and shear stresses in skin tissues. Based on this study, temporarily lifting (offloading) and then repositioning the heels on the support surface immediately after elevating the head of the bed or, in general, after repositioning, is crucial to tempering this increase in skin stresses. Furthermore, patients who are positioned in bed with their heads elevated (eg, to improve respiration) tend to slide down on the bed over time due to gravity, which then causes the development of recurrent shear loads in the weight-bearing soft tissues of the heels (and in the buttocks as well).40 Based on the present findings, the use of the dressing should theoretically minimize skin and subcutaneous fat stresses, even if shear loads redevelop over time (see Figure 7).

Questions have been raised regarding the modes of action and the sustainability of the protective effect of the dressing, and some bench tests were performed in this regard.38 In the current simulations, the cushioning effect of the dressing is formally calculated for a short period (in the order of minutes) following a positioning/repositioning action; however, results can still be generalized and extrapolated to longer times (ie, in the order of several hours) of immobility, within which transient viscoelastic phenomena typically plateau in tissues. This theoretical extrapolation can be made because the instantaneous dressing and tissue stiffness properties were considered, thereby describing the worst-case scenario in terms of exposure to internal tissue strains and stresses.6,27,41 Also, the authors’ previously published laboratory findings27 show negligible viscoelasticity of the dressing materials, so the cushioning effect of the dressing should persist, which further supports the above point.  

Based on animal model studies as well as mechanical tests of human tissue specimens, which are reviewed in Gefen,6,8 the altered mechanical properties of the skin, subdermal fat, and Achilles tendon in diabetes appear to play an important role in the etiology of HUs (and PUs in general). Although increased soft tissue stiffness (as in skin and fat) increases the risk of elevated tissue stresses, abnormal softening of tissues (such as at the insertion of the Achilles) exposes the affected and nearby tissues to an increased risk of deformation-inflicted injury. Reducing localized tissue deformation is particularly important in diabetes, because low deformation levels are needed to protect the vasculature in a situation where perfusion often already is compromised.42,43   

 

Limitations

Computational FE modeling is a powerful tool in PU research but it is not without limitations that originate from the assumptions and omissions made. First, the mechanical properties of the tissues are taken from animal studies. Furthermore, skin and fat tissues are considered hyperelastic. The Achilles tendon and the dressing materials are considered linear elastic; hence, any transient biomechanical viscoelastic phenomena are omitted in the modeling. 

Additionally, the reference model variant is based on anatomical data of a single young healthy subject, which does not necessarily represent all possible heel structures in terms of dimensions, sites, neutral external rotation, and the like. Moreover, the mechanical properties of healthy and diabetic soft tissues are considered homogeneous, although the alterations in tissue stiffness properties associated with diabetes are hardly homogeneous. Local stiffening of connective tissues is occurring as mechanical lesions, which exert greater localized tissue stresses as well as greater strains in the softer, adjacent regions of the affected tissues, and which then act to increase the risk of local tissue damage. 

 

Conclusion

In this study, the differences between models of a bare heel and models covered with the modeled dressing were considerably different in soft tissue exposures to internal tissue loads, where loads in presence of the dressing were lower. This suggests the dressings provide a cushioning effect to the soft tissues of the heel, as well as that they temper deformations from the tissues by deforming internally themselves in shear mode, hence consistently lowering exposure to hazardous levels of strains and stresses in the simulations in a variety of foot postures and tissue conditions including the case of diabetic tissue conditions. Increasing plantar flexion angles of the resting foot was found to result in safer mechanical states (lower tissue strain and stress exposures) for subcutaneous fat, but more plantar flexion also could worsen the loading state in skin if offloading the heels is not performed in a timely manner. However, the use of the dressing protected skin tissues by lowering the effective and shear stresses in skin for these plantar flexed positions compared to a bare heel state. It is still recommended to offload (ie, temporarily elevate) the heels immediately after elevation of the head of the bed, even if the dressings are used to protect the heels. This is in order to minimize shear loads in the soft tissues of the heels (and buttocks), which are formed as a consequence of elevating the head of the bed or other repositioning maneuvers, as the body tends to slide down in the bed, due to gravity.40 The results of this study suggest repositioning the heels immediately after elevating the head of the bed to mitigate the effects of gravity and then repeating this repositioning from time to time afterwards may be an important measure to reduce the risk of PU development. Randomized controlled clinical studies to examine the efficacy of dressings for the prevention of heel PUs are warranted. 

 

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36. Linder-Ganz E, Shabahin 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.

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

38. 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.

39. Zhang M, Mak AF. In vivo friction properties of human skin. Prosthet Orthot Int. 1999;23(2):135–141.

40. Shaked E, Gefen A. Modeling the effects of moisture-related skin-support friction on the risk for superficial pressure ulcers during patient repositioning in bed. Front Bioeng Biotechnol. 2013;1(9):1–7. 

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

42. Laing P. The development and complications of diabetic foot ulcers. Am J Surg. 1998;176(2A suppl):11S–19S. 

43. Sumpio BE, Lee T, Blume PA. Vascular evaluation and arterial reconstruction of the diabetic foot. Clin Podiatr Med Surg. 2003;20(4):689–708. 

 

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

 

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

Section: 

A Descriptive Study Assessing Quality of Life for Adults With a Permanent Ostomy and the Influence of Preoperative Stoma Site Marking

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Ostomy Wound Management 2016;62(5):14–24
Diane Maydick, EdD, RN, ACNS-BC, CWOCN
Topics: 
survey
surgical stoma
Quality of Life
preoperative care
nursing

Abstract

Diseases or anomalies of the genitourinary or gastrointestinal tract often require removal of organs and creation of an artificial opening (stoma) to allow for elimination of urine or stool. Preoperative stoma site marking can affect quality of life (QoL). A descriptive study was conducted to assess the relationship between QoL and preoperative stoma site marking in adults with a permanent ostomy.

Using convenience sampling methods, 230 eligible participants attending a United Ostomy Association of America conference were invited to complete a survey of demographics regarding age, gender, time since surgeries, and ostomy type and the City of Hope National Medical Center Quality of Life Ostomy Questionnaire. The latter contains 2 sections of 30 and 43 items each that address life impact and quality of life, respectively. The researcher explained the study and provided a study packet to volunteers who were interested in participating. Volunteers were to complete the surveys over a 4-day period while at the conference; the investigator collected all study materials. Inclusion criteria stipulated study participants must be English writing/reading persons at least 18 years of age with a colostomy, ileostomy, or urostomy. All descriptive statistics (means, standard deviation, frequency, and percents) used to describe demographic and surgical history and quantitative data (logistic regression, cross-tabulation, Pearson product moment correlations, and analysis of covariance) used to determine relationships among factors were entered and analyzed using a computer software program. Of the 140 participants who met inclusion criteria and provided data, the majority (85, 60.7%) had their stoma site marked by a wound, ostomy, continence (WOC) nurse. WOC nurse marking was more likely in recent years, and WOC nurse marking was 1.03 times more likely for each year since stoma surgery (M = 13.44, SD = 13.48). Mean QoL was 7.56 (SD = 1.59, range 3.84–10.00) and was positively correlated with age (r [137] = 0.27, P = 0.001), years since first surgery (r (138) = 0.25, P = 0.003), and years since most recent surgery (r [137] =0.28, P = 0.001). The total number of surgeries was unrelated to QoL. More than 75% of the participants received preoperative marking, with a significant difference in QoL for persons marked by a surgeon (M = 7.71, SE = 0.16) or a WOC nurse (M = 8.82, SE = 0.37) versus another professional (M = 4.83, SE = 1.05) (F [3.118] = 3.44, P = 0.19). The increasing prevalence of preoperative stoma site marking by a WOC nurse over time serves as a benchmark for this centerpiece of WOC nursing practice. The findings confirm the need for stoma site marking and validate the impact of stoma site marking by the WOC nurse. 

 

 

Despite advances in medical treatment of urothelial and colorectal cancers, inflammatory bowel disease, and diverticular disease, many ostomy surgeries are still performed in the United States each year.1 Creation of an ostomy (stoma) influences urine or fecal elimination and obliges patients to adjust to a new way of life.2 Disease-specific, quality-of-life (QoL) investigations have been conducted, but research linking outcomes for patients who receive preoperative stoma site marking by a wound, ostomy, continence (WOC) nurse or another clinician with specialized training in the principles of ostomy management is sparse. Additional research is needed to provide a base of evidence for the relationships between QoL, preoperative stoma site marking, and long-term adjustment.3

Background

Exact numbers of individuals living with a permanent stoma, or ostomy, are difficult to ascertain for a variety of reasons, including the way diseases are coded in the United States (US). Cooke1 provided a range of estimates of individuals currently living with an ostomy (650,000 to 730,000) and further estimated that more than 120,000 ostomy surgeries are performed each year. It is believed that more than 700,000 Americans, ranging from infants to senior citizens, have had fecal or urinary ostomy surgery.4

In 2004, the International Ostomy Association (IOA) House of Delegates5 issued the “Charter of Ostomate’s Rights” for individuals with an ostomy. According to this document, individuals who undergo ostomy surgery should receive preoperative counseling and be provided with facts about living with a stoma. The individual also should have a well-constructed stoma placed at an appropriate site and receive medical support, ostomy nursing care, and psychological support during the preoperative and postoperative phases, both in the hospital and in the community.

Historically, WOC nurses have advocated for preparing patients for ostomy surgery by performing preoperative stoma site marking and providing preoperative education.3 Recently, the American Society of Colon and Rectal Surgeons, the Wound, Ostomy and Continence Nurses Society, and the American Urological Association issued joint statements advocating a preoperative visit before ostomy surgery by a WOC nurse or another qualified, experienced, educated, and competent clinician.6,7 The preoperative visit should include assessment and education for both the individual scheduled for ostomy surgery and his/her significant others. Beginning to learn about ostomy care and ostomy appliances before surgery rather than during the immediate postoperative period is preferred. In addition to teaching about the ostomy surgery itself, selecting a site for the stoma should be a priority and should be performed during the preoperative visit.8 

Management guidelines6-8 state preoperative stoma site marking should be performed after a careful assessment of the abdomen in lying, sitting, and standing positions and should avoid folds and creases; placing a stoma in a fold, near a crease, or in a location that is not visible to the individual predisposes that person to postoperative problems that include pouch leakage, skin irritation, pain, clothing concerns, and the inability to see the stoma and be independent in self-care, issues that may lead to excessive supply use, the need for expensive customized ostomy pouches, and emotional and psychological distress.8-11 

Surveys12,13 of ostomates found preoperative stoma site marking can impact QoL and long-term adjustment. Person et al13 conducted a comparative, descriptive study to investigate the impact of preoperative stoma site marking on QoL, independence, and complication rates using a structured, validated stoma QoL questionnaire.14 Of the 105 participants (60 men and 45 women) with 60 (57%) permanent and 45 (43%) temporary stomas, 52 (49.5%) received preoperative stoma site marking and their QoL was significantly better than that of patients who did not receive preoperative stoma site marking (P<0.05), regardless of stoma type. The authors concluded preoperative stoma site marking is crucial for improving QoL, promoting independence, and reducing postoperative complications. 

Haugen et al12 conducted a descriptive study and researched perioperative factors associated with adjustment over time in a sample of individuals with incontinent stomas in the Midwestern US. An incontinent stoma leaves the individual without the ability to control and evacuate feces, flatus, or urine at times and places considered socially acceptable.8 The researchers mailed a survey packet including The Ostomy Adjustment Scale15 (OAS) and a survey for demographics to 200 eligible participants; the response rate was 73% (N = 146). Using a stepwise, multivariate regression analysis of the association of perioperative factors with the OAS, the authors found certain perioperative factors to be associated with more positive ostomy adjustment, including preoperative education by a WOC nurse that was “helpful,” ostomy creation by a colon and rectal surgeon or a urology surgeon, and ongoing/recurrent illness. Preoperative education by the ostomy nurse was associated with a statistically significant improved adjustment (P = 0.04).

In a comparative, descriptive study, Marquis et al16 investigated the effect of ostomy surgery on health-related QoL using the Stoma Quality of Life Index (SQLI). The self-administered questionnaire was completed immediately after surgery and then again at 3, 6, 9, and 12 months; 4,739 patients with stomas and 618 stoma care nurses from 16 European countries responded. The Montreux Study16 included analysis of 11,097 questionnaires in 12 languages. All patients had a fairly consistent SQLI immediately after surgery. QoL was found to improve over time, but time was not the only factor to influence QoL — patient satisfaction with the care received, confidence in changing the appliance, and the patient’s relationship with the ostomy nurse all affected QoL. Patients who reported a WOC nurse took a genuine interest in them had higher QoL index scores. The authors suggested these findings support the belief that a WOC nurse exerts a positive influence on adaptation and QoL. The authors concluded by advocating for increased access to specialist care for the first 3 to 6 postoperative months.

Although preoperative stoma site marking is receiving increased attention in the literature and it is generally agreed that preoperative stoma site marking and teaching before ostomy surgery are beneficial,17,18 documenting who provided preoperative stoma site marking (eg, a WOC nurse or another clinician with specialized training in principles of ostomy management) is important.3 Additional research is needed to provide a base of evidence for the relationships between QoL, preoperative stoma site marking, and long-term adjustment.3

The purpose of this comparative, descriptive study was to assess the relationship between QoL and preoperative stoma site marking in a sample of adults with a permanent ostomy.

Methods and Procedures

Institutional review board approval was obtained from Teachers College, Columbia University, New York, NY after the proposal for dissertation research was approved. 

The investigator attended the 2009 United Ostomy Association of America (UOAA) Second National Conference in New Orleans, LA for the sole purpose of soliciting volunteers for study participation using convenience sampling methods. At the beginning of the conference, the coordinator of the UOAA informed attendees about the research and invited them to participate. A room was available for participants to complete the study any time during the 4-day conference. Interested individuals were provided a cover letter informing them participation was voluntary and anonymous, they had the right to withdraw at any time, and they could omit questions. Before surveys and consent forms were distributed, a description of the research study and participants rights was provided to each attendee by the program coordinator. 

Persons who volunteered to participate were given a consent form and survey packet. The self-report surveys were stapled into one packet and were randomly ordered.  The order was rotated to establish different sets, which then were labeled and assigned an identification number. A survey packet was handed to each voluntary participant with appropriate instructions.  

Each participant received a blue or black pen, a large brown envelope in which to place their completed survey, and a survey packet containing the City of Hope-Quality of Life-Ostomy Questionnaire19 (COH-QOL-OQ) and a Demographic Data Survey. The consents and survey packets took approximately 30 minutes for the respondent to complete. The investigator stayed available to answer any questions and collected all completed consents separately from the survey packets. Respondents placed the survey instruments in a sealed brown envelope, which the investigator collected before leaving the conference venue.  

Criteria for inclusion were: 1) age 18 years or older; 2) having a permanent colostomy, ileostomy, or urostomy; and 3) being able to read and write English.

Instruments. COH-QOL-OQ19 is a comprehensive, multidimensional, self-report instrument designed to assess QoL for individuals with intestinal ostomies. The instrument contains 2 quantitative sections: The Lifestyle Impact and the Quality of Life Impact sections. Both quantitative sections of the instrument were utilized for data collection; reliability and validity have been demonstrated on these sections.20 

Lifestyle impact. The Lifestyle Impact Section consists of 31 descriptive Yes/No items organized into the following themes: 1) work-related, 2) health insurance, 3) sexual activity, 4) psychological support/concerns, 5) clothing, 6) diet, 7) time since surgery and adjustment (how long it took to be comfortable with ostomy care, diet, and how long it took your appetite to return), and 8) food groups. Each item answered Yes = 1 point and each No response = 0. 

QoL impact. The QOL Impact Section is divided into 4 domains with 43 items as conceptualized in the COH-QOL Model (see Figure 1): physical well-being (items 1 to 11), psychological well-being (items 12 to 24), social concerns (items 26 to 36), and spiritual well-being (items 37 to 43). Each item is scored using a linear analogue scale in terms of problem severity, rated from 0 to 10.20 For example, respondents can rate physical strength between 0 (no problem) and 10 (severe problem). A number of items are reverse scored to protect against response bias, including items 1–12, 15, 18, 19, 22, 30, 32–34, and 37. A mean QoL score was obtained by adding all scaled times and dividing by 43. Scores range from 0 to 10, with 10 being the best quality of life.  owm_0516_maydick_figure1

Grant et al20 reported the psychometric analysis of the revised COH QOL OQ confirmed a 4-dimensional model and established initial reliability and validity; the authors also confirmed the scale may be utilized to describe adjustment to colostomy, ileostomy, or urostomy for adults.20

Demographic survey. The demographic data survey included information such as gender, year of birth, height, weight, race, and education, as well as illness/reason for surgery, years since first surgery, number of surgeries, ostomy type (colostomy, ileostomy or urostomy), and who performed preoperative stoma site marking.

Data analysis. Data were entered into the Statistical Package for Social Sciences, version 17 (SPSS, Chicago IL) and analyzed. Study variables included participant demographics, QoL scores, illness or reason for surgery, years since first surgery, number of surgeries, ostomy type (colostomy, ileostomy or urostomy), preoperative stoma site marking, and length of time to 3 adjustment points (ie, how long before they were comfortable with their ostomy, how long before they were comfortable with their diet, and how long before appetite returned).

Descriptive statistics (means, SDs, frequencies, percentages) were used to describe the demographic makeup of the sample as well as participant surgical history. Logistic regression analysis was used to determine the relationship between being marked by a WOC nurse and year of first stoma creation. Cross-tabulation analyses were conducted to determine the relationship between being marked by a WOC nurse and adjustment items from the Lifestyle Impact section. Pearson product moment correlations were used to assess the relationship between COH-QOL-OQ score and background variables of age, years since stoma was created, and years since most recent surgery. These correlations led to selection of covariates.  

Analyses of covariance (ANCOVA) with Bonferroni post-hoc tests were used to determine the relationships between QoL and preoperative stoma site marking. These outcomes were compared among 4 groups: respondents who received no preoperative stoma site marking, persons who received preoperative stoma site marking by a WOC nurse, persons who received preoperative stoma site marking by a surgeon, and persons who received preoperative stoma site marking by someone other than an ostomy nurse or surgeon. Covariates of age, number of years since first surgery, and number of years since last surgery were used in all QoL analyses.  

Results

Of the 230 packets distributed, 149 were returned (response rate of 64.8%). One-hundred, forty (140) respondents met inclusion criteria, had complete data on 1 or more independent and dependent variables, and had provided sufficient demographic data to be part of the proposed sample (age, ostomy status, and preoperative stoma site marking). One participant did not complete a significant part of the QoL section in the COH-QOL-OQ and was not included in the data analysis. In order to maximize the sample size, all 140 cases with completed demographic data questionnaires were analyzed. Demographic characteristics of the sample are summarized in Table 1. owm_0516_maydick_table1

The vast majority of the respondents in this survey were Caucasian (134; 95.7%). The mean ages for female and male respondents were 59.06 ± 13.62 and 65.02 ± 13.06, respectively. The majority of the respondents (69.3%) reported being married before surgery; of those who had a change in marital status after surgery, 27 (84.37%) said the change was unrelated to the surgery. More than half of the respondents (61.4%) had an ileostomy and were more likely to be women; those with a colostomy were more likely to be employed full time; and those with an ileostomy were more likely to work part time or be unemployed (see Table 1). 

Slightly more than half of the sample (87, 63.0%) reported 1 surgery, and more than one third of the sample (51, 37.0%) reported multiple surgeries. The respondents reported a range of 0–62 years (M = 13.44, SD = 13.48) since their first surgery; the number of surgeries ranged between 1 and 32 (M = 2.12, SD = 3.50); and years since most recent surgery was between 0 and 58 years (M = 10.15, SD = 11.40). The majority of respondents (99, 70.7%) reported their surgery was planned; close to 75% of the respondents reported the stoma site was marked preoperatively, and most received preoperative marking by an ostomy nurse (see Table 2). owm_0516_maydick_table2

Using year of first surgery to predict whether a WOC nurse marked the stoma site, logistic regression analysis revealed that WOC nurse marking was more likely in more recent years, (B = .031, Wald = 4.06, P = 0.04, OR = 1.032 (95% CI: 1.001, 1.064), with WOC nurse marking 1.03 times more likely for each successive year. For example, a participant having surgery in 2016 was 1.32 times more likely to be marked by a WOC nurse than someone having surgery in 2006 (10 years ago) and 1.64 times more likely than someone having surgery in 1996 (20 years ago).

Lifestyle impact: length of time to adjustment points. Cross-tabulation analyses showed a significant association between being marked preoperatively by a WOC nurse and length of time until appetite returned (Somer’s d = -0.135, T = -2.32, = 0.02) and length of time until patients were comfortable with their diet (Somer’s d = -0.244, T = -2.706, P = 0.007), with WOC nurse-marked patients showing earlier return of appetite and comfort with diet than patients who were not marked by a WOC nurse. For example, in terms of comfort with their diet, those marked by a WOC nurse were more likely to report feeling “immediately” comfortable (8.6% compared to 0.0% for the WOC nurse-marked and non-marked patients, respectively) and less likely to report “never feeling comfortable” (9.9% compared to 20.0% for the WOC nurse-marked and non-marked, respectively). More WOC nurse-marked participants reported their appetite returned “immediately” (10.0% compared to 0.0% for non-marked), and fewer reported it took “years” (1.3% compared to 7.3%, WOC nurse-marked versus non-marked, respectively). No association was noted between being marked by a WOC nurse and how long it took to adjust to daily care (Somer’s d = -0.126, t = -1.521, = 0.13).

Quality-of-life impact. Mean COH-QOL-OQ score for the total sample was 7.56 (SD 1.59, range of 3.84–10.00). QoL total was positively correlated with age (r [137] = 0.27, = 0.001), years since first surgery (r [138] = 0.25, P = 0.003), and years since most recent surgery (r [137] = 0.28, P = 0.001). These correlations indicate that as age, time since first surgery, and time since most recent surgery increase, scores on the QoL measure also increase. Although years since first and last surgery were highly intercorrelated, only years since first surgery and age were used as covariates in QoL analyses. Total number of surgeries was unrelated to QoL total scores (r [137] = -0.09, P = 0.29). 

Relationships between QoL and preoperative stoma site marking. The 4 groups of individuals assessed included persons who received no preoperative stoma site marking (24, 19.4%) and persons who received preoperative stoma site marking by an ostomy nurse (83, 66.9%), surgeon (15, 12.6%), or “other” person (2, 1.6%). ANCOVA analyses, controlling for age and number of years since first surgery, revealed significant differences in QoL based on who marked the site (F [3, 118] = 3.44, P = 0.019). Bonferroni adjusted post-hoc tests showed the WOC nurse-marked group (M = 7.705, SE = 0.160) and the surgeon-marked group (M = 8.185, SE = 0.374) had a higher QoL than the “other” group (M = 4.831, SE = 1.049). The surgeon-marked and WOC nurse-marked groups did not differ, and patients whose stoma was marked by a WOC nurse or surgeon had the highest QoL scores.

Discussion 

The results of this descriptive study support the premise that preoperative stoma site marking is beneficial and should be done by someone qualified to perform the procedure.6,7,10,11,21 The significant differences in QoL based on who marked the site demonstrated that the WOC nurse-marked group and the surgeon-marked group had a higher QoL than the “other” group; this evidence further supports the need for preoperative stoma site marking.6,7   

This result is consistent with findings by Macdonald et al,21 who investigated the ability of surgeons to chose a stoma site against the gold standard (the ability of WOC nurses to chose a stoma site). The researchers found surgeons with a colorectal subspecialty chose sites consistent with WOC specialty nurses. In addition, persons who were not preoperatively marked or were marked by someone other than the surgeon or the WOC nurse had lower QoL scores; the authors concluded general surgeons may not be trained in stoma site marking and therefore results may be inconsistent. Stoma site marking is a skill often taught in the education, practice, and training of urologists, colorectal surgeons, and WOC nurses (ie, specialists).10,11 

QoL scores in this investigation are consistent with the range of QoL scores reported by others using the COH-QOL-OQ. Anaraki et al22 reported a mean score of 7.48; Gemmill et al23 reported a mean score of 7.7; and Grant et al20 reported a mean score of 7.65. In general, overall QoL scores have been reported to be lower for all patients with ostomies, but comparing populations that are slightly different must be done cautiously.24,25 The positive correlations with age, years since first surgery, and years since last surgery also are consistent with findings of others who reported QoL improves over time.16 

Although many have investigated the impact of an ostomy on QoL, only a few have specifically examined the impact of preoperative stoma site marking on QoL. The results of this study provide a glimpse into the prevalence of preoperative stoma site marking by a WOC nurse and may be the first to document that WOC preoperative stoma site marking has increased over time. Although studies have addressed preoperative stoma site marking,13 preoperative education by a WOC nurse,12 and preoperative education and stoma site marking,17 no data are available to use as a benchmark to describe the prevalence of preoperative stoma site marking by WOC nurses. 

The significant association between being marked by a WOC nurse preoperatively, length of time until patient appetite returned, and length of time until patients were comfortable with diet was an interesting and unexpected finding. Krouse et al26 investigated QoL for patients with cancer and patients without cancer with a colostomy and found patients without cancer reported diet-related issues were more problematic and required dietary adjustments, including avoiding certain foods such as dairy products, vegetables, and fruits. Although many participants in both these study groups altered their diet, the authors suggested the difference might be associated with dietary changes necessary for irritable bowel disease or diverticulosis or that more patients without cancer might avoid foods such as dairy products, fruits, and vegetables.  

In the current study, more than 75% of the respondents had either Crohn’s disease or ulcerative colitis and more than 50% had an ileostomy; thus, it is possible the surgery itself led to the return of their appetite and comfort with their diet.  

Although the majority of individuals in this study were marked by a WOC nurse, preoperative education was not assessed. Haugen et al12 reported postoperative adjustment improved with preoperative education provided by a WOC nurse.  In general, a preoperative stoma site marking session by a WOC nurse may allow time to provide education, but it is difficult to gauge the education provided and assess its impact on QoL.27 Furthermore, many patients continue to require ongoing education and support long after surgery.9,10,12,13,16,28 

The majority of the participants in this study belonged to an ostomy support group or another type of support group and may have had the opportunity to talk with someone else who was going to have or had an ostomy. The effects of these factors are elusive and deserve additional exploration.

Recommendations for further research include designing quantitative and qualitative studies to investigate ethnically diverse participants who are unable to travel or attend a national conference to identify variables that impact QoL. Further investigation in the form of a qualitative study might provide an additional avenue for the “voice” of the individuals with an ostomy to be heard. The voice of experience of living with an ostomy has great potential for teaching health care professionals about the individual needs for this patient population. Further investigation with regard to the elements of the preoperative visit for stoma site marking and the impact upon QoL should be undertaken. The return of appetite and comfort with diet should be further investigated to elucidate the information necessary for teaching and counseling patients with an ostomy.

Limitations

Several limitations of this investigation should be considered when interpreting the results. First, the sample was limited to adults who were motivated and physically and financially able to attend the conference. A potential for bias in the results exists because most participants were Caucasian college graduates. Results of this investigation can only be generalized to individuals between the ages of 23 and 89 years old with a permanent ostomy who were represented in this sample.  

Next, the instruments in this investigation were self-report surveys; recall bias may be a factor for participants because they had ostomy surgery an average of more than 13 years before this study. Additionally, when measuring an individual’s QoL, certain items may represent different levels of importance to the respondents. It is also possible the location and nature of the conference may have had an effect with regard to the participants’ state of mind, feelings of well-being, and sense of control.

Lastly, information was not elicited about surgical specialty (ie, general surgeon, colorectal surgeon, or urologist), which is now recommended by the American Society of Colorectal Surgeons, the American Urological Association, and the Wound, Ostomy and Continence Nurses Association.6,7 

Conclusion

A descriptive study was conducted to explore the relationship between QoL and preoperative stoma site marking for individuals with a permanent ostomy. The findings show living with an ostomy influences QoL. The majority of the study participants received stoma site marking, most were marked by a WOC nurse, and the prevalence of WOC nurse preoperative stoma site marking has increased over time. A significant difference in QoL was dependent on who marked the site; the surgeon-marked group and WOC nurse-marked group had the highest QoL scores when compared to the “other” group.  

The findings confirm the need for stoma site marking and validate the impact of stoma site marking by the WOC nurse. Findings of this investigation add to the current evidence base and provide a foundation for future research. Outcomes related to ostomy nursing interventions such as preoperative stoma site marking provide endless opportunity for additional research-related activities. n

Acknowledgment

The author is grateful for the warm welcome she received while attending the United Ostomy Associations of America Second National Conference in New Orleans, LA, August 5–8, 2009 and the sincere interest shown this project. She thanks each and every individual who willingly and enthusiastically participated in this study and hopes this work helps improve the care provided.

 

References

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4. Guiding Principles For Sustainable Access to Ostomy Services, Technologies and Innovation. Available at: www.wocn.org/news/211992/Guiding-Principles-For-Sustainable-Access-to-Os.... Accessed April 11, 2016. 

5. International Ostomy Association. Charter of Ostomates Rights. Available at: www.ostomy.org/Ostomate_Bill_of_Rights.html. Accessed April 11, 2016.

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10. Salvadalena G, Hendren S, McKenna L, et al. WOCN Society and ASCRS position statement on preoperative stoma site marking for patients undergoing colostomy or ileostomy surgery.  J Wound Ostomy Continence Nurs. 2015;42(3):249–252.

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12. Haugen V, Bliss DZ, Savik K. Perioperative factors that affect long-term adjustment to an ostomy. J Wound Ostomy Continence Nurs. 2006;33(5):525–535.

13. Person B, Ifargan R, Lachter J, Duek SD,  Kluger Y, Assalia A. The impact of preoperative stoma site marking on the incidence of complications, quality of life and patient’s independence. Dis Colon Rectum. 2012;55(7):783–787.  

14. Prieto L, Thorsen H, Juul K. Development and validation of an quality of life questionnaire for patients with colostomy or ileostomy. Health Qual Life Outcomes. 2005;3(1):62. 

15. Olsbrisch ME. Development and validation of the Ostomy Adjustment Scale.  Rehab Psyc. 1983;28(1):3–13. 

16. Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux study. Ostomy Wound Manage. 2003;49(2):48–55. 

17. Gulbiniene J, Markelis R, Tamelis A, Saladzinskas, Z. The impact of stoma siting and stoma care education on patient’s quality of life. Medicina. 2004;40(11):1045–1053.

18. Karadaq A, Mentes, BB, Uner A, Irkorucu O, Ayaz S, Ozkan S. Impact of stomatherapy on quality of life in patients with permanent colostomies or ileostomies.  Int J Colorectal Dis. 2003;18(3):234–238.  

19. City of Hope Quality of Life-Ostomy Questionnaire. Available at: http://cityofhope.org/prc/pdf/Quality%20of%20Life%20Ostomy.pdf. Accessed April 11, 2016.

20. Grant M, Ferrell B, Dean G, Uman G, Chu D, Krouse R. Revision and psychometric testing of the City of Hope Quality of Life-Ostomy Questionnaire. Qual Life Res. 2004;13(8):1445–1457.

21. Macdonald A, Chung D, Fell S, Pickford I.  An assessment of surgeons’ abilities to site colostomies accurately. Surg JR Coll Surg Edinb Irel. 2003;1(6):347–349.

22. Anaraki F, Vafaie M, Behboo R, Maghsoodi N, Esmaeipour S, Safaee A. Quality of life outcomes in patients living with a stoma. Indian J Pall Care. 2012;18(3):176–180. 

23. Gemmill R, Sun V, Ferrell B, Krouse RS, Grant M. Going with the flow: quality of life outcomes of cancer survivors with urinary diversion. J Wound Ostomy Continence Nurs. 2010;37(1):65–72. 

24. Krouse RS, Grant M, Wendel CS, et al. A mixed-methods evaluation of health-related quality of life for male veterans with and without intestinal stomas. Dis Colon Rectum. 2007;50(12):2054–2067.  

25. Krouse RS, Mohler M, Wendel C, et al. The VA ostomy health-related quality of life study: objectives, methods, and patient sample. Current Med Res Opin. 2006;22(4):781–791.

26. Krouse R, Grant M, Ferrell B, Dean G, Nelson R, Chu D. Quality of life outcomes in 599 cancer and non-cancer patients with colostomies. J Surg Res. 2007;138(1):79–87.

27. Aronovitch SA, Sharp R, Harduar-Morano L. Quality of life for patients living with ostomies: influence of contact with an ostomy nurse. J Wound Ostomy Continence Nurs. 2010;37(6):65–72.

28. Richbourg L, Thorpe JM, Rapp CG. Difficulties experienced by the ostomate after hospital discharge. J Wound Ostomy Continence Nurs. 2007;34(1):70–79.  

 

Potential Conflicts of Interest: none disclosed 

 

Dr. Maydick is an Assistant Professor of Nursing, Long Island University, Harriet Rothkopf Heilbrunn School of Nursing, Long Island, NY. Please address correspondence to: Diane Maydick, EdD, RN, ACNS-BC, CWOCN, 54 Valencia Avenue, Staten Island, NY 10301; email: dmaydick@gmail.com.

Section: 

A Retrospective, Observational Study of the Adequacy of Elective Loop Stoma Diversion

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Ostomy Wound Management 2016;62(5):26–30
Puja Shah, MD, MS; David Mauro, MD; Charles Friel, MD; and Traci Hedrick, MD
Topics: 
retrospective studies
loop ileostomy
Colostomy
postoperative complications
anastomosis

Abstract

Diverting stomas are employed for various clinical indications and easier to revert than end stomas. General, plastic, and colorectal surgeons continue to debate whether a diverting loop stoma adequately diverts stool, preventing spillage into the distal limb, which does not receive stool. A retrospective, descriptive study was conducted involving all patients who underwent loop ostomy surgery (colostomy or ileostomy) — defined by current procedural terminology (CPT) codes 44187, 44188, 44153, and 44155–44158 — between April 1, 2002 and October 12, 2010.

The purpose of the study was to determine if a diverting loop stoma is completely diverting with no efflux into the distal limb by examining the rate of distal limb contamination. Two surgeons identified patients at the University of Virginia who had loop ostomy surgery and subsequently underwent computed tomography (CT) scan with oral contrast for clinical suspicion of abnormal pathology. A radiologist reviewed these images to evaluate the presence or absence of oral contrast in the ostomy distal limb. Distal progression of oral contrast was deemed adequate if oral contrast was visualized within the ostomy bag or if contrast was intraluminal distal to the loop ostomy. The loop ostomy was considered diverting if oral contrast was only visualized in the ostomy bag with no oral contrast distally. Of the 202 eligible patients, 26 (13%) underwent 41 postoperative CT scans of the abdomen/pelvis. Four (4) were excluded due to inadequate exam or confounding contrast (rectal contrast, contrast retention from preoperative scan). Of the remaining 22 patients with 35 CT scans (median age 54 [range 26–82] years, 10 men, 18 Caucasian, 18 having elective surgery), no patient (0%) had evidence of distal contrast. In this and other studies, loop stomas were found to provide adequate diversion without spillage into the nonfunctional limb for the vast majority of patients and should strongly be considered as the procedure of choice for temporary diversion.

 

Colon and rectal surgeons commonly create a protective loop ostomy in order to decrease rates of clinically significant anastomotic leaks in colorectal procedures. Improved techniques in colorectal surgery allow for low (below the anterior peritoneal reflection) and ultra low (1.5 cm–2 cm above the dentate line) anastomoses in lieu of abdominoperineal resections.1 A low anastomosis allows patients to preserve bowel function without the need for a permanent ostomy. Unfortunately, these low anastomoses come with significant leak rates. Numerous descriptive studies and a randomized, controlled prospective study have demonstrated improved outcomes with a temporary defunctioning stoma when performing a low anastomosis, including lower rates of leakage with diverting ostomies in addition to lower rates of re-intervention with loop stomas.2-6

Initially popularized to avoid ischemia associated with ileal conduits and urostomies due to mesenteric undercutting,7 loop ostomies have increased in prevalence in colorectal procedures over the past 25 years for anastomotic protection.8,9 A literature review demonstrated fecal diversion decreased the risk of anastomotic leaks by diverting stool proximally; furthermore, diversion reduced the need for urgent re-operation when a leak occurs.9,10 

Loop ostomies are technically easy to create and are described in several retrospective reviews. Traditionally, the ostomy is sited within the rectus abdominus for loop ostomy formation.8,9 The mesentery of either the ileum or colon is mobilized and the antimesenteric border is grasped with tissue forceps.8 An enterotomy then is created, and the proximal end is anchored with mucocutaneous sutures. An enterotomy that encompasses 4/5 of the circumference will allow the distal bowel to “escape” from the skin.9 In addition, loop ostomies also are easy to reverse, especially with the advent of bowel staplers. End ostomies require large laparotomy incisions for reversal, whereas loop ostomies can be reversed directly through the ostomy incision, which should decrease morbidity.7,11

General, plastic, and colorectal surgeons debate the success of fecal diversion with loop stomas and whether they allow fecal contents to spill into the distal limb. Traditional teaching states loop stomas do not divert as adequately as end ostomies.12 The colorectal surgery division at the University of Virginia (UVA, Charlottesville, VA) has received referrals for conversion of loop ostomies to end ostomies to prevent sacral wound contamination, which in turn would allow for proper wound healing. To support the hypothesis that all loop ostomies are diverting, a retrospective study was conducted to determine if loop ostomies adequately divert stool without distal limb contamination, as shown via oral contrast and computed tomography (CT) of the abdomen/pelvis. The purpose of this retrospective study was to examine the rate of distal limb contamination following elective loop ostomy surgery.

Materials and Methods

Patient selection. The institutional review board at the UVA Health System approved this retrospective, observational study with a waiver for written informed consent. The general surgery and colorectal databases were queried for all patients undergoing a colorectal procedure between April 1, 2002 and October 12, 2010. Patients were eligible if they underwent ostomy creation and a subsequent CT scan in the study period. Patients undergoing any colorectal procedure between the specified dates had further chart review performed by a surgery resident and attending surgeon to determine the presence or absence of a loop ostomy (ileostomy or colostomy). Patient name, race, gender, medical record number, procedure type, date of operation, elective or emergent operation, current procedural terminology (CPT) code, and reason for surgery were abstracted and recorded in a separate database for all patients. Ostomy reversal was not abstracted, since it was not relevant for the purposes of the current study. Patients undergoing loop colostomy or ileostomy procedures were defined by CPT codes 44187, 44188, 44153, and 44155–44158. 

Information on type and date of CT scan, if any, was collected along with any recent non-oral contrast administration. CT scans were ordered at the discretion of the treating physician based on clinical suspicion for abnormal pathology or for cancer surveillance. Scans were appropriate for inclusion if they occurred after ostomy creation but before stoma reversal. If multiple scans were ordered for a patient, all eligible scans during the study period were included. Chart review was also essential to determine which patients underwent postoperative CT scans of both the abdomen and pelvis with oral contrast (iohexol). A radiologist independently retrieved and reviewed the scans and corroborated the presence or absence of distal contrast. 

This review was performed independently of the clinically indicated image review and was performed for study purposes only. Technically incomplete studies (ie, imaging of only the abdomen or pelvis, cessation of imaging after the scout acquisition and before cross-sectional imaging, or oral contrast not reaching the level of the ostomy) were excluded. Additionally, patients were excluded if they received rectal contrast or oral contrast within 1 week before creation of the loop ostomy. 

Surgical technique. Standard procedure, diverting loop ileostomies or colostomies were created under the supervision of 1 of 8 attending surgeons. One patient had a loop ileostomy created at another institution that was revised by one of the UVA surgeons during a concurrent operation. In general, patients presenting for elective ostomies undergo ostomy site marking by a specified ostomy team before surgery. Bowel preparation with polyethylene glycol for elective patients before colonic surgery was widely practiced during the study period. Emergent ostomies were placed in a location chosen by the attending surgeon. 

A muscle-splitting incision through rectus abdominus muscle and fascia is made at the preferred site. A loop of small or large bowel then is grasped with Babcock forceps and passed through the incision. Bovie electrocautery is used to create a small enterotomy. Typically, loop ileostomies are created using a Brooke technique, whereas loop colostomies are sutured to the skin. A Brooke ileostomy involves suturing a portion of the ileum to the skin so an inside-out portion of ileum serves as the ostomy.13 Surgeons at the authors’ institution classically place a supporting rod underneath the ostomy if any tension is noted during creation of the stoma. Stoma appliances then are fitted in the operating room. 

Examination technique. CT scans were performed at the discretion of the physician with a standardized protocol (single-breath hold, spiral-acquisition, 5-mm reconstructed images). Examinations with and without intravenous contrast medium were included. Oral contrast protocol recommends patients receive one oral dose as soon as the CT order is placed; dose 2 is given 30 minutes after completion of the first dose. The third and final dose of oral contrast is administered 15 minutes before transport to CT. Oral contrast dosing was variable given unpredictable patient wait times for an available scanner. A radiologist reviewed the scans in 3 planes on the hospital imaging system (PACS, Carestream Vue PACS, Rochester, NY). Both diagnostic and cancer surveillance scans were used in the study analysis.

Imaging and data analysis. Each CT was examined to determine the most distal extent of oral contrast progression. Distal progression of oral contrast was deemed adequate if oral contrast was visualized within the ostomy bag or if contrast was intraluminal in bowel distal to the loop ostomy. The loop ostomy was considered diverting if oral contrast was visualized only in the ostomy bag with no oral contrast distally. If oral contrast was visualized in the distal bowel, with or without contrast in the ostomy, the ostomy was considered incompletely diverting.

Data recording and analysis. Data were abstracted from retrospective chart review and maintained in a separate Excel database. Because there is no comparison group, no formal statistical analysis was performed. Descriptive summaries are provided for each variable, including overall number of patients and percent of total.

Results

During the study period, the records of 202 patients who underwent a loop colostomy or ileostomy were identified. Of these, 40 underwent a CT exam of the abdomen or pelvis with a total of 77 radiographic studies. Chart review and analysis of the operative reports excluded 1 patient with 2 CT exams who underwent a divided end ostomy. The radiologist reviewed the remaining CT examinations of 39 patients who underwent 75 studies. Of those, 30 studies were excluded due to technically incomplete examinations. An additional 2 patients were excluded for receiving a water-soluble contrast enema and not oral contrast. Lastly, 5 patients with 6 CT scans were excluded for confounding oral contrast (recent preoperative CT with oral contrast and recent rectal contrast). Ultimately, 22 patients (median age 54 [range 26–82] years) with 35 CT studies had adequate examinations for inclusion: 9 patients (41%) had loop colostomies — 7 patients with descending colostomies underwent 11 CT scans (2 patients with ascending colostomies underwent 1 scan each). The remaining 22 scans were from 13 patients (59%) with loop ileostomies (see Table 1). 

The study included an approximately equal number of men and women. The majority of patients were Caucasian (82%), and most stomas were created under elective conditions (82%). Seven (7) patients with a colostomy had a sigmoid colostomy; 2 patients had a right colostomy (see Table 1). owm_0516_shah_table1

None (0) of the 22 patients undergoing 35 CT scans of the abdomen/pelvis with oral iohexol contrast administration was identified as having contrast in bowel distal to the level of the loop ostomy, regardless of reason for ostomy formation. 

Discussion

Some colorectal surgeons have received referrals, particularly from plastic surgeons, requesting conversion of a loop to an end ostomy. The referrals frequently come with complaints of anal or rectal leakage, even with a diverting loop stoma. The concern is that the discharge may actually be nondiverted stool, causing contamination of wounds or flaps created in previous procedures. It is known that patients with diverting ostomies, even end stomas, continue to pass mucous discharge, which occurs even in the presence of true fecal diversion.14 Additionally, the drainage may result from diversion colitis, a term coined by David Glotzer,15 who first described this phenomenon in 1981 based on a 10-patient sample with inflammatory findings on proctoscopy. A systematic review by Kabir et al16 of 22 case series, 9 case reports, 2 retrospective, and 2 prospective studies qualitatively demonstrated diversion colitis occurs in colonic segments distal to the diversion and is thought to be a nonspecific inflammation occurring in up to 33% of patients with a diverting ostomy. Diversion colitis can be asymptomatic or can cause symptoms ranging from pelvic/abdominal pain and tenesmus in up to 15% of patients, bloody discharge or mucous discharge in up to 40%, and anorectal pain. 

Few studies have evaluated fecal diversion with loop ostomies. Winslet et al8 prospectively evaluated the effectiveness of the defunctioning capacity of the loop stoma by administering radioactive dye orally followed by rectal lavage with a Foley catheter to assess the presence of dye. The authors found a 99% effectiveness of complete diversion in 18 patients. Similarly, in a 10-patient prospective cohort Schofield et al17 were unable to detect any radiolabeled dye in the distal limb, concluding loop stomas are adequately diverting. Morris et al12 prospectively assessed diversion through administration of oral barium in 23 patients with loop colostomies followed by mechanical bowel preparation to determine if barium passed to the distal limb; similar to the current study, no patient was found to have barium in the distal portion of bowel.

In this study, CT scans of the abdomen/pelvis were evaluated in 22 patients who had previously undergone diverting stoma and the presence of contrast distal to the ostomy was used as an indicator of distal spillage of stool. The current study demonstrates no patient with either loop ileostomy or loop colostomy had evidence of contrast distal to the anastomosis, regardless of reason for operation. Patients who had distal contrast received oral or rectal contrast shortly before the CT in question and were therefore appropriately excluded from analysis. 

Limitations 

This retrospective, observational study has important limitations. The CT scans excluded for confounding oral contrast may have had contrast in the distal limb from post-ostomy formation iohexal. Although this is a possibility, it seems unlikely because no other patients had distal contrast in the nonfunctional limb. Additionally, the current study included a small sample size of 22 patients, which may limit the ability to identify distal contrast. Furthermore, newer imaging techniques may have greater sensitivity to detect distal contrast or radioactive tracer. The timing between administration of iohexol and initiation of CT imaging is unknown. Lastly, as a single institution, retrospective study, the generalizability to other patient cohorts is limited. 

Conclusion

The results from this and previous research confirm that loop stomas are adequately diverting. Given the ease of reversal, they serve as a preferred method for temporary diversion. n

References 

1. Ludwig KA. Sphincter-sparing resection for rectal cancer. Clin Colon Rectal Surg. 2007;20(3):203–212. 

2. Chude GG, Rayate NV, Patris V, et al. Defunctioning loop ileostomy with low anterior resection for distal rectal cancer: should we make an ileostomy as a routine procedure? A prospective randomized study. Hepatogastroenterology. 2008;55(86-87):1562–1567. 

3. Giuliani D, Willemsen P, Van Elst F, Vanderveken M. A defunctioning stoma in the treatment of lower third rectal carcinoma. Acta Chir Belg. 2006;106(1):40–43. 

4. Matthiessen P, Hallböök O, Rutegård J, Simert G, Sjödahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007;246(2):207–214. 

5. Marusch F, Koch A, Schmidt U, et al. Value of a protective stoma in low anterior resections for rectal cancer. Dis Colon Rectum. 2002;45(9):1164–1171. 

6. Rondelli F, Reboldi P, Rulli A, et al. Loop ileostomy versus loop colostomy for fecal diversion after colorectal or coloanal anastomosis: a meta-analysis. Int J Colorectal Dis. 2009;24(5):479–488. 

7. Fonkalsrud EW, Thakur A, Roof L. Comparison of loop versus end ileostomy for fecal diversion after restorative proctocolectomy for ulcerative colitis. J Am Coll Surg. 2000;190(4):418–422.

8. Winslet M, Drolc Z, Allan A, Keighley M. Assessment of the defunctioning efficiency of the loop ileostomy. Dis Colon Rectum. 1991;34(8):699–703.

9. Krausz M. Loop ileostomy for complete fecal diversion following colectomy and ileoanal anastomosis. Dis Colon Rectum. 1988;31(10):819–820.

10. Hanna MH, Vinci A, Pigazzi A. Diverting ileostomy in colorectal surgery: when is it necessary? Langenbecks Arch Surg. 2015;400(2):145–152. 

11. Shirley F, Kodner IJ, Fry RD. Loop ileostomy. Techniques and indications. Dis Colon Rectum. 1984;27(6):382–386. 

12. Morris DM, Rayburn D. Loop colostomies are totally diverting in adults. Am J Surg. 1991;161(6):668–671. 

13. Brooke BN. The management of an ileostomy. Lancet. 1952;260(6725):102–104.

14. Haas PA, Fox TA. The fate of the forgotten rectal pouch after Hartmann’s procedure without reconstruction. Am J Surg. 1990;159(1):106–110.

15. Glotzer DJ, Glick ME, Goldman H. Proctitis and colitis following diversion of the fecal stream. Gastroenterology. 1981;80(3):438–441.

16. Kabir SI, Kabir SA, Richards R, Ahmed J, MacFie J. Pathophysiology, clinical presentation and management of diversion colitis: a review of current literature. Int J Surg. 2014;12(10):1088–1092. Epub 2014 Aug 20.

17. Schofield PF, Cade D, Lambert M. Dependent proximal loop colostomy: Does it defunction the distal colon? Br J Surg. 1980;67(3):201–202. 

 

Dr. Shah is a general surgery resident, University of Virginia, Charlottesville, VA. Dr. Mauro is an internventional radiology fellow, Mount Sinai Hospital, New York, NY. Dr. Friel and Dr. Hedrick are colorectal surgeons, University of Virginia. Please address correspondence to: Puja M. Shah, MD, University of Virginia, Department of Surgery, PO Box 800679, Charlottesville, VA 22908-0679; email: ps5au@virginia.edu

 

Potential Conflicts of Interest: This research was funded by the National Institutes of Health Grant #Surgical Oncology T32 CA163177. The funding was used to provide salary support for the first author. The funder had no role in study design, data collection, or manuscript drafting.

Section: 

Hyperbaric Oxygen Therapy for the Adjunctive Treatment of Pyoderma Gangrenosum: A Case Report

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Ostomy Wound Management 2016;62(5):32–36
I-Han Chiang, MD; Yi-Shu Liao, MD; Niann-Tzyy Dai, MD, PHD; Hao-Yu Chiao, MD; Chang-Yi Chou, MD; Shyi-Gen Chen, MD, MPH; Tim-Mo Chen, MD; and Shun-Cheng Chang, MD
Topics: 
case reports
hyperbaric oxygenation
pyoderma gangrenosum
neutrophilic dermatosis
skin diseases

Abstract

Pyoderma gangrenosum (PG) is a neutrophilic dermatosis of unknown etiology characterized by an ulcerative skin condition and confirmed through a diagnosis of exclusion. Management usually consists of systemic drug therapy, such as corticosteroids, sulfones, or immunosuppressants, either alone or in combination. Long-term use of these medications often has untold side effects. Hyperbaric oxygen therapy (HBOT) has been shown effective in the treatment of PG, reducing pain and tempering the need for medication.

A case is presented of a 54-year-old woman with diabetes, hypertension, and a peptic ulcer who presented with painful, purulent ulcers on her buttocks, hands, and lower extremities of 2 weeks’ duration. She was ultimately diagnosed with PG and provided 20 mg/day of oral prednisone for 1 week, tapered to 10 mg/day in the next week and then stopped. In addition, she received 12 sessions of HBOT — she breathed in 100% oxygen under 2.5 atmospheres absolute pressure for 90 minutes over 2 weeks. Her wounds healed without scarring. This excellent outcome including good wound healing, decreased pain, and reduced doses of systemic corticosteroids warrants additional study of the adjunctive use of HBOT for PG. 

 

Pyoderma gangrenosum (PG) is a painful ulcerative neutrophilic disease of the skin with unknown origin. It was first described by Brunsting et al1 in 1930. von den Driesch2 presented a study of 44 patients with PG with follow-up. Initially, PG clinically presents as a sterile pustule with an inflamed base, an erythematous nodule, or a hemorrhagic bulla on a violaceous base, mostly involving the lower extremities. These lesions evolve to form shallow or painful ulcers with a purulent undermined base and a violaceous gunmetal-colored border that spreads peripherally. With treatment, the borders flatten and the ulcer heals to form a thin cribriform scar.  Based on Ruocco et al’s3 and Dabade and Davis’4 reviews, the incidence of PG is 3 to 10 cases per million persons per year globally. Patients are generally between 25 and 50 years of age with a slight female predominance. Oka et al5 found interleukin-8 (IL-8) overexpression in skin specimens from patients with PG, and their animal studies suggest an etiologic role of IL-8 in the pathogenesis of PG. 

The etiology of PG remains poorly understood, but a predominantly immunological pathogenesis involving neutrophil dysfunction seems most likely. According to Dabade and Davis’4 and Alavi et al’s6 reviews, half of the patients with PG have associated systemic diseases, including inflammatory bowel disease, rheumatoid arthritis, myeloproliferative disorders, and connective tissue disease. 

In reviews7,8 of several prospective, randomized, controlled studies, hyperbaric oxygen therapy (HBOT), the administration of 100% oxygen at 2 to 3 atmospheres absolute pressure, has shown benefits in treating acute and chronic wounds; because multiple cellular mechanisms are triggered by reactive oxygen and reactive nitrogen species, wounds treated with HBOT show improved neovascularization, decreased peripheral edema, and diminished inflammatory and immune responses. Complications (in <0.04% of cases) of HBOT include barotrauma, claustrophobia, myopia, and seizures. These are rare and usually reversible7,8; however, irreversible nuclear cataracts have been described with HBOT exceeding 150 hours.9 Several case reports reviewed by Tutrone et al10 have shown HBOT to effectively treat PG ulcers and reduce pain associated with PG. 

Treatment of PG with prolonged high-dose systemic corticosteroids (0.5–1 mg/kg/day; more than 1 month) or other immunosuppressants, in addition to careful local wound care, characterizes the mainstay of management.12-14 The following case study is presented to demonstrate that HBOT plays a role in moderating the dosage of steroids and reducing pain. 

Case Report

Ms. J is a 54-year-old woman weighing 65 kg with a history of type 2 diabetes mellitus, peptic ulcer disease, and hypertension controlled with oral medication. She presented at the authors’ dermatology department with a 2-week history of multiple painful ulcers with violaceous undermined borders and purulent bases located on her buttocks, both hands, and lower extremities (see Figure 1). She was afebrile and denied any history of skin disease or trauma. She was provided surgical debridement using a Goulian knife; wound dressings included povidone-iodine and gauze. Ms. J’s lesions quickly expanded laterally and developed a necrotic ulcerated center, worsening after 1 week of treatment. She rated her pain 8 out of 10 on a subjective visual analogue scale (VAS) and was given tramadol (50 mg) 6 times a day. She was referred to a plastic surgeon in a tertiary hospital for further evaluation who performed a skin biopsy of the lower extremities, 0.5 mm in diameter and deep to subcutaneous fat. All wounds were covered with alginate dressings to address absorption and possible infection. owm_0516_chang_figure1

Pathology revealed neutrophilic dermatoses (see Figure 2). In order to eliminate other causes of cutaneous ulcers, laboratory testing was performed and included a complete blood cell count, levels of C-reactive protein, fasting blood sugar and lipids, hepatitis screening, evaluation of renal function, and urinalysis. Ms. J’s levels were all normal except for hyperglycemia. Screenings for hypercoagulability factors such as anticardiolipin antibodies, proteins C and S, antithrombin III, Factor V Leiden, and toxicology panel also were negative. Immunological tests including those for antinuclear antibody, rheumatic factor complement, cryoglobulinemia, and anti-SCL-70 and anticentromere antibodies were unremarkable. Wound cultures revealed negative results. PG was diagnosed based on clinical, histopathology, and laboratory findings.11 Colonoscopy and blood tests for hematologic disorders showed no inflammatory bowel disease or hematologic disorders. Ms. J denied having arthritis. She was treated with 20 mg/day of oral prednisone for 1 week; this was tapered down to 10 mg/day in the next week and then stopped. owm_0516_chang_figure2

The plastic surgeon, also an expert in HBOT, added HBOT to the treatment protocol immediately after receiving the biopsy result. Ms. J breathed 100% oxygen under 2.5 atmospheres absolute pressure for 90 minutes through a facemask. Twelve (12) HBOT sessions were performed daily except on weekends. The pain decreased to a VAS pain score of 2 after 1 week, and Ms. J received no analgesics. The lesions were completely healed with scarring in 2 weeks (see Figure 3). owm_0516_chang_figure3

Ms. J continued to be monitored at the outpatient department and showed no evidence of relapse over 6 months. Considering the extensive PG observed at presentation, the cosmetic results were excellent with unapparent scars.

Discussion

PG is a rare form of neutrophilic dermatosis that presents as an inflammatory and ulcerative disorder of the skin. Because no diagnostic criteria have been established for clinical use, PG is a diagnosis of exclusion. In their review, Su et al11 proposed major and minor criteria for the diagnosis of PG: the major criteria are rapid progression of a painful, necrolytic cutaneous ulcer and exclusion of other cutaneous disease; the minor criteria are pathergy, systemic disease-associated PG (ie, inflammatory bowel disease, arthritis, IgA gammopathy, or malignancy), and/or rapid response to systemic glucocorticoid treatment. To be considered a definite case of PG, the condition should meet the 2 major criteria and at least 2 minor criteria. von den Driesch2 independently used inclusion criteria for the diagnosis of PG patients that are almost identical to Su et al.11 

Based on Oka et al’s5 study and Ahronowitz et al’s12 review, neutrophil dysfunction, genetic factors, and dysregulation of the immune system might contribute to PG. The condition requires multiple treatment modalities to reduce inflammation and optimize wound healing, in addition to treating any underlying diseases. Prednisone and cyclosporine have been mainstays of the systemic treatment for PG, although several clinical trials12 support the use of biological therapies such as tumor necrosis factor-α inhibitors for refractory cases of PG. According to Prystowsky et al’s13 summary of the management of 22 cases of PG over 4 years and Chow et al’s14 review of current PG treatment, experience suggests patients should receive 0.5–1 mg/kg per day of oral prednisone or its equivalent. The glucocorticoid treatments should be tapered off and discontinued within 4–10 weeks. 

Bennett et al15 performed a retrospective analysis of the medical records of 86 patients with PG who were evaluated and treated over 12 years at 2 university-based dermatology departments. Although clinical signs of improvement might be evident within a few days of initial treatment, the 86 PG patients reviewed required a mean 11.5 ± 11.1 months of treatment to achieve complete healing. 

Results of Dodiuk-Gad et al’s16 review included an evidence-based, strategic approach to the general risk management of systemic glucocorticoid use. Although the potent anti-inflammatory and immunosuppressive effects of systemic glucocorticoids have led to their wide use in the treatment of dermatologic diseases, long-term therapy of weeks or months with systemic glucocorticoids is associated with significant adverse effects, such as osteoporosis, myopathy, peptic ulcer disease, hyperglycemia, hypertension, and edema. For Ms. J, given her medical history, continued use of prednisone could have led to poor control of her diabetes and hypertension, and her peptic ulcer disease could have recurred.

Wound treatment with HBOT is well established. According to a Cochrane database systematic review,7 HBOT significantly improved the chance of healing foot ulcers in persons with diabetes mellitus. Dauwe et al9 conducted a systematic review of HBOT in the treatment of complicated acute wounds, flaps, and grafts: a total of 8 studies (4 prospective, randomized, controlled trials; 3 prospective, nonrandomized, controlled trials; and 1 retrospective, controlled trial) addressed the use of HBOT for wounds in humans. The results showed HBOT can augment healing in complicated acute wounds, such as skin graft survival, healing of burn injuries, and crush injuries. 

For Ms. J, hypertension, diabetes mellitus, and a history of peptic ulcer precluded long-term steroid use. Using adjuvant HBOT, the wounds heal rapidly in 2 weeks, allowing clinicians to decrease steroid dosage and duration. More studies are needed to increase the evidence base for this treatment approach.

Conclusion

PG is an uncommon inflammatory and ulcerative skin disorder characterized histopathologically by the accumulation of neutrophils in the skin. For patients with extensive PG, systemic glucocorticoids are used as first-line agents. For a patient with diabetes, hypertension, and a history of peptic ulcers, treatment of PG with a systemic glucocorticoid and HBOT allowed a decreased dosage and duration of steroid usage. Wound pain was diminished after 1 week and the wounds were healed after 2 weeks of treatment. Additional research is needed to determine the safety, efficacy, and effectiveness of this treatment approach for patients with PG. 

Acknowledgment

The authors thank the Civilian Administration Division of Tri-Service General Hospital, National Defense Medical Center and Shuang-Ho Hospital, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan, Republic of China.

References

1. Brunsting LA, Goeckerman WH, O’Leary PA. Pyoderma (echthyma) gangrenosum: clinical and experimental observations in five cases occurring in adults. Arch Derm Syphilol. 1930;22(4):655–680.

2. von den Driesch P. Pyoderma gangrenosum: a report of 44 cases with follow-up. Br J Dermatol. 1997;137(6):1000–1005.

3. Ruocco E, Sangiuliano S, Gravina AG, Miranda A, Nicoletti G. Pyoderma gangrenosum: an updated review. J Eur Acad Dermatol Venereol. 2009;23(9):1008–1017.

4. Dabade TS, Davis MD. Diagnosis and treatment of the neutrophilic dermatoses (pyoderma gangrenosum, Sweet’s syndrome). Dermatol Ther. 2011;24(2):273–284.

5. Oka M, Berking C, Nesbit M, et al. Interleukin-8 overexpression is present in pyoderma gangrenosum ulcers and leads to ulcer formation in human skin xenografts. Lab Invest. 2000;80(4):595–604.

6. Alavi A, Sajic D, Cerci FB, et al. Neutrophilic dermatoses: an update. Am J Clin Dermatol. 2014;15(5):413–423.

7. Kranke P, Bennett MH, Martyn-St James M, Schnabel A, Debus SF. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev. 2015.6:CD 004123

8. Thom SR. Hyperbaric oxygen: its mechanisms and efficacy. Plast Reconstr Surg. 2011;127(1):131–141.

9. Dauwe PB, Pulikkottil BJ, Lavery L, et al. Does hyperbaric oxygen therapy work in facilitating acute wound healing: a systematic review. Plast Reconstr Surg. 2014;133(2):208e–215e.

10. Tutrone WD, Green K, Weinberg JM, Caglar S, Clarke D. Pyoderma gangrenosum: dermatologic application of hyperbaric oxygen therapy. J Drugs Dermatol. 2007;6(12):1214–1219.

11. Su WP, Davis MD, Weenig RH, Powell FC, Perry HO. Pyoderma gangrenosum: clinicopathologic correlation and proposed diagnostic criteria. Int J Dermatol. 2004;43(11):790–800.

12. Ahronowitz I, Harp J, Shinkai K. Etiology and management of pyoderma gangrenosum: a comprehensive review. Am J Clin Dermatol. 2012;13(3):191–211.

13. Prystowsky JH, Kahn SN, Lazarus GS. Present status of pyoderma gangrenosum. Review of 21 cases. Arch Dermatol. 1989;125(1):57–64.

14. Chow RK, Ho VC. Treatment of pyoderma gangrenosum. J Am Acad Dermatol. 1996;34(6):1047–1060.

15. Bennett ML, Jackson JM, Jorizzo JL, et al. Pyoderma gangrenosum. A comparison of typical and atypical forms with an emphasis on time to remission. Case review of 86 patients from 2 institutions. Medicine (Baltimore). 2000;79(1):37–46.

16. Dodiuk-Gad RP, Ish-Shalom S, Shear NH. Systemic glucocorticoids: important issues and practical guidelines for the dermatologist. Int J Dermatol. 2015;54(6):723-729

 

Dr. Chiang is a plastic resident, Division of Plastic Surgery, Department of Surgery; Dr. Liao is a pathologist resident, Department of Pathology; Dr. Dai is vice-professor, Chief, and attending plastic physician; Dr Chiao and Dr. Chou are plastic residents; Dr. SG Chen is a vice-president of Tri-Service General Hospital, professor, and attending plastic physician; and Dr. TM Chen is a professor and attending plastic physician, Division of Plastic Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China. Dr. Chang is an assistant professor, Chief, and attending physician, Division of Plastic Surgery, Department of Surgery, Hyperbaric Oxygen Therapy Center, Shuang-Ho Hospital, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan, Republic of China. Please address correspondence to: Shun-Cheng Chang, No.291, Zhongzheng Rd, Zhonghe Dist, New Taipei City 235, Taiwan, Republic of China; email: csc901515@gmail.com.

 

Potential Conflicts of Interest: none disclosed 

Section: 

Using the Literature to Understand Achilles’ Fate

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Ostomy Wound Management 2016;62(5):38–42
Vesna S. Rakic, MD, MS
Topics: 
review
Achilles tendon
injuries
tibialis posterior artery
chronic wound

Abstract

According to Greek mythology, Achilles was fatally wounded in his heel, bled out, and died. Several unproven hypotheses mention poisoning, infection, allergy, hemophilia, thyrotoxic storm (ie, pain and stress), and suicide. The author, a plastic surgeon who often treats chronic wounds, proposes an additional scenario: Although not mortally wounded, Achilles was considered dead, because in his time a wounded hero was as good as a dead hero, so he lived out the remainder of his life as former hero with a chronic wound far away from everyone.

To determine whether his injury was enough to cause fatal bleeding and quick death or if other factors might have been in play, a search of the literature was conducted to enhance what is known about Achilles, basically through the tale related in The Iliad and the clinical impact of an Achilles’ injury. Search terms utilized included bleeding tibialis posterior artery (3 manuscripts were found) and chronic wound, Achilles tendon (631 manuscripts were located). Although science may not be able to explain how and why Achilles died, the literature supported the conjecture that Achilles probably had a chronic wound with skin and paratenon defect, devitalized tendon tissue, bleeding, granulation, and repeated infections. It is interesting to consider the state of his injury and his mind in the making of this legend.   

 

In Greek mythology, Achilles, the Greek hero of The Iliad,1 was the son of Peleus, the king of the Myrmidons, and the nymph Thetis. According to legend, fate brought him everything: exceptional strength, obvious beauty, and great courage. As a 10-year-old boy, he strangled a wild boar with his bare hands and caught up with a running deer. He fought for 9 years, conquering 23 cities. He was ruthless in the Trojan War; he is described as resembling a fire consuming a parched forest. His presence caused fear among Trojans. He killed Hector, the prince of Troy, to avenge a friend’s death and then repeatedly dragged the corpse around the city walls.2 

Achilles’ only weakness was his heel. According to legend, his mother had taken him to the River Styx, which was supposed to offer powers of invincibility, and dipped his body into the water. Because she held him by the heel, it was not washed over by the water of the magical river (see Figure 1). When Achilles was wounded in his heel, he bled out and died.2“Achilles’ heel” became a synonym for a vulnerable spot or human physical or mental weakness. owm_0516_rakic_figure1

Historical perspective. In the 11th and 12th centuries BC (ie, the years circa 1200 BC, the Mycenaean civilization, and the Trojan War), medicine largely had its origins in magic and priestly practices; humans were healed by the grace of the gods. Priests used rational therapy (ie, nonmagical practice) in addition to rituals, but patients could not clearly understand the differences between magic and science. Scientific principles of observation, comprehension, diagnosis, and treatment were slowly developing.3,4

Descriptions of war wounds and their treatment depict surgery from an empirical point of view. Physicians in The Iliad are referred to as persons “far more valuable than other persons.” This leads to the conclusion a physician had specific skills and was successful in treating people. Asclepius, the God of Medicine and healing, resurrected people from the dead and performed operations (ie, Caesarian sections) so successfully that Hades, God of the Underworld, complained to Zeus that nobody was dying; he asked Zeus to throw a thunderbolt at Asclepius to kill him.2,5 Two sons of Asclepius treated the injured during the Trojan War.6

Although the exact dates of the Trojan War are not clear (ie, whether it was during the Mycenaean civilization or during the Dark Age of Greece), the decline of the Mycenaean civilization resulted in wars, migration, and the destruction of the culture, literacy, communications, trade, and medicine. Regardless of when it occurred, the literature concludes that during the Trojan War, physicians were aware of the importance of body and therefore wound hygiene. Wounds were cleaned and sutured and herbs were used. To stop the bleeding, a red-hot iron was used (early cauterization). In those days, micro-organisms were unknown, and asepsis procedures and antibiotics were not used.3,4

What is known today is the anatomy of Achilles’ heel — a strong, wide, and thick tendon that plays an important role in the biomechanics of the foot — was partially understood in ancient Greece. The heel enables standing on the toes, walking, running, and jumping. Two arteries carry blood to the heel — the peroneal artery and the tibialis posterior artery (the latter ranging in diameter from 0.93 mm–3.1 mm)7— that descend behind the external and internal malleolus. The tendon has no blood vessels of its own sheath; the paratenon, a sheer, gossamer layer of connective tissue matrix fortified with capillaries, helps nourish the tendon.

Achilles’ legend. The story of Achilles is one of the most important legends in Greek mythology. Achilles was said to have died from a heel wound as the result of a poisoned arrow shot by Paris, Hector’s brother (see Figure 2).6 Arctinus of Miletus wrote, “The arrow hit Achilles in the right heel, his only vulnerable spot, and he died in terrible pain.”6 Were the injury and subsequent bleeding enough to immediately kill Achilles?8 Or did the wound become chronic? owm_0516_rakic_figure2

Few medical publications address the circumstances surrounding Achilles’ death.8-10 Some historians question the legend — that the myth of Achilles, half God, half human, is a fiction with no proof of existence.11 Some even question the reality of the Trojan War. The ancient Greeks believed the Trojan War was a historical event, but most of the information comes from The Iliad and The Odyssey, attributed without full certainty to Homer. The surrounding myths describe Homer as a blind poet who played lyre and recited poems. He lived in the 8th and 7th centuries BC, 4 or 5 centuries after the Trojan War.9 As such, this author believes Achilles’ death was not sufficiently explained, subsequently considering whether Achilles survived the aforementioned tendon wound and suffered from a chronic wound; if so, how would a war hero react to living with a chronic wound? 

To explore the legend/myth of Achilles, a literature search through the PubMed database was conducted using the following terms: bleeding tibialis posterior artery, chronic wound, and Achilles tendon. In addition, a search was conducted of history books that address Achilles and the time in which he lived.

Results and Discussion 

Literature. A significant disproportion exists between the number of publications on a chronic Achilles’ tendon wound (631) and those that focus on the problem of bleeding in the heel area (ie, Achilles tendon; 3 publications). Several texts2-6,11,12 covered the historical period or the epoch in which Achilles lived.

Biological warfare. Lee and Jacobs10 posited whether Achilles’ death could be attributed to bacteria that caused infection (eg, Clostridium tetany, C. botulinum, C. perfringens, Yerseniapestis) and if these bacteria were used as biological weapons/poison. Bacteria have always existed but probably were not deliberately used as a biological weapon. No one knew about bacteria in Achilles’ times. Although some publications state warriors dipped the tips of arrows into dead people’s fluids, this was probably because of beliefs that death magically can be transferred,5 not because warriors knew these fluids contain bacteria. 

Infection. C. tetany can be found in the intestinal tract of horses, cattle, and sheep (bred in ancient Greece). Could these bacteria get into a wound and cause tetanus? The tetanus agent develops toxin only in wounds lacking oxygen (anaerobic conditions). Tetanus is not likely to develop in open, bleeding wounds such as Achilles’.2 However, if the wound was narrow and deep, this would create favorable conditions for the development of tetanus. In addition, the description of Achilles’ armor mentions he had a shield and a helmet “with a mane of a horse that shines like a star…” (see Figure 3). A tetanus agent can be found in horsehair, so contact with the wound would not have been impossible.11 owm_0516_rakic_figure3

Botulinum toxin is found in rotten meat and canned food (anaerobic conditions). In ancient Greece, food included meat, fish, and olives.12 Finding food was difficult and it probably was consumed quickly; if not, the meat was not preserved properly. Botulinum toxin is the strongest toxin known to man; even a small dose (median lethal dose is 30 pg/kg) would be enough to kill Achilles if it entered the wound and was carried through the bloodstream.13

Arrowhead. It is highly unlikely that the tip of the arrow was made of lead, so lead poisoning can be eliminated as a possibility.10 Lead is a soft metal with a high density and low melting point, making it unsuitable for making arrows. In those days, shields and weapons were made of bronze. In addition, lead is not a factor in acute poisoning because it has a cumulative effect. It is also unlikely Achilles’ death was due to an allergen on the tip of the arrow.10

Pain and stress. Another potential cause of death could be thyrotoxic storm because of the pain and stress.10 However, the pain that accompanies an Achilles injury typically subsides when resting. Achilles tendon injury is a very common injury in professional athletes14; warriors in the time of the Trojan War were surely in the same top physical shape and accustomed to the same athletic prowess. In terms of stress, Achilles’ entire life as a warrior was stressful, so why would this event be decisive? Thus, no clear connection exists in the literature between such an injury and thyrotoxic storm.

Suicide. An immobilized Achilles might have feared falling into enemy hands. A wound near the triceps tendon is right beneath the skin, insufficiently protected, and exposed to mechanical influence. This area is poorly vascularized and any injury, defect, or lack of skin on the heel may lead to infection and a chronic wound that does not heal for weeks or months. Even a closed injury of the Achilles tendon requires rest (6 to 8 weeks), and typically weeks of immobilization and rehabilitation.15,16 

Struck by Paris, Achilles was crippled and angry, presumably felt severe pain, and could not run or walk. Were pain and loss of mobility enough cause for suicide for a war hero?10 This half-god, skillful, fearless, previously invincible warrior had spread fear among enemies by just standing in front of them. Per the legend, enemies retreated at the sight of Achilles’ armor (which in one circumstance, he had loaned to a friend). In The Iliad,1 Zeus gave permission to the assembly of gods “that each god may assist the army of his choice, in order to weaken the great power of Achilles, who could on that day and in spite of destiny, conquer Troy.” 

During the war, Achilles led not only the Myrmidons, but also often all of the Achaean forces, which included Spartan tribes, who must have influenced Achilles. Sparta, famous for its military force and civil discipline, completely focused on military training and excellence. Spartans managed to compensate for their paucity of numbers, which was their main disadvantage, by focusing on perfect discipline. Spartan warriors always wore red to cover the blood, if injured. For them, leaving the battlefield was never an option. Spartan mothers stayed physically active during their pregnancy in order to give birth to strong children; when they sent their sons to war, they gave them their shields saying, “With the shield or on the shield,”2 meaning their sons could return from war either as victors or dead on the shield. Therefore, Spartans and other warriors in ancient Greece would have respected a warrior injured in battled who committed suicide. Suicide was not only accepted among warriors, it was, in a way, expected. As a hero among heroes, Achilles could choose his fate — either a long and inglorious life or a short and glorious one. Therefore, the possibility that Achilles committed suicide is not far-fetched. 

Further conjecture. Homer might have wanted to present Achilles’ death as a heroic end (struck with a poisonous arrow, bleeding out, and dying). Could Achilles have lived as a helpless man with a cane? One might suppose that if Achilles survived his injury (which may be true), he would have hoped the wound would heal quickly and he could resume his warrior ways. However, during the Trojan War, all wounds seemed to become deadly or heal slowly (chronic). Wounds rarely healed per primam intentionem. According to Herodotus (5th century BC), the Trojan War may have never happened if the king of the Teucrians had not visited Greece with the hope of healing his wound. The prophetess told him only the person who injured him (Achilles) could cure him. When this came to pass, the king, out of gratitude, told the Greeks how to find Troy. Perhaps Achilles hoped the same fate would await his debilitating wound.

But what if a cure seemed never to come? Each time Achilles stepped on the foot, he would be reminded he was no longer invincible — that he was vulnerable and incapable of a full recovery. For the Greek people, Achilles was dead the moment he stopped being a warrior, because he could no longer lead the army. Perhaps he did not want the people to see him limping, to pity him. He might have secluded himself far away from people, to die alone with a chronic wound. 

Conclusion

Based on what is known of the injury, Achilles probably had a chronic wound with skin and paratenon defect, devitalized tendon tissue, bleeding, granulation tissue, and repeated infections. Each time he stepped on the foot, he would be reminded he was no longer invincible. One cannot be certain how or how quickly had the end come. For the Greek people, Achilles was dead the moment he lost the ability to fight. 

The myth of the hero Achilles is still very much alive and fraught with questions. Did Achilles die immediately after the arrow pierced his heel and then bleed out? Or did he live, abandoned and lonely, with a chronic wound because he was no longer a capable warrior? There is reason to believe the latter, because the literature does not show any patient who has bled out and died due to an injury of the Achilles tendon. Rather, numerous manuscripts focus on a chronic wound of Achilles’ tendon, leaving clinicians and historians to wonder about the nature and management of Achilles’ wound. Could the 2 “known” associated factors, bleeding and a poisonous arrow,8 have led to his death? 

Then, as now, a patient with an Achilles’ tendon injury is constantly reminded of his/her helplessness with every painful step. Because long-lasting treatment causes fear and anxiety in any person suffering from an Achilles’ tendon injury, it is not too far-fetched to consider the possibility that Achilles took himself away to deal on his own with the issues related to a chronic wound. To this day, an Achilles’ tendon injury poses a dilemma: should the tendon be left to heal in time using just immobilization and walking aids or should surgery be performed and, if so, what type?15,16 The answer is in the foot of the patient and the hands of the clinician. 

Acknowledgment

The author thanks Alisa Papadimitriou for assistance with preparation of the article.

References:

1. Homer. The Iliad. Available at: classics.mit.edu/Homer/iliad.html. Accessed May 3, 2016.

2. General Encyclopedia of the Yugoslav. Zagreb, Republic of Croatia: Lexicographical Institute. 1979;5. 

3. Laín Entralgo P. The human body in Greek culture. Ann R Acad Nac Me (Madr). 1988;105(2):219–233.

4. Laín Entralgo P. Rumour and reality of Hippocrates. Folia Clin Int (Barc). 1973;23(4):258–270. 

5. Graves R. Asklepij, Grčki bogovi i heroji, ed 49-50. Beograd;2003.

6. Graves R. The death of Achilles. In: The Greek Myths. London, UK: Penguin Books;1992;675–683. 

7. Sabatier MJ, Stoner L, Reifenberger M, Mc Cully K. Doppler ultrasound assessment of posterior tibial artery size in humans. J Clin Ultrasound. 2006;34(5):223–230. 

8. Anagnostopoulou S, Mavridis. I. Achilles’ death: anatomical consideration regarding the most famous trauma of the Trojan War. J Trauma Acute Care Surg. 2013;74(3):946–947. 

9. Wolf FA. Prolegomena to Homer,1795, ed 124. Princeton, NJ: Princeton University Press;1988. 

10. Lee CC,Jacobs RL. Achilles (the man, the myth, the tendon). Iowa Orthop J. 2002;22:108–109. 

11. Djordjevic C, Lucic P. Literature of the old century. In: Djordjevic C (ed).  Literature and Serbian Language: I. Novi Sad, Serbia: Novi Sad Publishing;2007:124–129.

12. Sherrat A. The Cambridge Encyclopedia of Archeology. Cambridge, UK: Cambridge University Press;1980.

13. Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatr. 1990;53(8):633–639. 

14. Elias DA, Carne A, Bethapudi S, Engebretsen L, Budgett R, O’Connor P. Imaging of plantar fascia and Achilles injuries undertaken at the London 2012 Olympics. Skeletal Radiol. 2013;42:1645–1655

15. Klein EE, Weil L Jr, Baker JR, Weil LS Sr, Sung W, Knight. Retrospective analysis of mini-open repair versus open repair for acute Achilles tendon ruptures. J Foot Ankle Spec. 2013;6(1):15–20.

16. Krapf D, Kaipel M, Majewski M. Structural and biomechanical characteristics after early mobilisation in an Achilles tendon rupture model: operative versus non-operative treatment. Orthopedics. 2012;35(9):e1383–e1388. 

 

Dr. Rakic is a plastic surgeon, Clinic for Burns, Plastic and Reconstructive Surgery, Clinical Center of Serbia, Belgrade, Zvecanska, Serbia. Please address correspondence to: Vesna S. Rakic, MD, MS, 11000 Belgrade, Zvecanska 9 Sebia; email: rakicdrvesna@gmail.com.

 

Potential Conflicts of Interest: none disclosed 

Section: 

A Randomized, Controlled Trial to Assess the Effect of Topical Insulin Versus Normal Saline in Pressure Ulcer Healing

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Ostomy Wound Management 2016;62(6):16–23
Shine Stephen, MSc; Meenakshi Agnihotri, MSc; and Sukhpal Kaur, MSc, PhD
Topics: 
Pressure Ulcer
normal saline
topical insulin
randomized controlled trial

Abstract

Insulin has been used in wound healing to increase wound collagen, granulation tissue, wound tensile strength, and local production of insulin-like growth factors by fibroblasts. Saline is a widely used irrigating and wound dressing solution. Patients admitted to an acute care facility who had a Grade 2 or Grade 3 pressure ulcer were recruited to participate in a randomized, controlled trial to compare the effect of normal saline-impregnated gauze and insulin dressing in pressure ulcer healing. Persons with immunodeficiency, diabetes mellitus, pregnancy, osteomyelitis, and peripheral vascular illness were not eligible for the study.

Study participants were randomized to receive either normal saline dressing gauze or insulin dressing twice daily for 7 days. At baseline, patient demographic data and ulcer history were recorded. Baseline and follow-up ulcer assessments (days 4 and day 7) included ulcer measurement (length and width) and completion of the Pressure Ulcer Scale for Healing (PUSH version 3.0) tool. Patients in the control group received dressings of sterile gauze soaked with normal saline; patients in the intervention group received topical insulin (1 U/cm2 wound area). The insulin was sprayed over the wound surface with an insulin syringe, allowed to dry for 15 minutes, and then covered with sterile gauze. To ascertain the safety of study participants, blood glucose levels were measured with a glucometer 10 minutes before and 1 hour after the topical insulin application in the intervention group. Treatment efficacy was determined by assessing the reduction in wound area and PUSH scores at follow-up. Statistical analysis was performed; data are expressed as mean ± SD and percentage for continuous and categorical variables respectively. The differences in PUSH score and ulcer sizes between the 2 groups were analyzed using independent t-test, and within-group differences were analyzed using ANOVA with repeated measures; Greenhouse-Geisser correction was applied for the 3 consecutive measurements (day 1, day 4 and day 7). Fifty (50) patients (40 men, 10 women), ages 42.46 ± 15.47 years, with 50 ulcers, 25 in each treatment group, were enrolled. At baseline, demographic variables and wound characteristics were comparable between the 2 groups. By day 7, mean wound area had decreased from 11.79 ± 8.97 cm2 (day 1) to 11.43 ± 9.06 cm2 in the saline group (P = 0.566) and from 9.61 ± 6.39 cm2 (day 1) to 6.24 ± 4.33 cm2 (P<0.01) in the insulin group. Mean PUSH scores decreased from 10.52 ± 2.37 at baseline to 10.36 ± 2.40 on day 7 in the saline group (P = 0.475), and from 10.28 ± 1.10 to 8.52 ± 1.58 on day 7 (P<0.01) in the insulin group. No significant decrease in blood glucose level before and after insulin application (P>0.05) was observed. Treatment with topical insulin was found be safe and effective in reducing pressure ulcer size as compared to normal saline-soaked gauze. Future studies utilizing larger sample sizes, longer follow-up times, and different types of chronic wounds and control treatments are warranted.  

 

A pressure ulcer is a wound caused by incessant pressure or repeated friction that damages the skin and its underlying architecture.1 A 2009, cross-sectional descriptive study2 conducted in Northern California revealed a pressure ulcer incidence between 0% and 5.4% and prevalence between 12% and 19.7%. The major risk factors were serum albumin level <3 (74%), fecal and/or urinary incontinence (73%), fragile skin (67%), and bedbound (63%). Increased life expectancy of the population, admission in long-term-care facilities, increasing health care costs, and advances in treatment modulate the management focus of these wounds.1 A systematic literature review3 performed to consolidate the Cochrane Collaboration guidelines for systematic reviews in Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science among the articles published from 2001 to 2013 revealed the cost of pressure ulcer prevention per patient per day varied from 2.65 ? to 87.57 ? across all settings, and the cost of pressure ulcer treatment per patient per day varied from 1.71 ? to 470.49 ? across different settings. A randomized, clinical trial4 performed in 2004 reported the cost of materials needed to treat a pressure ulcer ranged from $112 to more than $6000. A bottom-up costing study5 conducted to estimate the annual cost of treating pressure ulcers in the UK revealed a varied treating cost of £1064 (Grade 1) to £10,551 (Grade 4). 

Treatment recommendations guide evidence-based care for patients with existing pressure ulcers. The treatment recommendations should apply to all individuals with pressure ulcers regardless of the setting. Dressings used for pressure ulcers include hydrocolloid, transparent film, hydrogel, alginate, normal saline, foam, polymeric membrane, silver-impregnated, honey-impregnated insulin, cadexomer iodine, gauze, silicone dressings, collagen matrix, and composite dressings.6

Insulin and wound healing. Wound healing is a complex biologic process that affects gene and protein levels; clot formation, inflammation, granulation tissue development, and remodeling also influence wound healing. One important process initiated during the early stages of healing is reepithelialization; this involves the proliferation, migration, and differentiation of keratinocytes from the wound margins.7,8 In addition to maintaining the growth and development of different cell types, numerous experimental studies suggest insulin has the ability to enhance these processes, particularly proliferation, migration,9 and extracellular matrix secretion by keratinocytes, endothelial cells, and fibroblasts.10

Saline and wound healing. Clinical practice suggests a form of mechanical debridement occurs with frequent wet-to-dry dressing changes that aids in tissue rebuilding. In a quasi-experimental study11 conducted to assess the effectiveness of normal saline in wound healing, it was hypothesized that normal saline dressings have an osmotic effect: the dressing becomes hypertonic with evaporation of water and this provides an osmotic gradient for absorption of wound fluid, which aids in wound healing. Physiological saline is a widely used irrigating and wound dressing solution known to be compatible with human tissue. It causes no damage to new tissue and does not affect the functions of fibroblast and keratinocytes in healing wounds.11

The current study was conducted to evaluate the efficacy of topical insulin in pressure ulcer healing as compared to using saline-soaked dressings.

Materials and Methods

The study was conducted in neurosurgical intensive care units and neurology wards, male and female surgical wards, and trauma wards of the Advanced Trauma Centre of Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India over a period of 6 weeks (July 2011 to August 2011). PGIMER is a referral center for several North Indian states.

A patient survey was conducted to select study participants according to the inclusion criteria, which stipulated patients with Grade 2 or Grade 3 pressure ulcers according to European Pressure Ulcer Advisory Panel1 were eligible (see Table 1). Patients with immunodeficiency, diabetes mellitus, pregnancy, osteomyelitis, or peripheral vascular illness were excluded. owm_0616_stephen_table1

The study was approved by the Institutional Ethics Committee. Permission for the study also was obtained from the respective head of the departments. Written informed consent was obtained from all the patients/caregivers.

Study design and procedures. A randomized, controlled trial research design was employed. After baseline assessment of inclusion criteria and grade of pressure ulcer, patients were randomly assigned to the control group (normal saline dressing) or intervention group (insulin dressing), using the nonreplacement lottery method. Protocols for normal saline dressing and insulin dressing use were developed after an extensive literature search, which stipulated twice daily dressing. Researchers’ personal experience and suggestions from coinvestigators were considered for protocol development. Developed protocol was reviewed by experts from nursing and the medical field, all postgraduates in their area of expertise. 

Patients in the control group received a dressing that comprised sterile gauze soaked with normal saline (0.9%). Patients in the intervention group received regular insulin (human Actrapid, Novo Nordisk, Bangalore, India) dressing, 1 U/cm2 wound area. Insulin was cautiously and slowly sprayed over the wound surface with an insulin syringe and needle to avoid dripping out of the wound bed and allowed to dry for 15 minutes before the wound was covered with sterile gauze. The designated intervention was performed by one of the authors twice daily (morning and evening) for 7 continuous days in both groups. To ascertain the safety of study participants, blood glucose levels were measured with a glucometer 10 minutes before and 1 hour after topical insulin application in the intervention group. Normal saline (0.9%) dressing was changed twice daily after soaking sterile gauze with normal saline. The dressing then was secured with sterile gauze and adhesive binding.

Ulcer healing was assessed using the Pressure Ulcer Scale for Healing (PUSH version 3.0).12 The PUSH tool was developed by the National Pressure Ulcer Advisory Panel as a quick and reliable instrument to monitor changes in pressure ulcer status over time. The tool comprises 3 wound characteristics (ie, ulcer size [length and width], exudate amount, and tissue type) that are scored and summed to give a PUSH total score of 0 to 17. A score of 0 indicates complete healing and 17 indicates greatest severity of pressure ulcer. A comparison of total scores measured over time provides an indication of improvement or deterioration in pressure ulcer healing. 

PUSH score and ulcer size (area) were calculated on day 1 before starting the intervention and on days 4 and 7. A sterile transparent paper was placed on the wound to mark the wound borders. The 2 largest perpendicular diameters were measured (in cm) using a ruler. Wound area was calculated by multiplying the 2 diameters to obtain ulcer area in cm2. Tissue type (ie, the tissue present in the wound [ulcer] bed) also was observed and recorded. The estimate of the exudate amount (drainage) present after the removal of the dressing and before applying the new dressing was noted and recorded; exudate amount was scored on a 0 to 3 scale as none, light, moderate, or heavy, respectively. The investigator measured the wound using strict aseptic precautions. Demographic and clinical information was compiled on data collection sheets for the study and then entered into a database.

Statistical analysis. Data from all study participants were tabulated and expressed as mean ± SD and percentage for continuous and categorical variables, respectively. The chi-square test was employed for demographic and wound history variables. The differences in PUSH score and ulcer sizes between the 2 groups were analyzed using independent t-test, and within-group differences were analyzed using ANOVA with repeated measures with Greenhouse-Geisser correction for 3 consecutive measurements. Statistical evaluation of the data was performed using the Statistical Package for Social Sciences (SPSS) version 16.0, Chicago, IL. A P value <0.05 was considered statistically significant.

Results

Baseline characteristics of patients. Of the 78 patients assessed for eligibility, 11 did not meet inclusion criteria and 7 declined to participate. Ultimately, because 5 study participants in each group were lost to follow-up, analysis was performed for 50 persons who completed the 7-day intervention (see Figure 1). owm_0616_stephen_figure1

The mean age of participants in the control group was 41.56 ± 16.53 years (17 Grade 2 and 8 Grade 3 pressure ulcers) and 43.36 ± 14.41 years in the intervention group (20 Grade 2 and 5 Grade 3 pressure ulcers). Nineteen (19) patients in the control group and 21 in the intervention group were male; 6 in the control group and 4 in the intervention group were female. The mean baseline wound area was 11.78 ± 8.97 cm2 and 9.61 ± 6.38 cm2 in the normal saline and insulin groups, respectively. Mean PUSH 3.0 score was 10.52 ± 2.37 in the saline group and 10.28 ± 1.10 in the insulin group. The groups were comparable regarding pressure ulcer grade and patient characteristics (age, gender), as well as clinical characteristics (duration of hospital stay, number of days in hospital before the start of the study, duration of pressure ulcer before starting intervention, and frequency of position change), mean wound area, and PUSH score at baseline (P>0.05) (see Table 2). owm_0616_stephen_table2

Assessment of wound healing as per wound area. The decrease in wound area on day 4 and day 7 was significant in the intervention group (P<0.05). Mean wound area did not differ significantly between 3 days of observation (day 1, day 4, day 7) in the control group (F = 0.382, P = 0.566); whereas, the decrease was significant in the insulin group (F = 7.661, P = 0.009). Overall, mean wound area decreased from 11.79 ± 8.97 cm2 on day 1 to 11.43 ± 9.06 cm2 on day 7 in the control group (P = 0.566) and from 9.61 ± 6.39 cm2 to 6.24 ± 4.33 cm2 in the intervention group (P<0.01) (see Table 3). owm_0616_stephen_table3

Assessment of wound healing as per PUSH score. At day 7, the decrease in the mean PUSH score in the intervention group from 10.28 ± 1.10 to 8.52 ± 1.58 was significant (P<0.01). Between day 4 and day 7, a significant difference was noted between groups in PUSH scores (insulin: F = 14.273, P<0.01; saline: F = 0.609, P = 0.475) (see Table 4). owm_0616_stephen_table4

Pre- and post-intervention blood glucose level in the intervention group. A total of 350 blood glucose level measurements were obtained before and after insulin application. Mean blood glucose levels (mg/dL) before and after intervention were 130.62 ± 24.94 and 128.82 ± 25.14, respectively. Paired t-test revealed the slight reduction in blood glucose was not significant (P>0.05) (see Table 5). owm_0616_stephen_table5

Discussion

Wound healing is a complex and dynamic process; the person’s health status influences the wound healing environment. The phases of normal wound healing involve hemostasis, inflammation, granulation, and maturation.13 Cell types key to the healing process include macrophages and fibroblasts. Macrophages engulf and destroy bacteria and clean the wound site of debris. Fibroblasts synthesize collagen, the principle component of connective tissue.

Several clinical trials reported the beneficial effect of insulin compared to other agents in wound healing.14 Human growth hormone receptors are present throughout the skin; insulin acts on these receptors and increases reepithelialization as well as collagen content, granulation tissue, wound tensile strength, and local production of insulin-like growth factors by fibroblasts.15-17 Insulin also stimulates proliferation and migration of human keratinocytes, which stimulates cell growth and enhances wound healing.18

In this randomized, controlled trial, normal saline was used as the control. It is compatible with human tissues (ie, does not damage new tissues)19 and does not affect the function of fibroblasts and keratinocytes in healing wounds.7

The results of the present study suggest topical insulin significantly increases the rate of pressure ulcer healing compared with normal saline. A randomized, double-blind, placebo-controlled study14,20 with insulin and zinc also reported wounds treated with insulin healed faster. The dose of insulin (1 U/cm2 wound area) used in the present study also was found to be safe and effective for pressure ulcer management — none of the study participants in the insulin group developed hypoglycemia, and blood glucose levels before and after insulin application did not change significantly (P>0.05).

Limitations

Study limitations include a small sample size, short (7-day) study duration, and the fact the study was confined to a single setting. Also, a simple method (ruler) was used for wound measurement, and the PUSH score also contains the wound size variable. Due to the small sample size, outcomes were not controlled by ulcer grade or location. Recommendations for future studies include blinding of control and intervention groups, patient follow-up until complete healing occurs, comparison of insulin to moisture-retentive dressing treatment, and evaluation of patient quality of life and cost-effectiveness of the treatment. These studies also should be conducted in populations with other types of chronic ulcers.

Conclusion

The results of a randomized, controlled trial indicate insulin is a safe and effective topical agent that facilitates pressure ulcer healing when compared to normal saline. During the 7-day study, statistically significant differences in PUSH score and wound size change were observed between saline and insulin gauze dressings. Because the study duration was short (7 days), the long-term effect of topical insulin on pressure ulcer healing and other chronic wounds remains to be examined and compared to moisture-retentive dressing regimens. n

References 

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

2. Dealey C. Review of advances in pressure ulcer management since 1992. Br J Nurs. 2002;(11):486–490.

3. Demarré L, Van Lancker A, Van Hecke A, et al. The cost of prevention and treatment of pressure ulcers: a systematic review. Int J Nurs Stud. 2015;52(11):1754–1774.

4. Kerstein MD. Unexpected economics of ulcer care protocols. South Med J. 2004;(97):135–136.

5. Gallagher SM. Outcomes in clinical practice: pressure ulcer prevalence and incidence studies. Ostomy Wound Manage. 1997;43(1):28–38.

6. Aditya S, Mark SG, Nancy LT. Wound dressings and comparative effectiveness data. Adv Wound Care (New Rochelle). 2014;3(8):511–529.

7. Schilling JA. Wound healing. Surg Clin North Am. 1976;56(4):859–874.

8. Coulombe PA. Wound epithelialization: accelerating the pace of discovery. J Invest Dermatol. 2003;121(2):219–230.

9. Benoliel AM, Kahn-Perles B, Imbert J, Verrando P. Insulin stimulates haptotactic migration of human epidermal keratinocytes through activation of NF-kappa B transcription factor. J Cell Sci. 1997;110(17):2089–2097.

10. Madibally SV, Solomon V, Mitchell RN, Van de Water L, Yarmush ML, Toner M. Influence of insulin therapy on burn wound healing in rats. J Surg Res. 2003;109(2):92–100.

11. Lim, JK,Saliba L, Smith MJ, McTavish J, Raine C, Curtin P. Normal saline wound dressing —is it really normal? Br J Plast Surg. 2000;53(1):42–45.

12. National Pressure Ulcer Advisory Panel. National Pressure Ulcer Advisory Panel PUSH Tool Version 3.0. Available at: www.npuap.org. Accessed February 10, 2011.

13. Keast-Butler J. Honey for necrotic malignant breast ulcers. Lancet. 1980;2(8198):809.

14. Zhang XJ, Wu X, Wolf SE, Hawkins HK, Chinkes DL, Wolfe RR. How local insulin- zinc injection accelerates skin donor site wound healing? J Surg Res. 2007;14(2):90–96.

15. Pierre E, Perez-Polo J, Mitchell A. Insulin-like growth factor-1 liposomal gene transfer and systemic growth hormone stimulate wound healing. J Burn Care Rehabil.1997;18(4):287–289.

16. Biolo G, Fleming R, Wolfe R. Physiological hyperinsulinemia stimulates protein synthesis and enhances transport of selected amino acids in human skeletal muscle. J Clin  Invest. 1995;9(5):811–817.

17. Zhang X, Chinkes D, Irtun O, Wolfe R. Anabolic action of insulin on skin wound protein is augmented by exogenesis amino acids. Am J Physiol Endocrinol Metab.2002;28(2):308–315.

18. Lait M, Smith L. Wound management: a literature review. J Clinical Nurs. 1998;7(1):11–17.

19. Salami AA. A comparison of the effect of chlorhexidine, tap water and normal saline on healing wounds. Int J Morphol. 2006;24(4):673–676.

20. Greenway SE, Filler LE, Greenway FL. The role of topical insulin in wound healing. J Wound Care.1999;8(10):526–528.

 

 

Mr. Stephen is a staff nurse, ESIC Medical College Hospital, Parippally, Kollam, Kerala, India. Ms. Agnihotri and Dr. Kaur are faculty, National Institute of Nursing Education, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Please address correspondence to Shine Stephen at: shinestephentn@gmail.com.

Section: 

Estimating the Clinical Outcomes and Cost Differences Between Standard Care With and Without Cadexomer Iodine in the Management of Chronic Venous Leg Ulcers Using a Markov Model

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Ostomy Wound Management 2016;62(6):26–40
Leo M. Nherera; Emma Woodmansey, PhD; Paul Trueman; and Garry W. Gibbons, MD
Topics: 
Venous Ulcer
Markov chains
cadexomer iodine
healing
cost analysis

Abstract

Chronic venous leg ulcers (VLUs) affect up to 1% of the adult population in the developed world and present a significant financial and resource burden to health care systems. Cadexomer iodine (CI) is an antimicrobial dressing indicated for use in chronic exuding wounds. The aim of this study was to estimate the cost utility of using CI + standard care (SC) — ie, high compression multicomponent bandaging including debridement — compared with SC alone in the management of chronic (>6 months’ duration) VLUs from a payer’s perspective.

A Markov model was constructed to evaluate the cost and clinical benefits (healing and decreased infection rates) of the 2 treatment modalities over a 1-year period using data from 4 randomized, controlled clinical studies (RCTs) included in a recent Cochrane review and cost data from a recently published economic evaluation of VLUs. Costs were calculated using 2014 United States dollars; wound outcomes included complete healing in 212 patients reported in the Cochrane meta-analysis and quality-adjusted life years (QALYs), with utility values obtained from 200 patients with VLUs calculated using standard gamble. Treatment with CI over 1 year was $7,259 compared to $7,901 for SC. This resulted in a cost savings of $643/patient in favor of CI compared with SC. More patients treated with CI (61%) had their wounds healed compared to 54% treated with SC. Furthermore, patients treated with CI+SC experienced 6 additional ulcer-free weeks compared to persons treated with SC alone (ie, 25 ulcer-free weeks compared to 19 ulcer-free weeks, respectively). Overall, CI resulted in 0.03 more QALYs (ie, 0.86 QALYs compared to 0.83 for SC). The use of CI in addition to SC compared to SC alone over 52 weeks resulted in more wounds healed and more QALYs along with a decrease of overall costs The results of this study suggest CI is cost effective compared to SC alone in the management of patients with chronic VLUs. Prospective, controlled clinical studies are needed to elucidate the effect and cost effectiveness of CI on VLUs with and without signs of infection as compared to SC, other antiseptics, and more advanced topical treatment modalities.  

 

Chronic venous leg ulcers (VLUs) affect up to 1% of the adult population in the developed world; with an expected increase in the number of older people in future decades, a Cochrane review1 anticipates a corresponding increase in age-associated medical problems. A review of the burden of VLUs on the United States’ economy2 and a retrospective observational database study3 of 81,148 matched patients with or without VLUs concluded venous leg ulceration imposes a significant financial and resource burden to health care systems. According to a cost-effectiveness study by Jemec et al,4 VLUs are typically painful, malodorous, moderately to highly exudating, and have a significant negative impact on patients’ quality of life. Furthermore, a systematic review5 on the impact of leg ulceration on patients’ quality of life that included 24 original studies concluded patients had significantly more pain, more restrictions regarding social functioning, less vitality, and limitations with respect to emotional roles compared to the respective controls. 

The prevalence of VLUs in the US is approximately 600,000/year. VLUs are estimated to result in the loss of 2 million working days per year, and the annual cost of treating VLUs is estimated at $2.5 billion to $3.5 billion in the US.2 Compression therapy is considered the first-line treatment for uncomplicated venous ulcers. According to international clinical guidelines on VLUs,6,7 including a US VLU guideline8 and a clinical evidence review on the management and diagnosis of VLUs,9 multilayer compression systems are considered more effective than low-compression garments or stockings for the management of VLUs. 

High bioburden resulting in the development of biofilms, bacterial colonization, and ultimately wound infection are implicated in delayed wound healing.10,11 Furthermore, the presence of biofilms in wounds is also increasingly linked to delayed healing in both porcine12 and murine models13 and inferred by their presence in chronic wounds,14 with a high proportion of chronic wounds reported to contain such structures.15 A microscopic evaluation of specimens from chronic (n = 50) and acute (n = 16) wounds by James et al15 identified wound biofilms in more than 60% of chronic wounds (including VLUs, diabetic foot ulcers [DFUs], pressure ulcers [PUs], and other traumatic chronic wounds) compared to only 6% in acute wounds. The protective nature of a mature biofilm and the slow growth of bacteria within them, along with host components in wounds (ie, tissue protein, red blood cells, and serum), have been shown in a number of in vitro studies16-21 to inhibit antimicrobial penetration and activity, leading to enhanced survival and persistence of biofilm communities.

Cadexomer iodine (CI; IODOSORB™, Smith & Nephew, Hull, UK) is a topical antimicrobial dressing used in the treatment of infected or critically colonized leg ulcers. Critical colonization has been classified clinically as a level of bacterial colonization in a wound that leads to a subtle state of localized “covert” infection.22 CI is one of the few treatments demonstrated to kill mature biofilms in an ex vivo porcine skin model; CI and polyacrylate silver gel significantly reduced biofilm bacteria following 72-hour treatment in this test.23 Such evidence combined with clinical efficacy of CI on bioburden in DFUs and VLUs noted in noncomparative multicenter and RCTs, respectively,24,25 suggests a role for CI in successful treatment of biofilms in chronic wounds.

A clinical review of iodine use in clinical studies11 concluded CI promotes wound healing when compared to other dressings such as hydrocolloids, paraffin gauze, and compression therapy. A recent Cochrane meta-analysis1 of 212 patients included 4 RCTs among patients with chronic VLUs: Lindsay et al26 compared CI and dry sterile dressing with a nonadherent dressing plus support bandaging or stocking in 28 patients; Laudanska and Gustavson27 compared CI to saline wet-to-dry compressive dressing in 60 patients; Ormiston et al28 compared CI to gentian violet and polyfax ointment in 61 patients; and Steele et al29 compared CI in addition to compression therapy to compression therapy alone plus various topical agents including antibiotics, antiseptics, and hydrophilic agents in 60 patients. The meta-analysis1 of these 4 studies found evidence (risk ratio 2.17, 95% confidence interval 1.30–3.60, P = 0.003) supporting increased healing following the use of CI. However, only 2 trial-based clinical studies were identified that examined the cost effectiveness of CI in VLUs compared to hydrocolloid dressings and paraffin gauze30 and gentamicin solution, streptodornase/streptokinase, and dry saline gauze.31 Given the current health care environment, decision makers need to use all available clinical and cost-effectiveness information to help make policy decisions. 

The objective of the current study was to estimate the cost-effectiveness and cost utility of CI plus standard care (SC) compared with SC alone in the management of chronic VLUs. Although the studies included in the Cochrane meta-analysis used different comparators, they all used 0.9% CI as the intervention.

Methods and Perspective

A Markov model was used to simulate the expected cost and benefits of the 2 stated strategies in patients with chronic VLUs using all current available clinical evidence from RCTs included in the 2014 Cochrane review meta-analysis.1 A pragmatic decision was taken not to conduct a systematic literature search for clinical evidence because data used from the Cochrane review had involved a thorough literature search in 2013. 

Markov models are recursive (repetitive) decision trees used for modeling conditions involving events that may occur repeatedly over time, as is the case with VLUs and wound infections.32 For the purpose of this study, chronic VLUs were defined as ulcers >6 months in duration in line with the clinical effectiveness data taken from the Cochrane review1 where the mean ulcer duration ranged between 7–17 months. The model was developed in accordance with best practice standards for economic evaluations (ie, The Consolidated Health Economic Evaluation Reporting Standards [CHEERS])32 from the perspective of a US health care payer (ie, Centers for Medicare and Medicaid Services [CMS]). 

SC was defined as the use of high-compression, multicomponent bandaging, providing compression of 23 mm Hg to 35 mm Hg.1,6-9,33 In addition to compression therapy, other known barriers to healing such as infection, chronic inflammation, and necrotic or nonviable tissue and biofilms were managed by debridement to facilitate optimal wound healing. For the purpose of the study model, it was assumed a physician performed debridement in accordance with 2014 clinical practice guidelines of the Society for Vascular Surgery and American Venous Forum,34 although it was acknowledged that clinicians do not always follow these guidelines.35 The model assumed foam dressings were used as the primary dressing in both the CI and SC groups. The Markov model assumed the patient was always in 1 of a finite number of health states, which in this case were unhealed VLU, healed, infected, and dead. 

Two (2) measures of benefits were used in the model: incremental ulcer-free weeks for the cost-effectiveness analysis and quality-adjusted life years (QALYs) for the cost-utility analysis. A QALY is a measure of disease burden, which takes into account the quantity or length of life and quality of life generated by health care interventions. QALY is used to assess the value (in health gains) for a given cost of a medical intervention. A year of perfect health is worth 1 QALY, and a year of less than perfect health is worth <1. Death is equivalent to 0.36,37 

Model structure and assumptions. The model used weekly cycles to examine the costs and outcomes associated with the 4 Markov health states: healed, unhealed, infected, and dead over the 12-month time horizon (see Figure 1). The principle of Markov modelling is that the disease of interest is divided into discrete states by which the progression of disease falls over a certain amount of defined time (termed cycle length); in this study, the cycle length for this model was 1 week to represent the typical change frequency of compression bandages.9 In the Markov cohort, it is assumed transitions happen at the end of each cycle; in reality, patient transition is a continuous process that may occur during any time in the cycle. To address this assumption, a half-cycle correction can be used, which assumes health state transitions occur, on average, half way through the cycle. This correction approach is important when evaluating health outcomes, particularly when the cycle length is very long. For the study model, the cycle length was considered to be small enough not to require a half-cycle correction36; thus, the individual in the model is assumed to move between health states on a weekly basis. As such, the health benefits of the intervention (healing, reduction in infection rates) are evaluated together with the costs on a weekly basis for the duration of the model (1 year).  owm_0616_nherera_figure1_0

Neither costs nor health benefits (ulcer-free weeks and QALYs) were discounted because the time horizon was <1 year.35 Discounting renders benefits and costs that occur in different time periods comparable by expressing their values in present terms (ie, how much future benefits and costs are worth today). This is not a requirement in models with a short timeline of 1 year.  Baseline transition probabilities (expected events with SC) were taken from an RCT of 2 types of bandage for treating VLUs (the VenUS 1V trial33). These baseline data then were adjusted to reflect the expected reduction in adverse outcomes such as infection and recurrence while showing expected increase in healing rates observed in the clinical studies of CI. Evidence for the effectiveness of CI was taken from the Cochrane review1 of 4 RCTs for healing outcomes, which included a meta-analysis that evaluated 212 patients. Three (3) additional studies were identified in the Cochrane review that considered CI and SC; however, these studies were excluded in the meta-analysis because they did not report on the healing outcome. Two (2) of the studies25,26 excluded from the meta-analysis of healing outcome provided information on the effect of CI on infection control, which was meta-analyzed. Of the studies identified by the Cochrane review, only these 2 studies provided comparative evidence on infection control. The treatment effect of CI was assumed to persist for the duration of included trials (ie, 12 weeks) and thereafter all outcomes were treatment-independent, the same as seen in SC.

Model description. All patients start in the stalled/nonhealing health state. This health state represents a wound of >6 months that has failed to improve after 4 weeks of treatment with adequate compression therapy. Within each week, wounds can either remain in the stalled/nonhealing health state or move to any of the other 3 health states (ie, healed, infected, or death). People who transition to the healed health state are exposed to the risk of dying, have a recurrent ulcer, or remain in the healed state. Once healing is achieved, the model assumes patients will be put on below-knee graduated compression hosiery to prevent recurrence of a VLU in accordance with published guidelines.1,6-9

A proportion of ulcers (9.5% and 5% in the first 12 weeks and beyond 12 weeks, respectively) were assumed per Carter et al38 to recur. Ulcer recurrence was defined as a wound that had healed and reopened (ie, moved from the healed health state to the unhealed health state). Once an ulcer recurred, 3 possible transitions were assumed (ie, move to healing health state, remain unhealed, or death). Recurrence data used were taken from the 4-layer bandaging arm of the VenUS 1V study33 in accordance with international guidelines that recommend high-compression, multicomponent bandaging.1,7,9 Infection was modeled with 2 possible transitions assumed for the infection health state: either the infection was resolved (ie, patients transitioned to the unhealed health state) or the patient died. However, the model did not allow for an infected ulcer to become healed over the course of 1 week. Data on infection were taken from Carter et al,38 which examined the cost-effectiveness of 3 topically applied cellular/tissue-derived products (CTPs) used as adjunct therapies to SC in the management of VLUs. CTPs evaluated in the study were extracellular matrix, human skin equivalent, and living skin equivalent. The impact of infection in the model was to delay healing, because infection had to be resolved before patients could move to the healing health state. 

Mortality is the absorbing health state; no further transitions occur once a person enters this state. The model does not capture any VLU-specific mortality — rather, the age-specific mortality of the general population has been modeled. An annual mortality rate of 2% was taken from the Centers for Disease Control and Prevention’s 2010 life tables39 for the 70- to 75-year-old age group (a common age group for venous ulcer studies). The weekly probability was derived using a formula by Briggs et al,40 and none of the interventions was assumed to have an impact on mortality. Baseline transition probabilities and the effect of CI are summarized in Table 1. owm_0616_nherera_table1

Health-related quality of life (HRQOL) and utility data used in the model. The ultimate goal of health care is to restore or preserve functioning and well-being related to health (that is, HRQOL). As such, HRQOL is subjective and multidimensional, encompassing physical and occupational function, psychological state, and social interaction. A review41 discussing the developments in VLU management noted chronic leg ulcers significantly impact a person’s HRQOL because wounds make it difficult for patients to perform normal activities due to pain, exudate, and other issues. In a cross-sectional survey of 38 patients with VLUs, Hareendran42 identified the following VLU-specific HRQOL factors as concerning for patients: pain, itching, lack of quality sleep, and altered appearance. Furthermore, a cross-sectional study43 among 30 patients with DFUs has shown HRQOL is correlated with wound severity (ie, open ulcers associated with poor HRQOL) compared to healed ulcers. 

For the cost-utility analysis, data from a cost-utility analysis44 of bio-electric stimulation therapy compared to SC in 21 elderly patients with chronic, nonhealing wounds >6 months’ duration was used for the different health states. Researchers assumed HRQOL is dependent on age, owing to evidence suggesting HRQOL is negatively correlated with age.45 Hence, values are modeled to change as the patient ages. In order to demonstrate robustness of the model results, a sensitivity analysis was undertaken that assumed HRQOL was not related to age. Utility data used in the model are shown in Table 2. owm_0616_nherera_table2

Health care resource costs. Resource use costs were based on 2014 Medicare national average reimbursement rates and were calculated as the product of resources (quantity) used and the relevant unit costs. VLU medical diagnosis-related groups (DRGs) 571 and 593 were used to determine the cost of hospitalization of all unhealed ulcers. DRG data were taken from the Healthcare Cost and Utilization Project (HCUP) website (http://hcupnet.ahrq.gov). The rates of hospitalization were taken from Carter et al,38 who estimated the cost effectiveness of 3 adjunct cellular/tissue-derived products used in the management of chronic VLUs. Estimated hospitalization rates for up to 12 weeks were 4.8%. No data were available for weeks 13 through 52; it was assumed the rate would be 50% less than the rate seen at 12 weeks (2.4%). This resulted in an estimated annual probability of hospitalization of approximately 10%.

For infection, DRGs 602 and 603 were used. The estimated annual probability of hospitalization for infection was 10%. It was further assumed that 80% of hospitalization for infection would be without complications. 

Outpatient visits and home health care. Using data from Carter et al,38 25% of the patients were assumed to have additional home health care with a once-a-week visit to change dressings. The code C2F2S1, which denotes 1 visit per week for a compression dressing change with a 60-day episode of care, was used for Medicare. A proportion of patients was assumed to be debrided in the first 12 weeks with no debridement thereafter (according to clinical experts). The 12.5% weekly probability of debridement was taken from Clegg and Guest’s44 cost-utility study of bio-electric stimulation therapy. When debridement occurs, the clinic cannot bill for compression in accordance with CMS reimbursement policy. The current researchers assumed 1 hospital outpatient visit per week in accordance with the cycle length. CPT codes 11042 for debridement and 99203 for the evaluation and management visit were used for week 1, and CPT code 97597 (an established clinic visit for debridement) for weeks 2–12 were used to generate costs. In addition, the model did not include the cost of primary dressings and use of additional adjunctive therapies such as negative pressure or low-dose ultrasound; these were assumed to be used at the same rate between the treatment groups and cost-neutral in the model.

Infection control drugs, pain medication, and intervention costs. It was assumed the cost of treating wound infection would be included in the DRG for infection. Because one of the most common side effects of nonhealing VLUs is pain,1,9 the model incorporated the costs of managing pain; pain medications, their costs, and proportions of patients on each drug were taken from Carter et al.38 Expert opinion (personal communication) suggested CI would be applied once per week when patients have their weekly appointments to change compression therapy, especially in patients with low to moderately exuding wounds. The model assumed 40 mg of CI was used and compression was changed once a week (see Table 3). owm_0616_nherera_table3

Cost-effectiveness analysis. The incremental cost-effectiveness ratio (ICER) is the added cost per additional unit of health — in this model, measured in QALYs and ulcer-free weeks. This was calculated as the difference between the expected costs of the 2 strategies divided by the difference between the expected probability of ulcer-free days or QALYs between the 2 strategies over 52 weeks. To determine if the intervention is cost-effective, the ICER is compared with the maximum amount that can be paid by the health care payer for an additional unit of health benefit — in this case, assumed to be the CMS. Unlike some national payers, the US government has been reluctant to consider cost-effectiveness evidence in coverage decisions and does not have an explicit willingness to pay threshold.46 However, previous studies suggest the observed trend ranges from $50,000 to $100,000 per QALY for interventions that have been covered. Although some interventions have a significantly higher cost utility ratio,46 for the purpose of this study a maximum willingness to pay threshold of $50,000 per QALY was adopted based on empirical precedent.47 If the calculated ICER is less than this amount, intervention is deemed cost effective.   

Sensitivity analysis. One-way sensitivity analyses were conducted by varying some of the parameters in the model to address the impact of possible uncertainty in the best information available on clinical benefits and treatment costs. Each key parameter was alternately assigned a low and high value and the deterministic cost-effectiveness results using this value were recorded. For deterministic sensitivity analysis, baseline values were varied ±20% if ranges were not reported in the literature in accordance with other published economic studies.37 Furthermore, a probabilistic cost-effectiveness analysis was performed, which entails specifying a distribution for each model parameter to represent the uncertainty around the point estimate and then selecting values at random from those distributions using Monte Carlo simulation. Essentially, this means the uncertainty around multiple input assumptions can be tested simultaneously, distinct from one-way sensitivity analysis that allows uncertainty around single inputs to be tested individually. The lognormal distribution was implemented to capture the uncertainty surrounding the treatment effect; the gamma and beta distributions were used to capture the uncertainty in cost and utility values, respectively. The 2,000 trials or simulations conducted included the usual practice of running more than 1000 simulations.48 

Uncertainty regarding the ICER was assessed by Monte-Carlo simulation using 2000 iterations. To explore decision uncertainty regarding the cost-effectiveness of CI, the joint distribution of mean cost and mean outcomes was evaluated on a decision plane formally known as the incremental cost-effectiveness plane (see Figure 2). The decision plane is dived into 4 quadrants by the origin (ie, southeast [SE], northeast [NE], southwest [SW], and northwest [NW]), with each quadrant having a different implication for economic evaluation.49 The horizontal axis divides the plane according to incremental cost (positive above, negative below), and the vertical axis divides the plane according to incremental effect (positive to the right, negative to the left). Cost-effectiveness acceptability curves (CEACs) (see Figure 3) then are calculated by plotting the proportion of cost and effects pairs that are cost effective for a given value the payer is willing to pay. Thus, the CEAC expresses the likelihood the cost-effectiveness estimate reflects a cost-effective intervention based on the existing evidence.49 A scatter plot also is presented. 

owm_0616_nherera_figure2owm_0616_nherera_figure3

Results

Sixty-one (61%) percent of wounds are expected to heal with CI+SC compared to 54% treated with SC alone over a 52-week period. The model also predicts treatment with CI+SC will result in 6 additional ulcer-free weeks per patient over 52 weeks. In addition, the model suggests treatment with CI+SC is expected to lead to an overall health gain of 0.03 QALYs per patient over 52 weeks compared to a patient treated with SC. Treating patients with CI+SC rather than SC alone resulted in a cost savings of $643 per patient over 52 weeks. Consequently, CI+SC was found to be a dominant treatment for chronic VLU because it resulted in a reduction in health care costs (-$643) and an improvement in health benefits of 6 ulcer-free weeks or 0.03 QALYs (see Table 4 and Table 5).

owm_0616_nherera_table4owm_0616_nherera_table5

One-way sensitivity analyses did not materially affect the outcomes. CI remained dominant when key parameters were varied. The only time CI was not dominant was when lower values of treatment effect were used, but it remained cost-effective at $50,000/QALY threshold, which is commonly reported in many cost-effectiveness studies46 (see Table 6). owm_0616_nherera_table6

Uncertainty regarding the ICER is shown in Figure 3 which illustrates the probability any one strategy is cost-effective as a function of the willingness to pay. Given a willingness to pay $50,000/QALY, the probability CI is cost effective compared to SC is 96%. This is visually illustrated in Figure 2, which shows the majority of the samples are located in the SE and NE quadrants of the cost-effectiveness plane. The model estimates 83% of samples show CI is a dominant strategy, yielding better outcomes at a lower cost.

Discussion

The need for cost-effectiveness evidence has increased for many reasons, mainly due to limited financial resources and an increased demand for cost-effective health care technologies that consider acquisition and overall clinical and patient benefit. The Markov model estimated the 1-year clinical and cost effectiveness of adding CI to SC compared to SC alone from a US payer’s perspective in treating patients with VLUs. Using CI in addition to SC resulted in greater clinical benefit and lower treatment costs overall when compared to SC alone: using CI resulted in more wounds healed at 52 weeks (61% versus 54% wounds healed), more ulcer-free weeks (25 versus 19 ulcer-free weeks), and a cost savings of $643 per wound treated ($7259 versus $7901, respectively). Results of sensitivity analysis assigning high and low values of the clinical and cost data inputs remained robust (ie, the conclusions reached about the cost-effectiveness of CI were not sensitive to changes in the data input assumptions). 

Economic evaluations are relatively rare in wound care, largely due to an absence of sufficient robust clinical evidence.50 CI is one of the few wound care interventions with clinical evidence to support its efficacy (ie, the RCTs in the Cochrane review1). Two (2) economic evaluations compared the cost effectiveness of CI. Hansson30 compared the efficacy and cost effectiveness of CI in a multicenter RCT over a 12-week period with either a hydrocolloid dressing or paraffin gauze in 153 patients with exudating VLUs. The calculated mean ulcer reduction was 58%, 14.8%, and 45% for CI, hydrocolloid, and paraffin gauze, respectively. Total treatment costs over 12 weeks were calculated to be $517 for CI, $480 for hydrocolloid, and $582 for paraffin gauze. CI was found to be cost-effective with a lower average cost per percentage reduction in ulcers of $8.80 per percentage ulcer reduction compared with $32.50 and $21.90 per percentage ulcer reduction for hydrocolloid and paraffin gauze, respectively. A 12-week RCT by Apelqvist et al31 of 41 patients with exudating DFUs found the use of CI resulted in fewer dressing changes per week when CI was compared with gentamicin solution and dry saline gauze. The authors estimated that treatment with CI resulted in weekly treatment costs in Swedish Krona (SEK 1993) of 903 (524 to 1,697) versus 1,421 (428 to 2,679). 

The results of the current study are consistent with 2 previously published studies showing CI is either cost effective or cost saving in managing chronic wounds compared to SC of hydrocolloid dressings and paraffin gauze in 1 study30 and gentamicin solution, streptodornase/streptokinase, and dry saline gauze in another study.31 Unlike these studies, the current model extrapolated the cost and benefits over 1 year to reflect the actual costs of chronic ulcers, which in most cases are not healed by 12 weeks, making the results more relevant to policy makers.51 In addition, QALYs were considered regarding alternative treatment options. Although QALYs are not widely reported in wound care (again, largely due to an absence of robust clinical data), this is a concept widely used among health care payers and coverage bodies; it should make the findings of this study more widely relevant beyond the wound care community. 

The Markov model was based on the results of 4 RCTs included in an independent Cochrane review of  healing26-29 and infection25,26 outcomes. The use of Cochrane reviews and meta-analysis of RCTs is considered gold standard evidence for clinical and economic evaluations. Furthermore, the current results are robust because both one-way sensitivity and probabilistic sensitivity analysis were used to test the robustness of the model results and the CI remained cost effective in all cases of sensitivity analysis.

For instance, the model assumed treatment benefit of CI lasted for 12 weeks as determined by the duration of the trials and the usual treatment time for VLUs.33 However, a sensitivity analysis was conducted assuming that treatment effect lasted for 6 weeks to reflect the follow-up time in 2 of the studies included in the meta-analysis,27,29 and CI remained cost saving.  The model was also conservative in that the cost of infection was excluded from the model because the cost of antibiotics was deemed to be negligible. However, CI resulted in better infection control compared to SC. Thus, if the costs of infection control were included, an even greater cost savings would have been recognized. Resource use data were based on a recently published cost-effectiveness study38 that solicited input from a panel of chronic wound practitioners as opposed to protocol-driven data use obtained from clinical trials.

Limitations

An important limitation of the current evaluation is that it is a model that extrapolates clinical results from a 12-week trial out to a full year. Extrapolation was necessary to adequately capture all relevant health outcomes and costs associated with treatment. Another limitation is that for the clinical evidence review, not all possible databases were searched. However, given that the Cochrane review1 used herein included a systematic review of literature published up to 2013, it seems unlikely that any new relevant literature that reported on outcomes of interest has been excluded from the analysis. A further limitation is the sample sizes in the included trials, which ranged from 28 patients in 1 study26 to 66 in the biggest study.27

The model used baseline data from the VenUS IV trial,33 where the majority of patients included (72.6%) had ulcers of <6 months’ duration. However, the treatment effectiveness was taken from the Cochrane review,1 which included patients with mean ulcer duration of at least 7 months. The authors are aware ulcer duration is a prognostic factor in ulcer healing; nonetheless, because effectiveness data were obtained from patients with longer ulcer duration, the results of the model are deemed conservative (shorter ulcer duration is associated with better healing rates).25 In addition, the cost of primary dressings and other adjunctive therapies was assumed to be used at the same rate between CI and SC and hence were excluded in the model. This may not necessarily have been the situation and was likely to bias the results against the more effective intervention. In this scenario, the model is conservative (biased against CI) because CI was more effective in healing the wounds and therefore fewer wounds would have required the use of additional adjunctive therapies and primary dressings.

The authors are aware of concerns regarding cytotoxicity surrounding iodine use. Studies included in this analysis did not report on significant difference between CI and SC on any side effects; therefore, the current model did not include the management of this side effect and others except pain, which is widely reported in studies.25,27,28 Two of the included studies reported initial iodine absorption; however, they noted the amount of iodine absorbed was not cytotoxic because it did not affect thyroid function.25,27 One clinical review52 of iodine products in chronic wound care, including povidone-iodine solutions and CI, concluded that concerns about systemic toxicity are probably overstated in particular for the slow release CI. Furthermore, an in vivo study by Zhou et al53 highlighted the minimal cytotoxicity of CI due to the sustained release preparation; in this study, skin biopsies of chronic exudative wounds being treated with CI demonstrated no evidence of cell necrosis and displayed reepithelialization. This evidence supports the faster healing rates highlighted in the Cochrane review1 and associated clinical studies.26-28, 30

All of the included studies did not mention whether patients were infected at study entry with the exception of the Lindsay et al study,26 where the clinical signs of infection were monitored throughout the intervention. Nevertheless, high bioburden and infection are known to delay wound healing.54,55 In the studies assessed for this Markov model, the presence of infection at baseline may have led to increased bias toward healing due to the antimicrobial effect of the CI.

Conclusion

Using the Markov model, the use of CI in addition to SC compared to SC alone in the management of VLUs over 52 weeks resulted in more wounds healed and more QALYs along with a decrease of overall costs of care. Patients treated with CI experienced 25 ulcer-free weeks and 0.86 QALYs compared to 19 ulcer-free weeks and 0.82 QALYs for those treated with SC. Using CI was found to be cost effective with a total cost per patient over 52 weeks of $7259 compared $7901, saving the health payer $643 per patient treated. Prospective, controlled, clinical studies are needed to confirm the results of this study and elucidate the effect and cost-effectiveness of CI on VLUs with and without signs of infection as compared to SC, other antiseptics, and more advanced topical treatment modalities.  

References

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16. Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science. 1999;284(5418):1318–1322. 

17. Nickel JC, Ruseska I, Wright JB, Costerton JW. Tobramycin resistance of Pseudomonas aeruginosa cells growing as a biofilm on urinary catheter material. Antimicrob Agents Chemother. 1985;27(4):619–624. 

18. Kapalschinski N, Seipp HM, Onderdonk AB, et al. Albumin reduces the antibacterial activity of polyhexanide-biguanide-based antiseptics against Staphylococcus aureus and MRSA. Burns. 2013;39(6):1221–1225. 

19. Pitten F. Werner HP, Kramer A. A standardized test to assess the impact of different organic challenges on the antimicrobial activity of antiseptics. J Hosp Infect. 2003;55(2):108–115. 

20. Stewart PS, Costerton JW. Antibiotic resistance of bacteria in biofilms. Lancet. 2001;358(9276):135–138.

21. Singh R, Ray P, Das A, Sharma M. Penetration of antibiotics through Staphylococcus aureus and Staphylococcus epidermidis biofilms. J Antimicrob Chemother. 2010;65(9):1955–1958. 

22. World Union of Wound Healing Societies (WUWHS). Principles of Best Practice: Wound Infection in Clinical Practice. An International Consensus. London, UK: MEP Ltd, 2008. Available at: http://woundsinternational.com/article.php?contentid=127&articleid=31. Accessed May 8, 2015.

23. Phillips PL, Yang Q, Davis S, et al. Antimicrobial dressing efficacy against mature Pseudomonas aeruginosa biofilm on porcine skin explants. Int Wound J. 2013;12(4):1–15. 

24. Schwartz J, Lantis JC, Gendics C, Fuller AM, Payne W, Ochs D. A prospective, non-comparative, multicenter study to investigate the effect of cadexomer iodine on bioburden load and other wound characteristics in diabetic foot ulcers. Int Wound J. 2013;10(2):193–199. 

25. Skog E, Arnesjö B, Troëng T, et al. A randomized trial comparing cadexomer iodine and standard treatment in the out-patient management of chronic venous ulcers. Br J Dermatol. 1983;109(1):77–83. 

26. Lindsay G, Latta D, Lyons KGB, Livingstone ED. A study in general practice of the efficacy of cadexomer iodine in venous leg ulcers treated on alternate days. Acta Therapeutica. 1986;12:141–148. 

27. Laudanska H, Gustavson B. In-patient treatment of chronic varicose venous ulcers. A randomized trial of cadexomer iodine versus standard dressings. J Int Med Res. 1988;16(6):428–435. 

28. Ormiston MC, Seymour MTJ, Venn GE, Cohen RI, Fox JA. A randomized comparison of cadexomer iodine and a standard treatment in out-patients with chronic venous ulcers. Br Med J (Clinical Research Edition). 1985;291(6491): 308–310.

29. Steele K, Irwin G, Dowds N. Cadexomer iodine in the management of venous leg ulcers in general practice. Practitioner. 1986; 230(1411):63–68.

30. Hansson C. The effects of cadexomer iodine paste in the treatment of venous leg ulcers compared with hydrocolloid dressings and paraffin gauze dressing. Int J Dermatol. 1998;37(5):390–396.

31. Apelqvist J, Ragnarson Tennvall G. Cavity foot ulcers in diabetic patients: a comparative study of cadexomer iodine ointment and standard treatment. An economic analysis alongside a clinical trial. Acta Derm Venereol. 1996;76(3):231–235.

32. Husereau D, Drummond M, Petrou S, et al on behalf of the CHEERS Task Force. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Value in Health. 2013;2(16):231–250. 

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

34. O’Donnell FT, Passman MA, Marston WA, Ennis WJ, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2014;60(2):3S–59S. 

35. Gibbons GW, Orgill DP, Serena TE, et al. A prospective, randomized, controlled trial comparing the effects of noncontact, low-frequency ultrasound to standard care in healing venous leg ulcers. Ostomy Wound Manage. 2015;61(1):16–29.

36. Briggs A, Sculpher M. An introduction to Markov modelling for economic evaluation. Pharmacoeconomics. 1998;13(4):397–409.

37. Gold MR, Siegel JE, Russel LB, Weinstein MC (eds). Cost-effectiveness in Health and Medicine. New York, NY: Oxford University Press;1996. 

38. Carter MW, Waycaster CR, Schaum, K, Gilligan AM. Cost-effectiveness of three adjunct cellular/tissue-derived products used in the management of chronic venous leg ulcers. Value in Health. 2014;17(8):801–813. 

39. Arias E. United States Life Tables, 2010. National Vital Statistics Reports. Centers for Disease Control and Prevention. Available at: www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_07.pdf. Accessed May 7, 2015.

40. Briggs AHE, Claxton K, Sculpher M. Decision Modelling for Health Economic Evaluation. Oxford, UK: Oxford University Press;2006.

41. Anderson I. Developments in venous leg ulcer management. Nurs Times. 2011;107(35):14–18.

42. Hareendran A, Bradbury A, Budd J, et al. Measuring the impact of venous leg ulcers on quality of life. J Wound Care. 2005;14(2):53–57.

43. Jaksa PJ, Mahoney JL. Quality of life in patients with diabetic foot ulcers: validation of the Cardiff wound impact schedule in a Canadian population. Int Wound J. 2010;7(6):502–507.

44. Clegg JP, Guest JF. Modelling the cost-utility of bio-electric stimulation therapy compared to standard care in the treatment of elderly patients with chronic non-healing wounds in the UK. Curr Med Res Opin. 2007;23(4):871–883. 

45. Fryback DG, Dunham NC, Palta M, et al. US norms for six generic health-related quality-of-life indexes from the National Health Measurement Study. Med Care. 2007;45 12):1162–1170. 

46. Weinstein MC. How much are Americans willing to pay for a Quality-Adjusted Life Year? Med Care. 2008;46(4):343–345.

47. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness — the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371(9):796–797. 

48. Claxton K, Sculpher M, McCabe C, et al. Probabilistic sensitivity analysis for NICE technology assessment: not an optional extra. Health Econ. 2005;14(4):339–347.

49. Fenwick E, Byford S. A guide to cost-effectiveness acceptability curves. Br J Psychiatr. 2005;187(2):106–108.

50. Carter MJ. Economic evaluations of guideline-based or strategic interventions for the prevention or treatment of chronic wounds. Appl Health Econ Health Policy. 2014;12(4):373–389.

51. Drummond M. Experimental versus observational data in the economic evaluation of pharmaceuticals. Med Decision Making. 1998;8(2):S121–S128.

52. Leaper DJ, Durani P. Topical antimicrobial therapy of chronic wounds healing by secondary intention using iodine products. Int Wound J. 2008;5(2):361–368.

53. Zhou LH, Nahm WK, Badiavas E, Yufit T, Falanga V. Slow release iodine preparation and wound healing: in vitro effects consistent with lack of in vivo toxicity in human chronic wounds. Br J Dermatol. 2002;146(3):365–374.

54. Edwards R, Harding KG. Bacteria and wound healing. Curr Opin Infect Dis. 2004;17(2):91–96.

55. Menke NB, Ward KR, Witten TM, Bonchev DG, Diegelmann RF. Impaired wound healing. Clin Dermatol. 2007;25(1):19–25.

 

Mr. Nherera is Health Economics Manager; Dr. Woodmansey is Scientific Communications Manager; and Mr. Trueman is Vice President, Market Access, Smith & Nephew Advanced Wound Management, Hull, UK. Dr. Gibbons is Medical Director, South Shore Hospital Center for Wound Healing, Weymouth, MA. Please address correspondence to: Leo M. Nherera, Health Economics Manager, Smith & Nephew Advanced Wound Management, 101 Hessle Road Hull, HU3 2BN, UK; email: leo.nherera@smith-nephew.com.

Section: 

Polymeric Membrane Dressings for Topical Wound Management of Patients With Infected Wounds in a Challenging Environment: A Protocol With 3 Case Examples

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Ostomy Wound Management 2016;62(6):42–50
Linda L. Benskin, PhD, RN
Topics: 
Case Study
underdeveloped nation
wound infection
pain
wound healing

Abstract

Patients with acute wounds often delay seeking medical assistance until an incapacitating infection has developed. When such patients come for help at a remote Christian clinic in northern Ghana, West Africa, the goals of care are to resolve and prevent a return of infection, decrease pain, enable an immediate return to normal activities, and facilitate healing. Because the local protocol of care, Edinburgh University Solution of Lime (EUSOL)-soaked gauze, did not meet these goals, the author tried using a variety of donated wound dressing regimens.

Ultimately, polymeric membrane dressings (PMDs) were observed to meet patient care needs while also reducing clinic staff time and resources, and a PMD protocol of care was developed.Three (3) representative patients who presented with acute wounds and infection are described: a 20-year-old man with a hand abscess, a 16-year-old boy with a malleolus wound, and an approximately 20-year-old woman with an injection abscess, all otherwise relatively healthy, albeit undernourished. All 3 patients received oral antibiotics, their wounds were initially cleansed and debrided, and an appropriate configuration of either regular or silver-containing PMDs was applied to all exposed wound surfaces. Dressing changes were scheduled based upon the personalized plan of care. In all 3 patients, the pain-relieving properties of PMDs allowed resumption of activities within 1 day of initiating treatment, the dressings’ continuous wound cleansing system kept the wounds clean and free of infection despite the challenging environment, and the wounds healed steadily. Managing infected acute wounds with PMDs through complete wound closure was time efficient for clinic staff and met all 4 major patient goals of care. Randomized, controlled studies to compare wound and quality of life outcomes in patients whose infected wounds are managed with PMDs compared with those whose wounds are managed with other advanced dressings are warranted.

 

Acute wounds that initially are not managed appropriately  often become infected, particularly in areas with warm climates and unsanitary living conditions.1–3 A cross-sectional epidemiological study1 of 2 impoverished areas in the tropics (N = 6917) found the most common cause (51.61%) of a chronic wound was a mismanaged acute traumatic wound. In this author’s experience, patients suffering from infected acute wounds who are accustomed to being healthy are often reluctant to modify their activities of daily living to accommodate optimal wound healing conditions. Clinicians treating patients with infected acute wounds in a real-world setting may find it difficult to meet the conflicting goals of patients whose main priority of returning to work causes them to engage in activities that can delay wound healing or even exacerbate their injury.

At the rural Christian clinic in a remote area of northern Ghana, West Africa where the author worked for 5 years, the challenge was to meet patient goals by restoring functional quality of life while using minimal clinic resources. These patients often are subsistence farmers or laborers whose families would go hungry if they were unable to continue working. The environment in this area of Ghana is harsh: after an approximately 4-month rainy season, the remaining 8 months are mostly void of even dew, and when the arid Harmattan follows the rains, thick dust hangs in the air and permeates every crevice. In the humid hot season before the return of the rains, nightly low temperatures remain well over 80˚ F (27˚ C), with daily highs often soaring beyond 120˚ F (50˚ C). These year-round, incubator-like conditions contribute to a high rate of infections.4 

Patients with acute wounds in this setting are in many ways similar to farm workers in developed countries; both groups often delay seeking medical assistance until they are unable to work.5,6 Using a questionnaire, measurements of housing density and water quality, and skin examination of 1114 household members in 254 randomly selected households in 2 villages in Tanzania, Gibbs6 found 80% of individuals with lacerations or puncture wounds on the lower legs did not seek treatment. Thierry and Snipes5 reviewed 393 open-ended injury narratives from a database of face-to-face interviews by trained bilingual interviewers that included a nationally representative sampling of farmworkers (the National Agricultural Workers Survey) and compared the narratives with demographic surveys from the National Institute of Occupational Safety and Health’s supplemental injury module for hired crop workers using qualitative (grounded theory) and quantitative (descriptive discriminant analysis) research methods. Farm workers in the United States based their decision to seek medical treatment for an injury almost entirely upon whether they could continue working. In neither study was economic status of the injured person a major influence in the decision to seek medical assistance. 

During negotiations among Ghanaian clinic nurses and patients to create realistic treatment plans for acute wound patients, patients and caregivers consistently agreed upon 4 primary goals: establishing a clean wound bed and keeping it clean, decreasing persistent wound pain, facilitating the immediate resumption of normal activities, and promoting quick healing. 

The Setting. Very few health care professionals choose to work in remote areas of western Africa, including persons interested in wound care. Patients at the clinic in which the author volunteered benefited from the collaboration of 2 BSN Ghana State Registered Nurses (SRNs) who were committed to improving wound management in this harsh setting: a Ghanaian with decades of tropical wound management experience and the author, an American with extensive formal continuing education training in wound care. The wound protocols described in this study were refined by these 2 health care professionals over the years they worked together. 

The clinic gained a reputation for success in wound care, frequently serving patients with wounds who traveled from distant areas. These patients often stayed with distant relatives in villages closer to the clinic than their homes, allowing them to walk only 1 to 10 miles to reach the clinic for their dressing changes. On a typical day, the author, sometimes with an assistant, would dress wounds for as many as 20 patients before seeing the medical patients, who came to the clinic with illnesses such as malaria, dysentery, and pneumonia. This high volume of patients (~600/year) with a wide variety of acute and chronic wounds allowed the author to quickly discover what was successful (and what was not) in this environment. 

Wound infections are an especially common complication in warm unsanitary environments such as the one surrounding the clinic.1,4 Keeping wounds clean was extremely challenging in this setting. The clinic staff had very limited resources in terms of both supplies and personnel. However, a wide variety of advanced dressings and basic wound care supplies are donated to the clinic, primarily by individuals in the US. As such, cost, marketing, reimbursement, and formulary listings had no bearing on advanced wound dressing evaluations. The author trialed supplies, methodically using them as she had learned in her wound management course. She had some initial success with closing wounds using copious quantities of triple antibiotic ointment and gauze. However, this method of wound management was slow and painful, and the patients were unable to resume their usual work activities for weeks. 

Most of the other donated advanced wound products did not perform as well in keeping wounds clean as the local standard of care preferred by the author’s Ghanaian colleague (Edinburgh University Solution of Lime [EUSOL] soaked gauze) with one exception. Through trial and error, various configurations of polymeric membrane dressings (PMDs) (PolyMem®, Ferris Mfg. Corp, Fort Worth, TX), consistently were found to keep wounds far cleaner than any of the many other available products. Also, while EUSOL prevents infection, it is cytotoxic, which slows healing.2 When PMDs were used, a healthy deep pink wound bed with granulation buds along the edges often was established by the next daily dressing change. Wounds closed much more quickly with PMDs than with either EUSOL or thick antibiotic ointment, and patients found PMDs so comfortable they could usually return to work and to their usual roles in their families during treatment. In contrast with other modern dressing choices, infection did not regain a foothold in the wound bed after initial cleaning/debriding.

The author subsequently learned her positive experience when comparing PMDs with the other dressings was not unique; a distinction between PMDs and other advanced dressings has been reported in more than 30 studies7–40 and numerous conference poster presentations (see Table 1 for an annotated list of references and Table  2 for a breakdown of posters by topic). 

Mode of action. A prospective crossover study7 and case series8,10,12  have shown PMDs continuously cleanse wounds. Overviews, literature reviews, and case series18,19,32,34,35 support that PMDs release a nontoxic surfactant cleanser41 to break the chemical bounds between the wound bed and adhering slough, dirt, or other substances that may impair healing. As shown in case series and reviews,15,19,32,35,36,38 the hydrophilic (water-loving) components of PMDs (the substrate and glycerol, a bacteriostatic simple sugar) pull nutrient-filled, enzyme-rich fluid from the body into the wound bed, enhancing both healing and autolytic debridement. A case series,8 a literature review,35 and a randomized, controlled trial (RCT)13 found the loosened undesirable substances are drawn into the superabsorbent and substrate of the PMD along with excess fluid. Manual cleansing or rinsing can increase pain, and may slow healing by cooling, or can even damage fragile new granulation tissue.42-44 The literature shows these common interventions are rarely necessary when PMDs are used.8,13,18,31,34,35 Because PMDs are nonadherent, reviews and case reports8,12,14,18,31,36 show the dressing change process is quick and easy. 

Pain. Several RCTs and numerous clinical reviews and best practice documents10,11,14,15,18,21–24,27,29–31,33–35 support that PMDs relieve pain (see Table 1). The relief of persistent wound pain provided by PMDs goes beyond that obtained by simple occlusion; an RCT24 in 72 rats comparing PMDs with other dressings show PMDs placed on either intact skin or on wounded areas of the body subdue and focus the nociceptor response, as measured by a significant (P<0.05) decrease in spinal cord Fos expression at Laminae I through VI, inclusive, a significantly (P<0.05) smaller area of spread of inflammatory cells at the wounding site, and significantly (P<0.0001) decreased withdrawal latency. In humans, this ability of PMDs to subdue and focus the nociceptor response, as demonstrated in 2 RCTs10,22 and literature reviews and case series,14,23,30,34  explains the observed decrease in secondary inflammation and resultant decrease in pain, bruising, and edema. Patients with acute and chronic wounds treated at author’s clinic usually experienced such dramatic decreased pain and inflammation when PMDs were initiated their normal activities, such as walking and farming, could be resumed as soon as they stepped out of the clinic. 

Also, case series30,32,34 have shown this decreased secondary inflammation can help increase circulation, which facilitates healing. When wounds were managed with PMDs in the clinic in Ghana, granulation buds usually were observed at the first dressing change. 

Additional benefits. Unlike conventional foam dressings, in reviews and case series15,19,32,35,36 PMDs have been shown to be appropriate for use over structures that must be protected from desiccation, such as tendon and bone, as well as in heavily exudating wounds. This is because in addition to directly introducing glycerol onto all wound surfaces, the hydrophylic components of PMDs pull fluid from the body and redistribute it to dry areas of the wound bed while absorbing exudate from areas that are overly moist, as shown in reviews and case series.19,30,31,36,38 Reviews and case series8,19,35,36,38 also have found that because of this ability to optimize wound moisture and continuous wound cleansing, PMDs are indicated for use on every wound type at every stage of healing. 

The combination of keeping the wounds clean, decreasing pain, and brisk healing impressed the entire clinic staff so much that the author solicited donations of PMDs directly from the manufacturer, who provided enough PMDs for the clinic to use PMDs on virtually all patients with wounds. 

Clinic use. Using PMDs on hundreds of patients with wounds for more than 16 months demonstrated to the author and clinic staff that these dressings were able to meet or exceed all of the expectations of the clinic’s patients with wounds while decreasing the clinician time required for appropriate wound management. Using PMDs also resulted in a decrease in supplies needed for wound care, partly because when PMDs were used, wounds rarely needed to be rinsed during dressing changes. 

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Highlights from Published Independent Studies 

In response to successful use of PMDs on a variety of wound types, physicians Kim et al10 performed 3 prospective studies comparing PMDs with petrolatum gauze dressings: 1 with 15 rabbits (using contralateral sides) followed by 2 RCTs with human patients who had either second-degree burns (n = 44) or split-thickness skin graft donor sites (n = 28). The researchers found wounds in all 3 studies closed significantly faster with PMDs (P<0.05 for epithelization in the animal study and P <0.01 for healing time in both human patient groups). Both of the clinical trials with human patients demonstrated significantly decreased pain (P <0.01) and improved patient comfort (P<0.01) scores with PMDs. 

Yastrub,13 a nurse practitioner, conducted a RCT comparing PMDs with conventional moist dressings (antibiotic ointment and gauze) on 44 Stage II pressure ulcer patients in a long-term care facility.13 Using the Pressure Ulcer Scale for Healing (PUSH) tool, the author found significantly improved healing scores (P<0.001) in the PMD group. 

In a historical cohort comparison trial, Weissman et al30 compared PMDs to previous usual practice (an antibiotic plus steroid ointment) on patients with facial burns in Israel. Patients whose burns were managed with PMDs reepithelialized more quickly (6.5 days versus 8.5 days) and experienced less wound site pain (average 2.6 versus 4.7 on a scale of 0–10), as well as a complete lack of dressing change pain. No manual cleansing was needed at dressing changes when PMDs were used, a benefit of using PMDs that saved nurse time and dramatically decreased overall costs. The researchers also observed that typically facial burn patients suffer additional damage due to secondary (neurogenic) inflammation, but when PMDs were used on patients with facial burns, the area of inflammation did not extend beyond the actual area of the burn.30

A case series32 of 6 consecutive patients was conducted with a focus on the wound cleansing ability of PMDs in patients with diabetic foot ulcers complicated by both deep abscesses and osteomyelitis. The silver rope configuration of PMDs was inserted into the deep cavities, with adjunct topical oxygen therapy provided during twice a week dressing changes. Despite poorly controlled diabetes (HbA1c >9 throughout treatment) in 2 patients and significant arterial insufficiency (ankle-brachial indices of 0.57 and 0.61) in at least 2 patients, the wounds of all 6 patients healed completely and did not recur. The authors concluded surgical interventions can be safely replaced by the continuous wound cleansing actions of PMDs in at least some patients who have both deep diabetic foot ulcer abscesses and osteomyelitis.     

The use of PMDs was evaluated in a prospective case series31 of 20 consecutive patients with head and neck cancer, including patient reported pain-, sleep-, and free-text diaries, as well as objective measures and subjective reports from nursing staff. Compared with the facility’s standard treatment for radiation-induced skin damage (topical aqueous cream for initial burns with the addition of paraffin gauze when moist desquamation occurs), the use of PMDs decreased both moist and dry skin desquamation and decreased the sensation of burning for all 20 study patients, indicating PMDs were able to balance moisture and decrease inflammation. PMDs were easy for nursing staff to adapt to meet the patients’ individual needs. When PMDs were used, patients reported a cooling sensation on the skin, dramatically decreased pain in the radiation affected area, decreased dressing change pain, increased comfort, and increased sleep; nurses confirmed these findings and documented improved skin healing. Family members performed many of the dressing changes, and manual cleansing was eliminated for all but 6 of the patients by week 3. The facility changed its protocol for radiation-induced skin reactions as a result of this study, replacing the previous treatment method with PMDs.

The results of these studies are congruent with the current author’s experiences with PMDs. The purpose of reporting these cases is to provide examples of how the Ghanaian clinic’s PMD wound management protocol met the needs of patients with infected acute wounds in a challenging environment.

Protocol

The clinic’s usual PMD wound management protocol (see Figure 1) was followed for at least 900 patients (dozens with infected acute wounds), including the 3 example patients presented. After initial cleansing and/or debriding, PMD cavity filler (with or without silver, depending upon dressing availability and the patient’s perceived immune status) was inserted into any undermined areas, and then standard PMDs (with or without silver) were applied to the exposed surfaces of each wound and over any cavity filler. PMDs were changed daily at first, with intervals increasing up to a week as exudate levels diminished. Initial daily dressing changes were important because often the wound produces a large amount of exudate for the first few days of PMD use.18,19,35 As granulation tissue increased and the wounds became cleaner, exudate levels decreased so the patient could make less frequent clinic visits without jeopardizing healing. The optimal time for the patient to return to the clinic was easier to anticipate with experience. owm_0616_benskin_figure1

At their initial clinic visit, all patients with wounds also routinely received oral pain medications (usually over-the-counter dosages of a nonsteroidal anti-inflammatory), vitamins, extensive nutritional teaching, prayer, and antibiotics as appropriate in addition to direct topical wound care. Although many of the patients suffered from chronic protein deficits, it was not possible for this small clinic to provide nutritional supplements in this setting. Due to the need for all of these patients to continue working during treatment, PMDs often were covered with porous protective outer materials such as bedsheet strips or, occasionally, stretch gauze. The bedsheet strips could provide nonelastic compression.

The patients described here were chosen as representatives of the larger group because on the first day of their wound management each had provided written informed consent for their images and data to be used by the author, allowing the data to be prospective, and because their photographic and written documentation was relatively complete. All 3 patients were young and comparatively healthy other than their debilitating infected acute wounds (patients 2 and 3 showed some protein malnutrition, as was typical for individuals of low social status in this culture). None of the example patients sought treatment beyond self-care for their wounds until pain from severe infection motivated them to request care. 

Example Patients

Patient 1. An approximately 30-year-old, otherwise healthy man punctured his hand with a stick. Because it was not extremely painful at the time, he did not stop to wash the wound. Two (2) weeks later, a painful abscess had developed. He came to the clinic when the pain became unbearable (10 on a 0 – 10 scale) (see Figure 2a). owm_0616_benskin_figure2

His pain was so excruciating it was difficult for him to allow caregivers to touch his hand. Lancing the abscess released a large quantity of yellow and brown fluid. After thoroughly flushing the cavity with normal saline to remove clots of exudate, iodoform gauze (NuGauze, Johnson and Johnson, Princeton, NJ) packing strips were inserted into the undermined area. The dorsum of the hand then was covered with gauze and wrapped with stretch gauze. Ceftriaxone (2 g) was given intramuscularly (IM), and the patient went home with 5 days of oral cephalexin (500 mg, twice daily) and oral ibuprofen+caffeine to be taken as needed for pain. Because he reported having felt feverish, the patient also was presumptively treated for malaria, which was endemic in the area.

Dressings were changed daily by the author. The skin over the central wound area had been stretched so much by the pressure from the abscess it was not viable. This skin was left to demarcate and separated on its own at the first dressing change, leaving a 5 cm x 6 cm x 1 cm deep malodorous open wound with ~2 cm of undermining in all directions. By the second dressing change (day 3), it was clear the use of iodoform gauze packing strips in the large cavity wound could not provide satisfactory results for this patient. Despite antibiotics and pain medications, the extreme persistent wound pain prevented sleep, the quantity of purulent malodorous exudate indicated the infection was not resolving, and the undermining was expanding (see Figure 2b).

Treatment was changed to PMDs on day 3. Layers of silver PMD cavity filler were laid flat in the large area of undermining between the skin and the exposed muscle. Silver PMD cavity filler was used due to the risk of infection spreading up the tendons and down into the bones of the hand. Silver PMDs pull microbes into contact with silver locked into the dressings, making them safer than other silver dressings.37,39  The flexibility of PMDs was advantageous in this mobile area of the body. The patient was encouraged to move his hand to avoid contractures. One day later (day 4), the decreased pain and inflammation provided by the PMDs allowed the man to grip his hoe so he could farm again. A standard (not silver) PMD was used as the secondary dressing, and stretch gauze was used to protect the dressings from dirt. Dressings were changed daily.

On day 5 (the second dressing change with PMDs), the patient laughed and joked with the clinic staff about his previous pain, which was now a 0 on the 0 – 10 scale. The silver PMD cavity filler painlessly pulled the purulent malodorous exudate from the wound bed, even in the deepest areas of undermining (see Figure 2c). Within a week, the silver PMD cavity filler, when removed, was saturated with serous exudate only, indicating the infection was resolved. At that point, rather than using cavity filler, an extra-thick PMD (without silver) was placed over the entire open wound on the dorsum of the hand, and a pressure dressing was applied to allow the undermining to seal shut. Subsequent dressing changes consisted of replacing the PMD, then wrapping the hand to keep the dressing clean as the patient farmed. Dressing changes decreased from daily to twice a week when the cavity filler was no longer used. The PMDs continued to keep the wound bed clean without any rinsing at dressing changes. Granulation tissue formed rapidly. The patient remained virtually pain-free with full range of motion. At 4 weeks, a standard thickness, 2.5 cm x 2.5 cm bordered cloth adhesive PMD was used to dress the now small, superficial wound (see Figure 2d). The patient was dismissed from the clinic <6 weeks after the use of PMDs on his wound was initiated.

Patient 2. A 16-year-old, mildly protein-malnourished boy (nutrition status determined by midarm circumference measurement) cut the area of his medial malleolus while hoeing. He applied local leaves to the wound, which burned the tissue as they decomposed and may have contributed to his malodorous infection. He reported through a series of interpreters (his dialect was not spoken beyond his remote village) that his pain level was so high it completely prevented him from being able to farm. Because he needed to be able to farm again to help support his family, his wound management needed to diminish his persistent wound pain and to dress the wound in a way that would not inhibit his ankle movement. Ceftriaxone (1 g) IM and oral amoxycillin provided for 7 days diminished the wound odor and purulent drainage, but initial sharp debridement and wound cleansing was incomplete because of concern the boy’s tendons, visible through a thin layer of muscle tissue, could be damaged by aggressive debridement techniques (see Figure 3a). owm_0616_benskin_figure3

The avascular ankle wound measured 7 cm x 5 cm x 0.8 cm deep with 30% adherent yellow slough and moderate serosanguineous drainage when standard PMDs were initiated. Three (3) thin pieces of PMD cavity filler were cut to fit into the deep grooves between the visible tendons. The entire wound area then was covered with an improvised extra-thick dressing made of a PMD cavity filler covered with a standard-thickness PMD (at the time this boy was being cared for at the clinic, the clinic had a temporary shortage of extra-thick PMDs) (see Figure 3b). Due to the distance the boy had to travel to get to the clinic (more than 30 miles), the plan of care was for every-other-day dressing changes with extra-thick PMDs to absorb the wound exudate. However, flooding of local rivers led to his erratic clinic attendance. The wound developed thick green adherent slough when he was unable to come for dressing changes. This was managed with cleansing using a cotton-tipped applicator and rinsing with saline to remove the loose dirt and slough before applying a fresh extra-thick PMD. Otherwise, dressing changes consisted of removing the saturated PMD and applying a new one, then wrapping the ankle area with a bedsheet strip bandage or stretch gauze to protect it from dirt during farming. Saline rinses were added when visible dirt from farming found its way under the dressings. 

By day 3, the wound bed was already much cleaner with noticeably decreased size and depth at the first dressing change. On the second dressing change (day 7, because flooding prevented the boy from coming to the clinic sooner) the wound was 0.5 cm deep and the wound filler was no longer needed. At this second dressing change, through a series of interpreters the boy stated he had been completely pain free, even during farming. Oral antibiotics were restarted because it was anticipated that sporadic flooding would continue to prevent him from attending the clinic regularly. Granulation tissue filled in the wound bed steadily. After 4 weeks of PMDs, despite erratic clinic attendance and soaking the wound in muddy water for prolonged periods of time, the wound was 94% smaller, measuring 4.9 cm x 3.4 cm x 0.1 cm deep (see Figure 3c).

Patient 3. A relatively healthy young woman (uncertain of her age but probably ~20 years old based upon her appearance, her memory of historical events, and her circumstances in life) presented with a large injection abscess on her left buttock. Injection abscesses are a common complication of medical care provided by uneducated itinerant pharmaceutical sellers. These entrepreneurial individuals travel from village to village with a box containing a jumble of tablets, capsules, tonics, and injectables strapped to the back of a bicycle. They are often illiterate and rarely have sanitary equipment.

The woman’s occupation as the driver in a fufu pounding operation (food preparation) required her to be able to move vigorously while sitting on a low stool. Due to cultural taboos, young women are not permitted to eat meat, eggs, or peanuts, and milk products were unavailable where she lived; this patient’s protein intake was quite limited. The skin covering the abscess was not viable and sloughed off, exposing an approximately 5-cm diameter, 2-cm deep cavity with a base of muscle tissue (see Figure 4a). After the wound was irrigated with saline to remove the foul exudate, 4 layers of standard PMD cavity filler were torn to fit and placed one on top of another to gently fill the entire undermined area. A standard PMD was placed over the wound bed and window-pane taped in place. owm_0616_benskin_figure4

The young woman received oral antibiotics and ibuprofen (400 mg) as needed for her reported pain. Dressings were changed daily at first, with decreasing frequency as the cavity filled in and less exudate was produced. Because the surfactant from the PMDs continuously loosened wound debris and the superabsorbent pulled the contaminants and the excess exudate into and onto the dressings, no manual wound cleansing or even rinsing was required at dressing changes. The abscess granulated quickly and filled in; only 2 layers of PMD cavity filler were needed by treatment day 12 (see Figure 4b).

The patient walked several miles to and from the clinic for dressing changes during the entire course of her wound management. This young woman was able to return to her work on the day PMD wound management began with her pain controlled by pain medication and PMDs. The flexibility of the PMD cavity filler allowed her to sit and to move freely as her wound healed (see Figure 4c). The abscess closed completely in 8 weeks. 

Discussion

The patient cases presented demonstrate how infected acute wounds successfully healed with antibiotics and PMDs without return of the infection. Most patients with wounds treated at the clinic, including all 3 of the example patients, walked many miles for dressing changes. Due to the decreased wound pain following application of PMDs, patients were able to resume their normal daily activities, including strenuous manual labor, by their second dressing change at the latest. The flexibility of the dressings and the substantial reduction of their wound pain and inflammation increased patient quality of life by allowing the patients to resume the usual roles in their families. Wound bed cleansing during dressings changes was necessary only when dirt or debris was able to migrate under the dressings during farming. Eliminating routine wound cleansing at dressing changes significantly decreased the staff time and supplies needed to care for these patients. These attributes have been repeatedly cited in the literature described herein.

Managing infected acute wounds with PMDs also allowed care providers to meet all identified patient goals: freedom from infection, quick healing, significant pain relief, and minimal inconvenience. The clinic also benefitted when PMDs were used because patients required far fewer clinic resources for complete wound closure. 

Limitations

The author and the clinic staff successfully managed hundreds of wounds, ranging from minor tropical leg ulcers to life-threatening diabetic foot abscesses, with this PMD protocol. For the final 16 months of the author’s tenure at the clinic (after PMDs were donated in sufficient quantities to prevent serious shortages), it was rare for a wound to be managed with any other dressing type. However, due to time constraints, detailed documentation was gathered for only a small fraction of these patients, and many suffered from chronic rather than acute wounds. Therefore, no rigorous scientific study was performed, and only 3 patients with infected acute wounds are described here in detail. The external validity of this study is also limited by the unique location and observational nature of case studies.

Conclusion

Three (3) example cases illustrated how the use of PMDs met all goals of care for patients with infected acute wounds. The results seen in the Ghanaian clinic — specifically, the observations that PMDs clean wounds, keep them clean, decrease both dressing change and persistent wound pain, facilitate the immediate resumption of normal activities, and increase healing rates — have been documented in other studies. This suggests results observed may apply to patients in less challenging locales. RCTs to compare wound outcomes and quality of life of patients whose wounds are managed with PMDs compared with those whose wounds are managed with other advanced modalities are warranted. n

Acknowledgment

The Church of Christ Mission Clinic is directed by Peter Bombande, who worked together with the author to create the wound management protocols from which these patients benefited.  

References 

1. Gupta N, Gupta SK, Shukla VK, Singh SP. An Indian community-based epidemiological study of wounds. J Wound Care. 2004;13(8):323–325. 

2. Oluwatosin OM. Wound care practices and challenges in Nigeria. Adv Skin Wound Care. 2007;20(7):375–378. 

3. Belcher DW, Afoakwa SN, Osei-Tutu E, Wurapa FK, Osei L. Endemic pyoderma in Ghana: a survey in rural villages. Trans R Soc Trop Med Hyg. 1977;71(3):204–209.

4. Taplin D, Lansdell L, Allen AM, Rodriguez R, Cortes A. Prevalence of streptococcal pyoderma in relation to climate and hygiene. Lancet Lond Engl. 1973;1(7802):501–503.

5. Thierry AD, Snipes SA. Why do farmworkers delay treatment after debilitating injuries? Thematic analysis explains if, when, and why farmworkers were treated for injuries. Am J Ind Med. 2015;58(2):178–192. 

6. Gibbs S. Skin disease and socioeconomic conditions in rural Africa: Tanzania. Int J Dermatol. 1996;35(9):633–639.

7. Blackman JD, Senseng D, Quinn L, Mazzone T. Clinical evaluation of a semipermeable polymeric membrane dressing for the treatment of chronic diabetic foot ulcers. Diabetes Care. 1994;17(4):322–325.

8. Fowler E, Papen JC. Clinical evaluation of a polymeric membrane dressing in the treatment of dermal ulcers. Ostomy Wound Manage. 1991;35:35–44.

9. Carr RD, Lalagos DE. Clinical evaluation of a polymeric membrane dressing in the treatment of pressure ulcers. Decubitus. 1990;3(3):38–42.

10. Kim YJ, Lee SW, Hong SH, Lee HK, Kim EK. The effects of PolyMem® on the wound healing. J Korean Soc Plast Reconstr Surg. 1999;26(6):1165–1172.

11. Campton-Johnston S, Wilson J, Ramundo JM. Treatment of painful lower extremity ulcers in a patient with sickle cell disease. J Wound Ostomy Continence Nurs. 1999;26(2):98–104. 

12. Cimino P, Shipes E. Calciphylaxis in a patient with end-stage renal disease: Case situation. J Wound Ostomy Continence Nurs. 1999;26(3):161–166. 

13. Yastrub DJ. Relationship between type of treatment and degree of wound healing among institutionalized geriatric patients with stage II pressure ulcers. Care Manag J. 2004;5(4):213–218.

14. Bolhuis J. Evidence-based skin tear protocol. Long-Term Living Contin Care Prof. 2008;57(6):48–52.

15. Rafter L, Oforka E. Standard versus polymeric membrane finger dressing and outcomes following pain diaries. Wounds UK. 2014;10(2):40–49.

16. Denyer J. Management of the infant with epidermolysis bullosa. Infant. 2009;5(6):185–188.

17. Denyer JE. Wound management for children with epidermolysis bullosa. Dermatol Clin. 2010;28(2):257–264. 

18. Denyer JE, Pillay E. Best practice guidelines for skin and wound care in epidermolysis bullosa — International Consensus. 2012. Available at: www.woundsinternational.com/other-resources/view/best-practice-guideline.... Accessed March 30, 2015.

19. Denyer J, White R, Ousey K, Agathangelou C, HariKrishna R. PolyMem dressings made easy. Wounds Int. May 2015. Available at: www.woundsinternational.com/made-easys/view/polymem-dressings-made-easy. Accessed May 7, 2016.

20. Denyer J. Bathing in epidermolysis bullosa: benefit over trauma? Wounds UK. 2010;6(2):79–84.

21. Denyer J. Managing pain in children with epidermolysis bullosa. Nurs Times. 2012;108(29):21–23.

22. Hayden JK, Cole BJ. The effectiveness of a pain wrap compared to a standard dressing on the reduction of postoperative morbidity following routine knee arthroscopy: a prospective randomized single-blind study. Orthopedics. 2003;26(1):59–63; discussion 63.

23. Kahn AR, Sessions RW, Apasova EV. A superficial cutaneous dressing inhibits pain, inflammation and swelling in deep tissues. Pain Med. 2000;1(2):187. 

24. Beitz AJ, Newman A, Kahn AR, Ruggles T, Eikmeier L. A polymeric membrane dressing with antinociceptive properties: analysis with a rodent model of stab wound secondary hyperalgesia. J Pain Off J Am Pain Soc. 2004;5(1):38–47. 

25. Kammerlander G, Krammel M, Locherer E, Süss-Burghart A, Pichler H, Zweimüller P. PolyMem® QuadraFoam™ verkürzt die Heilungszeit bei sekundär heilenden und chronischen Wunden. Schwest Pfleg. 2008;47(11):1–4.

26. Stenius M. Holistic approach combined with PolyMem dressings healed a pressure wound grade 4 within 2.5 months. Sår. 2008;2008(3):28–29.

27. Langemo DK, Black J; National Pressure Ulcer Advisory Panel. Pressure ulcers in individuals receiving palliative care: a National Pressure Ulcer Advisory Panel white paper. Adv Skin Wound Care. 2010;23(2):59–72. 

28. Minniti CP, Eckman J, Sebastiani P, Steinberg MH, Ballas SK. Leg ulcers in sickle cell disease. Am J Hematol. 2010;85(10):831–833. 

29. Edwards J, Mason S. An evaluation of the use of PolyMem Silver in burn management. J Community Nurs. 2010;24(6):16–19.

30. Weissman O, Hundeshagen G, Harats M, et al. Custom-fit polymeric membrane dressing masks in the treatment of second degree facial burns. Burns. 2013;39(6):1316–1320. 

31. Scott A. Polymeric membrane dressings for radiotherapy-induced skin damage. Br J Nurs. 2014;23(10):S24–S31. 

32. Cahn A, Kleinman Y. A novel approach to the treatment of diabetic foot abscesses — a case series. J Wound Care. 2014;23(8):394–399. 

33. Hegarty F, Wong M. Polymeric membrane dressing for radiotherapy-induced skin reactions. Br J Nurs Mark Allen Publ. 2014;23(suppl 20):S38–S46. 

34. Davies SL, White RJ. Defining a holistic pain-relieving approach to wound care via a drug free polymeric membrane dressing. J Wound Care. 2011;20(5):250, 252, 254 passim.

35. Benskin LL. PolyMem® Wic® Silver® Rope: a multifunctional dressing for decreasing pain, swelling, and inflammation.  Adv Wound Care (New Rochelle). 2012;1(1):44–47. 

36. Dabiri G, Damstetter E, Phillips T. Choosing a wound dressing based on common wound characteristics. Adv Wound Care. 2016;5(1):32–41. 

37. Burd A, Kwok CH, Hung SC, et al. A comparative study of the cytotoxicity of silver-based dressings in monolayer cell, tissue explant, and animal models. Wound Repair Regen. 2007;15(1):94–104. 

38. Cutting KF, Vowden P, Wiegand C. Wound inflammation and the role of a multifunctional polymeric dressing. Wounds Int J. 2015;6(2). Available at: www.wintjournal.com/journal-content/view/wound-inflammation-and-the-role.... Accessed February 25, 2016.

39. Benskin LLL. Limitations of in vitro antimicrobial dressings study. Burns. 2016;42(6):1. doi:10.1016/j.burns.2016.01.034.

40. Rafter L, Oforka E. Trauma-free fingertip dressing changes. Wounds UK. 2013;9(1):96–100.

41. Rodeheaver GT, Kurtz L, Kircher BJ, Edlich RF. Pluronic F-68: a promising new skin wound cleanser. Ann Emerg Med. 1980;9(11):572–576.

42. Alferink M, de Zeeuw J, Sopoh G, et al. Pain associated with wound care treatment among Buruli ulcer patients from Ghana and Benin. PLoS ONE. 2015;10(6). doi:10.1371/journal.pone.0119926.

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Dr. Benskin is an independent researcher and Clinical Research and Education Liaison and Charity Liaison, Ferris Mfg. Corp, Fort Worth, TX. Please address correspondence to: Linda L. Benskin, PhD, RN, 11304 Prairie Dog Trail, Austin, TX  78750; email: LindaBenskin@utexas.edu

Section: 

Description of a Simple Method of Stoma Protection During Prone Positioning

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Ostomy Wound Management 2016;62(6):51–53
Gina A. Mackert, MD; Christopher M. Reid, MD; Marek K. Dobke, MD; and Mayer Tenenhaus, MD
Topics: 
Ostomy
patient positioning
Surgery
safety
pressure

Abstract

Surgeries conducted with the patient in the prone position are frequent and can be lengthy. Abdominal stomas and suprapubic catheters require protection for the complete duration of the procedure to avoid complications such as stomal ischemia, bleeding, or mucocutaneous separation. Standard protection strategies such as pillows and wedges can easily fail.

In the course of managing several patients who had sustained ostomy complications following surgery in a prone position, a simple method of stoma protection was devised. Instead of discarding the foam headrest typically used during induction by anesthesia staff, this device is placed with its central recess over the stoma and secured to the patient’s abdominal wall with gentle tape just before turning the patient into a prone position. This method, used in more than 80 patients, has been found to effectively relieve pressure, and no complications have been observed. The foam shape also enables unobstructed drainage of fluids, facilitating collection and preventing leakage and contamination of the surgical field. Because the device is widely used by anesthesia, it is readily available and does not add any extra cost.

 

The incidence of newly formed stomas is estimated to exceed 130,000 yearly, and the number of people in the United States currently living with an ostomy is estimated to be more than 1,000,000.1 These include colostomies, ileostomies, jejunostomies, gastrostomies, and urostomies; the resulting stomas, as well as suprapubic catheters, generally are positioned on the anterior abdominal wall and can be temporary or permanent. Among the numerous indications for stoma creation are chronic or acute bowel obstruction, trauma or perforation, rectal cancer, radiation, inflammatory bowel diseases, bladder cancer, spinal cord injury, immobility, major surgery of the digestive tract, gastrectomy, and nutritional insufficiency.2,3 

In the authors’ parent academic institution, prone positioning is commonly employed during trauma, orthopedic, plastic reconstructive, or neurosurgical interventions.4 Many surgical and nonsurgical interventions that require protracted periods of prone positioning can prove challenging when faced with a ventrally located conduit or stoma. This is particularly true with a newly created stoma. In addition to meticulous preventive efforts to protect delicate soft tissues such as those over bony prominences, eyes, and face, stoma protection also is needed to prevent complications due to compression, shearing, and inadequate drainage. The latter may lead to stomal injury and/or disruption of the appliance. Stoma complications can include ischemia, bleeding, dermatitis, retraction, and mucocutaneous separation.5,6 To the authors’ knowledge, the incidence of stoma complications related to surgery has not been reported. However, the authors have observed that kinking of the collection bag may result in inadequate evacuation and drainage as well as inaccurate volumetric recording of output during surgical cases. Damaged or dislodged stomal appliances can result in contamination of the operative field and the surrounding tissues. 

Before considering using the foam head rest for ostomy protection, the senior author had cared for several patients who had suffered ostomy-related complications after prone positioning. These complications included cases of dislodgement of the collection system with local soilage and contamination of the surgical field as well as a case of dehiscence in a newly established stoma. On careful review, several cases showed evidence of local trauma to the stoma and/or hematoma formation following a surgical procedure that required prone positioning. These complications, observed during postoperative patient care and through staff discussions, developed despite careful efforts by the operative team to protect and offload the stoma with the use of pillows and cushions. During the procedure, cushions would migrate, shearing forces would manifest, and local injury, kinking of drains, or obstruction would complicate care management and ostomy integrity. In some observed cases, further supportive attempts utilizing a larger number of additional cushions for further intraoperative stoma protection posed the potential for attenuation of respiratory excursions in paralyzed patients and poor offloading of pressure points. 

The Protective Device

Approximately a decade ago, the senior author developed a technique to protect the stoma when the patient is in the prone position. The technique involves using a standard foam headrest routinely utilized by anesthesia professionals. The headrest has a circular, central recess to stabilize the patient’s head and offload occipital pressure during the induction of anesthesia (see Figure 1). The largest diameter of the foam headrest usually utilized in the authors’ institution is 9 inches (228.6 mm), the diameter of the central recess is 4.5 inches (114.3 mm), and the height of the headrest is 2 inches (50.8 mm). When a patient with a stoma is transferred to a prone position, instead of discarding the device, it is repurposed to protect the stoma. owm_0616_reid_figure1

The recessed portion of the foam serves as a repository for the stoma appliance and its contents, while the broad cylindrical foam cushion minimizes the likelihood of shearing and offloads compressive forces. The foam can easily be trimmed to fit nearly any stomal appliance or tubing, and given the wide variety available, this “one-size fits all” solution is particularly appropriate.

In the authors’ experience, use of the headrest appears to ensure safe and secure prone patient positioning, particularly if the clinician complies with the following guidelines (see Figure 2 and Figure 3): 

  1. The clinicians should empty contents of the ostomy bag before the start of the procedure, either before or after the induction of anesthesia. This will minimize possible spillage and facilitate handling. 
  2. The foam headrest should be oriented to surround the appliance. It may be trimmed to fit and accommodate effluent tubing.
  3. If the stoma appliance is a bag, it can be accordion-folded into the foam’s central aperture or loosely inset so contents may still collect in the bag.
  4. The clinician should ensure adequate space for the stoma appliance and the contents in the vertical plane.
  5. Once the device is correctly placed, the foam should be secured to the abdominal wall with gentle tape.
  6. Once the patient is positioned prone, the clinician should ensure the headrest is properly positioned with no compressive forces acting on either the stoma or headrest and that respiratory excursion is not impaired.

owm_0616_reid_figure2owm_0616_reid_figure3

Discussion

Protecting the stoma is a critical element in the care and positioning of the surgical patient. Injury to these delicate, surgically created structures can have serious consequences. Dislodgement of collection devices and/or soilage of the operative field can compromise the integrity of the surgical field and local tissues while impairing drainage and monitoring efforts of stool, urine, and drainage output.

In the authors’ experience, repurposing the patient’s normally discarded foam headrest has proven to be an effective method of protecting both the patient and his/her stoma during prone positioning. The headrests are readily available; they are repurposed to the same individual at no additional cost to the patient. The foam is easily customized to accommodate a wide variety of applications, tubing, and connectors. The cushion protects the stoma from both direct and indirect trauma, minimizing the likelihood of dislodgement, soilage, maceration, or surgical field contamination while affording drainage and output monitoring when required. The foam ring is disposable, used exclusively on the same patient as well as on intact skin, and never reused. This technique, developed a decade ago, has gained wide acceptance throughout the authors’ institution and over the past 5 years has been adopted by multiple surgical specialties for intraoperative stoma protection in prone positioning. The senior author has utilized this technique in 80 patients for a variety of challenges, particularly in patients who have suffered pressure ulcers as well as patients being treated for major abdominal and spinal injuries. 

Guidelines for pressure relief over bony prominences generally advocate against the use of dense foam products. Moreover, properly designed stomas should be positioned appropriately to decrease chances of pressure injury.7 The headrest ring itself does not alter the patient’s positioning and creates minimal pressure on surrounding areas. The authors utilize standard established supportive positioning methods for securing and protecting the patient with particular attention paid to bony prominences, soft tissue, neurovascular structures, and eye protection while optimizing respiratory excursion. As with the application of any medical device or intervention, individualized considerations and judicious management are accordingly prioritized in the care of patients.

The stoma cap offers a preventive option.8 However, the foam headrest affords several advantages. The stoma cap does not allow for continued evacuation, drainage, or monitoring of effluences (eg, in the case of a urostomy). In addition, stoma caps are hard, fixed, and insufficiently cushioned to reduce pressure on the stoma or the surrounding skin.7 Finally, the stomal cap incurs additional cost to the patient.

In more than a decade of use by the senior author, the authors have not noted any complications from the technique. On rare occasions, an additional piece of tape was needed before turning the patient into the prone position to secure the foam before the start of surgery and after prone positioning to ensure the device is properly positioned.

Many hospitals in the United States utilize the same type of foam headrest during the induction of anesthesia; therefore, it is commonly available, making this technique easily and potentially widely implementable.

Conclusion

In the authors’ experience, using the patient’s discarded foam headrest is an effective method to protect his/her stoma during prolonged surgery in the prone position. Since employing this technique, no stomal complications from surgery have been noted following surgery in prone-positioned patients. This method is inexpensive, easily applied, and involves equipment that is readily available. n

References

1. United Ostomy Associations of America. Inc. About US. 2015. Available at: www.ostomy.org. Accessed April 7, 2015. 

2. Tapia J, Garcia G, Murguia R, Espinoza de los Monteros P, Onate E. Jejunostomy: techniques, indications, and complications. World J Surg. 1999:23(6):596–602.

3. Brand MI, Dujovny N. Preoperative considerations and creation of normal ostomies. Clin Colon Rectal Surg. 2008;21(1):5–16.

4. Rozet I, Vavilala MS. Risks and benefits of patient positioning during neurosurgical care. Anesthesiol Clin. 2007;25(3):631–653.

5. Kim JT, Kumar RR. Reoperation for stoma-related complications. Clin Colon Rectal Surg. 2006;19(4):207–212.

6. Husain SG, Cataldo TE. Late stomal complications. Clin Colon Rectal Surg. 2008;21(1):31–40.

7. Kroshinsky D, Strazzula L. Pressure Ulcers. Available at: www.merckmanuals.com/professional/dermatologic-disorders/pressure-ulcers.... Accessed May 15, 2016.

8. Cronin E. Colostomies and the use of colostomy appliances. Br J Nurs. 2008;17(17):S12–S16.

 

Potential Conflicts of Interest: none disclosed  

 

Dr. Mackert is a plastic and reconstructive surgery resident, Department of Hand, Plastic, and Recontructive Surgery, Burn Center, BG Trauma Center, Ludwigshafen, University of Heidelberg, Heidelberg, Germany. Dr. Reid is a plastic and reconstructive surgery resident; Dr. Dobke is Chief; and Dr. Tenenhaus is a Clinical Professor, Department of Surgery, Division of Plastic Surgery, University of California San Diego Medical Center, San Diego, CA. Please address correspondence to: Mayer Tenenhaus, MD, University of California San Diego, Department of Surgery, Division of Plastic Surgery, UC San Diego Medical Center, 200 W. Arbor Drive #8890, San Diego, CA 92103; email: m.tenenhaus@sbcglobal.net

Section: 

A Quasi-experimental Study to Assess an Interactive Educational Intervention on Nurses’ Knowledge of Pressure Ulcer Prevention in Nigeria

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Ostomy Wound Management 2016;62(4):30–40
Rose Ekama Ilesanmi, RN, PhD, IIWCC (Stellenbosch); and Odunayo Morohunfoluwa Oluwatosin, Professor
Topics: 
comparative study
education
nursing
professional competence
pressure ulcers

Abstract

Educational intervention programs are an important element to improve nurses’ knowledge of pressure ulcer (PU) prevention. Various teaching methods have been used with diverse results but none have been analyzed in Nigeria. A quasi-experimental study using a pretest/post test design was conducted among 193 registered nurses with >6 months experience who worked in purposefully selected wards (neuroscience, orthopedics, renal, and cardiac) in 3 teaching hospitals to examine the level of knowledge retention after interactive instruction.

Participants were randomized to intervention (IG, n = 127 from 2 hospitals) and control (CG, n = 66 from 1 hospital) groups; the IG was provided a 5-day, face-to-face interactive lecture, and the CG engaged in a 1-day, 4-hour discussion of PU prevention practices. The Pressure Ulcer Knowledge Tool, a 47-item questionnaire in which a correct answer = 1 point and an incorrect/“I don’t know” answer = 0 (maximum score 47), was used to assess and compare knowledge retention at 3 time points: baseline (T1), immediately after instruction (T2), and after 3 months (T3). Three trained research assistants assisted with registration of participants and distribution and collection of the questionnaires. All questionnaires were retrieved at T1 before the intervention began. Respondents were encouraged to respond to all questions. Data were analyzed using t-test and ANOVA (P = 0.05). At T1, knowledge scores were comparable between the IG and CG (32.5 ± 4.2 and 30.8  ± 5.0 for IG and CG, respectively). At T2, knowledge scores increased significantly only in the IG to 40.7 ± 3.4 (d = 1.94, P<0.05). The mean difference between T1 and T2 was  -8.2 ± 5.4, t = -17.0, P = 0.000. Similarly, mean scores increased significantly from T2 to T3 in the IG (mean= -2.0 ± 5.5, t = -4.1, P = 0.000); scores in the CG were -6.2 ± 7.2, t = -6.3 (P = 0.000). A face-to-face interactive lecture was shown to be an effective method of program delivery for nurses; other educational methods should be assessed and their effects on PU prevention practices and outcomes evaluated.  

 

Pressure ulcers (PUs) are a significant threat to the safety of patients and have a major negative impact on patients, their families, and the health care system.1,2 Findings from a cross-sectional observational study1 conducted among 2,000 patients in a tertiary care hospital in Australia confirm PUs were responsible for prolonged hospital stay and increased economic cost. According to a systematic review and meta-synthesis,3 PUs have a substantial impact on health-related quality of life among older patients. A prevalence study by Mclnerney4 showed the risk of mortality is 2 to 6 times greater in patients with PUs as opposed to persons without PUs.3,4 The negative effects may be even greater in the poorer nations of the world, particularly among patients with spinal cord injury. According to Zakrasek et al’s review of the literature5 on risk factors and cost of PU in low- and middle-income countries, the prevalence of PUs is high and comes with increasing complications.  

Various strategies regarding education and training for nurses have been shown to be factors in PU prevention.6-8 For example, Tweed and Tweed6 conducted an educational intervention study among critical care nurses (N = 62) and reported an increase in knowledge for PU prevention post intervention. Using a pretest/post test design, Cox et al7 compared the effectiveness of 2 methods of instruction on PU prevention among critical care and medical surgical nurses and found knowledge retention can be maintained by a quarterly educational program. These educational programs have produced good outcomes, such as reduced PU incidence,6,9 effective risk assessment, successful  planning, and implementation of interventions.10-12 

Despite these findings, evidence from the literature suggests nurses’ level of PU knowledge is not yet optimal.13,14 For example, although a systematic review13 of the effectiveness of educational programs in promoting knowledge among nurses for PU prevention showed educational programs have positive effects on nurses’ knowledge of PU prevention, similar reports of descriptive studies15,16 in Nigeria suggested inadequate knowledge of PU prevention among nurses in Nigeria. Such reports point to a need for repeated education and training as new information on PUs emerges for Nigerian nurses. 

 

Literature Review

The joint international organization for PUs17 asserts a number of contributing or confounding factors, yet to be fully elucidated, are associated with PU development, underscoring a need for consistent attention to issues regarding PUs. Patient quality care and safety organizations have focused on PU prevention issues. For example, the American Nurses Association Quality Forum18 recognized PUs as largely preventable, nursing-sensitive adverse events. The Joint Commission on Accreditation of Healthcare Organization19 included PU prevention as one of the National Patient Safety Goals. The strong position on PU prevention taken by these organizations commends programs that provide PU updates for nurses because nurses play significant roles in PU prevention. Quasi-experimental, pretest/post test and descriptive studies20,21 confirm that inadequate knowledge and skills for PU prevention among nurses working in acute care facilities can significantly influence PU rates13 and patients’ clinical outcomes. This is evident in Nigeria, where hospital-based surveys22-25 reported increased PU incidence rates are attributed partly to inadequate knowledge of evidence-based preventive interventions among care providers, particularly nurses. This conclusion was corroborated by other authors,15,16 who reported knowledge about PU prevention among nurses was less than optimal. 

Continuing education is vital to consistent, safe, and effective care delivery and also a prerequisite for reconfirmation of practice licenses in most countries.26,27 Specifically, continuing education comprises activities that increase the knowledge of workers toward improved performance.28 Different strategies including face-to-face lectures are employed in continuing education programs. Traditional lectures are typically teacher-focused, one-way communication, which leaves the learners inactive and passive.29,30 According to quasi-experimental studies involving nurses,28,31,32 the duration of knowledge retention by learners participating in the lecture method is short, usually no longer than 8 weeks, even with the use of PowerPoint® delivery. Based on this limitation, educational experts33 suggest integrating diverse or blended methods in any one teaching session for better outcomes.

Teaching theories. Adult, professional learners such as nurses would benefit from blended strategies, because these learners are self-directed and need to have control over their learning needs.34 Nursing professionals need to incorporate learning into their busy schedules to effectively  understand and be current with increasing research evidence in health care, which also drives health care improvements. Some descriptive studies35,36 involving medical students suggest when professionals are engaged in learning, they reflect on previous experiences to bring meaning to the new knowledge, enhancing the learning experience. To facilitate reflection and better understanding of new knowledge, particular delivery strategies should be incorporated into a professional continuing education program. According to Sandars’37 review on the concept of reflection,37 reflection is a metacognitive process that creates better understanding of both the self and the situation to inform future actions. As such, reflection is a major component of life-long learning and believed to improve professional competence. Experience is significant in professional learning, but it is not a stand-alone phenomenon. Drawing from Kolb’s38 theory of experiential learning, experience must be integrated into an existing knowledge structure to become new and expanded knowledge. This process requires the skill of reflection for a higher level of personal learning, such as when an individual learns about the side effects of a drug by observing reactions (experience) from a patient on the drug or when the clinician becomes more adept at a clinical skill after an experience demonstrating ineffective application of the skill. 

Interactive lecture is a form of inquiry learning that allows active learner participation and reduces the monotony of passive learning that occurs with the traditional lecture.39 Interactive lecture is implemented using methods such as brainstorming, small group discussion, role play, and simulations,40 enhancing student engagement with their course materials. Interactive lectures also may take the form of questioning the audience or using engagement triggers to stimulate interest and arouse the learner’s attention and serve as ice breakers.41 In his review of the literature describing the indicators of interactive learning, Steinert and Snell41 noted active participation of learners is a prerequisite for learning beyond the recall of facts. On a broader perspective, Lee42 acknowledged interactive learning  encompasses every method except traditional lecture. The effectiveness of the interactive mode of learning has been well documented as a preferred method to the traditional lecture. However, to the best of the authors’ knowledge, its effectiveness in delivering PU prevention education in Nigeria has not been documented. 

The aim of this study was to examine the effectiveness of a face-to-face, interactive lecture approach to education on knowledge retention among nurses in selected teaching hospitals in southwest Nigeria.

Four (4) research questions were raised: 

1. What is the knowledge of PU prevention strategies of the intervention and control groups at baseline?

2. What is the effect of interactive lecture on post test knowledge score in intervention and control groups?

3. What is the difference in post test scores immediately (T2) and 3 months (T3) post intervention in the intervention group?

4. What is the effect of selected demographic characteristics (years of experience, professional cadre based on profession, previous exposure to PU lecture) on knowledge score in the 2 groups before and after educational intervention?

 

Methods and Procedures 

The study adopted a nonequivalent control group, pretest/post test design and was conducted in 3 selected teaching hospitals in 3 (Oyo, Osun, and Lagos) of the 6 states in the southwest geopolitical zone in Nigeria. The hospitals included the University College Hospital (UCH) and Lagos State University Teaching Hospital (LASUTH), Ibadan; and Obafemi Awolowo University Teaching Hospital Complex (OAUTHC), Ile Ife. The hospitals were under 2 main clusters based on proprietorship: state government-owned and federal government-owned, publicly funded institutions. All of  the hospitals are large tertiary institutions, with a minimum of 300 beds each. Ethical approval was sought and obtained from the Health Research and Ethics Boards of each institution. 

A purposive sampling of the hospital was conducted based on inclusion criterion of providing care for patients with complex health problems. Balloting was done to determine which hospitals served as intervention and control groups. The intervention group (IG) included nurses from LASUTH and UCH, and the control group (CG) included nurses from OAUTHC. To limit inadvertent influence of treatment condition on the CG, the IG was completely separate from the CG. 

Participating wards also were selected purposively to reflect patients with health problems that would likely place them at risk for PUs; as such, all nurses from the surgical (orthopedics), medical, and neurological wards (except nurses on vacation) were invited to participate. 

Testing instrument. The Pressure Ulcer Knowledge Test (PUKT)43 was used to assess knowledge and information acquisition at the 3 testing time points. The tool is composed of 47 items that measure respondents’ knowledge of risk factors, preventive strategies, and PU staging. Correct Yes/No responses are scored 1 and incorrect responses of Yes, No, or I don’t know are scored 0. The maximum score is 47 (100%).  

The PUKT has been used in other countries9,44 with reported good reliability levels. A pilot survey was conducted in a different state teaching hospital (Ogun state) among 111 nurses 6 months before the main study to examine the feasibility of the study and to test the reliability of the testing tool.16 Findings from the pilot study led to the revision and rewording of some items in the instrument for clarity and in relation to the care environment. For example, in the local hospital, nurses use water-filled gloves to elevate the heels. Therefore, the item in  the original document that reads Heel protectors relieve pressure on the heels  was reworded to read A heel protector such as water-filled glove effectively relieves pressure on the heels. In addition, the item that relates to the appointment of a governmental panel to study PU risk, prevention, and treatment were removed because it was not applicable to Nigeria. This was the first time the PUKT was validated in Nigeria. The reliability coefficient was found to be 0.82. 

General procedure. In each setting, with the support of the Director of Nursing services, the pretest (paper-and-pencil PUKT) was administered to all participants at the same time. This was to ensure the uniformity of nurses’ entry behavior and to establish their level of PU knowledge at baseline (T1) to accurately examine the effect of the program. Each participant signed a register to document attendance. The researcher recruited and trained 3 research assistants (RAs) to assist with participant registration and to monitor and retrieve completed questionnaires. 

Study group procedure. The nature, purpose, and procedure of the study were explained to nurses who provided written consent for participation. The IG participants  (UCH and LASUTH) were invited to attend the educational workshop organized in the respective hospitals. 

The program was structured to accommodate various nursing schedules because it was not possible to take all nurses off the wards at the same time to attend the 4-hour workshop. In UCH, the nurses were divided into 2 groups. Each group attended the workshop for 5 consecutive days. In LASUTH, all participants attended the same 5-day workshop facilitated by a labor conflict that decreased patient load.

Intervention fidelity was maintained because the module curriculum was followed strictly by the principal investigator, who also delivered all the sessions. 

The interactive educational program. Participants were provided the program of events for each day. They were encouraged to choose an identification number to facilitate analysis in matching each participant’s pretest with post test scores, to assess full participation, and to easily identify missing questionnaires. The intervention was an interactive lecture that involved small group discussions and brainstorming. Participants were grouped based on the wards where they work to facilitate continual cooperative work on the wards. During the first 15 minutes of each module, participants brainstormed on specific questions and answers and shared experiences and practical ideas on PU prevention. The remaining period was used for lectures and discussion on current trends regarding PU prevention and related clinical correlations. For example, the researcher projected pictures of different stages of PUs and participants were asked to determine the stages. This helped actively involve participants in the sessions. Lectures were projected using PowerPoint® slides. The principles of adult learning34 guided the interaction with the participants (ie, learners connect learning with past experience). To facilitate this connection, the researcher also displayed different skin care products (eg, dimethicone-based barrier creams and sprays, dressings, foams, and corn starch) to stimulate discussions on nurses’ practices. At the end of the sessions, paper versions of the PowerPoint® slides were provided to participants. The level of each respondent’s participation was not documented or measured.

All modules were presented by the principal investigator in the 2 hospitals. Each session lasted for 4 hours per day. The curriculum consisted of 5 modules as shown in Table 1. owm_0416_illesanmi_table1

Assessment. A pencil-and-paper PUKT was readministered on day 5 as an immediate post test (T2). The test was completed under supervision, and participants did not refer to the paper versions of the slides. Completed tests were retrieved on the spot. Participants were informed they would be invited to a third round of testing after 12 weeks (T3).  owm_0416_illesanmi_table2

Participants returned to their respective wards but maintained the groupings to facilitate cooperative problem-solving while providing care. Over the 12-week between-test period, the researcher reinforced what was covered in the module with hands-on demonstrations. At the end of 12 weeks, participants were contacted by telephone, Short Message Services, and email for the second post test. The same test (PUKT) was administered at all 3 time points. owm_0416_illesanmi_table3

Control group procedure. The CG also was provided study details. The PUKT questionnaire was distributed to the participants to examine their baseline knowledge. The participants engaged in a general 1-day, 4-hour discussion on their usual practices for PU prevention. The session was facilitated by the RAs under the supervision of the principal investigator. This was followed by a second test (T2). Participants were contacted for the second post test at 3 months (T3). 

At the end of the third data collection (which marked the end of the study), the CG was provided the same package of educational materials as the IG on PU prevention for ethical reasons. owm_0416_illesanmi_table4

Data analysis. Data from the PUKT instrument were collected and entered into a database, the Statistical Package for Social Sciences (SPSS) (Version 17.0, Chicago, IL), for analysis. Data were checked to ensure consistency and to determine where information was missing. A complete case-wise analysis was performed for missing data because the proportion of missing data categorized as Missing Completely at Random (MCAR) was <10% and  was observed only at the 3-month post test (T3). Descriptive statistics using absolute number and relative frequencies (percentages) to describe the sample characteristics were used. Means and standard deviations were computed to ascertain nurses’ PU knowledge scores. A paired sample t-test was used to compare the differences in knowledge between IG and CG pre- and post intervention. Cohen’s d was calculated to determine the strength of the intervention effect. The effect of selected demographic variables on participants’ knowledge scores was examined using ANOVA, and the effect size (eta squared) also was computed. The level of significance was set at α = 0.05% owm_0416_illesanmi_table5

Results

Demographic characteristics. The sample consisted of 193 registered nurses, 127 in the IG and 66 in the CG. The level of education and areas of practice are described in Table 2. The majority of the respondents were basic diploma-certified registered nurses (RN) (133, 68%) and degreed nurses (BNSc) (26, 13.5%); a statistically significant difference was noted in both the IG (36.8 ± 10.3, P = 0.03) and CG (35.2 ± 11.9, P = 0.04). A similar trend was found with years of experience between IG and CG (14.5 ± 13.7, P = 0.04 and 12.6 ± 12.0, P = 0.03, respectively).

Baseline knowledge. The mean knowledge score at baseline was comparable in both IG (32.5, SD = 4.2) and CG (30.8, SD = 5.0), as shown in Table 3. 

Knowledge retention. The score at T2 significantly increased only in the IG from 32.5 ± 4.2 to 40.7 ± 3.4. In the CG, the T2 score did not increase significantly (31.2 ± 5.2, effect size, Cohen d = 1.94). At 3 months (T3), a further increase in knowledge score was observed in the IG from 40.7 ± 3.4 to 42.7 ± 4.0, P<0.001) and in the CG from 31.2 ± 5.2 to 37.8 ± -6.3 (P<0.001) (see Table 3).

Using a paired sample t-test to compare results between the IG and CG from T1 to T2 and T3, the increased mean difference in knowledge scores was noted to be significantly higher in the IG than in the CG (-8.2  ± 5.4, t = -17.0, P<0.001, d = 0.385) (see Table 4), suggesting the intervention accounted for 38.5% of the change in knowledge scores. 

Effect of selected demographic characteristic. The effect of selected demographic characteristics (eg, years of experience, professional cadre, and previous exposure to a PU lecture) on respondents’ scores pre- and post intervention was determined using one-way ANOVA. Findings were not significant (see Table 5). An examination45 of the combined effect (interaction) of selected respondents’ factors (eg, years of experience, previous exposure to PU lecture) on the post test scores using a one-way ANOVA showed a significant interaction effect with previous exposure to PU education (F[1,192] = 2.781, P<0.05). However, the interaction effect with both years of experience and professional cadre was not significant (P>0.05).

 

Discussion  

The aim of this study was to examine the effectiveness of a face-to-face, interactive PU lecture approach to education on knowledge retention among nurses by comparing pretest and post test knowledge scores. The major hypothesis was that nurses will be able to retain knowledge for 3 months post intervention better than nurses who were not exposed to a similar learning method. The intervention was carried out in the same manner by the researcher in all the settings using the modules designed for the program. Participants were selected from neurology, orthopedic surgery, and medical inpatients units because reports from previous studies indicated the risk of PU was higher in patients admitted to these units as a consequence of impaired physical mobility.45 Results of Niederhauser et al’s46 systematic review of literature underscored the importance of PU educational programs in successful implementation of preventive protocols.  

The current study showed nurses had some basic knowledge about PU prevention because they were experienced practitioners. However, after the interactive lecture, the knowledge level increased significantly in the IG as compared to what was observed in the CG.   In addition, participants were able to retain the knowledge acquired as indicated by the mean scores at the 3-month follow-up. This suggests the intervention was effective. In contrast to these findings, reports from previous quasi-experimental studies30,31 involving nursing and medical science students showed students tend to forget ~80% of presented education within 8 weeks of a lecture. The current findings showed knowledge of PU prevention was sustained for 12 weeks (3 months) post intervention among the study cohort, as well as in the CG. This sustained knowledge retention may be linked to the fact respondents in both groups were adult learners, with varied previous experiences and learning they brought to the fore. In addition, hands-on experience and reinforcement of what was learned during the follow-up period in the IG could have contributed to the sustained knowledge 

Khatoni et al’s47 pretest/post test study among nurses (N = 140) suggested both lecture and elearning methods are effective in increasing students’ knowledge. Although opinions tend to differ regarding the most effective method of teaching, evidence supports the effectiveness of interactive lectures, which enhance active student engagement and participation and demonstrate more positive learning gains than traditional lecture methods. For example, from results of their study, Prince and Felder39 proposed inductive learning methods, including cooperative or team learning, active learning, case studies, projects, or presentations, are more effective than the traditional lecture. 

In this study, sustained knowledge retention may be explained using the principles of cooperative learning as proposed by Johnson et al.48 Accordingly, the authors described cooperative learning as the instructional use of small groups to facilitate students’ working together to maximize their learning through mutual dependence rather than competition. It is proposed such learning strategy promotes deep understanding of the subject matter and enhances knowledge retention. It follows that within the small groups, participants can easily exchange views and develop self-confidence. Johnson and Johnson49 also believed working/learning in small groups works among health care professionals to help develop communication skills essential for building stronger communication with patients.  

In the current study, participants worked in small groups based on their respective wards. During the 3-month follow-up period, the researcher visited the nurse participants on the wards weekly, and teaching was reinforced at the bedside to promote evidence-based practice. The practice component is not part of this current report. The authors strongly believe the small group discussions and the supplemental printed materials (ie, PowerPoint® slides) sustained the interactive learning and also enhanced self-instruction and knowledge retention. Additionally, participants were experienced practitioners. Goldberg et al’s50 pretest/post test study (N = 130) noted interactive lecture increased students’ self-efficacy, which is  associated with academic achievement. Similarly, Knight and Wood’s51 pretest post test study (N = 700) to compare the learning gains between traditionally taught lecture and interactive classroom format concluded collaborative work in student groupings and discussions significantly increased learning gains and conceptual understanding. Furthermore, Prince and Felder39 noted a strong motivation to learn when learners clearly perceive a need to know. It follows that learners’ perception of their specific learning needs influences the motivation to learn. The findings in the current study also can be explained by Kolb’s38 model of experiential learning, which hypothesized that concrete experience allows for reflection (ie, incorporation of experience with teaching). The current study authors assert such reflection was demonstrated by study participants, which possibly also strengthened their ability to recall new knowledge, as observed only in the IG. 

Adult learners have previous experiences that help illuminate a new learning situation. As such, the current study examined the interaction effect of treatment, years of experience, and exposure to previous PU lectures on post test scores in the IG and CG. The findings indicated a significant difference, suggesting the educational intervention accounted for the difference in post test scores and was not independently determined by demographic characteristics. This finding is consistent with Hulsenboom et al,52 whose cross-sectional, comparative study among nurses (N = 522) concluded demographics, including age and nurse experience, had no significant influence on knowledge of PU preventive interventions. 

Nurses play a significant role in PU prevention, requiring ongoing acquisition of knowledge. Because the interactive lecture contributed significantly to knowledge retention, a more consistent use of interactive methods of teaching, such as case presentations, brainstorming, and small group discussions, is suggested for continuing nurse education.  

 

Limitations 

The present study was conducted among nurses in 3 tertiary institutions. A study with a wider scope that may include nurses in secondary care facilities is warranted. In addition, comparison of the effectiveness of lecture with other methods of program delivery also should be considered. 

Limitations also include the fact the interactive face-to-face lecture method was compared with only 1 other method of program delivery (discussion group), so the findings should be interpreted with caution. Additionally, the pretest/post test design of this study limits the degree to which the results may be attributed to the effects of the intervention (ie, the authors had no control over natural events in the comparison group hospital). Therefore the effects of history may be a threat to internal validity. In this vein, history describes events that occur concurrently with the treatment, which the researcher may not have control over, thereby influencing the results obtained. In the current study, the possibility of another educational program in the CG institution during the period of this study that could provide information on the subject matter to respondents cannot be ruled out. To the best of the authors’ knowledge, the CG participants were not exposed to another learning situation except that the intervention package was provided at the end of the study to the CG participants. Finally, knowledge retention was monitored for only 3 months post intervention.

 

Conclusion 

A pretest/post test study was conducted to measure gains in knowledge retention for nurses following an interactive lecture on PU prevention. The results demonstrate an interactive lecture using small groups can effectively facilitate knowledge retention among nurses in a continuing education program. The effect of intervention was significantly higher in the IG than in the CG. Interactive engagement of nurses and inductive methods of instruction for program delivery appear to be successful approaches in continuing education programs for nurses. Future studies are needed to examine how acquired knowledge translates into effective PU prevention practices and influences clinical outcomes. 

                                 

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Dr. Ilesanmi is a lecturer and a certified wound care nurse, Department of Nursing; and Prof Oluwatosin is a Professor of Plastic and Reconstructive Surgery, Department of Surgery, College of Medicine, University of Ibadan, Ibadan, Nigeria. Please address correspondence to: Dr. Rose Ekama Ilesanmi, Department of Nursing, University of Ibadan, Ibadan, Nigeria; email: ekamailesanmi@yahoo.com.

 

Potential Conflicts of Interest: none disclosed 

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