An extracellular matrix graft (Oasis® wound matrix) for treating full-thickness pressure ulcers: A randomized clinical trial.

AIM: The purpose of the study was to evaluate clinical safety and effectiveness of Oasis® Wound Matrix as a treatment for full-thickness pressure ulcers and compare it to Standard Care. METHODS: A total of 130 adults with Stage III or Stage IV pressure ulcers were randomly assigned, received either multiple topical treatments of SIS plus standard care (n = 67), or standard care alone (n = 63), and were subsequently evaluated. Ulcer size was determined at enrollment and weekly throughout treatment. Healing was assessed at each visit for a period of up to 12 weeks, with incidence of complete healing and 90% reduction in ulcer area being the primary outcome measures. RESULTS: The proportion of complete healing in the SIS group was 40% as compared to 29% in the standard of care group (p = 0.111); the percentage of patients having a 90% reduction in ulcer surface area was 55% in the SIS group versus 38% in the standard of care group (p = 0.037). CONCLUSIONS: The results of this study suggest that within the setting of a comprehensive wound care program, weekly treatment of chronic pressure ulcers with SIS wound matrix increases the incidence of 90% reduction in wound size versus standard of care alone.

Clinical Evaluation of a Skin Protectant for the Management of Incontinence-Associated Dermatitis: An Open-Label, Nonrandomized, Prospective Study.

PURPOSE: The purpose of this study was to evaluate the efficacy of an investigational skin protectant product at managing severe skin breakdown associated with incontinence. DESIGN: Open-label, nonrandomized, prospective study. SUBJECTS AND SETTING: The sample comprised 16 patients; inclusion criteria were: patients older than 18 years, cared for in the intensive care unit of a level I trauma center hospital or in long-term care facilities in the northeast region of the United States, and had incontinence-associated dermatitis (IAD). Twelve of the patients had epidermal skin loss and 4 had severe redness. METHODS: The investigational product is a formulation based on acrylate chemistry. The skin protectant application schedule was twice weekly for up to 3 weeks for a maximum of 6 applications during the study period. The skin was evaluated via a skin assessment instrument specifically designed for use in this study; this instrument has not undergone validation studies. The main outcome measure was changes in the instrument score over time. In addition, complete reepithelialization was recorded when observed, and pain scores (associated with IAD) were noted in participants who were able to report pain. RESULTS: The IAD score improved in 13 of 16 patients, remained unchanged in 1 patient, and deteriorated in 2 patients. The median percent improvement in the skin assessment instrument was 96% (P = .013). Four of the patients with epidermal skin loss had complete reepithelialization of the skin surface with 4 to 6 applications of the skin protectant, and 5 had substantial improvement. The 4 patients with severe red skin returned to healthy normal skin with 2 to 4 skin protectant applications. Substantial pain reduction was reported by all 9 patients who reported pain at enrollment. No adverse events associated with the skin protectant application were reported during data collection. CONCLUSION: Results of this study suggest that an acrylate-based product, evaluated here for the first time in patients, may be effective as a protective barrier in the presence of continued incontinence. Additional research is needed to confirm these findings.

Evaluation of a cyanoacrylate protectant to manage skin tears in the acute care population.

Skin tears are a common problem that can impact the quality of life due to pain and the potential of becoming complicated wounds if not treated properly. The use of a cyanoacrylate skin protectant to manage skin tears was evaluated in 30 patients in an acute care setting.

A comparison of collagenase to hydrogel dressings in maintenance debridement and wound closure.

UNLABELLED:  The role of maintenance debridement in wound healing has been well described, yet little is known regarding comparative methods and associated outcomes with this process when using collagenase or hydrogel. OBJECTIVE: Evaluation of maintenance debridement and wound closure with collagenase compared to hydrogel in institutionalized adults with pressure ulcers from time of necrotic tissue removal up to 84 days from enrollment. METHODS: This second phase of a rollover evaluation enrolled only subjects who successfully completed phase 1 (previously reported) from time of necrotic tissue debridement. Subjects received daily dressing changes with either hydrogel or collagenase followed by a standard semiocclusive dressing to evaluate wound-healing parameters and wound closure from initial enrollment to day 84. Investigators blinded to randomization evaluated weekly wound photographs using a digital planimetry software package for wound-healing parameters. Additionally, Pressure Ulcer Scale for Healing (PUSH) © Tool and wound bed scores (WBS) were monitored. RESULTS: Eleven of 13 subjects from the collagenase group entered into phase 2, with 4 of the 14 subjects from the hydrogel group. One subject from each group was eliminated within the first week of phase 2. All subjects (n = 3) in the hydrogel group reached complete epithelialization with a mean of 32.6 days. Nine of 10 subjects in the collagenase group reached completed epithelialization with a mean of 45 days. An independent samples t test showed no statistical significance between the 2 groups (P = 0.121) in days to healing. A Fisher's exact test performed on the primary endpoint of complete epithelialization also demonstrated no significant difference in outcomes between the groups (P = 0.99). Mean WBS at the onsetof phase 2 was 13.7 (range 12-16), and the PUSH Tool mean score was 1.0 (range 0-3). In aggregating phase 1 and phase 2 data, a difference in the closure rates at the end of the study, 69% (collagenase) vs 21% (hydrogel), was statically significant (P = 0.0213) using a Fisher's exact test. CONCLUSION: Facilitating maintenance debridement by either collagenase or hydrogel can be used to complete wound closure when used in conjunction with a validated predictive wound-healing tool that closely monitors therapy. This study showed statistical significance in favor of collagenase when evaluating closure rates from the onset of the pressure ulcer. .

Evaluation of a cyanoacrylate dressing to manage peristomal skin alterations under ostomy skin barrier wafers.

BACKGROUND: Peristomal skin alterations under ostomy barrier wafers are a commonly reported problem. While a number of interventions to manage this issue have been reported, the use of a topically applied cyanoacrylate has received little attention. This case series describes the use of a topical cyanoacrylate for the management of peristomal skin alterations in persons living with an ostomy. CASE PRESENTATIONS: Using a convenience sample, the topical cyanoacrylate dressing was applied to 11 patients with peristomal skin disruption under ostomy wafers in acute care and outpatient settings. The causes of barrier function interruption were also addressed to enhance outcomes. Patients were assessed for wound discomfort using a Likert Scale, time to healing, and number of appliance changes. Patient satisfaction was also examined. CONCLUSION: Average reported discomfort levels were 9.5 out of 10 at the initial peristomal irritation assessment visit decreased to 3.5 at the first wafer change and were absent by the second wafer change. Wafers had increasing wear time between changes in both settings with acute care patients responding faster. Epidermal resurfacing occurred within 10.2 days in outpatients and within 7 days in acute care patients. Because of the skin sealant action of this dressing, immediate adherence of the wafer was reported at all pouch changes.

A comparison of collagenase to hydrogel dressings in wound debridement.

UNLABELLED:  Comparisons of collagenase to other methods of debridement, including wet to dry dressings, have been reported in the literature; however, studies comparing collagenase to hydrogel have not been reported. OBJECTIVE: Time to complete necrotic tissue debridement with collagenase compared to hydrogel in institutionalized adults with pressure ulcers. METHODS: Randomization occurred after obtaining informed consent to avoid selection bias. Subjects received daily dressing changes with either hydrogel or collagenase followed by a standard semi-occlusive dressing to evaluate time to debridement up to Day 42. Investigators, who were blinded to randomization, evaluated weekly wound photographs for necrotic tissue debridement and wound healing parameters using a digital planimetry software package. Nonviable tissue was not cross-hatched in either group. RESULTS: Twenty-seven nursing home residents were enrolled over a period of 1 year. According to a Student's t test, there were no significant differences between groups for age, gender, age of wound, or percentage of nonviable tissue at the time of enrollment (P = .03). Using a Pearson Chi square analysis, the collagenase group was found to have statistical (P = .003) significance in achieving full debridement by Day 42. CONCLUSION: This study showed statistical significance in favor of collagenase when used to debride nonviable tissue in pressure ulcers. Despite recommendations to cross-hatch eschar, statistical significance was still achieved when wounds were not cross-hatched, indicating clinical utility in settings without clinician availability for the cross-hatching procedure.

Reducing pressure ulcer prevalence rates in the long-term acute care setting.

Information about pressure ulcer prevalence, prevention, and optimal management strategies in the long-term acute care hospital (LTACH) setting is sparse. Although care processes in other patient care settings have been reported to affect pressure ulcer prevalence rates, the effect of such programs in the LTACH is unknown. To reduce perceived above-average pressure ulcer prevalence rates and improve care processes, a 108-bed LTACH used a failure mode and effects analysis to identify and address high-priority areas for improvement. Areas in need of improvement included a lack of 1) wound care professionals, 2) methods to consistently document prevention and wound data, and 3) an interdisciplinary wound care team approach, as well as a faulty electronic medical record. While prevalence data were collected, policies and procedures based on several published guidelines were developed and incorporated into the pressure ulcer plan of care by the newly established wound care team. Improved assessment and documentation methods, enhanced staff education, revised electronic records, wound care product reviews, and a facility-wide commitment to improved care resulted in a reduction of facility-acquired pressure ulcer prevalence from 41% at baseline to an average of 4.2% during the following 12 months as well as fewer missing electronic record data (<1% of charts had missing data). These study results suggest that staff education, better documentation, and a dedicated wound care team improves care practices and reduces pressure ulcer prevalence in the LTACH. Studies to increase knowledge about the LTACH patient population and their unique needs and risk profiles are needed.

A New Mobile-responsive Solution to Increase Patient Adherence: Instant Personalized Product Handouts.

OBJECTIVE: This study aims to develop a solution for clinicians to quickly generate customized product handouts with clinical, coverage, pricing, and supplier information for patients, with the goal of increasing patient adherence. METHODS: Using design thinking methodology, a digital solution was developed as a module within a clinical/reimbursement decision-support web application for wound care and hyperbaric clinicians. The module was tested at 4 wound clinics (beta-sites) located in the Midwest region of the United States following a 1-group posttest study design. RESULTS: Ten clinicians at the 4 beta-sites completed a survey upon evaluation. All respondents indicated they would use the module daily or weekly. Most users (80%) indicated it met their needs very well (vs. moderately or not as much). Nurses who shared handouts with patients found 7 of 8 handouts were useful or very useful in increasing patient adherence to the plan of care. CONCLUSIONS: A digital point-of-care solution that generates customized product handouts with clinical, coverage, pricing, and supplier information may significantly improve patient adherence while saving clinicians time.

Cost Effectiveness of Becaplermin Gel on Wound Closure for the Treatment of Pressure Injuries.

OBJECTIVE: This study aims to determine the cost effectiveness of becaplermin gel on wound healing for the treatment of stage 3 and stage 4 pressure injuries (PIs). MATERIALS AND METHODS: A 2-stage Markov model was used to predict expected costs and outcomes of wound healing for becaplermin gel once daily plus good wound care (BGWC) compared with a placebo gel plus good wound care (control) over 1 year; good wound care consisted of debridement, infection management, and moisture balance. Patients in both arms received dressing changes and gel applications twice daily. Outcome data used in the analysis were derived from a 16-week randomized clinical trial. The primary outcome of interest was PI-free weeks. Transition probabilities for the Markov states were estimated from the clinical trial. Pressure injury recurrence rates were derived from PI literature. Utilization for becaplermin was calculated using the manufacturer's recommended dosing algorithm. Costs were derived from standard cost references and medical supply wholesalers; economic perspective taken was that of the long-term care facility. RESULTS: A total of 62 patients completed the study: 31 for BGWC and 31 for control. Over 1 year, patients treated with BGWC had substantially higher PI-free weeks compared with control patients (11.6 vs. 3.1, respectively). Patients treated with BGWC incurred higher total costs than those receiving the control treatment. Expected annual direct costs for PI were $3827 for BGWC and $1279 for the control. The incremental cost-effectiveness ratio was $298 (about $43/day), indicating that patients would have to pay an extra $298 to gain 1 additional PI-free week. CONCLUSIONS: Becaplermin gel plus good wound care was cost effective over standard of care, yielding better outcomes at a slightly higher cost and should be considered for management of PIs.

Comparative cost and clinical effectiveness of clostridial collagenase ointment for chronic dermal ulcers.

Chronic dermal ulcers affect approximately 2.4-4.5 million people in the USA and are associated with loss of function, decreased quality of life and significant economic burden. Debridement is a critical component of wound care involving removal of nonviable tissue from chronic wounds to stimulate the granulation and epithelialization process. Clostridial collagenase ointment has been used as a method of wound debridement for more than 50 years and is currently the only enzymatic debriding ointment with US FDA approval. This review discusses the results of recent real-world studies that build upon the evidence demonstrating the clinical effectiveness, cost-effectiveness and safety of clostridial collagenase ointment across wound types and care settings.

A Prospective, Multicenter Study to Compare a Disposable, High-fluid Capacity Underpad to Nonpermeable, Disposable, Reusable Containment Products on Incontinence-associated Dermatitis Rates Among Skilled Nursing Facility Residents.

Due to the high prevalence of incontinence among skilled nursing facility (SNF) residents, incontinence-associated derma- titis (IAD) is a common occurrence. In addition, facility staff may mistakenly identify IAD as a pressure injury. A prospective, descriptive, multicenter study was conducted in 3 Connecticut facilities to evaluate the effect of substituting a disposable, high- uid capacity underpad for nonpermeable disposable and reusable containment products on the rate of IADs. Residents with and without IAD but with high IAD risk scores who were bed- or chairbound or ambulatory and used disposable nonpermeable briefs and underpads or reusable, laundered containment products when in bed longer than 2 hours were randomly enrolled and observed for a 4-week period. Facility staff were trained on the importance of differentiating between IAD and pressure injury; they substituted the study product (a disposable, high- uid capacity underpad) for all previously used containment products. Patient risk for IAD and skin condition were assessed using the Perineal Assessment Tool (PAT) and the Skin Condition Assessment Tool (SAT), respectively, at 5 time points: baseline, week 1, week 2, week 3, and week 4. The PAT is a 4-item instrument based conceptually on the 4 determinants in perineal skin breakdown; subscales are rated from 1 (least risk) to 3 (most risk), with a total score range of 4 to 12. The SAT is used to evaluate IAD speci cally, generating a cumulative severity score ranging from 0 to 3 on area of skin affected, degree of redness, and depth of ero- sion. Final data analysis was conducted on 40 residents: 25 had IAD present at enrollment and 15 were deemed high risk for developing IAD. Mean SAT scores in the 25 participants with IAD decreased with signi cance at week 1 (P = .0016), week 2 (P = .0023), week 3 (P = .0005), and week 4 (P <.0001). Baseline IAD severity scores averaged 3.3 ± 1.7. Overall IAD average severity scores in this group decreased from baseline mean of 3.3 ± 1.7 to 0.7 ± 1.4 at week 4 (P <.001). The 15 participants with intact, nondamaged skin at enrollment did not develop IAD from baseline to week 4, and PAT score risk levels decreased from high (7 or greater) to low (6 or less) as a result of a speci c reduction in the duration of irritant exposure category for 11 (73%) of this group of participants by week 4. PAT risk level scores for both IAD and non-IAD participants at baseline averaged 8.1 ± 1.4; after 4 weeks, they averaged 7.0 ± 1.5). Although change was not significant, results suggest the use of a disposable, high- uid capacity underpad improved SAT scores over time. IAD rates increased in each facility, but pressure injury incidence rates decreased for the study duration. Replacing a nonpermeable, reusable containment product with a disposable, high- uid capacity underpad when SNF residents are in bed longer than 2 hours may impact the severity of IAD and reduce its incidence. The inverse impact reported on IAD and pressure injury incidence rates 1 month after training suggest study educational efforts had a short-lasting effect. Future research is indicated to determine the most effective method to improve nurses' ability to identify and distinguish IAD from pressure injury in the SNF setting.

The AAWC conceptual framework of quality systems for wound care.

When the Association for Advanced Wound Care Quality of Care Task Force members determined there was no unanimously accepted definition of quality as it relates to wound care, they: 1) identified relevant components of quality wound care, and 2) created a framework of quality wound care indicators to enable the creation or assessment of wound care delivery systems. The framework is an innovative conceptual model that serves as a basis for the Association strategies to facilitate high quality wound care for patients/clients across the continuum of care and recognizes the role of the supporting systems necessary to provide wound care services. It uses the Institute of Medicine's Crossing the Quality Chasm: A New Health System for the 21st Century to define quality systems for wound care and includes safety and effectiveness coupled with the delivery of timely, efficient, equitable, collaborative, patient-centered care. This framework can be utilized during clinical, managerial, or regulatory review of wound care service delivery.

Guest Editorial: Pressure Injury Brexit?

Christopher Columbus initially was scorned because he believed an alternative trade route to the East existed. Like most groundbreaking exploration, Columbus' came with unintended consequences. His serendipitous findings: a new land. The consequence? Transmitting devastating illnesses with massive population loss to indigenous people.

Impact of antimicrobial gauze on bacterial colonies in wounds that require packing.

Heavy microbial contamination has been associated with delayed wound healing and infection in both acute and chronic wounds. A prospective, randomized, 5-week controlled, open label, multicenter study was conducted to determine whether using antimicrobial gauze containing polyhexamethylene biguanide in wounds that require packing will result in a greater reduction of bacterial colony counts than using a gauze without polyhexamethylene biguanide (the control). Twenty-one subjects were randomized to the treatment or control dressing. Wounds were evenly distributed with respect to etiology and both study groups had a median baseline wound size of 7 cm2. At baseline, 15 microbial isolates were recovered and counted in treatment group wounds and 12 were recovered in the controls. At Week 1, six isolates were recovered from subjects in the polyhexamethylene biguanide antimicrobial gauze treatment group while 10 were recovered in the control. Change in polymicrobial bioburden was most prominent during the first few weeks of the study in the polyhexamethylene biguanide group. Polymicrobial counts in the treatment group remained reduced for the following three study weeks, returning to baseline at Week 4. In the control group, the number of polymicrobial cultures rose to 60% above baseline at Week 4. Two wounds of subjects randomized to the polyhexamethylene biguanide antimicrobial gauze healed; one wound in the control group healed. Polyhexamethylene biguanide antimicrobial gauze dressing could be an important adjunct to control the polymicrobial bioburden of delayed closure surgical wounds, pressure ulcers, and diabetic foot ulcers. Additional studies seem warranted.

Clinical and economic benefit of enzymatic debridement of pressure ulcers compared to autolytic debridement with a hydrogel dressing.

OBJECTIVE: The purpose of this study was to determine the cost-effectiveness of enzymatic debridement using collagenase relative to autolytic debridement with a hydrogel dressing for the treatment of pressure ulcers. METHODS: A 3-stage Markov model was used to determine the expected costs and outcomes of wound care for collagenase and hydrogel dressings. Outcome data used in the analysis were taken from a randomized clinical trial that directly compared collagenase and hydrogel dressings. The primary outcome in the clinical trial was the proportion of patients achieving a closed epithelialized wound. Transition probabilities for the Markov states were estimated from the clinical trial. A 1-year time horizon was used to determine the expected number of closed wound days and the expected costs for the two alternative debridement therapies. Resource utilization was based on the wound care treatment regimen used in the clinical trial. Resource costs were derived from standard cost references and medical supply wholesalers. The economic perspective taken was that of the long-term care facility. No cost discounting was performed due to the short time horizon of the analysis. A deterministic sensitivity analysis was conducted to analyze economic uncertainty. RESULTS: The number of expected wound days for the collagenase and hydrogel cohorts are estimated at 48 and 147, respectively. The expected direct cost per patient for pressure ulcer care was $2003 for collagenase and $5480 for hydrogel debridement. The number of closed wound days was 1.5-times higher for collagenase (317 vs 218 days) than with the hydrogel. The estimated cost/closed wound day was 4-times higher for the hydrogel ($25) vs collagenase ($6). CONCLUSIONS: In this Markov model based on a randomized trial of pressure ulcer care in a long-term care setting collagenase debridement was economically dominant over autolytic debridement, yielding better outcomes at a lower total cost. Since it was a single institution study with a small sample size, the results should be interpreted with caution. Specifically, the findings may not necessarily be generalized to other hydrogel dressings, healthcare settings, age groups, or to wounds of other etiologies.