Pressure ulcer treatment in a long-term care setting: wound bed healing with clostridial collagenase ointment versus hydrogel dressing

Curtis R Waycaster,1,2 Adrienne M Gilligan,1,2 Catherine T Milne3 1Smith and Nephew Inc., Fort Worth, TX, USA; 2Department of Pharmacotherapy, University of North Texas Health Sciences Center, Fort Worth, TX, USA; 3Connecticut Clinical Nursing Associates LLC, Bristol, CT, USA Purpose: To compare clinical outcomes in patients with pressure ulcers (PUs) who were treated with enzymatic debridement using clostridial collagenase ointment (CCO) with those treated with autolytic debridement using a hydrogel dressing. Patients and methods: This prospective, randomized, blinded, single-site trial directly compared the use of CCO and hydrogel dressings for treatment of PUs in patients in a long-term care facility. Changes in wound bed scores (WBS), tissue granulation, wound surface area, and epithelialization were assessed weekly during the 6-week treatment. Effects of treatment time, treatment method, and the combination of treatment time and method on continuous outcomes were analyzed by linear regression; the effects of covariates on epithelialization were analyzed by logistic regression. Results: Overall, 27 patients completed the study; 13 patients were treated with CCO and 14 with hydrogel. Baseline demographic and clinical characteristics were similar between the treatment groups. Patients treated with CCO had a granulation rate approximately twice that of those receiving hydrogel and showed a significantly higher rate of granulation tissue formation at week 6. Treatment duration and the combination of treatment duration and method were significant predictors of granulation tissue formation. WBS improvements from baseline to week 6 were greater in patients who received CCO than in those treated with hydrogel (+4.6 units versus +2.6 units, respectively). Treatment duration and the combination of treatment duration and method were predictors of WBS improvement. Patients treated with CCO showed significant reductions in wound surface area from baseline (10.3 cm2) to week 6 (2.1 cm2). At week 6, epithelialization was numerically higher in patients treated with CCO than in patients treated with hydrogel. Conclusion: Long-term care facility patients with PUs who received enzymatic debridement with CCO had greater improvements in granulation tissue formation, WBS, wound surface area, and wound closure than did those treated with hydrogel. Keywords: debridement, wound surface area, wound bed score, epithelialization, hydrogel dressing, collagenase ointmen

Difficult-to-heal wounds of mixed arterial/venous and venous etiology: a cost-effectiveness analysis of extracellular matrix

Marco Romanelli,1 Adrienne M Gilligan,2,3 Curtis R Waycaster,3,4 Valentina Dini1 1Department of Dermatology, University of Pisa, Pisa, Italy; 2Department of Life Sciences, Truven Health Analytics, Fort Worth, TX, USA; 3Department of Pharmacotherapy, University of North Texas Health Sciences Center, Fort Worth, TX, USA; 4Department of Market Access, Smith and Nephew Inc., Fort Worth, TX, USA Importance: Difficult-to-heal wounds pose clinical and economic challenges, and cost-effective treatment options are needed. Objective: The aim of this study is to determine the cost-effectiveness of extracellular matrix (ECM) relative to standard of care (SC) on wound closure for the treatment of mixed arterial/venous (A/V) or venous leg ulcers (VLUs). Design, setting, and participants: A two-stage Markov model was used to predict the expected costs and outcomes of wound closure for ECM and SC. Outcome data used in the analysis were taken from an 8-week randomized clinical trial that directly compared ECM and SC. Patients were followed up for an additional 6 months to assess wound closure. Forty-eight patients completed the study; 25 for ECM and 23 for SC. SC was defined as a standard moist wound dressing. Transition probabilities for the Markov states were estimated from the clinical trial. Main outcomes and measures: The economic outcome of interest was direct cost per closed-wound week. Resource utilization was based on the treatment regimen used in the clinical trial. Costs were derived from standard cost references. The payer’s perspective was taken. Results: ECM-treated wounds closed, on average, after 5.4 weeks of treatment, compared with 8.3 weeks for SC wounds (P=0.02). Furthermore, complete wound closure was significantly higher in patients treated with ECM (P<0.05), with 20 wounds closed in the ECM group (80%) and 15 wounds closed in the SC group (65%). After 8 months, patients treated with ECM had substantially higher closed-wound weeks compared with SC (26.0 weeks versus 22.0 weeks, respectively). Expected direct costs per patient were $2,527 for ECM and$2,540 for SC (a cost savings of $13). Conclusion and relevance: ECM yielded better clinical outcomes at a slightly lower cost in patients with mixed A/V and VLUs. ECM is an effective treatment for wound healing and should be considered for use in the management of mixed A/V and VLUs. Keywords: extracellular matrix, adjunct therapy, venous leg ulcers, wound care, compression therapy, economic outcome

Economic analysis and budget impact of clostridial collagenase ointment compared with medicinal honey for treatment of pressure ulcers in the US

Elizabeth S Mearns,1 Michael Liang,1 Brendan L Limone,1 Adrienne M Gilligan,1 Jeffrey D Miller,1 Kathleen D Schaum,2 Curtis R Waycaster2 1Truven Health Analytics, an IBM Company, Cambridge, MA, USA; 2Smith & Nephew, Inc., Fort Worth, TX, USA Objectives: Pressure ulcer (PU) treatment poses significant clinical and economic challenges to health-care systems. The aim of this study was to assess the cost-effectiveness and budget impact of enzymatic debridement with clostridial collagenase ointment (CCO) compared with autolytic debridement with medicinal honey (MH) for PU treatment from a US payer/Medicare perspective in the hospital outpatient department setting.Methods: A cost-effectiveness analysis using a Markov model was developed using a 1-week cycle length across a 1-year time horizon. The three health states were inflammation/senescence, granulation/proliferation (ie, patients achieving 100% granulation), and epithelialization. Data sources included the US Wound Registry, Medicare fee schedules, and other published clinical and cost studies about PU treatment.Results: In the base case analysis over a 1-year time horizon, CCO was the economically dominant strategy (ie, simultaneously conferring greater benefit at less cost). Patients treated with CCO experienced 22.7 quality-adjusted life weeks (QALWs) at a cost of $6,161 over 1 year, whereas MH patients experienced 21.9 QALWs at a cost of$7,149. Patients treated with CCO achieved 11.5 granulation weeks and 6.0 epithelization weeks compared with 10.6 and 4.4 weeks for MH, respectively. The number of clinic visits was 40.1 for CCO vs 43.4 for MH, and the number of debridements was 12.3 for CCO compared with 17.6 for MH. Probabilistic sensitivity analyses determined CCO dominant in 72% of 10,000 iterations and cost-effective in 91%, assuming a benchmark willingness-to-pay threshold of $50,000/quality-adjusted life year ($962/QALW). The budget impact analysis showed that for every 1% of patients shifted from MH to CCO, a cost savings of $9,883 over 1 year for a cohort of 1,000 patients was observed by the payer. Conclusion: The results of these economic analyses suggest that CCO is a cost-effective, economically dominant alternative to MH in the treatment of patients with PUs in the hospital outpatient department setting. Keywords: cost-effectiveness, budget impact, pressure ulcer, debridement, clostridial collagenase, outpatien