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

Authors Romanelli M, Gilligan A, Waycaster C, Dini V, Bray C

Received 12 January 2016

Accepted for publication 7 March 2016

Published 4 May 2016 Volume 2016:8 Pages 153—161


Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Qian Ding

Peer reviewer comments 2

Editor who approved publication: Professor Giorgio Lorenzo Colombo

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 outcomes

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