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,...

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Main Authors: Romanelli M, Gilligan AM, Waycaster CR, Dini V
Format: Article
Language:English
Published: Dove Medical Press 2016-05-01
Series:ClinicoEconomics and Outcomes Research
Subjects:
Online Access:https://www.dovepress.com/difficult-to-heal-wounds-of-mixed-arterialvenous-and-venous-etiology-a-peer-reviewed-article-CEOR
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author Romanelli M
Gilligan AM
Waycaster CR
Dini V
author_facet Romanelli M
Gilligan AM
Waycaster CR
Dini V
author_sort Romanelli M
collection DOAJ
description 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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spelling doaj.art-67cfee52be10486194db29ef78e8cdcd2022-12-21T17:30:46ZengDove Medical PressClinicoEconomics and Outcomes Research1178-69812016-05-012016Issue 115316126767Difficult-to-heal wounds of mixed arterial/venous and venous etiology: a cost-effectiveness analysis of extracellular matrixRomanelli MGilligan AMWaycaster CRDini VMarco 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 outcomeshttps://www.dovepress.com/difficult-to-heal-wounds-of-mixed-arterialvenous-and-venous-etiology-a-peer-reviewed-article-CEORextracellular matrixadjunct therapyvenous leg ulcerscost-effectivenesscompression therapyeconomic outcomes
spellingShingle Romanelli M
Gilligan AM
Waycaster CR
Dini V
Difficult-to-heal wounds of mixed arterial/venous and venous etiology: a cost-effectiveness analysis of extracellular matrix
ClinicoEconomics and Outcomes Research
extracellular matrix
adjunct therapy
venous leg ulcers
cost-effectiveness
compression therapy
economic outcomes
title Difficult-to-heal wounds of mixed arterial/venous and venous etiology: a cost-effectiveness analysis of extracellular matrix
title_full Difficult-to-heal wounds of mixed arterial/venous and venous etiology: a cost-effectiveness analysis of extracellular matrix
title_fullStr Difficult-to-heal wounds of mixed arterial/venous and venous etiology: a cost-effectiveness analysis of extracellular matrix
title_full_unstemmed Difficult-to-heal wounds of mixed arterial/venous and venous etiology: a cost-effectiveness analysis of extracellular matrix
title_short Difficult-to-heal wounds of mixed arterial/venous and venous etiology: a cost-effectiveness analysis of extracellular matrix
title_sort difficult to heal wounds of mixed arterial venous and venous etiology a cost effectiveness analysis of extracellular matrix
topic extracellular matrix
adjunct therapy
venous leg ulcers
cost-effectiveness
compression therapy
economic outcomes
url https://www.dovepress.com/difficult-to-heal-wounds-of-mixed-arterialvenous-and-venous-etiology-a-peer-reviewed-article-CEOR
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AT waycastercr difficulttohealwoundsofmixedarterialvenousandvenousetiologyacosteffectivenessanalysisofextracellularmatrix
AT diniv difficulttohealwoundsofmixedarterialvenousandvenousetiologyacosteffectivenessanalysisofextracellularmatrix