International Wound Journal

<jats:title>ABSTRACT</jats:title><jats:p>Venous leg ulcers (VLUs) are traditionally managed with standard‐of‐care dressings, compression and appropriate adjunctive venous interventions for pathologic venous reflux. Due to pathophysiological complexity and underlying patient comorbidities, conducting randomised controlled trials to evaluate the comparative efficacy of advanced treatment modalities is difficult, as many patients would likely be excluded. This retrospective, pragmatic, real‐world evidence (RWE) study compared the healing outcomes of VLUs treated with either ovine forestomach matrix (OFM) (<jats:italic>n</jats:italic> = 312) or collagen/oxidised regenerated cellulose (ORC) (<jats:italic>n</jats:italic> = 239) in outpatient wound care centres. Unlike restrictive randomised controlled trials, minimal inclusion and exclusion criteria were applied to create two treatment cohorts that reflected the general VLU population. The incidence (%) of closure was greater in OFM‐treated VLUs at 12, 24 and 36 weeks, and this difference was significant at 24 and 36 weeks compared to collagen/ORC. Median time to wound closure was significantly faster (<jats:italic>p</jats:italic> = 0.045) in the OFM cohort (11.1 ± 0.6 weeks) compared to the collagen/ORC group (12.3 ± 1.0 weeks). Cox proportional hazards analysis demonstrated that OFM‐treated VLUs had a significantly greater probability of healing (up to ~40%). This RWE comparative efficacy study further substantiates the clinical benefit of OFM in the treatment of chronic wounds, such as VLU, in a real‐world patient cohort.</jats:p>

publication_history

received

accepted

published

Venous Leg Ulcers

BMJ Clinical Evidence

Venous Ulcers: Diagnosis and Treatment

American Family Physician

Wound Cleansing for Treating Venous Leg Ulcers

Cochrane Database of Systematic Reviews

Hydrogel Dressings for Venous Leg Ulcers

Therapeutic Ultrasound for Venous Leg Ulcers

Debridement for Venous Leg Ulcers

Assessing the Application and Effectiveness of Human Amniotic Membrane in the Management of Venous and Diabetic Ulcers: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Cureus

A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers

Wounds

Use of an Advanced Extracellular Matrix Dressing in the Treatment of Acute and Chronic Wounds: A Malaysian Case Series

Wounds Asia

Use of an Ovine Collagen Dressing With Intact Extracellular Matrix to Improve Wound Closure Times and Reduce Expenditures in a US Military Veteran Hospital Outpatient Wound Center

Surgical Technology International

Use of Ovine‐Based Collagen Extracellular Matrix and Gentian Violet/Methylene Blue Antibacterial Foam Dressings to Help Improve Clinical Outcomes in Lower Extremity Wounds: A Retrospective Cohort Study

Proactive and Early Aggressive Wound Management: A Shift in Strategy Developed by a Consensus Panel Examining the Current Science, Prevention, and Management of Acute and Chronic Wounds

In‐Vivo Evaluation of a Reinforced Ovine Biologic for Plastic and Reconstructive Procedures in a Non‐Human Primate Model of Soft Tissue Repair

Eplasty

Venous leg ulcers (VLUs) are traditionally managed with standard-of-care dressings, compression and appropriate adjunctive venous interventions for pathologic venous reflux. Due to pathophysiological complexity and underlying patient comorbidities, conducting randomised controlled trials to evaluate the comparative efficacy of advanced treatment modalities is difficult, as many patients would likely be excluded. This retrospective, pragmatic, real-world evidence (RWE) study compared the healing outcomes of VLUs treated with either ovine forestomach matrix (OFM) (n = 312) or collagen/oxidised regenerated cellulose (ORC) (n = 239) in outpatient wound care centres. Unlike restrictive randomised controlled trials, minimal inclusion and exclusion criteria were applied to create two treatment cohorts that reflected the general VLU population. The incidence (%) of closure was greater in OFM-treated VLUs at 12, 24 and 36 weeks, and this difference was significant at 24 and 36 weeks compared to collagen/ORC. Median time to wound closure was significantly faster (p = 0.045) in the OFM cohort (11.1 ± 0.6 weeks) compared to the collagen/ORC group (12.3 ± 1.0 weeks). Cox proportional hazards analysis demonstrated that OFM-treated VLUs had a significantly greater probability of healing (up to ~40%). This RWE comparative efficacy study further substantiates the clinical benefit of OFM in the treatment of chronic wounds, such as VLU, in a real-world patient cohort.

Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidised Regenerated Cellulose for the Treatment of Venous Leg Ulcers: A Retrospective Comparative Real-World Evidence Study.

Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidised Regenerated Cellulose for the Treatment of Venous Leg Ulcers: A Retrospective Comparative Real‐World Evidence Study

Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidised Regenerated Cellulose for the Treatment of Venous Leg Ulcers: A Retrospective Comparative Real‐World Evidence Study

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