Multi-Centre, Single-Arm, Prospective Evaluation of Ovine Forestomach Matrix for the Treatment of Complex Wounds in the South Asian Population

Abstract

Acute and chronic wounds are a significant clinical and economic challenge worldwide. In India, adoption of advanced bioscaffolds remains constrained by cost, limited healthcare access and cultural/religious beliefs. Ovine forestomach matrix (OFM)-based devices have demonstrated utility in wound bed preparation and soft tissue reconstruction for complex wounds. This prospective multi-centre study evaluated a structured treatment algorithm incorporating OFM-based dressings for wound bed preparation, and grafts for reconstruction. Participants with acute or chronic wounds were assessed weekly for adverse events, granulation tissue coverage, volumetric defect fill and wound closure. Enrolled participants (n = 100) presented with common complicating comorbidities and included mainly traumatic wounds (41%) and diabetic foot ulcers (17%). Most lesions were chronic (60%), large (median area: 40.1 cm²) and contaminated (77.0%, CDC Grade II or CDC Grade III). Participants who completed the study (n = 83) achieved granulation tissue coverage in a median of 4.0 (3.7, 5.0) weeks. Full closure was reached at a median of 9.0 (IQR: 8.0, 11.0) weeks. No device-related adverse events or complications were observed. Sequential use of OFM dressings and grafts with a defined treatment algorithm safely facilitated wound bed preparation and reconstruction whilst supporting streamlined clinical decision-making and workflow.

Keywords: chronic wounds; complex wounds; diabetic foot ulcer; ovine forestomach matrix; wound healing; wound reconstruction.