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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.

Aim: To evaluate the safety and effectiveness of various ovine forestomach matrix (OFM) products for managing acute and chronic wounds in the Indian population. Method: Patients with acute or chronic wounds were prospectively enrolled into the study across four medical centers in India. Wounds were debrided as needed, then treated with antimicrobial single-layer OFM twice weekly, for a maximum of two weeks. Afterward, wounds received weekly single-layer OFM applications until considered suitable for multi-layer OFM device placement with suturing/stapling. Weekly assessments determined the need for a second multi-layer OFM application until 100% granulation tissue formation was achieved. Definitive closure occurred either by secondary intention with weekly single-layer OFM applications, or through split-thickness skin grafting (STSG). Demographics, wound characteristics, healing outcomes, and adverse events were analyzed. Results / Discussion: One hundred patients were enrolled (74% male, 26% female), primarily middle-aged and of normal weight. Most wounds were traumatic (41%), followed by diabetic foot ulcers (17%) and soft tissue infections (15%). Wounds were predominantly located on the lower extremities (82%), were clean-contaminated (72%), and primarily chronic (median wound age of 4 weeks, IQR: 3, 9). Complete wound closure was achieved in a median of 9.02 (IQR: 5.56, 13.99) weeks. Full granulation tissue formation was attained in a median of 1.99 (IQR: 1.01, 2.13) weeks, and the median take of STSG at 1-week post-placement was 95 (IQR: 88.75, 100)%. No adverse events related to the OFM devices were observed. Conclusion: OFM bioscaffolds are safe and effective for treating acute and chronic wounds in the Indian population.

Introduction: In India, both acute and chronic wounds place a significant burden on overall quality of life and healthcare costs. However, chronic wounds are notoriously difficult to treat due to delayed diagnosis, poor patient treatment compliance, limited healthcare accessibility, constrained economic resources, and social stigma [1-3]. Also, wound care treatments are limited, particularly in rural areas, increasing overall morbidity [4]. Ovine forestomach matrix (OFM) represents a responsibly priced graft that can effectively treat various wounds but remains under-researched among Indian communities. Here, we present a prospective evaluation of OFM safety and effectiveness in India. Methods: One hundred patients with acute or chronic wounds were prospectively enrolled from four medical centers in India. Treatment included antimicrobial single-layer OFM (twice weekly) to manage underlying inflammation and infection, followed by natural single-layer OFM (weekly) to promote the proliferative phase of healing and finally surgical placement of a multi-layer OFM device to induce vascularized tissue formation. Definitive closure was accomplished either through split-thickness skin grafting (STSG), or via secondary intention with further natural single-layer OFM applications. Demographics, wound characteristics, healing outcomes, and adverse events were analyzed. Results: Most patients were male, middle-aged and of normal weight. Wounds were primarily traumatic (41%), followed by diabetic foot ulcers (17%) and soft tissue infections (15%). Wounds were predominantly located on the lower extremities (82%), were clean-contaminated (72%), and chronic (median wound age of 4 weeks, IQR: 3, 9). Complete wound closure was achieved with a median of 9.02 (IQR: 5.56, 13.99) weeks. Full granulation tissue formation was attained in a median of 1.99 (IQR: 1.01, 2.13) weeks, and the median take of STSG at 1-week post-placement was 95 (IQR: 88.75, 100)%. No OFM-related adverse events were observed. Discussion: Across a large prospective clinical trial, OFM supported complete wound closure without complications, despite the challenging-to-treat patient population. In fact, most patients had highly complicated, contaminated wounds. Moreover, this study demonstrated that different OFM grafts can be applied sequentially to promote different phases of healing. Overall, this study showed that OFM bioscaffolds are safe and effective for treating both acute and chronic wounds in the Indian population. References 1. Bal A, et al., Assessment of chronic wound patients’ journey in India: a survey of the perspectives of healthcare professionals and patients. Wounds International, 2023. 14(4). 2. Deshmukh D, et al., Data driven evidence-based wound care in developing countries: challenges, requirements and significance. Wounds Asia, 2022. 5(1). 3. Sharma, A., Epidemiological profile of chronic wounds in a rural and urban community of an Indian district: A feasibility study trial. Formosan Journal of Surgery, 2023. 56(5): p. 167–169. 4. Patil O, Faras F, and K. Bharadia, Negative pressure wound therapy versus conventional dressing in treatment of infected chronic wounds in rural hospital: a prospective case control study. International Journal of Scientific Research, 2025. 14(10).