Abstract
PURPOSE: Traumatic soft tissue defects present challenges due to their diverse presentations. This variability necessitates tailored approaches for effective management, requiring advanced reconstruction strategies to achieve rapid coverage and tissue infill while minimizing complications. The study aimed to evaluate the safety of ovine forestomach matrix (OFM) grafts in traumatic defects from four level I trauma centers. METHODS: This prospective observational study used a multicenter registry to collect deidentified data from adult trauma/acute care surgery patients who received OFM-based grafts for soft tissue repair from August 2022 through September 2024. After the application of OFM grafts, defects were regularly assessed for the development of vascularized tissue coverage and/or fill, and ultimately epithelialization. RESULTS: During the study, 49 participants with 61 soft tissue defects underwent procedures with OFM-based grafts. The mean participant age was 58.8±17.7 years. Most defects (55.7%) resulted from traumatic injuries, with additional etiologies including necrotizing soft tissue infections (13.1%), enterocutaneous fistulas (4.9%), acute pressure injuries (stages III and IV, 6.6%), surgical dehiscence (4.9%), amputations (3.3%), and hematoma evacuation (3.3%). All defects achieved vascularized tissue coverage within a median of 22.5 days (interquartile range, 13.3-33.5 days) after a median of one product application (interquartile range, 1-1). Four cases of superficial infection were reported, all resolving without major complications. CONCLUSIONS: OFM-based grafts showed promising results in tissue regeneration for trauma and acute care defects, with minimal postoperative complications. These results are interim findings from an ongoing prospective multicenter registry study evaluating the safety and efficacy of OFM-based grafts in various surgical applications.