Safety of Ovine Forestomach Matrix Across 474 Soft Tissue Defects: Interim Results from the Prospective Multicenter MASTRR Registry

Well-powered, prospective, registry-based clinical studies present the opportunity for broad safety surveillance of bioscaffolds used in soft tissue reconstruction but remain limited in the field. The Myriad™ Augmented Soft Tissue Reconstruction Registry (“MASTRR Registry”) was established as an ongoing multicenter prospective registry to evaluate the real-world safety and performance of ovine forestomach matrix (OFM)-based devices in complex soft tissue reconstruction. The interim safety analysis included prospective subject data from the first 411 subjects and 474 defects undergoing reconstruction with OFM-based devices from 10 participating sites. The analysis included subjects from trauma, colorectal, burn, and limb salvage specialties. All adverse events (AEs) were categorized based on severity, causality in relation to the investigational device, and correlated to the surgical procedure and relationship to the index defect. Subjects represented a medically complex population with substantial comorbidity burden and challenging defect characteristics. Most defects were chronic (59.8