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

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INTRODUCTION: 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. METHODS: 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. RESULTS: Subjects represented a medically complex population with substantial comorbidity burden and challenging defect characteristics. Most defects were chronic (59.8%) and classified as Centers for Disease Control class II (38.2%) or III (50.4%), indicating that nearly 90% of defects were clean-contaminated or contaminated. Exposed structures (11.4%) and osteomyelitis (15.0%) were also common. A broad range of defect etiologies were included, such as diabetic foot ulcers (22.6%), traumatic injuries (16.5%), ostomy takedowns (11.2%), and pilonidal sinuses (10.8%). Across 411 subjects 12.2% experienced one or more AE. No AEs were determined to be definitively related to OFM-based devices and only a single AE (0.2%) was considered probably device-related. AEs occurring at the index defect were infrequent and included superficial infection (2.9%), dehiscence (3.2%), and deep tissue infection (0.7%). CONCLUSION: The registry framework provides a valuable mechanism for evaluating device safety and performance under real-world conditions. OFM-based devices demonstrated a favorable safety profile across a broad range of reconstructive applications, surgical specialties, and defect types, with only a single application required in most patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05243966.

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