A Large, Real-World, Prospective, Single-Arm Study Evaluating Outcomes Following Complex Lower Extremity Reconstruction with Ovine Forestomach Matrix Graft

Introduction: Complex and chronic lower extremity wounds have numerous etiologies and can progress to require eventual amputation. In addition to morbidity and mortality, chronic lower extremity soft tissue defects have a significant impact on patient quality-of-life and represent a significant cost burden to the healthcare system. Ovine forestomach matrix (OFM) graft was employed as a surgical limb salvage technique to achieve healing in chronic lower extremity soft tissue defects at high risk of major amputation.Methods:Prospective data was collected on 120 in-patients (totaling n=130 defects) reflecting a real-world cohort at high-risk of major lower extremity amputation from a single site as part of the “Myriad™ Augmented Soft Tissue Reconstruction Registry” (NTC05243966). All participants received OFM (graft^ and/or morselized*) for surgical reconstruction as a means of lower limb salvage.[BM1]  Progress of the soft tissue defect was monitored for time (days) to 75-100% granulation tissue formation and time (days) to complete defect closure. Results:Participant demographics and defect characteristics were reflective of a real-world inpatient population with highly complex soft tissue defects. 95.8% of the cohort had one or more predictors of major lower extremity amputation. Median defect area was 7.5 cm2 (IQR: 3.9, 14.9) (mean, 11.3±13.5). The median time to 75-100% granulation tissue formation was 30 (IQR: 20, 46.5) (mean, 36.1±26.2) days and the median time to complete defect closure was 103 (IQR: 54, 168) (mean, 133.5±109.3) days. There was an 89.2% incidence of complete healing at 90 days. The median cost per episode was $220.50 (IQR: 220.50, 1,112.00) (mean, 827.80±1,001.00) with a median of 1.0 (IQR: 1.0, 1.0) (mean, 1.4±0.89) application.Discussion: OFM was found to be a safe and effective limb salvage treatment for complex and chronic lower extremity defects requiring surgical intervention while controlling cost per-episode and per-defect exemplified by median of one application to achieve 100% depth fill and granulation. The real-world inclusion/exclusion criteria of these prospective data reflect those who are most vulnerable to life-altering limb loss and are frequently excluded from randomized controlled trials.References: