Document Type

Oral Presentation

Publication Date

2026

Abstract

Background: Major lower extremity amputations are associated with substantial postoperative morbidity and mortality (Belmont). Restrata is a synthetic electrospun fiber matrix that is engineered to closely resemble human extracellular matrix to facilitate wound healing while avoiding the drawbacks of traditional biologic wound matrices (MacEwan, Fernandez). There have been no studies which have directly compared micronized electrospun fiber matrix (MEFM) to biologic xenograft matrices in patients undergoing major lower extremity amputation. The purpose of this study is to compare postoperative wound recovery in patients undergoing major lower extremity amputation, treated with MEFM (Restrata Minimatrix, Acera, St.Louis, Missouri ) versus a type I bovine hydrolyzed collagen powder (CellerateRx). Methods: We conducted a retrospective, single-institution cohort study of adult patients undergoing major lower extremity amputation (BKA or AKA) between 2021 and 2024, comparing Restrata versus Cellerate powder applied in a 1:1 ratio with vancomycin at the index operation. Patients were included if they were ≥18 years and had documented postoperative follow-up. The primary outcome was postoperative wound complications, including surgical site infection (SSI), revision, and re-amputation during early and late follow-up. Results: Seventy-seven patients underwent major amputation, with a mean (sd) age of 63 (±14) years. The cohort was medically complex and socially vulnerable, with a median (IQR) Elixhauser comorbidity index of 5 (1-10), median (IQR) BMI of 27.4 (22.8-33.1), 76.3% insured through Medicaid/Medicare, 50.7% current smokers, and 14.3% experiencing financial instability. Follow-up rates were high, with 96% early follow-up at a median of 26 (20-34) days and 87% late follow-up at 86 (74-97) days. Early SSI and revision demonstrated an approximately 10% absolute difference between groups favoring Restrata; however, these differences did not reach statistical significance. At late follow-up, the absolute differences narrowed to approximately 7% for SSI and 4% for revision and re-amputation. Conclusion: In a medically complex and socially vulnerable amputation population, early surgical site infection and revision rates were higher in the Cellerate group compared to Restrata group, although these differences did not reach statistical significance. These results warrant further investigation with a larger sample size.

Journal/Conference Details

Presented at the 2026 UT Tyler School of Medicine Research Day and UT Health Tyler GME Quality Improvement and Research Day.

Persistent Identifier

http://hdl.handle.net/10950/5161

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