• Angela L F Gibson, James H Holmes, Jeffrey W Shupp, David Smith, Victor Joe, Joshua Carson, Jeffrey Litt, Steven Kahn, Tracee Short, Leopoldo Cancio, Julie Rizzo, Jeffrey E Carter, Kevin Foster, Mary A Lokuta, Allen R Comer, Janice M Smiell, and Allen-HoffmannB LynnBLDepartment of Pathology and Department of Surgery, University of Wisconsin School of Medicine and Public Health, 5605 MSC 1300 University Avenue Madison, WI 53706, United States..
• Department of Surgery, University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, Madison, WI 53792, United States. Electronic address: gibson@surgery.wisc.edu.
• Burns. 2021 Aug 1; 47 (5): 1024-1037.

ObjectiveThis phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns.MethodsPatients aged ≥18 years with 3-49% total body surface area (TBSA) thermal burns were enrolled. In each patient, 2 DPT areas (≤2000cm2 total) of comparable depth after excision were randomized to either cryopreserved StrataGraft or autograft. Coprimary endpoints were: the difference in percent area of StrataGraft treatment site and autograft treatment site autografted at Month 3 (M3), and the proportion of patients achieving durable wound closure of the StrataGraft site without autograft at M3. Safety assessments were performed in all patients. Efficacy and safety follow-up continued to 1 year.ResultsSeventy-one patients were enrolled. By M3, there was a 96% reduction in mean percent area of StrataGraft treatment sites that required autografting, compared with autograft treatment sites (4.3% vs 102.1%, respectively; P<.0001). StrataGraft treatment resulted in durable wound closure at M3 without autografting in 92% (95% CI: 85.6, 98.8; n/n 59/64) of patients for whom data were available. The most common StrataGraft-related adverse event was pruritus (15%).ConclusionsBoth coprimary endpoints were achieved. StrataGraft may offer a new treatment for DPT burns to reduce the need for autografting.Clinical Trial IdentifierNCT03005106.Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.

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