A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft® construct in patients with deep partial-thickness thermal burns
Angela Gibson, James H. Holmes, Jeffrey W. Shupp, David J. Smith, Victor Joe, Joshua Carson, Jeffrey Litt, Steven A. Kahn, Tracee Short, Leopoldo C. Cancio, Julie A Rizzo, Jeffrey E Carter, Kevin N Foster, Mary A. Lokuta, Allen R. Comer, Janice M. Smiell, B. Lynn Allen‐Hoffmann
Abstract
OBJECTIVE: This phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns. METHODS: 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. RESULTS: Seventy-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%). CONCLUSIONS: Both coprimary endpoints were achieved. StrataGraft may offer a new treatment for DPT burns to reduce the need for autografting. CLINICAL TRIAL IDENTIFIER: NCT03005106.