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

Document Type

Article

Publication Date

8-1-2021

Publication Title

Burns

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: Patients aged ≥18 years with 3–49% total body surface area (TBSA) thermal burns were enrolled. In each patient, 2 DPT areas (≤2000 cm2 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.

First Page

1024

Last Page

1037

PubMed ID

34099322

Volume

47

Issue

5

Publisher

Elsevier

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