• James H Holmes Iv, Leopoldo C Cancio, Jeffrey E Carter, Lee D Faucher, Kevin Foster, Helen D Hahn, Booker T King, Randi Rutan, Janice M Smiell, Richard Wu, and Angela L F Gibson.
• Department of Surgery, Wake Forest University School of Medicine, Winston-Salem, NC, United States.
• Burns. 2022 Dec 1; 48 (8): 181618241816-1824.

ObjectiveThis analysis includes pooled safety data from 2 clinical trials (NCT01437852; NCT03005106) that evaluated the safety and efficacy of StrataGraft in patients with deep partial-thickness (DPT) burns.MethodsThe study enrolled 101 adult patients with thermal burns covering 3-49% of total body surface area. Patients were followed for up to 1 year. The pooled safety events included: adverse events (AEs), adverse reactions (ARs), serious AEs (SAEs), discontinuation, and deaths; immunological responses (reactivity to panel reactive antibodies [PRA] and human leukocyte antigen [HLA] class 1 alleles); and persistence of allogeneic DNA from StrataGraft.ResultsEighty-seven (86.1%) patients experienced 397 AEs. Thirty patients (29.7%) experienced ARs; 16 patients (15.8%) experienced SAEs. The most frequent AEs were pruritus (n = 31; 30.7%), and blister, hypertension, and hypertrophic scar (n = 11 each; 10.9%); the most common AR was pruritus (n = 13; 12.9%). One patient discontinued the study; 2 patients experienced SAEs (unrelated to StrataGraft) leading to death. PRA and HLA allele reactivity was ≤ 25% at Month 3, with no persistent allogeneic DNA from StrataGraft.ConclusionsStrataGraft was well tolerated by patients, with a safety profile similar to autograft. StrataGraft may offer a safe alternative to autograft for DPT burns.Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.

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