PMID- 35941023 OWN - NLM STAT- MEDLINE DCOM- 20221130 LR - 20221227 IS - 1879-1409 (Electronic) IS - 0305-4179 (Linking) VI - 48 IP - 8 DP - 2022 Dec TI - Pooled safety analysis of STRATA2011 and STRATA2016 clinical trials evaluating the use of StrataGraft(R) in patients with deep partial-thickness thermal burns. PG - 1816-1824 LID - S0305-4179(22)00196-6 [pii] LID - 10.1016/j.burns.2022.07.013 [doi] AB - OBJECTIVE: This 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. METHODS: The 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. RESULTS: Eighty-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