%0 Journal Article
%T A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft® treatment in adults with deep partial-thickness thermal burns.
%A Holmes Iv JH
%A Gibson ALF
%A Short T
%A Joe VC
%A Litt J
%A Carson J
%A Carter JE
%A Wibbenmeyer L
%A Hahn H
%A Smiell JM
%A Rutan R
%A Wu R
%A Shupp JW
%J Burns
%V 0
%N 0
%D 2024 Jun 6
%M 39043513
%F 2.609
%R 10.1016/j.burns.2024.05.023
%X <B>BACKGROUND: </B>A phase 3b, open-label, multicenter, expanded-access study (NCT04123548) evaluated safety and clinical outcomes of StrataGraft treatment in adults with deep partial-thickness thermal burns with intact dermal elements.<BR><B>METHODS: </B>Adult patients with 3 % to < 50 % total body surface area burns were treated with a single application of ≤ 1:1 meshed StrataGraft and followed for 24 weeks. Primary endpoint was count and percentage of patients with treatment-emergent adverse events (TEAEs). Secondary endpoints included confirmed wound closure (WC) at Week 12, durable WC at Week 24, time to WC, scar evaluation, and wound infection-related events.<BR><B>RESULTS: </B>Fifty-two patients with 96 treatment sites were enrolled. Pruritus was the most common TEAE (22 patients [42.3 %]). Twenty serious TEAEs occurred in 10 patients (19.2 %); none were related to StrataGraft. There were 4 (7.7 %) deaths (aspiration, myocardial infarction, self-injury, Gram-negative rod sepsis); none were related to StrataGraft. Confirmed WC was achieved by Week 12 in 33 patients (63.5 %; 95 % CI: 50.4-76.5 %) and 69 treatment sites (71.9 %; 95 % CI: 62.9-80.9 %). Durable WC was achieved by Week 24 in 29 patients (55.8 %; 95 % CI: 42.3-69.3 %) and 58 treatment sites (60.4 %; 95 % CI: 50.6-70.2 %).<BR><B>CONCLUSIONS: </B>StrataGraft demonstrated clinical benefit. Safety data were consistent with previously reported findings.