Journal article
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
Burns, Vol.50(8), pp.2013-2022
11/2024
DOI: 10.1016/j.burns.2024.05.023
PMID: 39043513
Abstract
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.
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.
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 %).
StrataGraft demonstrated clinical benefit. Safety data were consistent with previously reported findings.
•The safety of StrataGraft remained consistent with the prescribing information.•StrataGraft showed clinical benefit in adults with deep partial-thickness burns.•Use of StrataGraft in adults with deep partial-thickness burns spared donor sites.
Details
- Title: Subtitle
- 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
- Creators
- James H Holmes IV - Wake Forest UniversityAngela L.F. Gibson - University of Wisconsin School of Medicine and Public HealthTracee Short - Baton Rouge GeneralVictor C. Joe - University of California, Irvine Medical CenterJeffrey Litt - The CentersJoshua Carson - Loyola University Medical CenterJeffrey E. Carter - University Medical Center New OrleansLucy Wibbenmeyer - University of IowaHelen Hahn - MallinckrodtJanice M. Smiell - MallinckrodtRandi Rutan - MallinckrodtRichard Wu - MallinckrodtJeffrey W. Shupp - MedStar Georgetown University Hospital
- Resource Type
- Journal article
- Publication Details
- Burns, Vol.50(8), pp.2013-2022
- DOI
- 10.1016/j.burns.2024.05.023
- PMID
- 39043513
- NLM abbreviation
- Burns
- ISSN
- 0305-4179
- eISSN
- 1879-1409
- Publisher
- Elsevier Ltd
- Grant note
This work was supported by Stratatech, a Mallinckrodt Company. Medical writing and editorial support, conducted in accordance with Good Publication Practice (GPP2022) and International Committee of Medical Journal Editors (ICMJE) guidelines, was provided by Oxford PharmaGenesis Inc., Newtown, PA, and funded by Mallinckrodt Pharmaceuticals, plc., Bridgewater, NJ.
- Language
- English
- Electronic publication date
- 06/2024
- Date published
- 11/2024
- Academic Unit
- Surgery; Injury Prevention Research Center
- Record Identifier
- 9984649059402771
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