An open-label, prospective, randomized, controlled, multicenter, phase 1b study of StrataGraft skin tissue versus autografting in patients with deep partial-thickness thermal burns
| Autor: | Michael J. Schurr, James H. Holmes, Angela Gibson, Kelly F. Barbeau, Stuart T. Mohoney, Lee D. Faucher, Mary A. Lokuta, Peggy J. Rooney, B. Lynn Allen-Hoffmann, Allen R. Comer, Kevin N Foster, Booker T. King |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Salvage therapy Critical Care and Intensive Care Medicine Transplantation Autologous law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Re-Epithelialization Randomized controlled trial law medicine Humans Skin Salvage Therapy Skin Artificial Wound Healing Intention-to-treat analysis Tissue Engineering business.industry Pruritus Cosmesis 030208 emergency & critical care medicine Dermis Skin Transplantation General Medicine Middle Aged Intention to Treat Analysis Surgery Transplantation Treatment Outcome surgical procedures operative Tolerability Emergency Medicine Cryopreserved Tissue Female Epidermis Burns business Total body surface area |
| Zdroj: | Burns. 45:1749-1758 |
| ISSN: | 0305-4179 |
| DOI: | 10.1016/j.burns.2019.07.021 |
| Popis: | Objective This open-label, controlled, randomized study assessed the safety, tolerability, and efficacy of StrataGraft tissue compared to autograft in the treatment of deep partial-thickness (DPT) burns. Methods Thirty subjects with DPT thermal burns (3%–43% total body surface area) were treated with StrataGraft tissue as follows: cohort 1, ≤220 cm2 refrigerated tissue; cohort 2, ≤440 cm2 refrigerated tissue; and cohort 3, ≤440 cm2 cryopreserved tissue. On each subject, two comparable areas of DPT burn were randomized to receive StrataGraft tissue or autograft. Coprimary end points were the percent area of the StrataGraft tissue treatment site undergoing salvage autografting by Day 28 and wound closure of treatment sites by 3 months. Results By Day 28, no StrataGraft tissue treatment sites underwent autografting. By 3 months, 93% and 100% of the StrataGraft tissue and autograft treatment sites achieved complete wound closure, respectively. No significant differences in observer total and overall opinion POSAS scores between StrataGraft tissue and autograft treatment sites were observed at any timepoint. The most common adverse event was pruritus (17%). Conclusions StrataGraft tissue treatment of DPT thermal burns reduced the need for autograft, resulted in wound closure and treatment-site cosmesis comparable to that of autograft, and was well tolerated. |
| Databáze: | OpenAIRE |
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