Maximizing wound coverage in full-thickness skin defects: A randomized-controlled trial of autologous skin cell suspension and widely meshed autograft versus standard autografting.

Autor:	Henry S; From the University of Maryland Medical Center (S.H.), Baltimore, Maryland; John Peter Smith Health Network (S.M.), Fort Worth, Texas; Cook County Health (M.G.), Chicago, Illinois; Arizona Burn Center Valleywise Health (K.N.F.), Phoenix, Arizona; University Medical Center New Orleans (H.P.), New Orleans, Louisiana; MedStar Washington Hospital Center, Washington (J.S.), District Columbia; Metis Foundation (R.C.), San Antonio, Texas; Rhode Island Hospital (D.H.), Providence, Rhode Island; Carle Foundation Hospital (N.M.), Urbana, Illinois; Duke University Medical Center (D.A.B.), Durham, North Carolina; Kendall Regional Medical Center (H.M.), Miami, Florida; Lundquist Institute (G.S.), Torrance, California; Ohio State University Wexner Medical Center (A.C.), Columbus, Ohio; Temple University (L.R.), Philadelphia, Pennsylvania; University of California Irvine (T.C.), Irvine, California; University of Arizona (L.C.), Tucson, Arizona; University of Rochester (D.B.), Rochester, New York; Thomas Jefferson University Hospital (W.H.), Philadelphia, Pennsylvania; and Wake Forest Baptist Medical Center (J.A.M.), Winston-Salem, North Carolina., Mapula S, Grevious M, Foster KN, Phelan H, Shupp J, Chan R, Harrington D, Mashruwala N, Brown DA, Mir H, Singer G, Cordova A, Rae L, Chin T, Castanon L, Bell D, Hughes W, Molnar JA
Jazyk:	angličtina
Zdroj:	The journal of trauma and acute care surgery [J Trauma Acute Care Surg] 2024 Jan 01; Vol. 96 (1), pp. 85-93. Date of Electronic Publication: 2023 Sep 01.
DOI:	10.1097/TA.0000000000004120
Abstrakt:	Background: Traumatic insults, infection, and surgical procedures can leave skin defects that are not amenable to primary closure. Split-thickness skin grafting (STSG) is frequently used to achieve closure of these wounds. Although effective, STSG can be associated with donor site morbidity, compounding the burden of illness in patients undergoing soft tissue reconstruction procedures. With an expansion ratio of 1:80, autologous skin cell suspension (ASCS) has been demonstrated to significantly decrease donor skin requirements compared with traditional STSG in burn injuries. We hypothesized that the clinical performance of ASCS would be similar for soft tissue reconstruction of nonburn wounds. Methods: A multicenter, within-patient, evaluator-blinded, randomized-controlled trial was conducted of 65 patients with acute, nonthermal, full-thickness skin defects requiring autografting. For each patient, two treatment areas were randomly assigned to concurrently receive a predefined standard-of-care meshed STSG (control) or ASCS + more widely meshed STSG (ASCS+STSG). Coprimary endpoints were noninferiority of ASCS+STSG for complete treatment area closure by Week 8, and superiority for relative reduction in donor skin area. Results: At 8 weeks, complete closure was observed for 58% of control areas compared with 65% of ASCS+STSG areas (p = 0.005), establishing noninferiority of ASCS+STSG. On average, 27.4% less donor skin was required with ASCS+ STSG, establishing superiority over control (p < 0.001). Clinical healing (≥95% reepithelialization) was achieved in 87% and 85% of Control and ASCS+STSG areas, respectively, at 8 weeks. The treatment approaches had similar long-term scarring outcomes and safety profiles, with no unanticipated events and no serious ASCS device-related events. Conclusion: ASCS+STSG represents a clinically effective and safe solution to reduce the amount of skin required to achieve definitive closure of full-thickness defects without compromising healing, scarring, or safety outcomes. This can lead to reduced donor site morbidity and potentially decreased cost associated with patient care.Clincaltrials.gov identifier: NCT04091672. Level of Evidence: Therapeutic/Care Management; Level I. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Association for the Surgery of Trauma.)
Databáze:	MEDLINE
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