PMID- 32537348 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220415 IS - 2169-7574 (Print) IS - 2169-7574 (Electronic) IS - 2169-7574 (Linking) VI - 8 IP - 3 DP - 2020 Mar TI - ALGINATE versus NPWT in the Preparation of Surgical Excisions for an STSG: ATEC Trial. PG - e2691 LID - 10.1097/GOX.0000000000002691 [doi] LID - e2691 AB - A calcium alginate dressing (ALGINATE) and negative pressure wound therapy (NPWT) are frequently used to treat wounds which heal by secondary intention. This trial compared the healing efficacy and safety of these 2 treatments. METHODS: This randomized, non-inferiority trial enrolled patients who underwent skin excision (>30 cm(2)), which was left open to heal by secondary intention. They received ALGINATE or NPWT by a centralized randomization. Follow-up was performed weekly until optimal granulation tissue was obtained. The primary outcome was time to obtain optimal granulation tissue for a split thickness skin graft take (non-inferiority margin: 4 days). Secondary outcomes were occurrence of adverse events (AEs) and impact of the treatments on the patient's daily life. RESULTS: ALGINATE and NPWT were applied to 47 and 48 patients, respectively. The mean time to optimal granulation was 19.98 days (95% CI, 17.7-22.3) with ALGINATE and 20.54 (95% CI, 17.6-23.5) with NPWT. Between group difference was -0.56 days (95% CI -4.22 to 3.10). The non-inferiority of ALGINATE versus NPWT was demonstrated. No AE related to the treatment occurred with ALGINATE versus 14 AEs with NPWT. There was no difference in the impact of the treatments on the patient's daily life. CONCLUSION: This trial demonstrates that ALGINATE has a similar healing efficacy to that of NPWT and that is markedly better with regard to patient safety. CI - Copyright (c) 2020 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons. FAU - Casanova, Dominique AU - Casanova D AD - Department of Plastic and Reconstructive Surgery, Hospital Conception, Marseille, France. FAU - Guerreschi, Pierre AU - Guerreschi P AD - Department of Plastic, Cosmetic and Reconstructive Surgery, Regional and University Hospital Centre Lille, Lille, France. FAU - Sinna, Raphael AU - Sinna R AD - Department of Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Amiens-Picardie, Amiens, France. FAU - Bertheuil, Nicolas AU - Bertheuil N AD - Department of Plastic, Reconstructive and Aesthetic Surgery, University Hospital Centre Rennes, Rennes, France. FAU - Philandrianos, Cecile AU - Philandrianos C AD - Department of Plastic and Reconstructive Surgery, Hospital Conception, Marseille, France. FAU - Chignon-Sicard, Berengere AU - Chignon-Sicard B AD - Department of Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Nice, Nice, France. FAU - Duteille, Franck AU - Duteille F AD - Department of Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Nantes, Nantes, France. FAU - Atlan, Michael AU - Atlan M AD - Department of Plastic, Cosmetic and Reconstructive Surgery, Hospital Tenon, Paris, France. FAU - Rousseau, Pascal AU - Rousseau P AD - Department of Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Angers, Angers, France. FAU - Chatellier, Gilles AU - Chatellier G AD - Unite de Recherche Clinique, European Hospital Group Georges-Pompidou, Unite de Recherche Clinique, INSERM, CIC 1418, Paris, France. FAU - Boucher, Fabien AU - Boucher F AD - Department of Burns, Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Lyon, Lyon, France. FAU - Pham Dang, Nathalie AU - Pham Dang N AD - Department of Maxillofacial and Plastic Surgery, University Hospital Centre Clermont-Ferrand, Clermont-Ferrand, France. FAU - Cambon-Binder, Adeline AU - Cambon-Binder A AD - Department of Orthopaedic and Hand Surgery, Hospital Saint-Antoine, Paris, France. FAU - Michot, Audrey AU - Michot A AD - Department of Plastic and Reconstructive Surgery, University Hospital Centre Bordeaux, Bordeaux, France. FAU - Pluvy, Isabelle AU - Pluvy I AD - Department of Plastic Surgery, University Hospital Centre Besancon, Besancon, France. FAU - Seigle-Murandi, Frederic AU - Seigle-Murandi F AD - Department of Plastic, Cosmetic and Reconstructive Surgery, University Hospital Centre Strasbourg, Strasbourg, France. FAU - Hu, Weiguo AU - Hu W AD - Department of Plastic, Cosmetic and Reconstructive Surgery, University and Regional Hospital Centre Brest, Brest, France. FAU - Revol, Marc AU - Revol M AD - Department of Plastic, Cosmetic and Reconstructive Surgery, Hospital Tenon, Paris, France. LA - eng PT - Journal Article DEP - 20200327 PL - United States TA - Plast Reconstr Surg Glob Open JT - Plastic and reconstructive surgery. Global open JID - 101622231 PMC - PMC7253249 COIS- This trial was funded by a grant from BROTHIER, resources directly paid to each investigator's institutions. Trial treatments were not provided by the funder given that the trial was conducted as a usual care clinical trial. The funding sources contributed to the study design, monitoring, data analysis, data interpretation, and to the writing of the study report. This trial was sponsored by BROTHIER Company, Nanterre, France. All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/conflicts-of-interest/. All authors (except G.C.) reports grants from BROTHIER during the conduct of the study. B.C.-S., P.G., C.P., N.B., A.C.-B., R.S., I.P., F.D., and W.H. report personal fees and P.R. reports non-financial support from BROTHIER during the conduct of the study. D.C., B.C.-S., N.B., F.D., M.A., F.B., C.P., I.P., and W.H. report non-financial support and F.D., N.B., F.B., and C.P. report personal fees from BROTHIER outside the submitted work. D.C. reports personal fees and non-financial support from URGO outside the submitted work. R.S. reports non-financial support from URGO and MOLNLYCKE outside the submitted work. B.C.-S. reports non-financial support from SMITH & NEPHEW and CONVATEC outside the submitted work. F.D. reports personal fees and non-financial support from URGO, SMITH & NEPHEW, and HARTMANN and non-financial support from CONVATEC, and personal fees from GENEVRIER outside the submitted work. P.R. reports non-financial support from KCI outside the submitted work. N.P.D. reports non-financial support from CONVATEC outside the submitted work. EDAT- 2020/06/17 06:00 MHDA- 2020/06/17 06:01 PMCR- 2020/03/27 CRDT- 2020/06/16 06:00 PHST- 2019/12/16 00:00 [received] PHST- 2020/01/15 00:00 [accepted] PHST- 2020/06/16 06:00 [entrez] PHST- 2020/06/17 06:00 [pubmed] PHST- 2020/06/17 06:01 [medline] PHST- 2020/03/27 00:00 [pmc-release] AID - 10.1097/GOX.0000000000002691 [doi] PST - epublish SO - Plast Reconstr Surg Glob Open. 2020 Mar 27;8(3):e2691. doi: 10.1097/GOX.0000000000002691. eCollection 2020 Mar.