ALGINATE versus NPWT in the Preparation of Surgical Excisions for an STSG: ATEC Trial.

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. This randomized, non-inferiority trial enrolled patients who underwent skin excision (>30 cm 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. This trial demonstrates that ALGINATE has a similar healing efficacy to that of NPWT and that is markedly better with regard to patient safety.

Informations de copyright

Copyright © 2020 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons.

Déclaration de conflit d'intérêts

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.