ALGINATE versus negative-pressure therapy: Comparison of the clinical effectiveness, tolerance and costs in management of patients after surgical excision. Multicenter, randomized non-inferiority clinical trial on 113 patients - Université de Lille Accéder directement au contenu
Article Dans Une Revue Annales de Chirurgie Plastique Esthétique Année : 2020

ALGINATE versus negative-pressure therapy: Comparison of the clinical effectiveness, tolerance and costs in management of patients after surgical excision. Multicenter, randomized non-inferiority clinical trial on 113 patients

Résumé

Introduction Pure calcium alginate dressing (ALGINATE) and Negative Pressure Wound Therapy (NPWT) are frequently used for the preparation of skin excisions for a split thickness skin graft take. The trial compared the healing efficacy, safety and cost of patient care for these two treatments. Patients and methods This randomized, non-inferiority trial enrolled 113 patients who underwent skin excision (> 30 cm2) and received ALGINATE or NPWT. The primary outcome was the time to obtain optimal granulation tissue for a split thickness skin graft take. Secondary outcomes were the occurrence of adverse events (AEs) and the impact of the patient care cost on the Social Security budget. Results The mean time to optimal granulation was similar between ALGINATE and NPWT: approximately 20 days. No AE was reported with ALGINATE while 24 % of patients treated with NPWT presented an AE. Following hospitalization, 94 % of ALGINATE patients were cared for at home by a private nurse, while 90 % of NPWT patients were followed up in aftercare and rehabilitation facilities or home hospitalization. Therefore, the cost of treatment per patient for the French Social Security was 498 € with ALGINATE and 2104 € with NPWT. Conclusion This trial has demonstrated that ALGINATE has a similar healing efficacy to that of NPWT, and that it is markedly better with regard to patient safety and cost savings. ALGINATE should therefore be preferred to NPWT in this indication.
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Dates et versions

hal-04000274 , version 1 (22-02-2023)

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Pierre Guerreschi, D. Casanova, F. Maunoury, R. Sinna, M. Revol. ALGINATE versus negative-pressure therapy: Comparison of the clinical effectiveness, tolerance and costs in management of patients after surgical excision. Multicenter, randomized non-inferiority clinical trial on 113 patients. Annales de Chirurgie Plastique Esthétique, 2020, Annales de Chirurgie Plastique Esthétique, 66 (1), pp.3-9. ⟨10.1016/j.anplas.2020.11.001⟩. ⟨hal-04000274⟩

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