ALGINATE versus traitement par pression négative : comparaison de l’efficacité, de la tolérance et des coûts de prise en charge de patients après exérèse chirurgicale. Étude clinique multicentrique, randomisée de non-infériorité sur 113 patients

Abstract

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. This randomized, non-inferiority trial enrolled 113patients who underwent skin excision (>30cm2) 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. The mean time to optimal granulation was similar between ALGINATE and NPWT: approximately 20days. 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. 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.