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Randomized clinical trial A novel absorbable stapler provides patient-reported outcomes and cost-effectiveness non-inferior to subcuticular skin closure: a prospective single-blinded randomized clinical trial.

BACKGROUND: Deep dermal suturing is critical for scar quality outcomes. We evaluated a new fast medical device for dermal suturing, with hypothesis of non-inferiority with regard to clinical scar and cost-effectiveness.

METHODS: prospective, patient-blind, randomized, multicentre noninferiority study in 26 french hospitals. Patients were randomized 1:1 to suturing with conventional thread or a semi-automatic stapler. The Patient Scar Assessment Scale (PSAS) was rated at 3 months for primary endpoint effectiveness. Secondary endpoints were cost-effectiveness of the two suturing methods, prevalence of complications, suturing/operating time, Observer Scar Assessment Scale (OSAS) and PSAS, scar's aesthetic quality 18 months after surgery, and occupational exposure to blood (OEB) during surgery.

RESULTS: 664 patients were enrolled, 660 randomized, 649 constituted the full analysis (n=324 and 325 in the stapler/needle arms). Primary endopoint PSAS score at 3 months in the stapler arm was not inferior to that in the needle arm, neither after 18 months. The mean operating time was 180 minutes in the stapler arm and 179 in the needle arm (p=ns). The mean suturing time was significantly lower in the stapler arm (p<0.001). There were seven occupational OEB in the needle arm and one in the stapler arm. The two arms did not differ significantly in terms of complications (p=0.41). The additional cost of using the device was 51.57 euros for the complete-case population.

CONCLUSION: Wound healing outcome was no worse than with conventional suturing using a semi-automatic stapler and associated with less OEB.

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