1. A Novel Absorbable Stapler Provides Patient-Reported Outcomes and Cost-Effectiveness Noninferior to Subcuticular Skin Closure: A Prospective, Single-Blind, Randomized Clinical Trial.
- Author
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Malard O, Duteille F, Darnis E, Espitalier F, Perrot P, Ferron C, Planche L, Hardouin JB, Tessier P, Bellanger M, and Dert C
- Subjects
- Adolescent, Adult, Aged, Cicatrix diagnosis, Cicatrix etiology, Cost-Benefit Analysis, Dermatologic Surgical Procedures adverse effects, Dermatologic Surgical Procedures economics, Dermatologic Surgical Procedures instrumentation, Female, Follow-Up Studies, Humans, Male, Middle Aged, Patient Reported Outcome Measures, Prospective Studies, Severity of Illness Index, Single-Blind Method, Skin pathology, Surgical Staplers economics, Surgical Stapling adverse effects, Surgical Stapling economics, Surgical Stapling instrumentation, Treatment Outcome, Wound Healing, Young Adult, Cicatrix prevention & control, Dermatologic Surgical Procedures methods, Surgical Stapling methods, Sutures adverse effects
- Abstract
Background: Deep dermal suturing is critical for scar quality outcomes. The authors evaluated a new, fast medical device for dermal suturing, with the hypothesis of noninferiority with regard to clinical scar and cost-effectiveness., Methods: A prospective, patient-blind, randomized, multicenter noninferiority study in 26 French hospitals was conducted. Patients were randomized 1:1 to suturing with conventional thread or a semiautomatic stapler. The Patient Scar Assessment Scale 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 and Patient Scar Assessment Scale score, scar aesthetic quality 18 months after surgery, and occupational exposure to blood during surgery., Results: Six hundred sixty-four patients were enrolled, 660 were randomized, and 649 constituted the full analysis (stapler arm, n = 324; needle arm, n = 325). Primary endpoint Patient Scar Assessment Scale score in the stapler arm was not inferior to that in the needle arm at 3 months or after 18 months. The mean operating time was 180 minutes in the stapler arm and 179 minutes in the needle arm (p = not significant). The mean suturing time was significantly lower in the stapler arm (p < 0.001). There were seven occupational exposures to blood 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 &OV0556;51.57 for the complete-case population., Conclusion: Wound healing outcome was no worse than with conventional suturing using a semiautomatic stapler and associated with less occupational exposure to blood., Clinical Question/level of Evidence: Therapeutic, I.
- Published
- 2020
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