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A Novel Absorbable Stapler Provides Patient-Reported Outcomes and Cost-Effectiveness Noninferior to Subcuticular Skin Closure: A Prospective, Single-Blind, Randomized Clinical Trial.
- Source :
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Plastic and reconstructive surgery [Plast Reconstr Surg] 2020 Dec; Vol. 146 (6), pp. 777e-789e. - Publication Year :
- 2020
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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.<br />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.<br />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.<br />Conclusion: Wound healing outcome was no worse than with conventional suturing using a semiautomatic stapler and associated with less occupational exposure to blood.<br />Clinical Question/level of Evidence: Therapeutic, I.
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 1529-4242
- Volume :
- 146
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Plastic and reconstructive surgery
- Publication Type :
- Academic Journal
- Accession number :
- 33234974
- Full Text :
- https://doi.org/10.1097/PRS.0000000000007356