A Novel Absorbable Stapler Provides Patient-Reported Outcomes and Cost-Effectiveness Noninferior to Subcuticular Skin Closure: A Prospective, Single-Blind, Randomized Clinical Trial - EHESP - École des hautes études en santé publique Access content directly
Journal Articles Plastic and Reconstructive Surgery Year : 2020

A Novel Absorbable Stapler Provides Patient-Reported Outcomes and Cost-Effectiveness Noninferior to Subcuticular Skin Closure: A Prospective, Single-Blind, Randomized Clinical Trial

Olivier Malard
  • Function : Author
Franck Duteille
  • Function : Author
Eric Darnis
  • Function : Author
Florent Espitalier
  • Function : Author
Pierre Perrot
  • Function : Author
Christophe Ferron
  • Function : Author
Lucie Planche
  • Function : Author
Jean-Benoit Hardouin
  • Function : Author
Philippe Tessier
  • Function : Author
Martine Bellanger
  • Function : Author
Cécile Dert
  • Function : Author

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 €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.
No file

Dates and versions

hal-04027123 , version 1 (13-03-2023)

Identifiers

Cite

Olivier Malard, Franck Duteille, Eric Darnis, Florent Espitalier, Pierre Perrot, et al.. A Novel Absorbable Stapler Provides Patient-Reported Outcomes and Cost-Effectiveness Noninferior to Subcuticular Skin Closure: A Prospective, Single-Blind, Randomized Clinical Trial. Plastic and Reconstructive Surgery, 2020, 146 (6), pp.777e-789e. ⟨10.1097/PRS.0000000000007356⟩. ⟨hal-04027123⟩
4 View
0 Download

Altmetric

Share

Gmail Facebook Twitter LinkedIn More