RecruitingNot ApplicableNCT06990425

CLOSM Trial: Groin Closure Using Layered Option for Suture Material


Sponsor

The Cleveland Clinic

Enrollment

259 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized controlled trial comparing groin closure after vascular intervention with Vicryl suture versus PDS (polydioxanone) suture. This will be a single center trail performed at CCF main campus. Patients will be enrolled in a prospective fashion and will be randomized 1:1 to either PDS or Vicryl closure. Patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • All patients > 18 years who undergo ELECTIVE vascular surgery that would require groin incisions
  • Patients with to undergo ELECTIVE bilateral groin incisions will be matched to receive closure with PDS in one groin and Vicryl in the other groin

Exclusion Criteria7

  • Age 17 or younger
  • Prisoners
  • Pregnant patients
  • Emergent cases
  • Active groin infection prior to intervention
  • History of prior surgical groin access (re-operative groin)
  • Groin closure after extracorporeal membrane oxygenation (ECMO)

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Interventions

PROCEDUREGroin closure with PDS suture

Closure of the groin will be performed with PDS suture

PROCEDUREGroin closure suture material

Closure of the groin will be performed with Vicryl suture


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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NCT06990425


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