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Recruiting NCT06990425

CLOSM Trial: Groin Closure Using Layered Option for Suture Material

Trial Parameters

Condition Vascular Diseases
Sponsor The Cleveland Clinic
Study Type INTERVENTIONAL
Phase N/A
Enrollment 259
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-27
Completion 2027-12-31
Interventions
Groin closure with PDS sutureGroin closure suture material

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: 1. Age 17 or younger 2. Prisoners 3. Pregnant patients 4. Emergent cases 5. Active groin infection prior to intervention 6. History of prior surgical groin access (re-operative groin) 7. Groin closure after extracorporeal membrane oxygenation (ECMO)

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