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Recruiting
NCT06990425
CLOSM Trial: Groin Closure Using Layered Option for Suture Material
Conditions: Vascular Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 259
Sponsor: The Cleveland Clinic
Location: Cleveland Clinic Cleveland Ohio
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)
Source: ClinicalTrials.gov (NCT06990425). StuddyBuddy aggregates publicly available trial information.
