NCT06990425 CLOSM Trial: Groin Closure Using Layered Option for Suture Material
| NCT ID | NCT06990425 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Vascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 259 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 259 participants in total. It began in 2025-03-27 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Francis Caputo, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06990425 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06990425 currently recruiting?
Yes, NCT06990425 is actively recruiting participants. Contact the research team at SOROURA2@ccf.org for enrollment information.
Where is the NCT06990425 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06990425 clinical trial?
NCT06990425 is sponsored by The Cleveland Clinic. The principal investigator is Francis Caputo, MD at The Cleveland Clinic. The trial plans to enroll 259 participants.