Comparing two types of sutures for closing groin incisions after vascular surgery
CLOSM Trial: Groin Closure Using Layered Option for Suture Material
This study is testing whether using Vicryl or PDS sutures helps reduce complications after groin surgery for patients over 18.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 259 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06990425 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effectiveness of Vicryl versus PDS sutures in reducing complications after groin closure following vascular surgery. Conducted at the Cleveland Clinic, patients over 18 undergoing elective vascular procedures requiring groin incisions will be enrolled and randomized to receive either suture type. Those with bilateral groin exposure will receive both sutures in a crossover design. The study aims to fill the knowledge gap regarding the relative effectiveness of these suture materials in this specific surgical context.
Who should consider this trial
Good fit: Ideal candidates are patients over 18 years old scheduled for elective vascular surgery requiring groin incisions.
Not a fit: Patients who are under 18, pregnant, or undergoing emergency procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced complications for patients undergoing vascular surgery.
How similar studies have performed: Previous studies have explored various suture materials, but this specific head-to-head comparison in vascular surgery is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Francis Caputo, MD — The Cleveland Clinic
- Study coordinator: Ahmed Sorour, MD
- Email: SOROURA2@ccf.org
- Phone: 216-399-9224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.