CLOSM Trial: Groin Closure Using Layered Option for Suture Material

Not Applicable

Recruiting

• Conditions: Vascular Diseases

• Registration Number: NCT06990425
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Previous research has provided insights into the properties of various suture materials, yet there remains a gap in our understanding of their relative effectiveness in groin closure specifically within the context of vascular surgery. The lack of definitive evidence on whether Vicryl or PDS (polydioxanone) sutures offer superior outcomes necessitates further investigation. This study aims to address this gap by conducting a head-to-head comparison of these sutures, focusing on their impact on postoperative groin complications.

This is a randomized controlled trial comparing groin closure after vascular intervention with Vicryl versus PDS. 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.

The primary objective of this randomized controlled trial (RCT) is to evaluate the effectiveness of Vicryl versus PDS sutures in reducing groin complications following vascular surgery.

Study Timeline

• Study Start: 2025-03-27
• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-29
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 259

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of groin complication	30 days and 1 year	Number of occurrence of the access site complication

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States