NCT06990425

CLOSM Trial: Groin Closure Using Layered Option for Suture Material

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 259 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Diseases

Interventions

Type	Name	Description
PROCEDURE	Groin closure with PDS suture	Closure of the groin will be performed with PDS suture
PROCEDURE	Groin closure suture material	Closure of the groin will be performed with Vicryl suture

Timeline

• Start date: 2025-03-27
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-05-25
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States