CLOSM Trial: Groin Closure Using Layered Option for Suture Material
The Cleveland Clinic
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.
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 aft…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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)
Interventions
- ProcedureGroin closure with PDS suture
Closure of the groin will be performed with PDS suture
- ProcedureGroin closure suture material
Closure of the groin will be performed with Vicryl suture
Location
- Cleveland ClinicCleveland, Ohio