Recruiting

Vicryl vs. PDS

Sponsor:

The Cleveland Clinic

Code:

NCT06990425

Conditions

Vascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Groin closure with PDS suture

Groin closure suture material

Study Details

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.

Conditions

Vascular Diseases

Study ID

NCT06990425

Start date

Mar 27, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

259 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Groin closure after vascular intervention with PDS suture

Vascular intervention access site closed with PDS suture

active comparator: Groin closure after vascular intervention with Vicryl suture

Vascular intervention access site closure with Vicryl suture

Interventions

Groin closure with PDS suture

Closure of the groin will be performed with PDS suture

Groin closure suture material

Closure of the groin will be performed with Vicryl suture

Primary outcome measure

  • Rate of groin complication [ Time Frame: 30 days and 1 year ]

Central Contacts and Locations

Central contacts

Ahmed Sorour, MD

216-399-9224SOROURA2@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Ahmed Sorour, MD

216-399-9224SOROURA2@ccf.org

Principal Investigator:

Francis Caputo, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • surgical site complication
  • vascular surgery
  • wound healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-06-03.