Suture Material for Vascular Disease

(CLOSM Trial)

Overseen By Ahmed Sorour, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Age 17 or younger, prisoners, pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

259 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Francis Caputo, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

The CLOSM Trial is for individuals with vascular disease who have undergone or will undergo a vascular intervention requiring groin closure. Participants must be treated at the CCF main campus and willing to be randomly assigned to different suture materials. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am scheduled for surgery that involves cuts in both groins, with different stitches on each side.

Exclusion Criteria

Groin closure after extracorporeal membrane oxygenation (ECMO)

Prisoners

Pregnant patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo groin closure after vascular intervention using either Vicryl or PDS sutures

Immediate post-surgery

Follow-up

Participants are monitored for groin complications following the intervention

1 year

Treatment Details

Interventions

• Groin Closure

Trial Overview This study tests two types of sutures, Vicryl and PDS, used in groin closures after vascular interventions. It's a randomized controlled trial where patients are equally divided into two groups: one group receives Vicryl sutures, while the other gets PDS sutures.

Participant Groups

Group I: Groin closure after vascular intervention with PDS suture Active Control 2 Interventions

Vascular intervention access site closed with PDS suture

Group II: Groin closure after vascular intervention with Vicryl suture Active Control 1 Intervention

Vascular intervention access site closure with Vicryl suture

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+