CLOSM Trial: Groin Closure Using Layered Option for Suture Material

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06990425
Status
Recruiting
Apply to this trial

Conditions

  • Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Groin closure with PDS suture — PROCEDURE
    Closure of the groin will be performed with PDS suture
  • Groin closure suture material — PROCEDURE
    Closure of the groin will be performed with Vicryl suture

Study Details

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.

Key Dates

Start date
Mar 27, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
259 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Ahmed Sorour, MD
[email protected]
216-399-9224
Francis Caputo, MD (PRINCIPAL_INVESTIGATOR)
Ahmed Sorour, MD (SUB_INVESTIGATOR)
Jon Quatromoni, MD (SUB_INVESTIGATOR)
Ali Khalifeh, MD (SUB_INVESTIGATOR)
Ravi Ambani, MD (SUB_INVESTIGATOR)
Courtney Hanak, MD (SUB_INVESTIGATOR)
Nicohlas Hoell, MD (SUB_INVESTIGATOR)
Reinis Ozolins, MD (SUB_INVESTIGATOR)
Connor Crudeli, MD (SUB_INVESTIGATOR)
Thomas Perry, MD (SUB_INVESTIGATOR)
Emma Fulton, MD (SUB_INVESTIGATOR)
Nathan Reinert, MD (SUB_INVESTIGATOR)
John Taaffe, MD (SUB_INVESTIGATOR)
Keith Garber, MD (SUB_INVESTIGATOR)
Bryan Cass, MD (SUB_INVESTIGATOR)
Brendan Jones, MD (SUB_INVESTIGATOR)
Michael Gibbons, MD (SUB_INVESTIGATOR)
Blake Westling, MD (SUB_INVESTIGATOR)
Abdullah Khan, MD (SUB_INVESTIGATOR)
Ryan Ellis, MD (SUB_INVESTIGATOR)
Lee Kirksey, MD (SUB_INVESTIGATOR)
Sami Abou-Assi, MD (SUB_INVESTIGATOR)
Antoine Marc, MD (SUB_INVESTIGATOR)
D'Andre Williams, MD (SUB_INVESTIGATOR)
Alice Alexander, MD (SUB_INVESTIGATOR)

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