CLOSM Trial: Groin Closure Using Layered Option for Suture Material
CLOSM
1 other identifier
interventional
259
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2025
CompletedFirst Submitted
Initial submission to the registry
May 22, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 3, 2026
June 1, 2026
2.8 years
May 22, 2025
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of groin complication
Number of occurrence of the access site complication
30 days and 1 year
Study Arms (2)
Groin closure after vascular intervention with PDS suture
ACTIVE COMPARATORVascular intervention access site closed with PDS suture
Groin closure after vascular intervention with Vicryl suture
ACTIVE COMPARATORVascular intervention access site closure with Vicryl suture
Interventions
Closure of the groin will be performed with PDS suture
Closure of the groin will be performed with Vicryl suture
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age 17 or younger
- Prisoners
- Pregnant patients
- Emergent cases
- Active groin infection prior to intervention
- History of prior surgical groin access (re-operative groin)
- Groin closure after extracorporeal membrane oxygenation (ECMO)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis Caputo, MD
The Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 22, 2025
First Posted
May 25, 2025
Study Start
March 27, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share