CLOSM Trial: Groin Closure Using Layered Option for Sutur... | NCT06990425

Studies
CLOSM Trial: Groin Closure Using Layered Option for Suture Material

NCT06990425

Sponsor

The Cleveland Clinic

Status

Recruiting

Last Update Posted

Jun 3, 2026Actual

Enrollment

259Estimated

Phase

Not Applicable

Conditions

Vascular Diseases

Interventions

Groin closure with PDS suture
Groin closure suture material

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2025Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

May 22, 2025

First Submission Date that Met QC Criteria

May 22, 2025

First Posted Date

May 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2026

Last Update Posted Date

Jun 3, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francis Caputo, MD, Principal Investigator, The Cleveland ClinicPrincipal Investigator

Lead Sponsor

The Cleveland ClinicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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 after vascular intervention with Vicryl versus PDS. 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.

The primary objective of this randomized controlled trial (RCT) is to evaluate the effectiveness of Vicryl versus PDS sutures in reducing groin complications following vascular surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

259Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Groin closure after vascular intervention with PDS suture	Active Comparator	Vascular intervention access site closed with PDS suture	Procedure: Groin closure with PDS suture
Groin closure after vascular intervention with Vicryl suture	Active Comparator	Vascular intervention access site closure with Vicryl suture	Procedure: Groin closure suture material

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Groin closure with PDS suture	Procedure	Closure of the groin will be performed with PDS suture	Groin closure after vascular intervention with PDS suture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of groin complication	Number of occurrence of the access site complication	30 days and 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Sorour, MD	Contact	216-399-9224		SOROURA2@ccf.org

Overall Officials

Name	Affiliation	Role
Francis Caputo, MD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic	Recruiting	Cleveland	Ohio	44195	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014652	Vascular Diseases

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided