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RecruitingNCT06990425CLOSMUpdated Jun 3, 2026

CLOSM Trial: Groin Closure Using Layered Option for Suture Material

An interventional study of Groin closure with PDS suture and Groin closure suture material in Vascular Diseases, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
259
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vascular Diseases

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Keywords

  • surgical site complication
  • vascular surgery
  • wound healing
03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's planned enrollment of 259 is above the median of 78 across 639 interventional studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
259 participants (estimated)

Study arms

  • Active comparator
    Groin closure after vascular intervention with PDS suture

    Vascular intervention access site closed with PDS suture

    Procedure: Groin closure with PDS suture

  • Active comparator
    Groin closure after vascular intervention with Vicryl suture

    Vascular intervention access site closure with Vicryl suture

    Procedure: Groin closure suture material

Interventions

  • ProcedureGroin closure with PDS suture

    Closure of the groin will be performed with PDS suture

  • ProcedureGroin closure suture material

    Closure of the groin will be performed with Vicryl suture

06

What researchers measure

Primary outcomes

  1. Rate of groin complication

    Number of occurrence of the access site complication

    Time frame: 30 days and 1 year

07

Study locations

1 of 1 sites recruiting
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
    • Ahmed Sorour, MD · Contact · SOROURA2@ccf.org · 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
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06990425
Lead sponsor
The Cleveland Clinic
Responsible party
Francis Caputo, MD (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
May 25, 2025
Start date
Mar 27, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 3, 2026

Study contacts

Ahmed Sorour, MD
Contact
SOROURA2@ccf.org
216-399-9224
Francis Caputo, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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