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Recruiting

NCT Number: NCT06990425

CLOSM Trial: Groin Closure Using Layered Option for Suture Material

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Abdullah Khan, MD

SUB_INVESTIGATOR

Ahmed Sorour, MD

CONTACT

[email protected]

216-399-9224

Ahmed Sorour, MD

SUB_INVESTIGATOR

Ali Khalifeh, MD

SUB_INVESTIGATOR

Alice Alexander, MD

SUB_INVESTIGATOR

Antoine Marc, MD

SUB_INVESTIGATOR

Blake Westling, MD

SUB_INVESTIGATOR

Brendan Jones, MD

SUB_INVESTIGATOR

Bryan Cass, MD

SUB_INVESTIGATOR

Connor Crudeli, MD

SUB_INVESTIGATOR

Courtney Hanak, MD

SUB_INVESTIGATOR

D'Andre Williams, MD

SUB_INVESTIGATOR

Emma Fulton, MD

SUB_INVESTIGATOR

Francis Caputo, MD

PRINCIPAL_INVESTIGATOR

John Taaffe, MD

SUB_INVESTIGATOR

Jon Quatromoni, MD

SUB_INVESTIGATOR

Keith Garber, MD

SUB_INVESTIGATOR

Lee Kirksey, MD

SUB_INVESTIGATOR

Michael Gibbons, MD

SUB_INVESTIGATOR

Nathan Reinert, MD

SUB_INVESTIGATOR

Nicohlas Hoell, MD

SUB_INVESTIGATOR

Ravi Ambani, MD

SUB_INVESTIGATOR

Reinis Ozolins, MD

SUB_INVESTIGATOR

Ryan Ellis, MD

SUB_INVESTIGATOR

Sami Abou-Assi, MD

SUB_INVESTIGATOR

Thomas Perry, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Rate of groin complication

    Time frame: 30 days and 1 year

    Number of occurrence of the access site complication

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Sorour, MD

CONTACT

[email protected]

216-399-9224

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: CLOSM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 25, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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