RECRUITING

CLOSM Trial: Groin Closure Using Layered Option for Suture Material

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CLOSM Trial: Groin Closure Using Layered Option for Suture Material

Quick Facts

Study Start:2025-03-27
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06990425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients \> 18 years who undergo ELECTIVE vascular surgery that would require groin incisions
  2. * 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
  1. 1. Age 17 or younger
  2. 2. Prisoners
  3. 3. Pregnant patients
  4. 4. Emergent cases
  5. 5. Active groin infection prior to intervention
  6. 6. History of prior surgical groin access (re-operative groin)
  7. 7. Groin closure after extracorporeal membrane oxygenation (ECMO)

Contacts and Locations

Study Contact

Ahmed Sorour, MD
CONTACT
216-399-9224
SOROURA2@ccf.org

Principal Investigator

Francis Caputo, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Francis Caputo, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-27
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-03-27
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • surgical site complication
  • vascular surgery
  • wound healing

Additional Relevant MeSH Terms

  • Vascular Diseases