Vascular DiseasesCLOSMNCT06990425
CLOSM Trial: Groin Closure Using Layered Option for Suture Material
A study testing Groin closure with PDS suture and Groin closure suture material in people with Vascular Diseases, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Groin closure with PDS suture and Groin closure suture material
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Ahmed Sorour, MD, 216-399-9224, SOROURA2@ccf.org
Francis Caputo, MD
About this study
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.
- Conditions
- Vascular Diseases
- Being tested
- Groin closure with PDS suture, Groin closure suture material
- Keywords
- surgical site complication, vascular surgery, wound healing
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Groin closure with PDS sutureProcedure or surgery
Closure of the groin will be performed with PDS suture
Groin closure suture materialProcedure or surgery
Closure of the groin will be performed with Vicryl suture
| Study group | Role | What they receive |
|---|---|---|
| Groin closure after vascular intervention with PDS suture | Active comparator | Vascular intervention access site closed with PDS suture Receives: Procedure: Groin closure with PDS suture |
| Groin closure after vascular intervention with Vicryl suture | Active comparator | Vascular intervention access site closure with Vicryl suture Receives: Procedure: Groin closure suture material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of groin complication
Number of occurrence of the access site complication
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start27 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 259 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francis Caputo, MD, The Cleveland Clinic
- Investigators
- Francis Caputo, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990425
- Sponsor's protocol ID
- 25-149
- Acronym
- CLOSM
- Status last verified
- Jun 2026
- First submitted
- 22 May 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLOSM Trial: Groin Closure Using Layered Option for Suture Material
- ClinicalTrials.gov ID
- NCT06990425
- Acronym / sponsor ID
- CLOSM / 25-149
- Conditions
- Vascular Diseases
- Keywords
- surgical site complication, vascular surgery, wound healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 259 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Groin closure after vascular intervention with PDS suture | Active comparator | Procedure: Groin closure with PDS sutureVascular intervention access site closed with PDS suture |
| Groin closure after vascular intervention with Vicryl suture | Active comparator | Procedure: Groin closure suture materialVascular intervention access site closure with Vicryl suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Age 17 or younger
- Prisoners
- Pregnant patients
- Emergent cases
- Active groin infection prior to intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Groin closure with PDS sutureClosure of the groin will be performed with PDS suture | Procedure or surgery | Groin closure after vascular intervention with PDS suture |
| Groin closure suture materialClosure of the groin will be performed with Vicryl suture | Procedure or surgery | Groin closure after vascular intervention with Vicryl suture |
Primary outcome
Rate of groin complication
Time frame: 30 days and 1 year
Number of occurrence of the access site complication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francis Caputo, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Groin closure with PDS suture and Groin closure suture material in people with Vascular Diseases, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Sorour, MD (216-399-9224, SOROURA2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of groin complication (time frame: 30 days and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.