CLOSM Trial: Groin Closure Using Layered Option for Suture Material
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Groin closure with PDS suture, Groin closure suture material.
- Who it may be relevant to
- Registry conditions: Vascular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Groin closure with PDS suture
Closure of the groin will be performed with PDS suture - Procedure Groin closure suture material
Closure of the groin will be performed with Vicryl suture
Primary outcome measures
- Rate of groin complication [Time frame: 30 days and 1 year]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cleveland Clinic — Cleveland
Identifiers
NCT: NCT06990425 · 25-149