CLOSM Trial: Groin Closure Using Layered Option for Suture Material

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Vascular Diseases

Treatments: Procedure: Groin closure with PDS suture; Procedure: Groin closure suture material

Study type: Interventional

Funder types: Other

Identifiers

NCT06990425

25-149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 259 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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259 participants in 2 patient groups

Groin closure after vascular intervention with PDS suture

Active Comparator group

Description:

Vascular intervention access site closed with PDS suture

Treatment:

Procedure: Groin closure with PDS suture

Groin closure after vascular intervention with Vicryl suture

Active Comparator group

Description:

Vascular intervention access site closure with Vicryl suture

Treatment:

Procedure: Groin closure suture material