Vascular Diseases
Conditions
Keywords
surgical site complication, vascular surgery, wound healing
Brief 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. 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
PROCEDUREGroin closure with PDS suture
Closure of the groin will be performed with PDS suture
PROCEDUREGroin closure suture material
Closure of the groin will be performed with Vicryl suture
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of groin complication | 30 days and 1 year | Number of occurrence of the access site complication |
Countries
United States
Contacts
CONTACTAhmed Sorour, MD
PRINCIPAL_INVESTIGATORFrancis Caputo, MD
The Cleveland Clinic
Outcome results
None listed