Negative Pressure Wound Therapy for Prevention of Groin Infection Following Vascular Surgery

Not Applicable

• Conditions: Infection Wound
• Interventions: Device: Standard cutiplast®; Device: PICO®

• Registration Number: NCT03460262
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

Surgical site infection in vascular surgery is a relatively common event with reported incidence as high as 43%. When considering the groin alone, the incidence is around 20% (30% when considering any wound complication). This complication may sometimes lead to heavier complication (leg amputation, longer hospital stay, high costs...) and affects the early postoperative quality of life of the patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-05
• Study First Posted: 2018-03-09
• Last Update Posted: 2018-03-09
• Study Start: 2018-03-15
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Every high-risk patient (meeting one of the criteria of table I) undergoing vascular surgery with groin incision (without ongoing infection)

Exclusion Criteria

• Patients who need a transverse incision before EndoVascular Aortic Repair procedure, considering that in our experience surgical site infection almost never occurs after these procedures and patients with mental incapacities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dressing-Cutiplast®	Standard cutiplast®	-
Negative pressure wound therapy-PICO®	PICO®	-

Primary Outcome Measures

Name	Time	Method
The rate of wound complications	at one year

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium