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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Unknown

Conditions: Infection Wound

Treatments: Device: PICO®; Device: Standard cutiplast®

Study type: Interventional

Funder types: Other

Identifiers

NCT03460262

2017/483

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Standard dressing-Cutiplast®

Active Comparator group

Treatment:

Device: Standard cutiplast®

Negative pressure wound therapy-PICO®

Experimental group

Treatment:

Device: PICO®