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

Negative Pressure Wound Therapy for Prevention of Groin Infection Following Vascular Surgery in High Risk Patient: a Randomized Control Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03460262

Acronym

PICO

Enrollment

160

Registered

2018-03-09

Start date

2018-03-15

Completion date

2019-11-30

Last updated

2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection Wound

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.

Interventions

DEVICEStandard cutiplast®

Our standard dressing consists in a usual ready-to-use Smith and Nephew Cutiplast®. This dressing is open 48 hours after the operation (CDC recommendation) for the first time and then changed every day after wound disinfection.

DEVICEPICO®

PICO® is a negative pressure wound therapy consisting in a 4 layers ready-to-use dressing connected to a small console, responsible for the aspiration. The system is canister free. The fluid drained from the wound is lost by evaporation for 80% of it and only 20% remains in the dressing. This permits to the dressing to be kept in place for maximum 7 days. The wound is not checked during the hospital stay, allowing the patient to leave the hospital earlier after the operation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
The rate of wound complications	at one year

Countries

Belgium

Contacts

Primary ContactParla Astarci, MD, PhD

parla.astarci@uclouvain.be0032 2 764

Backup ContactJulien Possoz, MD

julien.possoz@uclouvain.be0032 2 764

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026