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

NCT03460262 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2018-03-09

No results posted yet for this study

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.

Conditions

  • Infection Wound

Interventions

DEVICE

Standard 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.

DEVICE

PICO®

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.

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Parla Astarci, MD, PhD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03460262 on ClinicalTrials.gov