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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03460262
Other study ID # 2017/483
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 5, 2018
Last updated March 5, 2018
Start date March 15, 2018
Est. completion date November 30, 2019

Study information

Verified date March 2018
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Parla Astarci, MD, PhD
Phone 0032 2 764
Email parla.astarci@uclouvain.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 160
Est. completion date November 30, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.
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.

Locations

Country Name City State
Belgium Cliniques Universitaires Saint-Luc Brussels

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of wound complications at one year
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