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

Primary Purpose

Infection Wound

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Standard cutiplast®

PICO®

About this trial

This is an interventional treatment trial for Infection Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Cliniques Universitaires Saint-Luc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard dressing-Cutiplast®

Negative pressure wound therapy-PICO®

Arm Description

Outcomes

Primary Outcome Measures

The rate of wound complications

Secondary Outcome Measures

Full Information

NCT ID

NCT03460262

First Posted

March 5, 2018

Last Updated

March 5, 2018

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT03460262

Brief Title

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

Acronym

PICO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 15, 2018 (Anticipated)

Primary Completion Date

November 30, 2019 (Anticipated)

Study Completion Date

November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection Wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard dressing-Cutiplast®

Arm Type

Active Comparator

Arm Title

Negative pressure wound therapy-PICO®

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Standard cutiplast®

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

PICO®

Intervention Description

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.

Primary Outcome Measure Information:

Title

The rate of wound complications

Time Frame

at one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Parla Astarci, MD, PhD

Phone

0032 2 764

Ext

6412

parla.astarci@uclouvain.be

First Name & Middle Initial & Last Name or Official Title & Degree

Julien Possoz, MD

Phone

0032 2 764

Ext

8069

julien.possoz@uclouvain.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Parla Astarci, MD, PhD

Organizational Affiliation

Cliniques universitaires Saint-Luc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques Universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Parla Astarci, MD, PhD

Phone

0032 2 764

Ext

6412

parla.astarci@uclouvain.be

First Name & Middle Initial & Last Name & Degree

Julien Possoz, MD

Phone

0032 3 764

Ext

8069

julien.possoz@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

It is not decided yet.

Learn more about this trial

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

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