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®
Sponsored by
About this trial
This is an interventional treatment trial for Infection Wound
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.
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Email
parla.astarci@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Possoz, MD
Phone
0032 2 764
Ext
8069
Email
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
Email
parla.astarci@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Julien Possoz, MD
Phone
0032 3 764
Ext
8069
Email
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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