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

Infection Wound Clinical Trial

— PICO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03460262
• Other study ID #: 2017/483
• 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
• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infection Wound
• Wounds and Injuries

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