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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infection Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard dressing-Cutiplast®

Group Type ACTIVE_COMPARATOR

Standard cutiplast®

Intervention Type DEVICE

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.

Negative pressure wound therapy-PICO®

Group Type EXPERIMENTAL

PICO®

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No