Evaluation of the Effectiveness of a Closed-incision Negative-pressure Therapy (Prevena®) on Bilateral Groin Incision

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-24

Study Completion Date

2022-07-31

Brief Summary

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Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The aim of this study is to compareon on the same patient a Closed-incision negative-pressure therapy (Prevena®, KCI) versus a traditional gauze dressings after a bilateral vascular groin surgery. To do this, each device is applied on one groin incision and the side, left or right, is randomized.

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Detailed Description

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The prevalence of surgical site infections in groin vascular surgery is 3-44%. The factors causing these infections are well identified: disruption of lymphatic vessels, proximity of genital organs, presence of prosthetic material, etc. The risk of developing an infection of the surgical site is also influenced by the patient's comorbidities and by the surgical context.

Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The mechanisms of action for negative-pressure therapy include protecting the wound bed, splinting soft tissue, reducing oedema,increasing perfusion and enhancing development of granulation tissue.

Presently, there are no guidelines for the use of this device or not in groin incision and this decision is left to the surgeon's discretion.

The main objective is to demonstrate the superiority of closed-incision negative-pressure therapy over the application of a traditional gauze dressings to reduce the rate of major complications (i.e. requiring an extension of hospitalization time) during bilateral vascular groin surgery. To do this, each device is applied on one groin incision and the side, left or right, is randomized.

The secondary objectives are:

1. To demonstrate the superiority of closed-incision negative-pressure therapy over the application of a dry dressing in reducing the score of complications (major and minor) during vascular groin surgery. The complication score is the number of complications observed during the consultation conducted on day four after the surgery, among the following:

* Major :

1. Presence of pus
2. Bloody and/or lymphatic discharge
3. Disunity
4. Necrosis
* Minor :

5\) Bruising 6) Hematoma 7) Wound extension
2. To compare the rate of major complications between closed-incision negative-pressure therapy and dry dressing application in different clinical settings.

3\. To demonstrate the superiority of closed-incision negative-pressure therapy over the application of a dry dressing in reducing the score of complications 2-3 months after surgery.

Conditions

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Bilateral Vascular Groin Surgery

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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Prevena (right side) - Dry dressing (left side)

Group Type EXPERIMENTAL

Closed-incision Negative-pressure Therapy - Dry dressing

Intervention Type DEVICE

A Closed-incision Negative-pressure Therapy is applied on one groin incision - A dry dressing is applied on one groin incision .

Prevena (left side) - Dry dressing (right side)

Group Type EXPERIMENTAL

Closed-incision Negative-pressure Therapy - Dry dressing

Intervention Type DEVICE

A Closed-incision Negative-pressure Therapy is applied on one groin incision - A dry dressing is applied on one groin incision .

Interventions

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Closed-incision Negative-pressure Therapy - Dry dressing

A Closed-incision Negative-pressure Therapy is applied on one groin incision - A dry dressing is applied on one groin incision .

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Person affiliated to a health insurance system
* Person who has received full information on the organization of the research and has signed his or her informed consent
* Person presenting a bilateral vascular groin surgery
* Major person

Exclusion Criteria

* Person with a known allergy to one of the components of the evaluated product (including: acrylic or silver-based adhesives)
* Person with a contraindication to the product(s) being evaluated
* Non-collaborative or agitated patient
* Patients with hemostasis problems
* Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code:
* Pregnant woman, parturient or breastfeeding mother
* Minor person (not emancipated)
* Adult person subject to a legal protection measure (guardianship, curatorship, protection of justice)
* Adult person unable to consent
* Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No