Clinical trial NCT04174183: Evaluation of the Effectiveness of a Closed-incision Negative-pressure Therapy (Prevena®) on Bilateral Groin Incision
Official title: Evaluation of the Effectiveness of a Closed-incision Negative-pressure Therapy (Prevena®) on Bilateral Groin Incision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bilateral Vascular Groin Surgery
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound aspect - major complication
timeFrame: 4 days
Secondary outcomes:
measure: Score of complications
timeFrame: 4-days
measure: Major complication in different clinical settings
timeFrame: 4-days
measure: Wound aspect - major complication (long term)
timeFrame: 2-3 months
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy
state: Grand Est
Study officials:
affiliation: Service de chirurgie vasculaire - Centre Hospitalier Régional Universitaire de Nancy - Allée du Morvan - 54511 Vandœuvre-lès-Nancy Cedex
name: Nicla Settembre
role: PRINCIPAL_INVESTIGATOR
References: