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

Central Hospital, Nancy, France

Status

Unknown

Conditions

Bilateral Vascular Groin Surgery

Treatments

Device: Closed-incision Negative-pressure Therapy - Dry dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT04174183

2019-A02416-51

Details and patient eligibility

About

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.

Full 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:

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

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.