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

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.

Study Overview

• Status: Unknown
• Conditions: Bilateral Vascular Groin Surgery
• Intervention / Treatment: Device: Closed-incision Negative-pressure Therapy - Dry dressing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grand Est
    • Vandoeuvre-lès-Nancy, Grand Est, France, 54500
      • Recruiting
      • Centre Hospitalier Régional Universitaire de Nancy
      • Contact: Nicla Settembre, M.D.; Phone Number: +33 3 831 543 84; Email: n.settembre@chru-nancy.fr
      • Principal Investigator: Nicla Settembre, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prevena (right side) - Dry dressing (left side)	Device: 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 .
Experimental: Prevena (left side) - Dry dressing (right side)	Device: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound aspect - major complication	Left and right wound incision are inspected and the presence of major complication are reported. Major complication : Presence of pus Bloody and/or lymphatic discharge Disunity Necrosis	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of complications	Left and right wound incision are inspected and the presence of major and minor complication are reported. A score of complications is established. - Major : Presence of pus Bloody and/or lymphatic discharge Disunity Necrosis - Minor : Bruising Hematoma Wound extension Each complication amount to 1 point on the complication score.	4-days
Major complication in different clinical settings	Left and right wound incision are inspected and the presence of major complication are reported. Major complication : Presence of pus Bloody and/or lymphatic discharge Disunity Necrosis During the analysis, patient are divided into several group depending of the presence or absence of comorbidities.	4-days
Wound aspect - major complication (long term)	Left and right wound incision are inspected and the presence of major complication are reported. Major complication : Presence of pus Bloody and/or lymphatic discharge Disunity Necrosis	2-3 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Nicla Settembre, Service de chirurgie vasculaire - Centre Hospitalier Régional Universitaire de Nancy - Allée du Morvan - 54511 Vandœuvre-lès-Nancy Cedex

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 2019-A02416-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No