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

Bilateral Vascular Groin Surgery Clinical Trial

— PREVISION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174183
• Other study ID #: 2019-A02416-51
• Status: Recruiting
• Phase: N/A
• Start date: December 24, 2019
• Est. completion date: July 2022

Study information

• Verified date: October 2019
• Source: Central Hospital, Nancy, France
• Contact: Nicla Settembre, M.D
• Phone: +33 3 831 543 84
• Email: n.settembre[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bilateral Vascular Groin Surgery
• Surgical Wound

Intervention

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 .

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Nancy	Vandoeuvre-lès-Nancy	Grand Est

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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