NCT04174183

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bilateral Vascular Groin Surgery

Interventions

Type	Name	Description
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 .

Timeline

• Start date: 2019-12-24
• Primary completion: 2022-01-01
• Completion: 2022-07-01
• First posted: 2019-11-22
• Last updated: 2020-05-08

Locations

1 site across 1 country: France