Bilateral Vascular Groin Surgery Clinical Trial
Official title:
Evaluation of the Effectiveness of a Closed-incision Negative-pressure Therapy (Prevena®) on Bilateral Groin Incision
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.
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.
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