An interventional study of Closed-incision Negative-pressure Therapy - Dry dressing in Bilateral Vascular Groin Surgery, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-08.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Treatment
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:
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 :
Minor :
519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.
This study's planned enrollment of 84 is close to the median of 80 across 412 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Device: Closed-incision Negative-pressure Therapy - Dry dressing
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 .
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
Time frame: 4 days
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.
Time frame: 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.
Time frame: 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
Time frame: 2-3 months
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France