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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 :
5) Bruising 6) Hematoma 7) Wound extension
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevena (right side) - Dry dressing (left side) | Experimental |
| |
| Prevena (left side) - Dry dressing (right side) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-incision Negative-pressure Therapy - Dry dressing | Device | A Closed-incision Negative-pressure Therapy is applied on one groin incision - A dry dressing is applied on one groin incision . |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicla Settembre, M.D | Contact | +33 3 831 543 84 | n.settembre@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicla Settembre | Service de chirurgie vasculaire - Centre Hospitalier Régional Universitaire de Nancy - Allée du Morvan - 54511 Vandœuvre-lès-Nancy Cedex | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Nancy | Recruiting | Vandœuvre-lès-Nancy | Grand Est | 54500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41159585 | Derived | Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2. |
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| 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 |