Incisional Negative Pressure Dressing on Clean Closed Groin Incisions

Study Overview
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Brief Summary
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Wound complications associated with surgical incisions range from minor to life threatening. Surgical site infections occurring usually occur within 30 days and are one of the most common surgical complications. Perigraft infections in groin wounds can be devastating. Even superficial wounds can progress to deep wounds resulting in graft infection, need for explantation, and sepsis or amputation requirement. Negative pressure wound therapy has had favorable results on closed wounds in trauma populations. Similarly, negative pressure wound therapy has had positive benefits in closed incisions such as sternal wounds following cardiac surgery. As a result, the PrevenaTM Incision Management System(IMS) was developed to allow easier application of negative pressure therapy to closed wounds. Application of the PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure (VAC®) therapy with the added benefits of protecting the wound from contamination and bolstering the wound edges for better approximation and consequently better aesthetic outcome. However, no comparison between negative pressure therapy as a dressing and standard wound dressings exists. The purpose of this study is to assess the efficacy and safety of topical negative pressure therapy application with Prevena™ versus standard of care wound therapy on closed groin incisions in high risk patients undergoing vascular surgery.

Official Title
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Incisional Negative Pressure Dressing on Clean Closed Groin Incisions in High Risk Patients

Conditions
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Complication of Surgical Procedure

Intervention / Treatment
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* Device: Incisional Neg Pressure Wound Therapy (Prevena™)
* Other: Standard of Care wound therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or greater Scheduled elective vascular surgery which requires groin incision. Elective surgery is defined as planned surgery a minimum of 24 hours before the procedure. Meets high risk criteria according to the following rating system Scores at least 8 points for the following risk factors: • MAJOR 4 points: BMI of <18 kg/m2 or ≥BMI 40 kg/m2 *** Insulin dependent Diabetes Mellitus* Dialysis (hemodialysis or peritoneal dialysis)** • INTERMEDIATE 2 points: Previous groin surgery Diabetes Mellitus not requiring insulin* Chronic lung disease GOLD >2 On long-term immunosuppressive medication (>3 months at time of enrollment) Chronic kidney disease (defined as a GFR <30ml/min/1.73m2 for 3 months)** Previous lower extremity or abdominal wall radiotherapy radiotherapy BMI between 35 and 40*** • MINOR 1 point: Previous abdominal surgery Peripheral vascular disease Female gender Age >75 years old Hospitalized at least 7 days before surgery *, **, *** mutually exclusive, highest score should be used Capable of providing informed consent or has a legally authorized representative (LAR) if unable to provide informed consent Willing and able to adhere to the study visit schedule Exclusion Criteria: Subjects meeting any of the following criteria may not be enrolled in the study: Is pregnant Has a systemic infection at the time of surgery (ie bacteremia) Has a remote body site infection at the time of surgery (ie UTI) Has a known allergy or hypersensitivity to silver, adhesive, or dressing material Has a requirement for competing therapy (ie open negative pressure wound therapy) Is simultaneously participating in another interventional trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Incisional Neg Pressure Wound Therapy<br>Incisional negative pressure wound therapy dressings applied to the surgical site | Device: Incisional Neg Pressure Wound Therapy (Prevena™)<br>* Negative pressure wound therapy dressing applied over closed surgical incision<br>|
| Active Comparator: Standard of care wound dressing<br>Standard of care wound dressing of gauze and tape or the equivalent applied to the surgical site | Other: Standard of Care wound therapy<br>* Gauze type dressing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep wound infection |  | within 30 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superficial Wound Infection | Cellulitis or other superficial infection of the wound or tissue immediately surrounding the wound | within 30 postoperative days | 
| Wound dehiscence | Spontaneous opening of a previously closed surgical wound | within 30 postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incisional negative pressure wound therapy, groin incision, incisional VAC, Prevena, groin wound