Prophylactic NPWT to Reduce SSI in Colorectal Surgery

Study Overview
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Brief Summary
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The purpose of this study is to see if the Negative Pressure Wound Therapy (NPWT) system is effective and safe for the prevention of superficial and deep incisional surgical site infections (SSI) in high risk patients within 30 days after elective colorectal surgery. It has been shown that patients with an IBD, patients undergoing a reoperation or patients with certain comorbidities are at a higher risk of developing an SSI. The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds. The study will include up to 400 patients at this single site, where these high risk patients will be randomized to receive either one of two arms. The first arm involves the placement of the NPWT device in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures. The device would then be left on for 5 days. The second arm would be standard of care and would entail routine postoperative protocols. Subjects will then be seen once at a 30 day (± 7 days) follow-up visit to assess for the development of SSIs.

Official Title
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Prophylactic Negative Pressure Wound Therapy to Reduce Surgical Site Infections in Elective Clean-Contaminated Colon Resections

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Device: Prevena


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 18-80 patients who will undergo an open or laparoscopic-assisted clean/contaminated colorectal surgical procedure. Patients must either have an inflammatory bowel disease, undergoing reoperation within 30 days, or have two or more of the following risk factors: presence of an ostomy, type II diabetes, BMI greater than 30, immunosuppression, malnutrition, current smoker, chronic kidney disease (creatinine > 1.2), and disseminated cancer. Exclusion Criteria: patients currently enrolled in another interventional clinical trial, patients with a BMI less than 20, patients with a current abdominal abscess or infection (including a known urinary tract infection), patients allergic to or hypersensitive to silver, patients planning to undergo a second colorectal surgical procedure (e.g., colostomy or ileostomy takedown) or any other general surgery in less than 30 days of index-surgery, any patient in which the planned surgery would include: i) placement of a stoma in the principal incision; ii) placement of a drain into the supra-peritoneal fascia space that emerges through the principal incision; iv) placement of a drain into the intraperitoneal space that emerges through the principal incision; and v) supplementation of any of the irrigation fluid with antibiotic or antiseptic drugs, patients with healing disorders, pregnant women, prisoners, or any patient that is deemed unsuitable for the study by the Principal Investigator or the operating surgeon/Co-Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: Two cohorts. Experimental group receives the study device and the control group receives the standard of care (No device). Patients are randomized to either group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevena<br>This group will receive the negative pressure wound therapy device. | Device: Prevena<br>* The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.<br>* Other names: Negative pressure wound therapy device;|
| No Intervention: Standard of Care<br>This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Surgical Site Infection | Any type of Surgical site infection as defined by the CDC developed within the follow-up period. | 37 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay |  | average of 7 days | 
| Number of Serious Adverse Events | Number of serious adverse events developed within the follow-up period | up to 37 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Negative Pressure Wound Therapy, Colorectal Surgery, Prevena, Surgical Site Infection