Negative Pressure Wound Therapy to Reduce Surgical Site Infection

Study Overview
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Brief Summary
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The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery.

Official Title
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Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery

Conditions
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Patients Undergoing Hepatopancreatobiliary Surgery

Intervention / Treatment
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* Device: Conventional wound therapy
* Device: Negative pressure wound therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male patients 18 years of age or older Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction Exclusion Criteria: The need for emergency surgery. The need for use of only laparoscopic surgery. Presence of bowel obstruction, strangulation, peritonitis or perforation. The presence of local or systemic infection preoperatively. ASA class ≥4. Inability to provide informed consent and authorization. Known allergy or hypersensitivity to silver. Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Negative Pressure Wound Therapy<br>The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure | Device: Negative pressure wound therapy<br>* The Prevena Incision Management System covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump may be used with the Prevena dressings as well in some situations to achieve negative pressure.<br>* Other names: Prevena Incision Management System; ActiVAC;|
| Active Comparator: Conventional wound therapy<br>Traditional wound therapy (sterile bandages and dressing) | Device: Conventional wound therapy<br>* Sterile bandages and wound coverings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With a Surgical Site Infection | Number and percentage of participants with at least 1 surgical site infection (SSI). | 30 days after surgery; assessed at 4-5 days and 30 days post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Surgical Site Infections by Type | Each surgical site infection was classified into one of the following categories: superficial incisional, deep incisional, or organ/space (as defined by The American College of Surgeons NSQIP [National Surgical Quality Improvement Program] guidelines). The number of infections in each category is reported separately for both treatment arms. Some participants had multiple infections. | 30 days post-surgery | 
| Length of Hospital Stay | Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS. | Up to 62 days post-surgery |