Negative Pressure Wound Therapy to Reduce Surgical Site Infection
- Conditions
- Patients Undergoing Hepatopancreatobiliary Surgery
- Registration Number
- NCT01905397
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Participants With a Surgical Site Infection 30 days after surgery; assessed at 4-5 days and 30 days post-operation Number and percentage of participants with at least 1 surgical site infection (SSI).
- Secondary Outcome Measures
Name Time Method Number of Surgical Site Infections by Type 30 days post-surgery 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.
Length of Hospital Stay Up to 62 days post-surgery Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS.
Trial Locations
- Locations (2)
Indiana University
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Indiana University🇺🇸Indianapolis, Indiana, United States