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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
164
Sterile bandages and wound coverings
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.
Indiana University
Indianapolis, Indiana, United States
Duke University Medical Center
Durham, North Carolina, United States
Participants With a Surgical Site Infection
Number and percentage of participants with at least 1 surgical site infection (SSI).
Time frame: 30 days after surgery; assessed at 4-5 days and 30 days post-operation
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.
Time frame: 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.
Time frame: Up to 62 days post-surgery
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