This vanguard study will be conducted at two study sites in Canada. It is a cluster randomized trial to test a combination of two antibiotics for antibiotic prophylaxis as compared to routine prophylaxis with one single antibiotic, and to test a negative-pressure wound management system (Prevena) versus standard wound dressing to reduce chest wound infections.
Despite the routine use of antibiotics before and after cardiac surgery, infections of the chest wound remain a common life threatening complication of heart surgery that is preventable. Antibiotic prophylaxis is well accepted to be the cornerstone of prevention for these infections. The best choice of antibiotic prophylaxis in patients undergoing open heart surgery is, however, unclear. A large number of relevant pathogens are not covered by the primarily recommended antibiotic for prophylaxis, and there is a large variability in the antibiotics physicians use in practice and a lack of evidence supporting these choices. Appropriate management of the wound is probably also highly relevant in terms of infection prevention; however, there is a lack of strong evidence guiding the choice of wound management strategies as a means to reduce surgical site infection. The proposed study will test whether dual antibiotic prophylaxis is superior to single-agent prophylaxis with cefazolin, and shed light on whether or not modern negative-pressure wound management technology lower the risk of sternal surgical site infections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
4,107
Negative-Pressure Wound Management System
antibiotic
antibiotic
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre & Lawson Health Research Institute
London, Ontario, Canada
Adherence to the wound management system
goal is \>90%
Time frame: Prevena or standard wound dressing applied after surgery as per protocol, assessed up to 90 days after surgery
Adherence to the antibiotic regimen
goal is \>90%
Time frame: Cefazolin: within an hour of surgery; one intra-operative dose at 4 hours after the first dose or upon wound closure (whatever comes first); two post-operative doses q8h. Vancomycin: initially intravenously; second dose 12 hrs after the first dose.
Loss of follow-up
goal is \<10%
Time frame: up to 90 days after surgery
Deep incisional and organ/space sternal-surgical site infection (s-SSI)
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
Time frame: up to 90 days after surgery
Wound dehiscence
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
Time frame: up to 90 days after surgery
C. difficile infection
laboratory confirmed
Time frame: up to 90 days after surgery
Mortality in patients with an active infection
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
Time frame: up to 90 days after surgery
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Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.
ICU (Intensive Care Unit) and hospital stay
length
Time frame: Length of ICU - from date of surgery to initial ICU discharge date, assessed up to 90 days after surgery. Hospital Stay - date of surgery to date of hospital discharge, assessed up to 90 days after surgery.
Pain on day 7
Visual analog scale (VAS)
Time frame: Pain at Day 7 (+/- 1 day)
Acute kidney injury
Based on serum creatinine, following Acute Kidney Injury Network definition
Time frame: within 7 days of surgery