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Prevention of Infections in Cardiac Surgery: a Cluster-randomized Factorial Cross-over Trial
There is clinical equipoise about the question of whether antibiotic prophylaxis should be given for a short period or an extended period of time as reflected by inconsistencies in major guidelines, current practices at Canadian centers, and as concluded in the three systematic reviews. There also is clinical equipoise on whether the addition of vancomycin to routine cefazolin prophylaxis can further reduce s-SSI rates. A short duration of combined antimicrobial prophylaxis can reduce side effects of exposure to antimicrobials such as infections with C. difficile or emergence of resistance, but may also reduce the incidence of s-SSIs. The objective of the eventual full scale study is to determine whether adding vancomycin to cefazolin can reduce SSIs as well as whether short-term prophylaxis is as effective as long-term prophylaxis. The rationale to conduct the proposed pilot study is to assess the feasibility to conduct this factorial cluster randomized cross-over trial, the adherence to the study protocol at each pilot site, the length of time to fill out the case report forms, and to get reliable estimates of event rates for sample size calculation for the main study
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Jewish Hospital
Montreal, Quebec, Canada
University of Sherbrook
Sherbrook, Quebec, Canada
Start Date
April 1, 2015
Primary Completion Date
March 10, 2025
Completion Date
March 10, 2025
Last Updated
March 12, 2025
5,989
ACTUAL participants
Cefazolin
DRUG
Vancomycin
DRUG
Lead Sponsor
Hamilton Health Sciences Corporation
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07213375