Prevention of Infections in Cardiac Surgery
Information source: Hamilton Health Sciences Corporation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thoracic Surgery; Antibiotic Prophylaxis
Intervention: Cefazolin (Drug); Vancomycin (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Hamilton Health Sciences Corporation Official(s) and/or principal investigator(s): Dominik Mertz, MD, MSc, Principal Investigator, Affiliation: Hamilton Health Sciences Corporation
Overall contact: Dominik Mertz, MD, MSc, Phone: (905) 521-2100, Ext: 43952, Email: mertzd@mcmaster.ca
Summary
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
Clinical Details
Official title: Prevention of Infections in Cardiac Surgery: a Cluster-randomized Factorial Cross-over Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Proportion of patients receiving antibiotics according to study protocolProportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95% Agreement of blinded outcome assessment based on information from the case report form
Secondary outcome: Deep incisional and organ/space sternal surgical site infection (NHSN/CDC)All types of sternal surgical site infection (superficial, deep, organ; NHSN/CDC) Mortality Clostridium difficile infection
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All adult patients (≥18 years of age) undergoing open-heart surgery (sternotomy,
including minimally-invasive surgical techniques).
Exclusion Criteria:
- Patients on antibiotics at the time of surgery.
- Previous enrollment in this trial.
- Known MRSA carriers. Beta-lactam allergy (IgE-mediated) precluding the use of
cefazolin
- Participant in another study that may interfere with this trial.
Locations and Contacts
Dominik Mertz, MD, MSc, Phone: (905) 521-2100, Ext: 43952, Email: mertzd@mcmaster.ca
Hamilton Health Sciences, Hamilton, Ontario L8L 2X2, Canada
Additional Information
Starting date: April 2015
Last updated: November 4, 2014
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