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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 protocol

Proportion 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

Page last updated: August 20, 2015

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