Prevention of Infections in Cardiac Surgery

Not Applicable

Terminated

• Conditions: Thoracic Surgery; Antibiotic Prophylaxis
• Interventions: Drug: Cefazolin; Drug: Vancomycin

• Registration Number: NCT02285140
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-06
• Study Start: 2015-04
• Status Verified: 2025-03
• Primary Completion: 2025-03-10
• Study Completion: 2025-03-10
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5989

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cefazolin monotherapy, short course	Cefazolin	One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered
Combination therapy, short course	Cefazolin	One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered. In addition, one dose of vancomycin 60-90min pre-op will be administered.
Combination therapy, short course	Vancomycin	One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered. In addition, one dose of vancomycin 60-90min pre-op will be administered.
Cefazolin monotherapy, long course	Cefazolin	One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose).
Combination therapy, long course	Cefazolin	One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose). In addition, one dose of vancomycin 60-90min pre-op will be administered followed by 3 post-op doses every 12 hours (last dose 36 hours after first dose)
Combination therapy, long course	Vancomycin	One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose). In addition, one dose of vancomycin 60-90min pre-op will be administered followed by 3 post-op doses every 12 hours (last dose 36 hours after first dose)

Primary Outcome Measures

Name	Time	Method
Proportion of patients receiving antibiotics according to study protocol	3 months post-surgery	Co-Primary outcome of pilot study
Proportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95%	3 months post-surgery	Co-Primary outcome of pilot study
Agreement of blinded outcome assessment based on information from the case report form	3 months post-surgery	Co-Primary outcome of pilot study

Secondary Outcome Measures

Name	Time	Method
Deep incisional and organ/space sternal surgical site infection (NHSN/CDC)	3 months post-surgery	Primary outcome of eventual full trial
Clostridium difficile infection	3 months post-surgery	Secondary outcome of eventual full trial
All types of sternal surgical site infection (superficial, deep, organ; NHSN/CDC)	3 months post-surgery	Secondary outcome of eventual full trial
Mortality	3 months post-surgery	Secondary outcome of eventual full trial

Trial Locations

Locations (4)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Jewish Hospital; 🇨🇦 Montréal, Quebec, Canada

University of Sherbrook; 🇨🇦 Sherbrook, Quebec, Canada