PICS: Prevention of Infections in Cardiac Surgery
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cefazolin monotherapy, short course 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 |
Drug: Cefazolin
administration as outlined
|
| Experimental: Cefazolin monotherapy, long course 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). |
Drug: Cefazolin
administration as outlined
|
| Experimental: Combination therapy, short course 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. |
Drug: Cefazolin
administration as outlined
Drug: Vancomycin
administration as outlined
|
| Experimental: Combination therapy, long course 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) |
Drug: Cefazolin
administration as outlined
Drug: Vancomycin
administration as outlined
|
Outcome Measures
Primary Outcome Measures
- 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
- Deep incisional and organ/space sternal surgical site infection (NHSN/CDC) [3 months post-surgery]
Primary 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
- Clostridium difficile infection [3 months post-surgery]
Secondary outcome of eventual full trial
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hamilton Health Sciences | Hamilton | Ontario | Canada | L8L 2X2 |
| 2 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B1W8 |
| 3 | Jewish Hospital | Montréal | Quebec | Canada | H3T 1E2 |
| 4 | University of Sherbrook | Sherbrook | Quebec | Canada | J1H 5N4 |
Sponsors and Collaborators
- Hamilton Health Sciences Corporation
- The Physicians' Services Incorporated Foundation
Investigators
- Principal Investigator: Dominik Mertz, MD, MSc, Hamilton Health Sciences Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PICS