Prevention of Infections in Cardiac Surgery (PICS)

Hamilton Health Sciences (HHS)

Status: Terminated

Conditions: Antibiotic Prophylaxis; Thoracic Surgery

Treatments: Drug: Cefazolin; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02285140

PICS Vanguard

Details and patient eligibility

About

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

Enrollment: 5,989 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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5,989 participants in 4 patient groups

Cefazolin monotherapy, short course

Experimental group

Description:

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

Treatment:

Drug: Cefazolin

Cefazolin monotherapy, long course

Experimental group

Description:

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).

Treatment:

Drug: Cefazolin

Combination therapy, short course

Experimental group

Description:

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.

Treatment:

Drug: Vancomycin

Drug: Cefazolin

Combination therapy, long course

Experimental group

Description:

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)

Treatment:

Drug: Vancomycin

Drug: Cefazolin