Prevention of Infections in Cardiac Surgery

NCT ID: NCT02285140

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5989 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2025-03-10

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

Conditions

Thoracic Surgery; Antibiotic Prophylaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Cefazolin

Intervention Type: DRUG

administration as outlined

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).

Group Type: EXPERIMENTAL

Cefazolin

Intervention Type: DRUG

administration as outlined

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.

Group Type: EXPERIMENTAL

Cefazolin

Intervention Type: DRUG

administration as outlined

Vancomycin

Intervention Type: DRUG

administration as outlined

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)

Group Type: EXPERIMENTAL

Cefazolin

Intervention Type: DRUG

administration as outlined

Vancomycin

Intervention Type: DRUG

administration as outlined

Interventions

Cefazolin

administration as outlined

Intervention Type: DRUG

Vancomycin

administration as outlined

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Dominik Mertz

Assistant Professor, Medical Director Infection Prevention and Control

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominik Mertz, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

Hamilton Health Sciences

Hamilton, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Jewish Hospital

Montreal, Quebec, Canada

University of Sherbrook

Sherbrook, Quebec, Canada

Countries

Canada

References

van Oostveen RB, Romero-Palacios A, Whitlock R, Lee SF, Connolly S, Carignan A, Mazer CD, Loeb M, Mertz D. Prevention of Infections in Cardiac Surgery study (PICS): study protocol for a pragmatic cluster-randomized factorial crossover pilot trial. Trials. 2018 Dec 17;19(1):688. doi: 10.1186/s13063-018-3080-y.

Reference Type: DERIVED

PMID: 30558680 (View on PubMed)

Other Identifiers

PICS Vanguard

Identifier Type: -

Identifier Source: org_study_id