Prevention of Infections in Cardiac Surgery

NCT02285140 | Terminated

• 1 other identifier: PICS Vanguard
• Study Type: interventional
• Target: 5,989
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (3)

• Proportion of patients receiving antibiotics according to study protocol

  Co-Primary outcome of pilot study

  3 months post-surgery

• Proportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95%

  Co-Primary outcome of pilot study

  3 months post-surgery

• Agreement of blinded outcome assessment based on information from the case report form

  Co-Primary outcome of pilot study

  3 months post-surgery

Secondary Outcomes (4)

• Deep incisional and organ/space sternal surgical site infection (NHSN/CDC)

  3 months post-surgery

• All types of sternal surgical site infection (superficial, deep, organ; NHSN/CDC)

  3 months post-surgery

• Mortality

  3 months post-surgery

• Clostridium difficile infection

  3 months post-surgery

Study Arms (4)

Cefazolin monotherapy, short course

EXPERIMENTAL

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

Cefazolin monotherapy, long course

EXPERIMENTAL

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

Combination therapy, short course

EXPERIMENTAL

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; Drug: Vancomycin

Combination therapy, long course

EXPERIMENTAL

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; Drug: Vancomycin

Interventions

Cefazolin DRUG

administration as outlined

Cefazolin monotherapy, long course; Cefazolin monotherapy, short course; Combination therapy, long course; Combination therapy, short course

Vancomycin DRUG

administration as outlined

Combination therapy, long course; Combination therapy, short course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients (≥18 years of age) undergoing open-heart surgery (sternotomy, including minimally-invasive surgical techniques).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (4)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Jewish Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

University of Sherbrook

Sherbrook, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 30558680 DERIVED

MeSH Terms

Interventions

Cefazolin; Vancomycin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dominik Mertz, MD, MSc

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Medical Director Infection Prevention and Control

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 6, 2014
• Study Start: April 1, 2015
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CA (4)