Prevention of Infections in Cardiac Surgery (PICS) Prevena Study

Last updated: February 27, 2025
Sponsor: Population Health Research Institute
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

Vancomycin

Cefazolin

standard wound dressing

Clinical Study ID

NCT03402945
PICS-PREVENA V1_20171106
  • Ages > 18
  • All Genders

Study Summary

This vanguard study will be conducted at two study sites in Canada. It is a cluster randomized trial to test a combination of two antibiotics for antibiotic prophylaxis as compared to routine prophylaxis with one single antibiotic, and to test a negative-pressure wound management system (Prevena) versus standard wound dressing to reduce chest wound infections.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years of age undergoing open-heart surgery (sternotomy, includingminimally-invasive sternotomies)

Exclusion

Exclusion Criteria:

  • On systemic antibiotics or with an active bacterial infection at the time of surgery

  • Patients previously enrolled in this trial

  • Patients known to be colonized with Methicillin-resistant S. aureus (MRSA)(unethicalnot to administer glycopeptides), beta-lactam or vancomycin allergy precluding theuse of cefazolin or vancomycin, respectively, or to silver precluding the use ofPrevena

  • Participation in other studies that may interfere with this trial

Study Design

Total Participants: 4107
Treatment Group(s): 4
Primary Treatment: Vancomycin
Phase: 4
Study Start date:
March 05, 2018
Estimated Completion Date:
October 17, 2024

Study Description

Despite the routine use of antibiotics before and after cardiac surgery, infections of the chest wound remain a common life threatening complication of heart surgery that is preventable. Antibiotic prophylaxis is well accepted to be the cornerstone of prevention for these infections. The best choice of antibiotic prophylaxis in patients undergoing open heart surgery is, however, unclear. A large number of relevant pathogens are not covered by the primarily recommended antibiotic for prophylaxis, and there is a large variability in the antibiotics physicians use in practice and a lack of evidence supporting these choices. Appropriate management of the wound is probably also highly relevant in terms of infection prevention; however, there is a lack of strong evidence guiding the choice of wound management strategies as a means to reduce surgical site infection. The proposed study will test whether dual antibiotic prophylaxis is superior to single-agent prophylaxis with cefazolin, and shed light on whether or not modern negative-pressure wound management technology lower the risk of sternal surgical site infections.

Connect with a study center

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • London Health Sciences Centre & Lawson Health Research Institute

    London, Ontario N6A 5A5
    Canada

    Site Not Available

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