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Completed

NCT Number: NCT03402945

Prevention of Infections in Cardiac Surgery (PICS) Prevena Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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)(unethical not to administer glycopeptides), beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively, or to silver precluding the use of Prevena
  • Participation in other studies that may interfere with this trial

Treatment and study plan

Prevena

Device

Negative-Pressure Wound Management System

Cefazolin

Drug

antibiotic

Vancomycin

Drug

antibiotic

Other names: Vancocin

Standard wound dressing

Other

Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.

Primary outcomes

  1. Adherence to the wound management system

    Time frame: Prevena or standard wound dressing applied after surgery as per protocol, assessed up to 90 days after surgery

    goal is >90%

  2. Adherence to the antibiotic regimen

    Time frame: Cefazolin: within an hour of surgery; one intra-operative dose at 4 hours after the first dose or upon wound closure (whatever comes first); two post-operative doses q8h. Vancomycin: initially intravenously; second dose 12 hrs after the first dose.

    goal is >90%

  3. Loss of follow-up

    Time frame: up to 90 days after surgery

    goal is <10%

Secondary outcomes

  1. Deep incisional and organ/space sternal-surgical site infection (s-SSI)

    Time frame: up to 90 days after surgery

    using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions

  2. Wound dehiscence

    Time frame: up to 90 days after surgery

    using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions

  3. C. difficile infection

    Time frame: up to 90 days after surgery

    laboratory confirmed

  4. Mortality in patients with an active infection

    Time frame: up to 90 days after surgery

    using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions

  5. ICU (Intensive Care Unit) and hospital stay

    Time frame: Length of ICU - from date of surgery to initial ICU discharge date, assessed up to 90 days after surgery. Hospital Stay - date of surgery to date of hospital discharge, assessed up to 90 days after surgery.

    length

  6. Pain on day 7

    Time frame: Pain at Day 7 (+/- 1 day)

    Visual analog scale (VAS)

  7. Acute kidney injury

    Time frame: within 7 days of surgery

    Based on serum creatinine, following Acute Kidney Injury Network definition

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

A Cluster-randomized Factorial Crossover Trial, Comparing Antibiotic Mono-prophylaxis With Cefazolin vs. Dual-prophylaxis With Cefazolin Plus Vancomycin and Conventional Wound Dressing vs. Prevena Negative-pressure Wound Management

Acronym: PICS-Prevena

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Jan 18, 2018
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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