Prevention of Infections in Cardiac Surgery (PICS) Prevena Study

NCT03402945 | Completed Phase 4 DMC

• 1 other identifier: PICS-PREVENA V1_20171106
• Study Type: interventional
• Target: 4,107
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Surgical Site Infections

Keywords

negative pressure wound management system; open-heart surgery; antibiotic prophylaxis; surgical site infection

Outcome Measures

Primary Outcomes (3)

• Adherence to the wound management system

  goal is \>90%

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

• Adherence to the antibiotic regimen

  goal is \>90%

  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.

• Loss of follow-up

  goal is \<10%

  up to 90 days after surgery

Secondary Outcomes (7)

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

  up to 90 days after surgery

• Wound dehiscence

  up to 90 days after surgery

• C. difficile infection

  up to 90 days after surgery

• Mortality in patients with an active infection

  up to 90 days after surgery

• ICU (Intensive Care Unit) and hospital stay

  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.

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

cefazolin prophylaxis plus Prevena negative-pressure wound management system . Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery, followed by one intra-operative dose of cefazolin at 4 hours after the first dose or upon wound closure (whatever comes first), and finally two post-operative doses q8h. Prevena will be applied to all diabetic and/or obese patients (BMI \>30kg/m2) at the end of surgery on the sternal as well as the vein harvest site (if open saphenous vein harvest) in the OR and left in place for 7 day

Device: Prevena; Drug: Cefazolin

Arm 2

ACTIVE COMPARATOR

cefazolin and vancomycin prophylaxis plus Prevena negative-pressure wound management system. Cefazolin 2g (or 3g if greater than 120kg body weight) within an hour of surgery, followed by one intra-operative dose of cefazolin at 4 hrs after the first dose or upon wound closure (whatever comes first), and finally two post-operative doses q8h. Vancomycin at roughly 15mg/kg body weight intravenously, i.e. 1g, or 1.5g if greater than 85kg body weight. No intra-operative dose of vancomycin will be given, and a single second dose will be given 12 hours after the first dose. Prevena will be applied to all diabetic and/or obese patients (BMI \>30kg/m2) at the end of surgery on the sternal as well as the vein harvest site (if open saphenous vein harvest) in the OR and left in place for 7 days.

Device: Prevena; Drug: Cefazolin; Drug: Vancomycin

Arm 3

ACTIVE COMPARATOR

cefazolin prophylaxis plus standard wound dressing. Cefazolin 2g (or 3g if greater than 120kg body weight) within an hour of surgery, followed by one intra-operative dose of cefazolin at 4 hours after the first dose or upon wound closure (whatever comes first), and finally two post-operative doses q8h. Standard wound dressing: non-negative wound dressing as standard of care at the study site.

Drug: Cefazolin; Other: standard wound dressing

Arm 4

ACTIVE COMPARATOR

cefazolin and vancomycin prophylaxis plus standard wound dressing. Cefazolin 2g (or 3g if greater than 120kg body weight) within an hour of surgery, followed by one intra-operative dose of cefazolin at 4 hours after the first dose or upon wound closure (whatever comes first), and finally two post-operative doses q8h. Vancomycin at roughly 15mg/kg body weight intravenously, i.e. 1g, or 1.5g if greater than 85kg body weight. No intra-operative dose of vancomycin will be given, and a single second dose will be given 12 hours after the first dose. Standard wound dressing: non-negative wound dressing as standard of care at the study site.

Drug: Cefazolin; Drug: Vancomycin; Other: standard wound dressing

Interventions

Prevena DEVICE

Negative-Pressure Wound Management System

Arm 1; Arm 2

Cefazolin DRUG

antibiotic

Arm 1; Arm 2; Arm 3; Arm 4

Vancomycin DRUG

antibiotic

Also known as: Vancocin

Arm 2; Arm 4

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.

Arm 3; Arm 4

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (2)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre & Lawson Health Research Institute

London, Ontario, N6A 5A5, Canada

Location

Related Publications (6)

• Connolly SJ, Philippon F, Longtin Y, Casanova A, Birnie DH, Exner DV, Dorian P, Prakash R, Alings M, Krahn AD. Randomized cluster crossover trials for reliable, efficient, comparative effectiveness testing: design of the Prevention of Arrhythmia Device Infection Trial (PADIT). Can J Cardiol. 2013 Jun;29(6):652-8. doi: 10.1016/j.cjca.2013.01.020.

  PMID: 23702356 BACKGROUND

• Mertz D, Whitlock R, Kokoszka AY, Smith SW, Carignan A, Rehan M, Jaffer IH, Alsagheir A, Loeb M. Routine Surveillance Versus Independent Assessment by an Outcome Adjudication Committee in Assessing Patients for Sternal Surgical Site Infections After Cardiac Surgery. Infect Control Hosp Epidemiol. 2016 May;37(5):600-2. doi: 10.1017/ice.2015.347. Epub 2016 Jan 19.

  PMID: 26782707 BACKGROUND

• Filsoufi F, Castillo JG, Rahmanian PB, Broumand SR, Silvay G, Carpentier A, Adams DH. Epidemiology of deep sternal wound infection in cardiac surgery. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):488-94. doi: 10.1053/j.jvca.2009.02.007. Epub 2009 Apr 19.

  PMID: 19376733 BACKGROUND

• Edwards FH, Engelman RM, Houck P, Shahian DM, Bridges CR; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Practice Guideline Series: Antibiotic Prophylaxis in Cardiac Surgery, Part I: Duration. Ann Thorac Surg. 2006 Jan;81(1):397-404. doi: 10.1016/j.athoracsur.2005.06.034. No abstract available.

  PMID: 16368422 BACKGROUND

• Lador A, Nasir H, Mansur N, Sharoni E, Biderman P, Leibovici L, Paul M. Antibiotic prophylaxis in cardiac surgery: systematic review and meta-analysis. J Antimicrob Chemother. 2012 Mar;67(3):541-50. doi: 10.1093/jac/dkr470. Epub 2011 Nov 13.

  PMID: 22083832 BACKGROUND

• Mertz D, Johnstone J, Loeb M. Does duration of perioperative antibiotic prophylaxis matter in cardiac surgery? A systematic review and meta-analysis. Ann Surg. 2011 Jul;254(1):48-54. doi: 10.1097/SLA.0b013e318214b7e4.

  PMID: 21412147 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefazolin; Vancomycin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

  Juravinski Hospital and Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded adjudication of the s-SSIs will be performed by a committee consisting of three members.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1\) cefazolin prophylaxis plus Prevena\*(\*diabetic and/or obese patients (BMI \>30kg/m2)) 2) cefazolin and vancomycin prophylaxis plus Prevena\*(\*diabetic and/or obese patients (BMI \>30kg/m2)), 3) cefazolin prophylaxis plus standard wound dressing, 4) cefazolin and vancomycin prophylaxis plus standard wound dressing.

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 18, 2018
• Study Start: March 5, 2018
• Primary Completion: April 27, 2023
• Study Completion: October 17, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)