Back to resultsPrevention of Infections in Cardiac Surgery (PICS) Prevena Study (PICS-Prevena)
Primary Purpose
Surgical Site Infections
Status
Active
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Prevena
Cefazolin
Vancomycin
standard wound dressing
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infections focused on measuring negative pressure wound management system, open-heart surgery, antibiotic prophylaxis, surgical site infection
Eligibility Criteria
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
Sites / Locations
- Hamilton General Hospital
- London Health Sciences Centre & Lawson Health Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
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
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.
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.
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.
Outcomes
Primary Outcome Measures
Adherence to the wound management system
goal is >90%
Adherence to the antibiotic regimen
goal is >90%
Loss of follow-up
goal is <10%
Secondary Outcome Measures
Deep incisional and organ/space sternal-surgical site infection (s-SSI)
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
Wound dehiscence
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
C. difficile infection
laboratory confirmed
Mortality in patients with an active infection
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
ICU (Intensive Care Unit) and hospital stay
length
Pain on day 7
Visual analog scale (VAS)
Acute kidney injury
Based on serum creatinine, following Acute Kidney Injury Network definition
Full Information
NCT ID
NCT03402945
First Posted
January 8, 2018
Last Updated
October 23, 2023
Sponsor
Population Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03402945
Brief Title
Prevention of Infections in Cardiac Surgery (PICS) Prevena Study
Acronym
PICS-Prevena
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
April 27, 2023 (Actual)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infections
Keywords
negative pressure wound management system, open-heart surgery, antibiotic prophylaxis, surgical site infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Blinded adjudication of the s-SSIs will be performed by a committee consisting of three members.
Allocation
Randomized
Enrollment
4107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm 4
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Prevena
Intervention Description
Negative-Pressure Wound Management System
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
antibiotic
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancocin
Intervention Description
antibiotic
Intervention Type
Other
Intervention Name(s)
standard wound dressing
Intervention Description
Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.
Primary Outcome Measure Information:
Title
Adherence to the wound management system
Description
goal is >90%
Time Frame
Prevena or standard wound dressing applied after surgery as per protocol, assessed up to 90 days after surgery
Title
Adherence to the antibiotic regimen
Description
goal is >90%
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.
Title
Loss of follow-up
Description
goal is <10%
Time Frame
up to 90 days after surgery
Secondary Outcome Measure Information:
Title
Deep incisional and organ/space sternal-surgical site infection (s-SSI)
Description
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
Time Frame
up to 90 days after surgery
Title
Wound dehiscence
Description
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
Time Frame
up to 90 days after surgery
Title
C. difficile infection
Description
laboratory confirmed
Time Frame
up to 90 days after surgery
Title
Mortality in patients with an active infection
Description
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
Time Frame
up to 90 days after surgery
Title
ICU (Intensive Care Unit) and hospital stay
Description
length
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.
Title
Pain on day 7
Description
Visual analog scale (VAS)
Time Frame
Pain at Day 7 (+/- 1 day)
Title
Acute kidney injury
Description
Based on serum creatinine, following Acute Kidney Injury Network definition
Time Frame
within 7 days of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Mertz, MD,MSc
Organizational Affiliation
Juravinski Hospital and Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
London Health Sciences Centre & Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23702356
Citation
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. Erratum In: Can J Cardiol. 2013 Jul;29(7):889.
Results Reference
background
PubMed Identifier
26782707
Citation
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.
Results Reference
background
PubMed Identifier
16368422
Citation
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.
Results Reference
background
PubMed Identifier
19376733
Citation
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.
Results Reference
result
PubMed Identifier
22083832
Citation
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.
Results Reference
result
PubMed Identifier
21412147
Citation
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.
Results Reference
result
Learn more about this trial
Prevention of Infections in Cardiac Surgery (PICS) Prevena Study
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