PICS-Prevena: Prevention of Infections in Cardiac Surgery (PICS) Prevena Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm 1 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
Negative-Pressure Wound Management System
Drug: Cefazolin
antibiotic
|
| Active Comparator: Arm 2 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
Negative-Pressure Wound Management System
Drug: Cefazolin
antibiotic
Drug: Vancomycin
antibiotic
Other Names:
|
| Active Comparator: Arm 3 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
antibiotic
Other: standard wound dressing
Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.
|
| Active Comparator: Arm 4 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
antibiotic
Drug: Vancomycin
antibiotic
Other Names:
Other: standard wound dressing
Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.
|
Outcome Measures
Primary Outcome Measures
- Adherence to the wound management system [Prevena or standard wound dressing applied after surgery as per protocol, assessed up to 90 days after surgery]
goal is >90%
- Adherence to the antibiotic regimen [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%
- Loss of follow-up [up to 90 days after surgery]
goal is <10%
Secondary Outcome Measures
- Deep incisional and organ/space sternal-surgical site infection (s-SSI) [up to 90 days after surgery]
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
- Wound dehiscence [up to 90 days after surgery]
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
- C. difficile infection [up to 90 days after surgery]
laboratory confirmed
- Mortality in patients with an active infection [up to 90 days after surgery]
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
- 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.]
length
- Pain on day 7 [Pain at Day 7 (+/- 1 day)]
Visual analog scale (VAS)
- Acute kidney injury [within 7 days of surgery]
Based on serum creatinine, following Acute Kidney Injury Network definition
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hamilton General Hospital | Hamilton | Ontario | Canada | L8L 2X2 |
| 2 | London Health Sciences Centre & Lawson Health Research Institute | London | Ontario | Canada | N6A 5A5 |
Sponsors and Collaborators
- Population Health Research Institute
Investigators
- Principal Investigator: Dominik Mertz, MD,MSc, Juravinski Hospital and Cancer Centre
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review. Erratum in: Can J Cardiol. 2013 Jul;29(7):889.
- 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.
- 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.
- PICS-PREVENA V1_20171106