Prevention of Infections in Cardiac Surgery (PICS) Prevena Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

4107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2024-10-17

Brief Summary

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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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Detailed Description

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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.

Conditions

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Surgical Site Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Blinded adjudication of the s-SSIs will be performed by a committee consisting of three members.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Prevena

Intervention Type DEVICE

Negative-Pressure Wound Management System

Cefazolin

Intervention Type DRUG

antibiotic

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.

Group Type ACTIVE_COMPARATOR

Prevena

Intervention Type DEVICE

Negative-Pressure Wound Management System

Cefazolin

Intervention Type DRUG

antibiotic

Vancomycin

Intervention Type DRUG

antibiotic

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.

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

antibiotic

standard wound dressing

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

antibiotic

Vancomycin

Intervention Type DRUG

antibiotic

standard wound dressing

Intervention Type OTHER

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

Interventions

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Prevena

Negative-Pressure Wound Management System

Intervention Type DEVICE

Cefazolin

antibiotic

Intervention Type DRUG

Vancomycin

antibiotic

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Vancocin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No