Surgical Site InfectionsPhase 4PICS-PrevenaNCT03402945

Prevention of Infections in Cardiac Surgery (PICS) Prevena Study

A Phase 4 study testing Prevena, Cefazolin and Vancomycin in people with Surgical Site Infections, run by Population Health Research Institute at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgical Site Infections
What is being tested?: Prevena, Cefazolin and Vancomycin
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,107 participants
Where: 2 sitesCanada
Study dates: 5 Mar 2018to 17 Oct 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
London Health Sciences Centre & Lawson Health Research Institute
London, Ontario, N6A 5A5

Other trials in Canada

About this study

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

Read the 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.

Conditions: Surgical Site Infections
Being tested: Prevena, Cefazolin, Vancomycin, standard wound dressing
Keywords: negative pressure wound management system, open-heart surgery, antibiotic prophylaxis, surgical site infection
Medical subject headings: Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrevenaDevice
Negative-Pressure Wound Management System
CefazolinDrug
antibiotic
VancomycinDrug
Also called Vancocin
antibiotic
standard wound dressingOther
Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.

Study groups in NCT03402945
Study group	Role	What they receive
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 Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Cefazolin; Drug: Vancomycin; Other: standard wound dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

Adherence to the wound management system
goal is >90%
Measured: 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%
Measured: 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%
Measured: up to 90 days after surgery

Secondary outcomes (7)

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
Measured: up to 90 days after surgery
Wound dehiscence
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
Measured: up to 90 days after surgery
C. difficile infection
laboratory confirmed
Measured: up to 90 days after surgery
Mortality in patients with an active infection
using standardized CDC/NHSN (Centre for Disease Control and Prevention/National Healthcare Safety Network) definitions
Measured: up to 90 days after surgery
ICU (Intensive Care Unit) and hospital stay
length
Measured: 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.
Pain on day 7
Visual analog scale (VAS)
Measured: Pain at Day 7 (+/- 1 day)
Acute kidney injury
Based on serum creatinine, following Acute Kidney Injury Network definition
Measured: within 7 days of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 201817 Oct 2024

First posted18 Jan 2018
Study start5 Mar 2018
Primary completion27 Apr 2023
Study completion17 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 4,107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03402945
Sponsor's protocol ID: PICS-PREVENA V1_20171106
Acronym: PICS-Prevena
Status last verified: Feb 2025
First submitted: 8 Jan 2018
Last updated: 28 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 23702356
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.
PubMed 26782707
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.
PubMed 16368422
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.
PubMed 19376733
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.
PubMed 22083832
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.
PubMed 21412147

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgical Site Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03402945
Acronym / sponsor ID: PICS-Prevena / PICS-PREVENA V1_20171106
Conditions: Surgical Site Infections
Keywords: negative pressure wound management system, open-heart surgery, antibiotic prophylaxis, surgical site infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,107 participants (actual)
Lead sponsor: Population Health Research InstituteUniversity, hospital or other
Study start: 5 Mar 2018 (actual)
Primary completion: 27 Apr 2023 (actual)
Study completion: 17 Oct 2024 (actual)
First posted: 18 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 4
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.

Arm	Type	Receives
Arm 1	Active comparator	Device: Prevena, Drug: Cefazolincefazolin 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 2	Active comparator	Device: Prevena, Drug: Cefazolin, Drug: Vancomycincefazolin 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 3	Active comparator	Drug: Cefazolin, Other: standard wound dressingcefazolin 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 4	Active comparator	Drug: Cefazolin, Drug: Vancomycin, Other: standard wound dressingcefazolin 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrevenaNegative-Pressure Wound Management System	Device	Arm 1, Arm 2
Cefazolinantibiotic	Drug	Arm 1, Arm 2, Arm 3, Arm 4
VancomycinAlso: Vancocinantibiotic	Drug	Arm 2, Arm 4
standard wound dressingAny non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.	Other	Arm 3, Arm 4

Primary outcome

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%
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%
Loss of follow-up
Time frame: up to 90 days after surgery
goal is <10%

7 secondary outcomes

Deep incisional and organ/space sternal-surgical site infection (s-SSI)
Time frame: up to 90 days after surgery
Wound dehiscence
Time frame: up to 90 days after surgery
C. difficile infection
Time frame: up to 90 days after surgery
Mortality in patients with an active infection
Time frame: up to 90 days after surgery
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.
Pain on day 7
Time frame: Pain at Day 7 (+/- 1 day)
Acute kidney injury
Time frame: within 7 days of surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Background: PubMed 23702356Connolly 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.
Background: PubMed 26782707Mertz 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.
Background: PubMed 16368422Edwards 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 publication: PubMed 19376733Filsoufi 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 publication: PubMed 22083832Lador 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 publication: PubMed 21412147Mertz 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.
Individual participant dataSharing planned: No

Related trials for Surgical Site Infections

RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)
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The Mepilex Cesarean Delivery Trial / MEPIDEL
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dominik Mertz, MD,MSc principal investigator

Juravinski Hospital and Cancer Centre

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prevena, Cefazolin and Vancomycin in people with Surgical Site Infections, run by Population Health Research Institute at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03402945, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.