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Antibiotic

Antibiotics + Prevena Dressing for Surgical Site Infections (PICS-Prevena Trial)

Phase 4

Waitlist Available

Led By Dominik Mertz, MD,MSc

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pain at day 7 (+/- 1 day)

Awards & highlights

PICS-Prevena Trial Summary

This trial will test a new combination of antibiotics to see if it can reduce chest wound infections.

Who is the study for?

Adults over 18 who are undergoing open-heart surgery can join this trial. It's not for those already on antibiotics, with active infections, or previously in this study. People allergic to certain antibiotics or silver, which is used in one of the treatments being tested, or colonized with MRSA should not participate.Check my eligibility

What is being tested?

The study compares two different antibiotic prevention strategies and wound care methods after heart surgery. One group will receive a standard single antibiotic while another gets a combination of two. For wound care, some will get the usual dressing and others will try Prevena, a special negative-pressure system.See study design

What are the potential side effects?

Possible side effects may include skin reactions from dressings or Prevena system use; allergic reactions to Cefazolin or Vancomycin; and typical risks associated with taking antibiotics such as stomach upset.

PICS-Prevena Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pain at day 7 (+/- 1 day)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pain at day 7 (+/- 1 day)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pain at day 7 (+/- 1 day) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to the antibiotic regimen

Adherence to the wound management system

Loss of follow-up

Secondary outcome measures

Acute kidney injury

C. difficile infection

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

+4 more

PICS-Prevena Trial Design

4Treatment groups

Active Control

Group I: Arm 2Active Control3 Interventions

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 II: Arm 1Active Control2 Interventions

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 III: Arm 3Active Control2 Interventions

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 IV: Arm 4Active Control3 Interventions

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

675,805 Total Patients Enrolled

Dominik Mertz, MD,MScPrincipal InvestigatorJuravinski Hospital and Cancer Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks do individuals expose themselves to by participating in Arm 2?

"Arm 2 has been approved as a safe treatment, so it received the highest score of 3."

Answered by AI

In what circumstances is Arm 2 typically utilized?

"Arm 2 is a recommended therapy for various medical conditions like surgical prophylaxis, skin and subcutaneous tissue infections caused by susceptible bacteria, as well as clostridium difficile associated diarrhea."

Answered by AI

What is the current enrollment capacity of this clinical trial?

"Yes, the details on clinicaltrials.gov exhibit that this trial is recruiting participants presently. This study was initially posted March 5th 2018 and recently revised October 18th 2022. 4000 volunteers are being sought after from a single site."

Answered by AI

What purpose is this experiment attempting to fulfill?

"The purpose of this clinical trial, lasting approximately 90 days post-surgery, is to monitor adherence with the wound management system. Secondary objectives include tracking ICU and hospital stay duration, identifying instances of wound dehiscence through CDC/NHSN metrics and evaluating patient pain levels on day 7 using Visual Analog Scale (VAS)."

Answered by AI

What other research efforts have been undertaken related to Arm 2?

"Presently, the number of active clinical trials for Arm 2 stands at 68 with 7 in Phase 3. Of these studies, 354 are located across multiple sites and several are situated within Jupiter, Florida."

Answered by AI

Are there still openings for participants in this experimentation?

"Affirmative. The information available on clinicaltrials.gov indicates that this research is actively seeking volunteers, having been posted on March 5th 2018 and recently updated as of October 18th 2022. This study intends to recruit 4000 participants from 1 site.."

Answered by AI

Recent research and studies

Journal of Cardiothoracic and Vascular AnesthesiaJournal

Epidemiology of Deep Sternal Wound Infection in Cardiac Surgery

Filsoufi, Farzan, Javier G. Castillo, Parwis B. Rahmanian, Stafford R. Broumand, George Silvay, Alain Carpentier, and David H. Adams. 2009. “Epidemiology of Deep Sternal Wound Infection in Cardiac Surgery”. Journal of Cardiothoracic and Vascular Anesthesia. Elsevier BV. doi:10.1053/j.jvca.2009.02.007.

Canadian Journal of CardiologyJournal

Randomized Cluster Crossover Trials for Reliable, Efficient, Comparative Effectiveness Testing: Design of the Prevention of Arrhythmia Device Infection Trial (PADIT)

Connolly, Stuart J., Francois Philippon, Yves Longtin, Amparo Casanova, David H. Birnie, Derek V. Exner, Paul Dorian, Ratika Prakash, Marco Alings, and Andrew D. Krahn. 2013. “Randomized Cluster Crossover Trials for Reliable, Efficient, Comparative Effectiveness Testing: Design of the Prevention of Arrhythmia Device Infection Trial (PADIT)”. Canadian Journal of Cardiology. Elsevier BV. doi:10.1016/j.cjca.2013.01.020.

The Annals of Thoracic SurgeryJournal

The Society of Thoracic Surgeons Practice Guideline Series: Antibiotic Prophylaxis in Cardiac Surgery, Part I: Duration

Edwards, Fred H., Richard M. Engelman, Peter Houck, David M. Shahian, and Charles R. Bridges. 2006. “The Society of Thoracic Surgeons Practice Guideline Series: Antibiotic Prophylaxis in Cardiac Surgery, Part I: Duration”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2005.06.034.

Journal of Antimicrobial ChemotherapyJournal