← Back to Search

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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal 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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to the antibiotic regimen

Adherence to the wound management system

Loss of follow-up

Secondary study objectives

Acute kidney injury

C. difficile infection

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

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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