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Prevention of Infections in Cardiac Surgery (PICS) Prevena Study

NCT03402945 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4107

Last updated 2025-02-28

No results posted yet for this study

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.

Conditions

  • Surgical Site Infections

Interventions

DEVICE

Prevena

Negative-Pressure Wound Management System

DRUG

Cefazolin

antibiotic

DRUG

Vancomycin

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.

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Dominik Mertz, MD,MSc · Juravinski Hospital and Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2023-04-27
Completion
2024-10-17

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03402945 on ClinicalTrials.gov