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PICS-Prevena

Official Title

Prevention of Infections in Cardiac Surgery (PICS) PREVENA Vanguard Study

Status

Ongoing

Overview

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

Study Design

Randomized 2×2 factorial cluster crossover study

Primary Endpoint

The primary outcome of the vanguard study is adherence to the wound management system (Prevena) as per protocol; adherence to the antibiotic regime as per protocol; and loss of followup.

The primary outcome of the eventual full trial is to determine the effects of dual antibiotic prophylaxis and of a negative-pressure wound management system (Prevena) on deep and/or organ-space sternal surgical site infections (s-SSI).

Number of Patients

6000

Number of Sites

2

Number of Countries

1

Study Period

2018-2020

Principal Investigator

Dominik Mertz, PJ Devereaux, Stuart Connolly, Andre Lamy, Richard Whitlock, Michael McGillion

Program Manager

Shirley Pettit

Research Coordinator

Ingrid Copland