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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 main objective of this vanguard study is to test the feasibility of the study design.  The primary goal of the eventual full trial is to determine the effects of dual antibiotic prophylaxis and of a negative-pressure wound management system (PREVENA) on sternal surgical site infections in patients undergoing cardiac surgery.

Number of Patients

4000

Number of Sites

2

Number of Countries

1

Study Period

2018-2020

Principal Investigator

Dominik Mertz

Program Manager

Shirley Pettit

Research Coordinator

Ingrid Copland