CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 4,107 enrolled
Drug / intervention
Cefazolin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03402945
NCT03402945Phase 4Completed
CompareCT.gov

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

Population Health Research Institute·interventional·Posted Jan 18, 2018·Updated Feb 28, 2025

In Brief

A Phase 4 clinical trial evaluating Prevena, Cefazolin, and 2 other interventions for Surgical Site Infections. Completed, enrolled 4,107 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Site Infections
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJan 18, 2018
Enrollment StartMar 5, 2018
Primary CompletionApr 27, 2023
Study CompletionOct 17, 2024
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 8.5 years ago

Interventions

Prevenadevice

Negative-Pressure Wound Management System

Cefazolindrug

antibiotic

Vancomycindrug

antibiotic

standard wound dressingother

Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.