CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 248 enrolled
Drug / intervention
Prevena Incision Management Systemdevice
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/NCT01854138
NCT01854138N/ACompleted
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Evaluating the Efficacy of the Prevena Incision Management System in Patients Undergoing Total Knee and Hip Arthroplasty

ProMedica Health System·interventional·Posted May 15, 2013·Updated Jul 12, 2018

In Brief

A clinical study evaluating Prevena Incision Management System for Infection of Total Hip Joint Prosthesis. Completed, enrolled 248 participants across 1 site.

Detailed Summary

Determine the extent to which application of the Prevena vacuum system to clean surgical incisions immediately following surgical procedure (total hip or total knee arthroplasty) will reduce the rates of: * readmission to hospital for surgical intervention due to wound complications * seroma * hematoma * infection compared to group of patients whose wounds were covered with traditional gauze dressings.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection of Total Hip Joint Prosthesis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2013
Enrollment StartJan 1, 2014
Primary CompletionMar 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.1 years ago

Interventions

Prevena Incision Management Systemdevice

Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.