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Evaluating Advantages of Prevena After Hip and Knee Arthroplasty

NCT01854138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2018-07-12

Study results available
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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.

Conditions

  • Infection of Total Hip Joint Prosthesis

Interventions

DEVICE

Prevena Incision Management System

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.

Sponsors & Collaborators

  • ProMedica Health System

    lead OTHER

Principal Investigators

  • Karl Beer, MD · ProMedica Health System

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-03-31
Completion
2015-04-30

Countries

  • United States

Study Locations

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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 NCT01854138 on ClinicalTrials.gov