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The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.

NCT02195310 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2024-10-02

Study results available
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Summary

The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy). The subjects targetted for the study are at high risk for surgical complications (like infections) around the environment of the incision.

The study is conducted in The Netherlands, Germany and Austria.

Conditions

  • Surgical Site Occurences After Sternotomy
  • Wound Infection

Interventions

DEVICE

Prevena™ Incision Management System

Prevena™ Incision Management System is used after sternotomy on the closed incision

DEVICE

Conventional sterile wound dressings

Conventional sterile wound dressings are placed after sternotomy on the closed incision

Sponsors & Collaborators

  • KCI Europe Holding B.V.

    collaborator INDUSTRY

  • 3M

    collaborator INDUSTRY

  • Solventum US LLC

    lead INDUSTRY

Principal Investigators

  • Thanasie Markou, MD, PhD · Isala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-12
Primary Completion
2016-08-15
Completion
2016-10-17

Countries

  • Austria
  • Germany
  • Netherlands

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 NCT02195310 on ClinicalTrials.gov