NCT02195310

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Prevena™ IMS is intended to manage the environment of closed surgically incision and surrounding intact skin for patients with an increased risk for developing post-operative complications such as infection.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 Prevena™ IMS is a small portable device, which consists of a mild vacuum unit that delivers negative pressure and a dressing that is intended for use over closed incisions after surgery. It is used for a minimum of 4 days up to a maximum of 7 days. This system is commercially available and has a CE mark, which means that it is approved for the use on the European market. It is intended to be applied immediately post sternotomy surgery on a closed clean incision. The results of this study could contribute to a better and faster healing of the incision. The study is conducted in The Netherlands, Germany and Austria.

Conditions

• Surgical Site Occurences After Sternotomy
• Wound Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-11-12
• Primary completion: 2016-08-15
• Completion: 2016-10-17
• First posted: 2014-07-21
• Last updated: 2024-10-02
• Results posted: 2019-08-05

Locations

13 sites across 3 countries: Austria, Germany, Netherlands