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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
342
Prevena™ Incision Management System is used after sternotomy on the closed incision
Conventional sterile wound dressings are placed after sternotomy on the closed incision
Medizinische Universitat Graz
Graz, Austria
Clinical Research Center Salzburg GmbH
Salzburg, Austria
Medizinische Universitaet Wien, Universitätsklinik für Chirurgie
Vienna, Austria
Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.
The SSI rate (in %) was calculated for each treatment arm as follows: SSI rate = \[Number of Subjects who experienced SSI\] / \[Number of Subjects Analyzed\] \* 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event
Time frame: 30 ± 4 days
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Deutsches Herzzentrum Berlin
Berlin, Germany
Charité Berlin
Berlin, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Westfälische Wilhelms-Universität Münster
Münster, Germany
Klinikum Nürnberg
Nuremberg, Germany
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, Netherlands
Isala Klinieken
Zwolle, Overijssel, Netherlands
...and 3 more locations