Clinical Trial: Sternal Closure With STERNUMFIX in Patients With High Risk

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Multicenter Controlled Study on the Safety and Efficacy of Sternal Closure With STERNUMFIX in Patients With High Risk

Brief Summary: The primary objective is to establish if the SternumFix System improves sternal closure. The study should test the hypothesis that in a high risk patient population with increased risk for the development of sternal wound complications SternumFix will reduce the incidence of sternal healing complications. The control group will be treated with wire cerclage, the standard method of sternal closure.

Detailed Summary:
Sponsor: Aesculap AG

Current Primary Outcome: cumulative three-months incidence of re-operation rates due to sternal instability or infection for patients with SternumFix in comparison to sternal fixation with wires in a high risk patient population [ Time Frame: within three months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse event rate. Postoperative chest pain. Length of postoperative hospital stay. Blood loss within the first 12 hours p.o. Duration of the sternal fixation. [ Time Frame: within 3 months ]

Original Secondary Outcome: Same as current

Information By: Aesculap AG

Dates:
Date Received: July 19, 2011
Date Started: June 2008
Date Completion:
Last Updated: April 13, 2015
Last Verified: April 2015