NCT01408745

Sternal Closure With STERNUMFIX in Patients With High Risk

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Sternum Wound Infection
• Nonunion of Fracture of Sternum

Interventions

Type	Name	Description
DEVICE	Sternumfix	sternotomy closure with Sternumfix
PROCEDURE	steel wire	sternotomy closure with steel wire

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-08-01
• Completion: 2012-11-01
• First posted: 2011-08-03
• Last updated: 2015-04-14

Locations

4 sites across 2 countries: Germany, Switzerland