Sternal Closure With STERNUMFIX in Patients With High Risk

Phase 4

Terminated

• Conditions: Nonunion of Fracture of Sternum; Sternum Wound Infection
• Interventions: Device: Sternumfix; Procedure: steel wire

• Registration Number: NCT01408745
• Lead Sponsor: Aesculap AG

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 Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sternumfix	Sternumfix	sternotomy closure with Sternumfix
Steel wire	steel wire	sternotomy closure with steel wire

Primary Outcome Measures

Name	Time	Method
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	within three months

Secondary Outcome Measures

Name	Time	Method
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.	within 3 months

Trial Locations

Locations (4)

Kerckhoff Klinik; 🇩🇪 Bad Nauheim, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau; 🇩🇪 Bernau, Germany

University Hospital Zürich; 🇨🇭 Zürich, Switzerland