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Sternal Closure With STERNUMFIX in Patients With High Risk

NCT01408745 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2015-04-14

No results posted yet for this study

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

DEVICE

Sternumfix

sternotomy closure with Sternumfix

PROCEDURE

steel wire

sternotomy closure with steel wire

Sponsors & Collaborators

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Roland Hetzer, Prof. · Direktor der Klinik für Herz-, Thorax- und Gefäßchirurgie des DHZB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-08-31
Completion
2012-11-30

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01408745 on ClinicalTrials.gov