Sternal Closure With STERNUMFIX in Patients With High Risk

Nonunion of Fracture of Sternum Clinical Trial

— STEPHIX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01408745
• Other study ID #: AAG-G-H-0802
• Status: Terminated
• Phase: Phase 4
• First received: July 19, 2011
• Last updated: April 13, 2015
• Start date: June 2008
• Est. completion date: November 2012

Study information

• Verified date: April 2015
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany:Regierungspräsidium Freiburg
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 166
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion:

• Patients undergoing elective cardiac surgery with a median sternotomy

• Age >18 years

• Male and female sex

• Informed consent

• Patients with high risk for sternal wound complications

Patients are designated as high risk patients if they have either:

• one or more major risk factors or

• four or more minor risk factors.

Major risk factors are:

• Obesity: BMI > 30.

• Diabetes: intake of oral anti-diabetic drugs and/or insulin at time of surgery.

• COPD: history of chronic coughing plus expectoration for at least 3 months by at least two consecutive years, plus evidence of restrictive pattern at spirometry.

• Planned BITA: bilateral use of thoracic artery

• Age > 75 years

Minor risk factors are:

• History of smoking;(minimum of 1 year of history of smoking)

• Hyperlipoproteinaemia (as stated in the patient data)

• Planned surgery is a CABG

• Patient is on dialysis

• Repeat sternotomy

• Left ventricular ejection fraction < 30% (as stated in the patient data)

• Male sex

Exclusion:

• Active infection

• Participation in a pharmaceutical clinical study or any trial with interfering endpoints within the last 30 days

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Ununited
• Nonunion of Fracture of Sternum
• Sternum Wound Infection
• Wound Infection

Intervention

Device:
• Sternumfix
sternotomy closure with Sternumfix

Procedure:
• steel wire
sternotomy closure with steel wire

Locations

Country	Name	City	State
Germany	Kerckhoff Klinik	Bad Nauheim
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau	Bernau
Switzerland	University Hospital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes