Status:
TERMINATED
Sternal Closure With STERNUMFIX in Patients With High Risk
Lead Sponsor:
Aesculap AG
Conditions:
Sternum Wound Infection
Nonunion of Fracture of Sternum
Eligibility:
All Genders
Phase:
PHASE4
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 develop...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT01408745
Start Date
June 1 2008
End Date
November 1 2012
Last Update
April 14 2015
Active Locations (4)
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1
Kerckhoff Klinik
Bad Nauheim, Germany, 31231
2
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
3
Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
Bernau, Germany, 16321
4
University Hospital Zürich
Zurich, Switzerland, 8091