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

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.

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