Sternal Closure With STERNUMFIX in Patients With High Risk (STEPHIX)

Aesculap

Status and phase: Terminated; Phase 4

Conditions: Nonunion of Fracture of Sternum; Sternum Wound Infection

Treatments: Procedure: steel wire; Device: Sternumfix

Study type: Interventional

Funder types: Industry

Identifiers

NCT01408745

AAG-G-H-0802

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups

Sternumfix

Experimental group

Description:

sternotomy closure with Sternumfix

Treatment:

Device: Sternumfix

Steel wire

Active Comparator group

Description:

sternotomy closure with steel wire

Treatment:

Procedure: steel wire