Sternal Closure With STERNUMFIX in Patients With High Risk

Study Overview
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Brief Summary
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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.

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

Conditions
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Sternum Wound Infection, Nonunion of Fracture of Sternum

Intervention / Treatment
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* Device: Sternumfix
* Procedure: steel wire


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sternumfix<br>sternotomy closure with Sternumfix | Device: Sternumfix<br>* sternotomy closure with Sternumfix<br>|
| Active Comparator: Steel wire<br>sternotomy closure with steel wire | Procedure: steel wire<br>* sternotomy closure with steel wire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical device, sternal closure, sternotomy, dehiscence, sternal wound healing, randomized trial, steel wire