Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure

Study Overview
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Brief Summary
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The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure. The data from 2 clinics located in Germany and Spain participating in the OPTICABG as well as in the PREMIVALVE study will be used for assessment. Only patients receiving a complete or a partial sternotomy closed with Steelex® Sternum Set will be included in the analysis. OPTICABG patients were followed up 3 months after surgery and PREMIVALVE patients until 6 months after surgery. Adverse Events (AE) / Serious Adverse Events (SAE)(e.g. surgical site infection, sternum stability, stroke, myocardial infraction, death etc.) reported in both studies will be used for the STERCCAS analysis.

Official Title
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Multi Center, International, Single-arm, Retrospective, Observational Post Market Clinical Follow-Up (PMCF) Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure in Patients Undergoing Cardiac Surgery

Conditions
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Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis

Intervention / Treatment
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* Device: Sternum Closure after Cardiac Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OPTICABG study patients undergoing an elective, primary coronary artery bypass graft surgery (CABG) receiving a sternotomy, by whom the sternum was closed using Steelex® Sternum Set. PREMIVALVE study patients undergoing a cardiac valve replacement or reconstruction receiving a complete or partial sternotomy, by whom the sternum was closed using Steelex® Sternum Set. Eligible patients from the OPTICABG study and PREMIVALVE study who have provided their written informed consent Age ≥18 years Exclusion Criteria: OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.

Ages Eligible for Study
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Minimum Age: 18 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STEELEX<br>Steelex® Sternum Set for sternal closure | Device: Sternum Closure after Cardiac Surgery<br>* Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection | Combination of: Incidence of sternum instability Incidence of sternum dehiscence Incidence of superficial and deep sternal wound infection according to classification of Centers for Disease Control and Prevention (CDC) | up to 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sternum instability | Number of patients presenting with instability of the sternum after sternal closure with Steelex® Sternum Set | up to 6 months after surgery | 
| Incidence of sternum dehiscence | Number of patients presenting with dehiscence of the sternum after sternal closure with Steelex® Sternum Set | up to 6 months after surgery | 
| Incidence of superficial and deep sternal wound infection | Number of patients presenting with superficial and deep sternal wound infection according to CDC classification after sternal closure with Steelex® Sternum Set | up to 6 months after surgery | 
| Incidence of other cardiac and cerebral complications | Number of patients presenting with other cardiac and cerebral complications such as stroke, myocardial infarction, death, as well as mediastinitis after sternal closure with Steelex® Sternum Set | up to 6 months after surgery | 
| Incidence of suture related complications | Number of patients presenting with suture related complications (e.g. wire breakage) after sternal closure with Steelex® Sternum Set | up to 6 months after surgery | 
| Length of hospital stay | Number of days the patient has to stay in hospital | until discharge (approximately 10 days postoperative) | 
| Length of intensive care unit stay | Number of days the patient has to stay in intensive care unit after intervention | until discharge (approximately 10 days postoperative) | 
| Health Status measured with EQ-5D-5L Score | EQ-5D-5L is a Quality of Life Score introduced by the EuroQol Group. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Descriptive system comprises five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels (5L): no problems, slight problems, moderate problems, severe problems, extreme problems. Each answer results in a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. | up to 6 months after surgery | 
| Intraoperative handling of the Steelex® Sternum Set | the handling is examined using a survey, which will be answered and filled out prospectively and anonymously once by all involved cardiac surgeons | at time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Median Sternotomy, Partial Sternotomy, Coronary Artery Bypass Grafting (CABG), Cardiac Valve Replacement, Cardiac Valve Reconstruction