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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEELEX | Steelex® Sternum Set for sternal closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sternum Closure after Cardiac Surgery | Device | Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection | Combination of:
| up to 6 months after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving a partial or a complete sternotomy closed with Steelex Sternum Set participating either in the OPTICABG or PREMIVALVE study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Bosch KH Stuttgart | Stuttgart | 70376 | Germany | |||
| Hospital de la Santa Creu I Sant Pau |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| Barcelona |
| 08026 |
| Spain |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |