Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
- Conditions
- Coronary Artery DiseaseCardiac Valve InsufficiencyAortic Valve Stenosis
- Interventions
- Device: Sternum Closure after Cardiac Surgery
- Registration Number
- NCT05439395
- Lead Sponsor
- Aesculap AG
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
- 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
- OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description STEELEX Sternum Closure after Cardiac Surgery Steelex® Sternum Set for sternal closure
- Primary Outcome Measures
Name Time Method Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection up to 6 months after surgery 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)
- Secondary Outcome Measures
Name Time Method Incidence of sternum instability up to 6 months after surgery Number of patients presenting with instability of the sternum after sternal closure with Steelex® Sternum Set
Incidence of superficial and deep sternal wound infection up to 6 months after surgery Number of patients presenting with superficial and deep sternal wound infection according to CDC classification after sternal closure with Steelex® Sternum Set
Incidence of other cardiac and cerebral complications up to 6 months after surgery 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
Length of hospital stay until discharge (approximately 10 days postoperative) Number of days the patient has to stay in hospital
Length of intensive care unit stay until discharge (approximately 10 days postoperative) Number of days the patient has to stay in intensive care unit after intervention
Health Status measured with EQ-5D-5L Score up to 6 months after surgery 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'.Intraoperative handling of the Steelex® Sternum Set at time of surgery the handling is examined using a survey, which will be answered and filled out prospectively and anonymously once by all involved cardiac surgeons
Incidence of sternum dehiscence up to 6 months after surgery Number of patients presenting with dehiscence of the sternum after sternal closure with Steelex® Sternum Set
Incidence of suture related complications up to 6 months after surgery Number of patients presenting with suture related complications (e.g. wire breakage) after sternal closure with Steelex® Sternum Set
Trial Locations
- Locations (2)
Hospital de la Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Robert Bosch KH Stuttgart
🇩🇪Stuttgart, Germany