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

Aesculap AG229 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

229

Conditions

Coronary Artery Disease Cardiac Valve Insufficiency Aortic Valve Stenosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Robert Bosch KH Stuttgart

Stuttgart, Germany

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain

Outcomes

Primary Outcomes

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)

Time frame: up to 6 months after surgery

Secondary Outcomes

Incidence of sternum instability

Number of patients presenting with instability of the sternum after sternal closure with Steelex® Sternum Set

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: up to 6 months after surgery

Length of hospital stay

Number of days the patient has to stay in hospital

Time frame: 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

Time frame: 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'.

Time frame: 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

Time frame: at time of surgery