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

Coronary Artery Disease Clinical Trial

— STERCCAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05439395
• Other study ID #: AAG-O-H-2028
• Status: Completed
• Start date: May 18, 2022
• Est. completion date: April 7, 2023

Study information

• Verified date: April 2023
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: April 7, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Coronary Artery Disease

Intervention

Device:
• Sternum Closure after Cardiac Surgery
Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.

Locations

Country	Name	City	State
Germany	Robert Bosch KH Stuttgart	Stuttgart
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of hospital stay	Number of days the patient has to stay in hospital	until discharge (approximately 10 days postoperative)
Secondary	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)
Secondary	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
Secondary	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