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

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Aortic Valve Stenosis; Cardiac Valve Insufficiency
• Intervention / Treatment: Device: Sternum Closure after Cardiac Surgery

• Study Type: Observational
• Enrollment (Actual): 229

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70376
    • Robert Bosch KH Stuttgart
• Spain
  • Barcelona, Spain, 08026
    • Hospital De La Santa Creu I Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving a partial or a complete sternotomy closed with Steelex Sternum Set participating either in the OPTICABG or PREMIVALVE study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STEELEX; Steelex® Sternum Set for sternal closure	Device: Sternum Closure after Cardiac Surgery; Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): April 7, 2023

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Bypass Grafting (CABG); Median Sternotomy; Partial Sternotomy; Cardiac Valve Replacement; Cardiac Valve Reconstruction
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Coronary Artery Disease; Aortic Valve Stenosis
• Other Study ID Numbers: AAG-O-H-2028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No