NCT05439395

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

June 22, 2022

Last Update Submit

April 12, 2023

Conditions

Coronary Artery DiseaseCardiac Valve InsufficiencyAortic Valve Stenosis

Keywords

Median SternotomyPartial SternotomyCoronary Artery Bypass Grafting (CABG)Cardiac Valve ReplacementCardiac Valve Reconstruction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Incidence of sternum instability

    up to 6 months after surgery

  • Incidence of sternum dehiscence

    up to 6 months after surgery

  • Incidence of superficial and deep sternal wound infection

    up to 6 months after surgery

  • Incidence of other cardiac and cerebral complications

    up to 6 months after surgery

  • Incidence of suture related complications

    up to 6 months after surgery

  • +4 more secondary outcomes

Study Arms (1)

STEELEX

Steelex® Sternum Set for sternal closure

Device: Sternum Closure after Cardiac Surgery

Interventions

Sternum Closure after Cardiac SurgeryDEVICE

Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.

STEELEX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Robert Bosch KH Stuttgart

Stuttgart, 70376, Germany

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, 08026, Spain

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 30, 2022

Study Start

May 18, 2022

Primary Completion

October 1, 2022

Study Completion

April 7, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)DE(1)