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

NCT05439395 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 229

Last updated 2023-04-13

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Sternum Closure after Cardiac Surgery

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

Sponsors & Collaborators

  • B.Braun Surgical SA

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2022-10-01
Completion
2023-04-07

Countries

  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05439395 on ClinicalTrials.gov