Status:
COMPLETED
STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Sternum Closure
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the study is to assess the effectiveness and performance of using STEELEX® Sternum Set, BONE WAX® and STEELEX® Electrode Set in patients undergoing cardiac surgery. The primary endpoint is ...
Eligibility Criteria
Inclusion
- Male or female patients.
- Age ≥ 18 years.
- Scheduled sternotomy within the next 3 days.
- Use of STEELEX® Sternum Set + Bone Wax® for sternotomy following routine clinical practice
- Use of STEELEX® Electrode Set in temporary epicardial cardiac pacing during the postoperative phase of open-heart surgery in combination with an external pacemaker following routine clinical practice.
- Written Informed Consent form.
Exclusion
- Participation or planned participation in any clinical trial before study follow-up is completed.
- Pregnancy and/or breastfeeding.
- Patient undergoing emergency surgery.
- Patients taking medical consumption that might affect sternal healing (based on investigator's own clinical criteria)
- Patient with any hypersensitivity or allergy to the components of the medical device.
- Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
- Use of STEELEX® Electrode Set in permanent cardiac pacing or for permanent monitoring.
Key Trial Info
Start Date :
May 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 11 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06065800
Start Date
May 17 2023
End Date
April 11 2025
Last Update
November 17 2025
Active Locations (1)
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1
Department of Cardiovascular Surgery
Valencia, Spain, 46026