STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery (STEADY)

Aesculap

Status

Completed

Conditions

Sternum Closure

Treatments

Device: STEELEX® Sternum Set

Study type

Observational

Funder types

Industry

Identifiers

NCT06065800

AAG-O-H-2045

Details and patient eligibility

About

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 the assessment of STEELEX® Sternum Set effectiveness for sternal healing at month 1 ± 1 week post-surgery. This study is designed as a prospective, non-interventional, single center, Post Market Clinical Follow-Up cohort study.

The products under investigation will be used in routine clinical practice and according to the instructions of use. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied, and all study visits will coincide with those that will be scheduled for routine follow-up.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.