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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-17

Study Completion Date

2025-04-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Sternum Closure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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STEELEX®

STEELEX® Sternum Set in Patients undergoing cardiac surgery

STEELEX® Sternum Set

Intervention Type DEVICE

Sternal Closure with stainless steel suture (STEELEX®) in patients undergoing cardiac surgery

Interventions

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STEELEX® Sternum Set

Sternal Closure with stainless steel suture (STEELEX®) in patients undergoing cardiac surgery

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No