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Heart surgery patients watched: do new sternum closures heal well?

NCT ID NCT06065800

Knowledge-focused Sponsor: Aesculap AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a set of medical products (STEELEX® Sternum Set, BONE WAX®, and STEELEX® Electrode Set) work when used in routine heart surgery to close the breastbone. 150 adults having open-heart surgery were observed for one month after surgery. The main goal was to check if the breastbone healed properly and stayed stable. The study did not add any extra tests or treatments beyond normal care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

150 people

The number who actually took part.

Started

May 2023

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients undergoing scheduled sternotomy for cardiac surgery

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sternum closure

Contacts and locations

Locations

  • Department of Cardiovascular Surgery

    Valencia, 46026, Spain