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

NCT06065800 | Completed

• 1 other identifier: AAG-O-H-2045
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sternum Closure

Keywords

non resorbable suture; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Assessment of STEELEX® Sternum Set effectiveness for sternal healing

  The primary variable will be the Sternal Instability Scale (SIS), based on a 4-point scale that is anchored by a grade of 0 that corresponds to a clinically stable sternum with no detectable motion or separation of the sternal edges and a grade 3 that corresponds to a completely separated sternum with marked increased motion or separation of the sternal edges

  at month 1 ± 1 week post-surgery

Secondary Outcomes (11)

• Assessment of STEELEX® Sternum Set effectiveness for sternal healing

  at month 6 ± 1 week post-surgery

• Rate of sternal dehiscence over time

  at month 1 ± 1 week and at month 6 ± 1 week post-surgery.

• Incidence of post-surgery sternal wound complications

  at month 1 ± 1 week and at month 6 ± 1 week post-surgery.

• Incidence of post-surgery sternal wound infections

  at month 1 ± 1 week and at month 6 ± 1 week post-surgery.

• Incidence of re-exploration for bleeding over study period

  during the first 24-48 hours postoperatively, at hospital discharge (approximately 10 days after surgery), at month 1 ± 1 week

Study Arms (1)

STEELEX®

STEELEX® Sternum Set in Patients undergoing cardiac surgery

Device: STEELEX® Sternum Set

Interventions

STEELEX® Sternum Set DEVICE

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

STEELEX®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing scheduled sternotomy for cardiac surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (1)

Department of Cardiovascular Surgery

Valencia, 46026, Spain

Location

Study Officials

• Juan Martinez León, Dr.

  Department of Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: October 4, 2023
• Study Start: May 17, 2023
• Primary Completion: November 13, 2024
• Study Completion: April 11, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)