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

NCT06065800 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-11-17

No results posted yet for this study

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

Interventions

DEVICE

STEELEX® Sternum Set

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

Sponsors & Collaborators

  • B.Braun Surgical SA

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Juan Martinez León, Dr. · Department of Cardiovascular Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-17
Primary Completion
2024-11-13
Completion
2025-04-11

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06065800 on ClinicalTrials.gov