Sternum ClosureSTEADYNCT06065800
STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery
An observational study of Sternum Closure, run by Aesculap AG at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sternum Closure
- What is being tested?
- STEELEX® Sternum Set
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 17 May 2023to 11 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing scheduled sternotomy for cardiac surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Performance of STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery. A Prospective, Mono-center, Single-arm, Observational Study in Daily Practice
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
- Being tested
- STEELEX® Sternum Set
- Keywords
- non resorbable suture, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEELEX® Sternum SetDevice
Sternal Closure with stainless steel suture (STEELEX®) in patients undergoing cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| STEELEX® | STEELEX® Sternum Set in Patients undergoing cardiac surgery Receives: Device: STEELEX® Sternum Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at month 1 ± 1 week post-surgery
Secondary outcomes (11)
Assessment of STEELEX® Sternum Set effectiveness for sternal healing
The Sternal Instability Scale (SIS) is a clinical physical assessment tool that aims to assess the stability of the sternum and assign a corresponding grade to the findings of examination. It is 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 measured at 6 months postoperative
Measured: at month 6 ± 1 week post-surgery
Rate of sternal dehiscence over time
Frequency of sternal dehiscence (classified in four types according to the deepness and in two sub-groups according to the vertical extension based on the inferior insertion of the pectoralis major muscle).
Measured: at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
Incidence of post-surgery sternal wound complications
The incidence of post-surgery sternal wound complications at hospital discharge, at month 1 ± 1 week and month 6 ± 1 week post-surgery. Frequency of patients with sternal wound complications at hospital discharge, at month 1 ± 1 week and month 6 ± 1 week post-surgery.
Measured: at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
Incidence of post-surgery sternal wound infections
The incidence of post-surgery wound infections during the 6-month ± 1 week study follow-up. Frequency of wound infections (superficial sternal wound infections [SSWI], or deep sternal wound infections [DSWI]) during the 6-month ± 1 week study follow-up.
Measured: at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
Incidence of re-exploration for bleeding over study period
The incidence of re-exploration for bleeding during the 24-48h post-operation, at hospital discharge and 1-month ± 1 week of study follow-up. Frequency of re-exploration for bleeding until 1-month ± 1 week of study follow-up after surgery.
Measured: during the first 24-48 hours postoperatively, at hospital discharge (approximately 10 days after surgery), at month 1 ± 1 week
Incidence of reoperations/readmission after surgery
The incidence of reoperations/readmission after surgery during the 6-month ± 1 week study follow-up. Frequency of reoperation/readmission after surgery during the 6-month ± 1 week study follow-up.
Measured: during the 6-month ± 1 week study follow-up
Length of hospital stay after surgery
Calculated number of days between surgery and discharge of the patient from hospital
Measured: at hospital discharge (approximately 10 days after surgery)
Progress of pain according to the Visual Analogue Scale (VAS) compared to baseline
The patient's self assessment of pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". The value is measured in [mm] with a ruler and documented in whole numbers.
Measured: preoperatively (baseline), at hospital discharge (approximately 10 days after surgery), at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
Rate of adverse device effects (ADEs)
The safety profile according to adverse device effects (ADEs) reported after surgery during the 6-month ± 1 week study follow-up. Frequencies of patients with ADEs reported during the 6-month ± 1 week study follow-up after surgery.
Measured: during the 6-month ± 1 week study follow-up.
Effectiveness of STEELEX® Electrode Set
The assessment of the STEELEX® Electrode Set effectiveness through the fixation ability of the electrode to the myocardium prior to removal. Percentage of patients with positive or negative myocardial stimulation at hospital discharge.
Measured: at hospital discharge (approximately 10 days after surgery)
Mean score of the intraoperative handling questions on STEELEX® Sternum Set and STEELEX® Electrode Set
The assessment of the STEELEX® Sternum Set and STEELEX® Electrode Set intraoperative handling through the physician opinion after surgery: Handling of STEELEX® Sternum Set is assessed in five dimensions (on a descending scale from excellent = 5 points to poor = 1 point) in five categories (Knot security, Tensile strength, Needle strength, Passage / Penetration of the needle through the bone, Quality of the connection between the needle and the thread). Handling of STEELEX® Electrode Set is assessed in five dimensions (on a descending scale from excellent = 5 points to poor = 1 point) in four categories (Wire placement in the myocardium, Straight break-off needle connection to the patient cable, Removal of STEELEX® Electrode set of the patient, Tensile strength) The points are added to a handling score ranging from a maximum of 45 to a minimum of 9 points.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start17 May 2023
- Primary completion13 Nov 2024
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sternum ClosureStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Juan Martinez León, Dr., Principal investigator, Department of Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065800
- Sponsor's protocol ID
- AAG-O-H-2045
- Acronym
- STEADY
- Status last verified
- Nov 2025
- First submitted
- 24 Aug 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Performance of STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery. A Prospective, Mono-center, Single-arm, Observational Study in Daily Practice
- ClinicalTrials.gov ID
- NCT06065800
- Acronym / sponsor ID
- STEADY / AAG-O-H-2045
- Conditions
- Sternum Closure
- Keywords
- non resorbable suture, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 17 May 2023 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEELEX® | – | Device: STEELEX® Sternum SetSTEELEX® Sternum Set in Patients undergoing cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing scheduled sternotomy for cardiac surgery
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEELEX® Sternum SetSternal Closure with stainless steel suture (STEELEX®) in patients undergoing cardiac surgery | Device | STEELEX® |
Primary outcome
Assessment of STEELEX® Sternum Set effectiveness for sternal healing
Time frame: at month 1 ± 1 week post-surgery
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
11 secondary outcomes
Assessment of STEELEX® Sternum Set effectiveness for sternal healing
Time frame: at month 6 ± 1 week post-surgery
Rate of sternal dehiscence over time
Time frame: at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
Incidence of post-surgery sternal wound complications
Time frame: at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
Incidence of post-surgery sternal wound infections
Time frame: at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
Incidence of re-exploration for bleeding over study period
Time frame: during the first 24-48 hours postoperatively, at hospital discharge (approximately 10 days after surgery), at month 1 ± 1 week
Incidence of reoperations/readmission after surgery
Time frame: during the 6-month ± 1 week study follow-up
Length of hospital stay after surgery
Time frame: at hospital discharge (approximately 10 days after surgery)
Progress of pain according to the Visual Analogue Scale (VAS) compared to baseline
Time frame: preoperatively (baseline), at hospital discharge (approximately 10 days after surgery), at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
Rate of adverse device effects (ADEs)
Time frame: during the 6-month ± 1 week study follow-up.
Effectiveness of STEELEX® Electrode Set
Time frame: at hospital discharge (approximately 10 days after surgery)
Mean score of the intraoperative handling questions on STEELEX® Sternum Set and STEELEX® Electrode Set
Time frame: intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Sternum Closure
Active, not recruitingObservational study
Sternal Closure in High-BMI Patients: Cable vs Wire
Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Martinez León, Dr. principal investigator
Department of Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sternum Closure, run by Aesculap AG at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of STEELEX® Sternum Set effectiveness for sternal healing (time frame: at month 1 ± 1 week post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.