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

Study Overview
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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.

Official Title
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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

Conditions
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Sternum Closure

Intervention / Treatment
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* Device: STEELEX® Sternum Set


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STEELEX®<br>STEELEX® Sternum Set in Patients undergoing cardiac surgery | Device: STEELEX® Sternum Set<br>* Sternal Closure with stainless steel suture (STEELEX®) in patients undergoing cardiac surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non resorbable suture, cardiac surgery