An observational study in Sternum Closure, sponsored by Aesculap AG. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by Aesculap AG · Observational
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.
Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing scheduled sternotomy for cardiac surgery
Exclusion Criteria:
STEELEX® Sternum Set in Patients undergoing cardiac surgery
Device: STEELEX® Sternum Set
Sternal Closure with stainless steel suture (STEELEX®) in patients undergoing cardiac surgery
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
Time frame: at month 1 ± 1 week post-surgery
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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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
Time frame: 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.
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)
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.
Time frame: 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.
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
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.
Time frame: intraoperatively
Plan to share: No
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Aesculap AG