Clinical trial NCT06065800: STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sternum Closure
Keywords: non resorbable suture
cardiac surgery
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2023-10-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing scheduled sternotomy for cardiac surgery

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of STEELEX® Sternum Set effectiveness for sternal healing
timeFrame: at month 1 ± 1 week post-surgery
Secondary outcomes:
measure: Assessment of STEELEX® Sternum Set effectiveness for sternal healing
timeFrame: at month 6 ± 1 week post-surgery
measure: Rate of sternal dehiscence over time
timeFrame: at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
measure: Incidence of post-surgery sternal wound complications
timeFrame: at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
measure: Incidence of post-surgery sternal wound infections
timeFrame: at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
measure: Incidence of re-exploration for bleeding over study period
timeFrame: during the first 24-48 hours postoperatively, at hospital discharge (approximately 10 days after surgery), at month 1 ± 1 week
measure: Incidence of reoperations/readmission after surgery
timeFrame: during the 6-month ± 1 week study follow-up
measure: Length of hospital stay after surgery
timeFrame: at hospital discharge (approximately 10 days after surgery)
measure: Progress of pain according to the Visual Analogue Scale (VAS) compared to baseline
timeFrame: preoperatively (baseline), at hospital discharge (approximately 10 days after surgery), at month 1 ± 1 week and at month 6 ± 1 week post-surgery.
measure: Rate of adverse device effects (ADEs)
timeFrame: during the 6-month ± 1 week study follow-up.
measure: Effectiveness of STEELEX® Electrode Set
timeFrame: at hospital discharge (approximately 10 days after surgery)
measure: Mean score of the intraoperative handling questions on STEELEX® Sternum Set and STEELEX® Electrode Set
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Department of Cardiovascular Surgery
Study officials:
affiliation: Department of Cardiovascular Surgery
name: Juan Martinez León, Dr.
role: PRINCIPAL_INVESTIGATOR
References: