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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Assessment of STEELEX® Sternum Set effectiveness for sternal healing
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Assessment of STEELEX® Sternum Set effectiveness for sternal healing
时间窗: 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
次要结局
- Incidence of reoperations/readmission after surgery(during the 6-month ± 1 week study follow-up)
- Incidence of post-surgery sternal wound complications(at month 1 ± 1 week and at month 6 ± 1 week post-surgery.)
- Incidence of post-surgery sternal wound infections(at month 1 ± 1 week and at month 6 ± 1 week post-surgery.)
- Incidence of re-exploration for bleeding over study period(during the first 24-48 hours postoperatively, at hospital discharge (approximately 10 days after surgery), at month 1 ± 1 week)
- Rate of sternal dehiscence over time(at month 1 ± 1 week and at month 6 ± 1 week post-surgery.)
- Assessment of STEELEX® Sternum Set effectiveness for sternal healing(at month 6 ± 1 week post-surgery)
- Length of hospital stay after surgery(at hospital discharge (approximately 10 days after surgery))
- Progress of pain according to the Visual Analogue Scale (VAS) compared to baseline(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)(during the 6-month ± 1 week study follow-up.)
- Effectiveness of STEELEX® Electrode Set(at hospital discharge (approximately 10 days after surgery))
- Mean score of the intraoperative handling questions on STEELEX® Sternum Set and STEELEX® Electrode Set(intraoperatively)