Multi Center, International, Single-arm, Retrospective, Observational Post Market Clinical Follow-Up (PMCF) Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 229
- 试验地点
- 2
- 主要终点
- Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection
研究概览
简要总结
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure. The data from 2 clinics located in Germany and Spain participating in the "OPTICABG" as well as in the "PREMIVALVE" study will be used for assessment. Only patients receiving a complete or a partial sternotomy closed with Steelex® Sternum Set will be included in the analysis. "OPTICABG" patients were followed up 3 months after surgery and "PREMIVALVE" patients until 6 months after surgery. Adverse Events (AE) / Serious Adverse Events (SAE)(e.g. surgical site infection, sternum stability, stroke, myocardial infraction, death etc.) reported in both studies will be used for the STERCCAS analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •OPTICABG study patients undergoing an elective, primary coronary artery bypass graft surgery (CABG) receiving a sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
- •PREMIVALVE study patients undergoing a cardiac valve replacement or reconstruction receiving a complete or partial sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
- •Eligible patients from the OPTICABG study and PREMIVALVE study who have provided their written informed consent
- •Age ≥18 years
排除标准
- •OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.
结局指标
主要结局
Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection
时间窗: up to 6 months after surgery
Combination of: * Incidence of sternum instability * Incidence of sternum dehiscence * Incidence of superficial and deep sternal wound infection according to classification of Centers for Disease Control and Prevention (CDC)
次要结局
- Incidence of sternum instability(up to 6 months after surgery)
- Incidence of superficial and deep sternal wound infection(up to 6 months after surgery)
- Incidence of other cardiac and cerebral complications(up to 6 months after surgery)
- Length of hospital stay(until discharge (approximately 10 days postoperative))
- Length of intensive care unit stay(until discharge (approximately 10 days postoperative))
- Health Status measured with EQ-5D-5L Score(up to 6 months after surgery)
- Intraoperative handling of the Steelex® Sternum Set(at time of surgery)
- Incidence of sternum dehiscence(up to 6 months after surgery)
- Incidence of suture related complications(up to 6 months after surgery)