Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 489
- 试验地点
- 4
- 主要终点
- Post-operative hospital LOS
研究概览
简要总结
A descriptive comparative project will be conducted to determine if there is a difference in outcomes for adult patients requiring pericardial reconstruction using CorMatrix compared to Gentrix
详细描述
A descriptive, comparative project will be conducted utilizing a retrospective chart review on patients at Methodist Mansfield Medical Center(MMMC) undergoing cardiac surgery requiring pericardial repair between the dates of January 1, 2017 through December 31, 2022. The project will compare outcomes of a pre- and post-intervention following use of Gentrix ECM and the CorMatrix Extracellular Matrix(ECM) pericardial patch using information gathered from the patient's electronic health record (EHR). The main outcome measures of post-operative Length of Stay(LOS), all-cause unplanned readmission within 30 days, and significant pleural effusion requiring thoracentesis within 30-days and 60 days as well as long-term (12 months) patient outcomes.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have undergone a Coronary Artery Bypass Grafting(CABG) or valve repair/replacement surgery requiring pericardial reconstruction.
- •CABG or valve repair/replacement surgery must have been either elective or urgent status
排除标准
- •CABG or valve repair/replacement surgery classified as emergent status Surgery classified as redo-sternotomy
结局指标
主要结局
Post-operative hospital LOS
时间窗: 30 days
30-day all-cause unplanned readmissions after discharge * Significant pleural effusion requiring thoracentesis within 30 days of surgery * Significant pleural effusion requiring thoracentesis within 60 days of surgery
次要结局
未报告次要终点