Efficacy of the Dabir Surfaces Micropressure Overlay for Decubitus Ulcer Prevention During Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,627
- 试验地点
- 1
- 主要终点
- Number of patient developing new perioperative pressure ulcers
研究概览
简要总结
This is a systematic random sampling study of the effects of the Dabir Micropressure Overlay on perioperative pressure injuries during cardiac surgery.
详细描述
This is a simple pragmatic systematic quality improvement study aimed at real-world evaluation of a device claimed to reduce pressure ulcers in patients undergoing cardiac surgery.
Data acquisition will be based on systematic sampling of cardiac surgery operations based on odd and even calendar dates. On odd dates the Dabir micropressure overlay will be functional on the operating room tables. On even dates the Dabir micropressure overlay will not be functional on the operating room tables. Data on baseline characteristics, operative parameters, and primary and secondary endpoints will be gathered from STS and wound care sources, which are routinely collected for all patients. There will be no additional patient information and data collected specifically for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •All cases scheduled in the cardiac surgery OR suites at the CCF main campus.
排除标准
- •Patients who have had previous surgery within 5 days of enrollment in the study will excluded from analysis.
结局指标
主要结局
Number of patient developing new perioperative pressure ulcers
时间窗: 5 days from operation
New pressure ulcers, any stage
次要结局
- Pressure ulcer stage(5 day from operation)
- Number of wound care consultations(From date of surgery until 30 days or the date of hospital discharge or the date of death from any cause, whichever came first, assessed up to 3 months)
研究者
Eric Roselli, M. D.
Principal Investigator
The Cleveland Clinic