NCT01647178已完成不适用
The Influence of the TORQ Sternal Closure Assistance Device on Post-Operative Pain, Pulmonary Function and Quality of Life Compared to Traditional Manual Wire Closure: A Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kardium Inc.
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Respiratory function
研究概览
简要总结
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Referred for elective cardiac surgery at St Paul's Hospital
- •Expected to live greater than 12 months
- •Capable of giving written informed consent
- •Willing to participate in follow-up
- •Greater than 18 years of age, and of legal age of consent in host country
排除标准
- •Patient has had previous median sternotomy, requiring redo sternotomy
- •Surgeon has, prior to enrollment, elected to use alternative closure technique to the interrupted single wire circlage technique (e.g. Figure of 8 technique)
- •Surgeon has elected, prior to enrollment. to treat with the TORQ as a prophylactic measure (e.g. in high risk cases where use of the TORQ has been shown to be effective in preventing dehiscence)
结局指标
主要结局
Respiratory function
时间窗: Pre-op, 2 and 4 days Post-op
Pain Score
时间窗: 2, 4, 14, 30 and 90 days post op
Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking
次要结局
未报告次要终点
研究者
研究点 (2)
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