NCT00819260终止不适用
A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Time for Operation
研究概览
简要总结
Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery.
The three metrics are:
- the time taken to complete the operation
- drainage volume in the days immediately following surgery,
- patient pain in the days immediately following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible for enrollment if they agree to provide informed consent, can read and speak English, are at least 18 years of age, and are in generally good health.
排除标准
- •under 18 years of age
结局指标
主要结局
Time for Operation
时间窗: day of surgery
Time to complete the breast reduction per breast.
次要结局
- Hematoma(first day after surgery)
- Volume of Drainage in Surgical Drains(within one week of surgery)
- Pain Level in Surgical Sites(first week after surgery)
研究者
研究点 (2)
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