跳至主要内容
临床试验/NCT00819260
NCT00819260终止不适用

A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2009年3月最近更新:
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:

  1. the time taken to complete the operation
  2. drainage volume in the days immediately following surgery,
  3. 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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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