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临床试验/NCT01765309
NCT01765309已完成不适用

A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 23 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
已完成
入组人数
23
试验地点
2
主要终点
Difference between preoperative and postoperative pain scale

研究概览

简要总结

Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin during breast reconstruction with tissue expanders results in decreased pain using a blinded, randomized, controlled trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Bilateral mastectomy with immediate tissue expander reconstruction

排除标准

  • Unwilling to receive study injections

结局指标

主要结局

Difference between preoperative and postoperative pain scale

时间窗: 12 weeks

Patients reported pain in each breast on a visual analog scale of 1-10 at each clinic visit

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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