NCT01810497已完成不适用
Analysis of the Influence of Different Protocols of Postoperative Elastic Bandage Use in the Results of Otoplasty
University of Campinas, Brazil2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Incidence of re-operation
研究概览
简要总结
The aim of the study is to investigate the possible influence of different durations of use of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty. We hypothesize that the duration of elastic bandage use has no significant influence on the incidence of relapse of prominence of the ears and need for reoperation.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Congenital bilateral ear prominence
- •10 years-old or older
- •No previous attempt of surgical treatment
排除标准
- •Pregnant women
- •Breastfeeding women
- •Blod clotting disorders or current anticoagulant use
- •Uncontrolled systemic diseases
结局指标
主要结局
Incidence of re-operation
时间窗: until 12 months
次要结局
- Change from immediate postoperative period of helix-mastoid distance(12 months)
研究者
Davi Reis Calderoni
Plastic Surgeon; Division of Plastic Surgery of the Faculty of Medical Sciences
University of Campinas, Brazil
研究点 (2)
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