NCT02593630已完成4 期
Field Study of Unicirc Circumcision in Adolescent Boys, Aged 12 to 15 Years.
Simunye Primary Health Care1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Intraoperative Duration
研究概览
简要总结
This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.
详细描述
Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy boys desiring circumcision
排除标准
- •current illness
- •bleeding disorder
- •reaction to local anaesthetic
- •infection
- •any penile abnormality potentially complicating circumcision
研究组 & 干预措施
Unicirc circumcision
Experimental
Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive
干预措施: Unicirc circumcision (Device)
结局指标
主要结局
Intraoperative Duration
时间窗: Intraoperative, 10-15 minutes
Duration from placement of instrument to dressing
次要结局
- Intraoperative Pain(Time of surgery, approximately 10-15 minutes)
- Healed at 4 Weeks(At the 4-week followup visit)
研究者
Peter Millard
PI
University of New England
研究点 (1)
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