NCT02443792已完成4 期
Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial
Simunye Primary Health Care1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2015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
- 75
- 试验地点
- 1
- 主要终点
- Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing
研究概览
简要总结
RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male
- •Uncircumcised
- •With normal penile anatomy
排除标准
- •Concurrent illness
- •History of bleeding disorder
- •Past reaction to local anesthetic
- •Infection
- •Penile abnormality which could complicate circumcision
研究组 & 干预措施
Open Surgical
Active Comparator
Open surgical circumcision under local anesthetic with suturing
干预措施: Open Surgical (Procedure)
Unicirc with tissue adhesive
Experimental
Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
干预措施: Unicirc with tissue adhesive (Procedure)
结局指标
主要结局
Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing
时间窗: Up to 30 minutes
Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing
次要结局
- Surgical Pain 0=no Pain; 10=Worst Pain Ever(Up to 30 minutes)
- Completely Healed at 4 Weeks(At the 4-week followup visit)
- Wound Dehiscence(Up to 4 weeks)
- Infection(Up to 4 weeks)
研究者
Justin Shenje, MB ChB
PI
University of Cape Town
研究点 (1)
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