NCT01739478Unknown不适用
Packing of Perianal Abscess Cavities (PPAC) Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity
North Western Research Collaborative0 个研究点目标入组 300 人开始时间: 2012年12月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- Time to wound healing in days, defined as complete epithelialisation of the abscess cavity.
研究概览
简要总结
The aim of this study is to compare the effect of packing and non-packing on the healing rate of perianal abscess cavities. Secondary objectives are to assess quality of life, cost effectiveness and rate of abscess recurrence and fistula-in-ano formation. If there is no difference in time to healing and non-packing is shown to be safe, acceptable to the patient and cost effective, this approach may become more widely accepted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute primary perianal abscess
- •Have undergone surgical incision and drainage as an emergency
排除标准
- •The abscess is the sequelae of concurrent disease or trauma
- •Fourniers gangrene is suspected
- •Unable to give informed consent
结局指标
主要结局
Time to wound healing in days, defined as complete epithelialisation of the abscess cavity.
时间窗: 1 day to 6 weeks
time to healing will be assessed in days
次要结局
- Quality of life scores as determined by the Euro QoL EQ-5D-3L(10 to 14 days)
研究者
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