跳至主要内容
临床试验/NCT01739478
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

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

发起方
North Western Research Collaborative
申办方类型
Network
责任方
Sponsor

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