EUCTR2012-003146-32-GB进行中（未招募）1 期
A randomised control trial to determine whether a 5 day course of antibiotics is more clinically and cost effective than a 24 hour prophylactic course for the prevention of surgical site infection following lower limb amputation surgery - The Amputation Surgical Site Infection Trial (ASSIT)
Hull and East Yorkshire Hospital Trust0 个研究点目标入组 164 人开始时间: 2013年3月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Inclusion Criteria
- •1. Adults =18 yrs undergoing lower limb amputation
- •2. Ability to understand the Patient Information Sheet and capable and willing to give
- •informed consent and follow the protocol requirements (including attending all
- •follow- up visits)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 108
排除标准
- •Exclusion criteria;
- •1.Allergies to chlorhexidine/ alcohol/ iodophors
- •2.Inability to give informed consent
- •3.Patients who are admitted to hospital with severe sepsis secondary to gas
- •gangrene requiring multiple operations and admission to Intensive Care Unit.
- •4.Aged under 18 years at the time of recruitment
- •5.Use of investigational drug/device therapy within preceding 4 weeks that may
- •interfere with this study.
- •6.Toe amputations
研究者
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