Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 73
- 试验地点
- 3
- 主要终点
- Number of Participants With Presence of Wound Infection
研究概览
简要总结
Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?
详细描述
Simple hand lacerations, defined as hand lacerations that do not involve special structures such as bones, tendons, vessels, or nerves, are common in the emergency departments. The exact rate of infection in such wounds is unclear. It is also not clear whether prescribing prophylactic antibiotics reduces the risk of infection in simple hand lacerations. The objective of this randomized double blind controlled study is to: 1. Identify the rate of infection in simple hand lacerations, 2. Identify factors or wound characteristics that increase the risk of infection, and 3. Assess whether prescribing prophylactic antibiotics decreases the risk of infections in such wounds compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All adult patients (≥ 18 years of age) presenting to the ED with simple hand lacerations. Anatomically, lacerations distal to the radial carpal ligament will be considered "hand" lacerations. "Simple" or "uncomplicated" laceration refers to one that does not involve any special tissue (bone, tendon, blood vessel, or nerve).
排除标准
- •Immunocompromised patients (cancer, chemotherapy, transplant, HIV/AIDs)
- •Current or recent (within two weeks) use of any antibiotics
- •Allergy to clindamycin or cephalexin
- •Bites (e.g. dog, cat, or human)
- •Lacerations resulted from crush injury
- •Lacerations involving bone, tendon, blood vessel, or nerve
- •Lacerations inflicted more than 12 hours prior to ED visit
- •Pregnant or breast-feeding women
研究组 & 干预措施
clindamycin
clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days
干预措施: clindamycin (Drug)
cepahlexin
干预措施: cephalexin (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Number of Participants With Presence of Wound Infection
时间窗: 2 weeks
Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.
次要结局
未报告次要终点
研究者
Shahriar Zehtabchi
Professor of Emergency Medicine
State University of New York - Downstate Medical Center