The Use of Prophylactic Antibiotics In the Management of Dog Bites
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 5
- 主要终点
- Wound infection
研究概览
简要总结
This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection.
By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.
详细描述
This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection.
By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients including all children and English speaking/reading persons who present with a full thickness dog bite to participating emergency departments will be considered. Non-English speaking/reading subjects for whom we can provide translation for will also be considered.
排除标准
- •Exclusion Criteria:
- •allergy to penicillin or amoxicillin/clavulanic acid
- •wounds presenting with an active infection (require antibiotics) or greater than 12 hours old.
- •patients with underlying fracture, joint or neurovascular injury, or multiple trauma requiring specialty referral. Specifically any broken skin over a joint will need treatment and be excluded from the study and randomization.
- •patients on immunosuppressive agents, prolonged chronic steroid use (defined as continuous use for > 14 days, 3 times a year) active HIV disease (determined by treating physician on history) or splenectomized. (could skew one group and at risk for overwhelming sepsis and death if infected)
- •patients unwilling or unable to complete the required follow-up, and those unable to provide a contact phone number
结局指标
主要结局
Wound infection
次要结局
- side effects of medication