Can Silversulfadiazine Prevent Pin-site Infection in Open Tibial Fracture?: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- incidence of pin site infection
研究概览
简要总结
This study aimed to compare the efficacy of pin-tract infection prevention between silversulfadiazine and dry dressing.
Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from September 2007 to June 2008 and treated by emergency debridement and external fixation were randomized into two groups, one treated with silversulfadiazine for infection prophylaxis (15) and a control group treated with dry dressing only (15). All patients were followed until the external fixator was removed. Pin-site infections were assessed and graded at each follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin site was done if an infection occurred.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open tibial fracture treated with external fixator age between 15-60 years
排除标准
- •Immunocompromised patients (diabetes, HIV or malignancy)
研究组 & 干预措施
dry dressing
local application
干预措施: silversulfadiazine (Drug)
结局指标
主要结局
incidence of pin site infection
时间窗: 2 years
次要结局
- type of organism(2 years)
- severity of pin site infection(2 years)