NCT00530400已完成4 期
Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,369
- 试验地点
- 2
- 主要终点
- Occurrence of a surgical site infection
研究概览
简要总结
The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18
- •spinal surgery for herniated disk
排除标准
- •known or suspected hypersensitivity to cephalosporins
- •type I hypersensitivity to betalactamic antibiotics
- •severe renal function impairment
- •acquired immune deficiency syndrome (AIDS) or other conditions of severe immuno-suppression
- •antibiotic therapy for concomitant infection at the time of surgery
- •pregnancy
- •refusal to participate
研究组 & 干预措施
1
Experimental
intravenous 1.5g cefuroxime
干预措施: cefuroxime (Drug)
2
Placebo Comparator
intravenous placebo
干预措施: placebo (Drug)
结局指标
主要结局
Occurrence of a surgical site infection
时间窗: 6 months
次要结局
- Occurrence of a post-operative infection other than surgical site infection(6 monts)
- Serious adverse event(6 months)
研究者
研究点 (2)
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