Prospective, Randomized Study of the Utilization of Antibiotics and Drains in Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 539
- 试验地点
- 1
- 主要终点
- Incidence of Infection
研究概览
简要总结
In spine surgery, postoperative spinal drains are often utilized to prevent fluid buildup around the spinal cord. The purpose of this study is to determine whether postoperative antibiotic treatment continued for the duration of time a drain is in place results in a lower infection rate than antibiotics given for only 24 hours postoperatively.
详细描述
Patients likely to receive postoperative spinal drains were enrolled and randomized preoperatively to receive one of two postoperative antibiotic treatments, either for 24 hours after surgery or for the duration of time the spinal drain was in place. If patients did not receive at least one spinal drain during surgery, they were excluded from the infection analysis and received the institutional standard of 24 hours of postoperative antibiotics. Patients that did receive drains were treated according to their randomization and followed for a minimum of one year for the incidence of surgical site infection. The diagnosis of surgical site infection was determined using the definition provided for the Center for Disease Control (CDC). All patients that developed surgical site infections were treated as appropriate by the attending physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Must be scheduled to undergo spine surgery with likely drain placement (3 or more vertebral levels, dependent upon attending surgeon)
- •Must be over the age of 18
- •Must consent to randomized postoperative antibiotic treatment
排除标准
- •Does not receive a drain at the time of surgery
- •Surgery is cancelled
- •Infection is present at the time of initial surgery
结局指标
主要结局
Incidence of Infection
时间窗: for one year after surgery
Patients were contacted and their medical records were reviewed for a minimum of one year after surgery in order to determine the incidence of postoperative infection. The Center for Disease Control's definition of surgical site infection was applied in determining infection rates.
次要结局
未报告次要终点