Pilot Project: Prevention of Neurosurgical Wound Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Incidence of Infection That Requires Removal of the Neurosurgical Device
研究概览
简要总结
The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •deep brain stimulators (DBS)
- •spinal cord stimulators (SCS)
- •motor cortex stimulators (MCS)
- •vagus nerve stimulators (VNS)
- •peripheral nerve stimulators (PNS)
排除标准
- •allergies to vancomycin
- •immunocompromise or taking immunosuppressant drugs
- •currently taking aminoglycoside antibiotics, such as amikacin, gentamicin, neomycin, streptomycin or tobramycin
- •diagnosed renal failure
- •currently undergoing chemotherapy
- •pregnancy
- •non-english speakers
- •unable to return for follow-up, or unable to be contacted by telephone
研究组 & 干预措施
Vancomycin
Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.
干预措施: Vancomycin (Drug)
Saline
Subjects in the saline group will receive a Saline injection directly into the wound pocket.
干预措施: Placebo (Saline Solution) (Drug)
结局指标
主要结局
Incidence of Infection That Requires Removal of the Neurosurgical Device
时间窗: Six months post-operation
The primary outcome was infection that required removal of the implanted device within 6 months of surgery. At our institution all patients with evidence of hardware infection have the entire stimulation/pump system removed. Subjects were either seen in clinic or reached by telephone more than 6 months after surgery and assessed for whether they had had infection requiring hardware removal or any superficial infection requiring additional post-operative antibiotics.
次要结局
未报告次要终点
研究者
Kim J. Burchiel
Kim J. Burchiel, MD / John Raaf Professor and Chairman, Department of Neurological Surgery
Oregon Health and Science University