Intrawound Vancomycin Prophylaxis During Stimulator Re-Implantation: A Multi-Center Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Device explantation 6 months post surgery
研究概览
简要总结
The implantable pulse generator (IPG) is a device that generates electrical current to stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG is implanted in a subcutaneous pocket under the collarbone. This pocket is highly avascular and thus, antibiotics administered intravenously cannot reach a potential surgical site infection (SSI). SSIs cause millions of health care dollars to be wasted due to repeat surgery and hospital re-admissions. The investigators hope to to determine the effects of "intrawound vancomycin-saline and IV antibiotics" compared to "saline and IV antibiotics" on the incidence of IPG SSI rates 6-months post-surgery.
详细描述
Patients requiring neurosurgical IPG replacements will be recruited into this trial on a volunteer basis. The participants meeting the inclusion criteria will be randomized to either the treatment arm (intrawound Vancomycin-saline + IV antibiotics) or control arm (intrawound saline + IV antibiotics alone) by site in a 1:1 ratio. A sample size calculation using STplan determined that 405 patients per arm is required to reduce overall infection rate from 3.5% to 0.5% (80% power, α=0.05, two-tailed). Final sample size per arm will be 410 after generously accounting for loss to follow-up, non-compliance, and unrelated death.
The primary outcome will be a binary Yes/No on if IPG explantation due to infection was required within 6-months post-surgery.
This is a superiority trial and the investigators hypothesize intrawound Vancomycin-saline + IV antibiotics is superior to intrawound saline + IV antibiotics alone. An intention-to-treat analysis will be applied in a blinded manner once all patients have completed the trial and the database is locked.
The results of this trial will not only be applicable to neurosurgery, but also spine and cardiology.
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
- Double (Participant, Care Provider)
盲法说明
Both patient and surgeon will be blinded to the treatment.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals who require INS replacement from Dr. C.R. Honey
- •individuals who are between the ages of 18 to
- •individuals who consent to report any redness or swelling to their primary caregiver and follow-up as requested by their surgeon
- •individuals who consent to keeping the study team informed of any medical concerns they may have regarding their INS for a minimum of 6 months postoperatively
- •individuals who are capable of providing informed consent
排除标准
- •individuals who have a history of autoimmune disease
- •individuals who are undergoing any surgery or procedural intervention within six-months post-operatively of entrance into this study
- •individuals who are on immunosuppression or any medication that would influence infection susceptibility
- •individuals who are allergic to Vancomycin or Cefazolin
研究组 & 干预措施
Vancomycin
These patients will receive intrawound Vancomycin-saline and IV antibiotics
干预措施: Saline Solution (Drug)
Vancomycin
These patients will receive intrawound Vancomycin-saline and IV antibiotics
干预措施: Vancomycin Hydrochloride (Drug)
Saline
These patients will receive intrawound saline + IV antibiotics alone
干预措施: Saline Solution (Drug)
结局指标
主要结局
Device explantation 6 months post surgery
时间窗: 6 months
The primary outcome measure will be determined at the 6 month post surgery point, where the binary yes/no question, "was the INS device explanted", will be answered.
次要结局
未报告次要终点
研究者
Christopher Honey
Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders
University of British Columbia