Randomized Controlled Trial Assessing Use of Vancomycin Powder in Craniotomy on Wound Infection Rates
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- rate of wound infection
研究概览
简要总结
Surgical site infection (SSI) after craniotomy is a major cause of morbidity and mortality besides its major health care cost. In each hospital, all measures are taken to decrease SSI. Despite current prophylactic measures, rates of SSIs have been reported in up to 5% of patients post craniotomy. Intrawound vancomycin powder has been studied extensively in spinal fusion surgeries and been found to reduce rates of surgical site infections (SSIs) significantly. Despite its success in spinal surgeries, topical vancomycin has not been extensively studied with respect to cranial neurosurgery.
The use of adjuvant vancomycin powder was associated with a significant reduction in the incidence of postoperative infection as well as infection-related medical costs. These findings suggest that the use of adjuvant vancomycin powder in high-risk patients undergoing spinal fusion is a cost-saving option for preventing postoperative infections, as it can lead to cost-savings of $438,165 per 100 spinal fusions performed.
The investigators believe that Topical vancomycin is a safe, effective, and cost-saving measure to prevent SSIs following craniotomy.
详细描述
its Prospective Randomized clinical trial. The investigator will do block randomization that is done by a biostatistician through SAS software . Patients will be divided in this Trial into two groups, first group (intervention arm) they will receive the drug (vancomycin). The second group (control arm) they will not receive the drug, otherwise both groups they will receive identical measure to decrease the postoperative SSI.
The investigator will use one vial of vancomycin that contains 1000 mg of the drug in the powder form.
The primary outcome variable will be SSI rate factored by cohort. Secondary outcome will be cost savings from vancomycin usage estimated from hospital costs associated with SSI in craniotomy patients, morbidity and mortality.
SSI found to be around 0.49% when vancomycin was used, while SSI in standard care found to be 5%, to get power of study 80% and level of significance 5%. Sample size will be 250 in each group using sample size calculator.
The statistical formula used in computation of required and adequate sample size in view of primary outcome i.e., SSI rate between the two groups:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any type of craniotomy whatever the cause.
- •Age more than 18 Years
- •Patient with no evidence of any source of infection
排除标准
- •Any evidence of infection.
- •Age less than 18 years
- •Previous and multiple craniotomies
- •Active infection
- •Craniectomy
- •wound laceration over the craniotomy site.
研究组 & 干预措施
vancomycin group (intervention arm)
We will use one vial of vancomycin that contains 1000 mg of the drug in powder form on the surgical site before closing the wound
干预措施: Vancomycin (Drug)
结局指标
主要结局
rate of wound infection
时间窗: 24 months
to assess the effectiveness of vancomycin in craniotomy on the surgical site infection rate as compared to controls.
次要结局
- asses the rate wound complication(24 months)
研究者
Dr. sirajeddin belkhair
Head of department, neurosurgery, neuroscience institute
Hamad General Hospital