Surgical Prophylaxis: Assessing Decolonization Efficacy of Polyhexanide Versus Mupirocin and Chlorhexidine in Decolonizing Staphylococcus Aureus Preoperatively in Elective Spine Surgery (SPADE): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- randomization rate
研究概览
简要总结
This pilot randomized controlled trial evaluates the feasibility, tolerability, and preliminary efficacy of a decolonization regimen using polyhexanide in reducing Staphylococcus aureus colonization in the preoperative phase of elective spine surgery, compared to the standard mupirocin and chlorhexidine regimen. The trial involves 24 participants randomized into two groups: one receiving polyhexanide and the other receiving mupirocin and chlorhexidine. The primary outcome is the randomization rate, with secondary outcomes including other feasibility outcomes, tolerability, and efficacy measures such as the reduction in S. aureus colony-forming units (CFUs) and changes in the nasal and skin microbiome composition.
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
- 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
- 否
入选标准
- •Age over 18 years
- •Scheduled for elective spinal surgery
- •Colonized with Staphylococcus aureus
- •Informed consent provided
排除标准
- •Emergency spine surgery
- •Methicillin-resistant Staphylococcus aureus (MRSA) or mupirocin-resistant S. aureus
- •Known allergies to products used in the trial
- •Pregnant or breastfeeding women
- •Recent antibiotic therapy (within 14 days)
- •Known non-compliance, substance abuse, or psychological disorders
- •Participation in another antimicrobial trial within the last 30 days
研究组 & 干预措施
Mupirocin and Chlorhexidine
干预措施: Mupirocin and Chlorhexidine (Drug)
Polyhexanide
干预措施: Polyhexanide (Drug)
结局指标
主要结局
randomization rate
时间窗: at study completion, an average of 2 years.
proportion of enrolled patients who were randomized
次要结局
- positive screening rate(at study completion, an average of 2 years)
- recruitment rate(at study completion, an average of 2 years)
- retention rate(at study completion, an average of 2 years)
- adherence rate(at study completion, an average of 2 years)
- trial burden(from start of treatment until last visit, up to 10 days)
- tolerability of decolonization regimen(day 5 of treatment)
- burden caused by side effects(day 5 of treatment)
- willingness to participate in future main trial(from start of treatment until last visit, up to 10 days)
- Staphylococcus aureus colonization(pre-treatment (-30days to -10days before surgery), post-treatment (first day after treatment), the day of discharge (within 3 to 5 days after treatment))
- The rate of mupirocin or oxacillin resistance(pre-treatment (-30days to -10 days before surgery))
- The rate of treatment side effects(day 1-5 of treatment])