Healthcare Associated Infection Reduction in Stem Cell Transplant Patients: a Randomized, Double-blind, Placebo-controlled Study Evaluating Twice Daily Xylitol Administration
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Incidence of bacteremia in the first 30 days post-HSCT with oral organisms
研究概览
简要总结
The central hypothesis is that daily dental xylitol wipes, in addition to current oral care practice, are effective at reducing BSI from oral organisms, and decreasing the incidence of gingivitis, oral plaque, and oral ulcerations after SCT.
详细描述
Our long-term goal is to develop and disseminate clinically relevant, and easily adoptable strategies to prevent BSI and improve outcomes after SCT. The overall objective of this proposal is to identify a clinically effective strategy to prevent or reduce BSI secondary to bacterial translocation through oral injured mucosa .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any age undergoing SCT.
排除标准
- •Prior proton or photon radiation treatment for cancer of the oral cavity, head or neck; cranial boost in patients receiving total body irradiation; known history of allergy to xylitol; inability to use a mouth rinse or dental wipes.
研究组 & 干预措施
Xylitol wipes
干预措施: Xylitol (Drug)
Placebo wipes
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of bacteremia in the first 30 days post-HSCT with oral organisms
时间窗: 30 days
Incidence of bacteremia in the first 30 days post-HSCT with any organism
时间窗: 30 days
次要结局
- Incidence of dental plaque(30 days)
- Incidence of oral microbiome diversity(30 days)
- Incidence of gingival inflammation(30 days)
- Incidence of oral pathogenic bacteria burden(30 days)
- Incidence of mucosal ulceration(30 days)
- Incidence of oral mucositis(30 days)