Differences Between Oral Colonization Rates of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine Mouthwash at 0.12% Versus Chlorhexidine Mouthwash at 2.0%
试验速览
- 阶段
- 3 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Gram-negative decolonization rate
研究概览
简要总结
This study will assess the utility of different chlorhexidine mouthwash concentrations on ICU patients to decolonize their oral cavities from gram-negative bacteria, since this is a non-desirable condition that leads to higher mortality rates and longer hospitalization times. One group will receive the 0.12% chlorhexidine mouthwash and the other group will receive the 2% chlorhexidine mouthwash.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with minimum required age of consent that were admitted to the intensive care unit and who received at least 48 hours of mechanical ventilation.
排除标准
- •Patients who wish to withdraw consent and leave the study.
研究组 & 干预措施
Chlorhexidine 2%
Subjects in this arm will receive standard care plus mouth rinse every 12 hours via spray with 2% chlorhexidine concentration, one week intervention, Drug: Chlorhexidine gluconate at 2%
干预措施: Chlorhexidine gluconate at 2% (Drug)
Chlorhexidine 0.12%
Subjects in this arm will receive standard care plus mouth rinse every 12 hours via spray with 0.12% chlorhexidine concentration, one week intervention, Drug: Chlorhexidine gluconate at 0.12%
干预措施: Chlorhexidine gluconate at 0.12% (Drug)
结局指标
主要结局
Gram-negative decolonization rate
时间窗: 2 weeks
Patients admitted to the ICU who were originally colonized with gram-negative bacteria and at the end of the study are no longer colonized by gram-negative bacteria.
Gram-negative colonization rate
时间窗: 2 weeks
Patients admitted to the ICU who were originally not colonized with gram-negative bacteria and at the end of the study are colonized by gram-negative bacteria.
次要结局
未报告次要终点
研究者
Jose Antonio de Jesus Alvarez Canales
PhD, MD, MSCR
Universidad de Guanajuato