Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7% to Reduce the Rate Oral Colonization by Gram-negative Bacteria in Patients With Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of oral colonization by gram-negative bacteria
研究概览
简要总结
Clinical triple-blind randomized controlled trial to assess the use of two different mouthwashes to reduce the oral colonization by gramnegative bacteria in patients with chemotherapy
详细描述
Clinical triple-blind randomized controlled trial.
With two arms to the study:
- Mouth rinses with chlorhexidine-based solution at a concentration of 0.12%, using as a vehicle to 7% ethyl alcohol.
- Mouthwashes with solution based only 7% ethyl alcohol.
GOAL. Assess whether there decrease in the rate of oral colonization by gram-negative bacteria in patients with chemotherapy by using chlorhexidine mouthwash.
SPECIFIC OBJECTIVES:
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, Investigator, 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
- •Patients over 18years, no upper age limit.
- •Acceptance of participation in the study.
- •Signature of informed consent.
- •Inpatient and remain hospitalized for at least 10 days.
- •The following haematological diagnosis:
- •acute lymphoblastic leukemia.
- •acute myelogenous leukemia.
- •relapsed non-Hodgkin lymphoma.
- •Receiving Chemotherapy scheme as a treatment for the underlying disease
排除标准
- •Patients who choose not to participate in the study.
- •Patients in whom no possible mouthwashes.
- •Patients who willingly choose to withdraw from the study.
- •Patients who develop conditions in which the administration is not possible rinses.
- •Duration of hospital stay less than 10 days, regardless of cause.
研究组 & 干预措施
Chlorhexidine 0.12% & Ethyl Alcohol 7%
Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days.
干预措施: chlorhexidine 0.12%/Ethyl alcohol 7% (Drug)
Ethyl Alcohol 7%
Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days.
干预措施: Ethyl Alcohol 7% (Drug)
Chlorhexidine 2% & Ethyl Alcohol 7%
Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days.
干预措施: Chlorhexidine 2%/Ethyl alcohol 7% (Drug)
结局指标
主要结局
Rate of oral colonization by gram-negative bacteria
时间窗: 10 days
次要结局
- Number of participants with presence of severe neutropenia and fever in each study group.(10 days)
- Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm.(Baseline)
- Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm(10 days)
研究者
Lauro Fabian Amador Medina
Researcher
Hospital Regional de Alta Especialidad del Bajio