A Double-blind Evaluation of Adverse Effects of Bath With Wipes Impregnated With 2% Chlorhexidine Versus Placebo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Skin reaction to chlorhexidine
研究概览
简要总结
Traditional bed bathing have been related to cross-infection. In order to avoid this complication, single-use products such as wipes impregnated with chlorhexidine use is increasing. Nevertheless among nursery staff concern about its side effects prevents its widespread use. The investigators want to know if there are any differences between the use of 2% chlorhexidine wipes and a placebo concerning side effects.
详细描述
Hygiene is part of health recovery in patients, nevertheless in unconscious or sedated patients this procedure becomes a task for the nursing staff. Traditional soap and water bed bath is becoming obsolete as soap could induce skin injuries due to changes in the pH of the skin and furthermore, almost every items used for this procedure could be a reservoir for pathogens, and therefore could lead to infection. Nowadays single-use products are a new option for prevent cross-infections. Nevertheless, traditional bed bathing is a tightly established practice among nursing staff. New evidence about side effects and comfort by wipe bed bathing is needed.
Chlorhexidine impregnated wipes have been used to perform the bed bathing in severe ill patients, as it can protect them from infections. The aim of this study is to determinate if bed bathing with 2% chlorhexidine impregnated wipes has a similar effect that a placebo.
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteer
排除标准
- •History of skin allergies or atopy, as well as reactions to soaps or chlorine compounds.
结局指标
主要结局
Skin reaction to chlorhexidine
时间窗: 24 hours
Presence of any cutaneous reaction in the first 24 hours after bathing with chlorhexidine. If the volunteers develop any skin reaction, a blinded dermatologist will evaluate it, and will perform a susceptibility test to determine if skin reaction is related to the antiseptic.
次要结局
- Comparison of bacterial colony count of skin.(24 hours)
研究者
Alejandro E. Macias
MD
Universidad de Guanajuato