A Total Body Wash Wipe Combined With a Genital Wipe Versus Standard Care (Water and pH Neutral Soap) for Washing of Incontinent Residents in a Long- Term Care Setting: a Multicenter Prospective Randomised Controlled Clinical Trial and Health Economical Analysis in Nursing Homes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 385
- 试验地点
- 12
- 主要终点
- Incidence and category of Incontinence-Associated Dermatitis
研究概览
简要总结
Incontinence is a widespread problem in all health care setting. One of the main complications of incontinence is inflammation of the skin in the genital and anal region, also known as incontinence-associated dermatitis (IAD). IAD is a known risk factor of pressure ulcer development. Prevalence figures of IAD vary between 5.6% and 50%.
The primary aim of this study is to compare the effectiveness of a 3-in-1 genital wipe versus standard care (traditional water and soap) for the prevention of IAD. The second aim is to perform a health economic evaluation of the 3-in-1 genital wipe versus standard care, and third to compare the cost of a 2-in-1 total body wash wipe versus standard care for total body wash. Other outcomes are the comfort and tolerance of both the nurses and participants.
In this Randomized Controlled Trial, performed in 13 long-term care settings, the participants will undergo a 30 day study period. In the experimental intervention, the participants will be washed with body wash wipes and genital wipes. In the control group, the subjects will receive traditional care. IAD as well as Pressure Ulcer prevalence will be monitored. Subjective and objective time measurements will be performed.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •urinary incontinence, fecal incontinence or double incontinence
- •depending on help for washing
- •free of skin damage (without signs of pressure ulcers or IAD such as skin breakdown or redness)
排除标准
- •not incontinent or minor incontinent (e.g. stress incontinence)
- •urinary or fecal catheter
- •use of incontinence wipes in the uro-genital area two weeks prior to the start of the study
- •the use of a skin barrier product in the uro-genital area two weeks prior to screening
- •presence of a bacterial/fungal infection in the uro-genital area
结局指标
主要结局
Incidence and category of Incontinence-Associated Dermatitis
时间窗: within the first 30 days after start of the study
次要结局
- Comfort and tolerance of the participant(On baseline, at day 14 and at day 30 (the end of the study))
- Comfort and preferences of the caregiver(On baseline, at day 14 and at day 30 (the end of the study))
- Cost of the experiment (use of wash wipes) versus the standard care(For the duration of the study (30 days))
- Incidence and category of Pressure Ulcers(within the first 30 days after start of the study)
- adverse effects of the intervention(within the first 30 days after start of the study)
研究者
UCVV
University Centre for Nursing and midwifery
University Ghent