Specific Factors Associated With the Development of Incontinence- Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence: Matched Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 19
- 主要终点
- Use of washing without water (wipes, skin cleansers)
研究概览
简要总结
This study aims to identify patient characteristics associated with the development of Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence).
380 ICU patients suffering of fecal incontinence will be included in the study. Data on 19 possible risk factors will be collected at one point in time by the research team. Different sources and methods will be used to collect patient data: skin assessment, patient record, direct patient observation, routine blood samples.
详细描述
Incontinence is a widespread problem in all health care settings. Prevalence figures of incontinence vary around 20.0% of all hospitalized patients. In acute and critical care units the proportion of patients with fecal incontinence may rise up to 33.0%.
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 defined as skin inflammation manifested as redness with or without blistering, erosion, or loss of skin barrier function that occurs as a consequence of chronically or repeated exposure of the skin to urine or faeces.
A range of skin care products and procedures for the prevention of IAD exists. In order to provide cost-effective IAD prevention, it's important to target preventive skin care interventions to patients at risk of IAD.
The aims of this study are:
- To identify specific factors associated with the development of Incontinence- Associated Dermatitis (IAD) in a recognized high risk patient population (ICU patients suffering from fecal incontinence)
- To develop and statistically validate patient profiles being associated with high risk for IAD development
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Being admitted to the intensive care unit
- •Being fecal incontinent (=unintentional loss of stool)
排除标准
- •Being < 18 years
- •No contact possible between skin en stool at the perianal region (e.g. due to enteral stoma)
结局指标
主要结局
Use of washing without water (wipes, skin cleansers)
时间窗: Up to six days
Presence of urinary incontinence
时间窗: Up to six days
Presence of diarrhea
时间窗: Up to six days
Measured by Bristol Stool Chart
Presence of Clostridium difficile
时间窗: Up to six days
Presence of mechanical chafing
时间窗: Up to six days
Presence of low hemoglobin level
时间窗: Up to six days
Presence of enteral nutrition
时间窗: Up to six days
Acute Physiology and Chronic Health Evaluation score (APACHE II)
时间窗: 1 day
Presence of mechanical ventilation
时间窗: Up to six days
Presence of dialysis
时间窗: Up to six days
Presence of infection
时间窗: Up to six days
Leucocyten count and white blood cell count
Presence of fever
时间窗: Up to six days
temperature \> 38.0°C
Presence of inadequate arterial oxygen pressure
时间窗: Up to six days
PaO2 \< 80mmHg
Administration of antibiotics
时间窗: Up to six days
Administration of steroids
时间窗: Up to six days
Presence of malnutrition
时间窗: Up to six days
Measured by serum albumin level
Presence of diabetes
时间窗: Up to six days
Use of continence products (diapers, underpads)
时间窗: Up to six days
Presence of diminished cognitive awareness
时间窗: Up to six days
Measured by Glasgow Coma Scale
次要结局
未报告次要终点