Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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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 This study is a matched case control study. The cases are defined as patients with IAD Cat. 2 (red skin with skin breakdown). The controls are defined as patients with IAD Cat. 0 (at risk, no redness and skin intact). The patient will be matched for fecal incontinence. In total, 380 ICU patients suffering from fecal incontinence will be included. 19 possible risk factors will be studied. All data 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. Specific IAD risk factors will be determined by applying univariate and multivariate binary logistic regression modeling.

Official Title
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Specific Factors Associated With the Development of Incontinence- Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence: Matched Case Control Study

Conditions
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Diaper Rash, Irritant Contact Dermatitis, Incontinence-associated Dermatitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being admitted to the intensive care unit Being fecal incontinent (=unintentional loss of stool) Exclusion Criteria: Being < 18 years No contact possible between skin en stool at the perianal region (e.g. due to enteral stoma)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients with IAD Category 2 (red skin with skin breakdown) | |
| Controls<br>Patients with IAD Cat. 0 (at risk, no redness and skin intact) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Physiology and Chronic Health Evaluation score (APACHE II) |  | 1 day | 
| Presence of mechanical ventilation |  | Up to six days | 
| Presence of dialysis |  | Up to six days | 
| Presence of infection | Leucocyten count and white blood cell count | Up to six days | 
| Presence of fever | temperature > 38.0°C | Up to six days | 
| Presence of inadequate arterial oxygen pressure | PaO2 < 80mmHg | Up to six days | 
| Administration of antibiotics |  | Up to six days | 
| Administration of steroids |  | Up to six days | 
| Presence of malnutrition | Measured by serum albumin level | Up to six days | 
| Presence of diabetes |  | Up to six days | 
| Use of continence products (diapers, underpads) |  | Up to six days | 
| Use of washing without water (wipes, skin cleansers) |  | Up to six days | 
| Presence of urinary incontinence |  | Up to six days | 
| Presence of diarrhea | Measured by Bristol Stool Chart | Up to six days | 
| Presence of Clostridium difficile |  | Up to six days | 
| Presence of mechanical chafing |  | Up to six days | 
| Presence of low hemoglobin level |  | Up to six days | 
| Presence of enteral nutrition |  | Up to six days | 
| Presence of diminished cognitive awareness | Measured by Glasgow Coma Scale | Up to six days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incontinence-associated dermatitis, Risk factor, Intensive care unit, Prevention