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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02996357
Enrollment
206
Registered
2016-12-19
Start date
2016-10-04
Completion date
2017-05-31
Last updated
2017-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaper Rash, Incontinence-associated Dermatitis, Irritant Contact Dermatitis

Keywords

Incontinence-associated dermatitis, Risk factor, Intensive care unit, Prevention

Brief summary

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

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: 1. 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) 2. 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.

Interventions

None listed

Sponsors

3M
CollaboratorINDUSTRY
University Ghent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Acute Physiology and Chronic Health Evaluation score (APACHE II)1 day
Presence of mechanical ventilationUp to six days
Presence of dialysisUp to six days
Presence of infectionUp to six daysLeucocyten count and white blood cell count
Presence of feverUp to six daystemperature \> 38.0°C
Presence of inadequate arterial oxygen pressureUp to six daysPaO2 \< 80mmHg
Administration of antibioticsUp to six days
Administration of steroidsUp to six days
Presence of malnutritionUp to six daysMeasured by serum albumin level
Presence of diabetesUp 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 incontinenceUp to six days
Presence of diarrheaUp to six daysMeasured by Bristol Stool Chart
Presence of Clostridium difficileUp to six days
Presence of mechanical chafingUp to six days
Presence of low hemoglobin levelUp to six days
Presence of enteral nutritionUp to six days
Presence of diminished cognitive awarenessUp to six daysMeasured by Glasgow Coma Scale

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026