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

Completed

• Conditions: Diaper Rash; Incontinence-associated Dermatitis; Irritant Contact Dermatitis

• Registration Number: NCT02996357
• Lead Sponsor: University Ghent

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.

Study Timeline

• Study First Submitted: 2016-08-26
• Study Start: 2016-10-04
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Use of washing without water (wipes, skin cleansers)	Up to six days
Presence of urinary incontinence	Up to six days
Presence of diarrhea	Up to six days	Measured by Bristol Stool Chart
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
Use of continence products (diapers, underpads)	Up to six days
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	Up to six days	Leucocyten count and white blood cell count
Presence of fever	Up to six days	temperature \> 38.0°C
Presence of inadequate arterial oxygen pressure	Up to six days	PaO2 \< 80mmHg
Administration of antibiotics	Up to six days
Administration of steroids	Up to six days
Presence of malnutrition	Up to six days	Measured by serum albumin level
Presence of diabetes	Up to six days
Presence of diminished cognitive awareness	Up to six days	Measured by Glasgow Coma Scale

Trial Locations

Locations (19)

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

Onze-Lieve-Vrouwziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

AZ Monica; 🇧🇪 Deurne, Belgium

Algemeen Ziekenhuis Jan Palfijn; 🇧🇪 Gent, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

Jan Yperman Ziekenhuis; 🇧🇪 Ieper, Belgium

Algemeen Ziekenhuis Delta; 🇧🇪 Roeselare, Belgium

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Belgium

De Gasthuiszusters Antwerpen; 🇧🇪 Wilrijk, Belgium

ZiekenhuisNetwerk Antwerpen; 🇧🇪 Antwerpen, Belgium

Algemeen Ziekenhuis Sint Maarten; 🇧🇪 Mechelen, Belgium

Algemeen Ziekenhuis Groeninge; 🇧🇪 Kortrijk, Belgium

Universitaire Ziekenhuizen van de K.U. Leuven; 🇧🇪 Leuven, Belgium

O.L.V. van Lourdesziekenhuis; 🇧🇪 Waregem, Belgium

Algemeen Ziekenhuis Sint-Augustinus; 🇧🇪 Veurne, Belgium

Algemeen Ziekenhuis Maria Middelares; 🇧🇪 Gent, Belgium

AZ Sint-Lucas; 🇧🇪 Ghent, Belgium