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

Last updated: July 17, 2017
Sponsor: University Ghent
Overall Status: Completed

Phase

N/A

Condition

Allergy

Contact Dermatitis (Pediatric)

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT02996357
2016/0883
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Being admitted to the intensive care unit

  • Being fecal incontinent (=unintentional loss of stool)

Exclusion

Exclusion Criteria:

  • Being < 18 years

  • No contact possible between skin en stool at the perianal region (e.g. due to enteralstoma)

Study Design

Total Participants: 206
Study Start date:
October 04, 2016
Estimated Completion Date:
May 31, 2017

Study 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.

Connect with a study center

  • Onze-Lieve-Vrouwziekenhuis Aalst

    Aalst, 9300
    Belgium

    Site Not Available

  • ZiekenhuisNetwerk Antwerpen

    Antwerpen,
    Belgium

    Site Not Available

  • AZ Monica

    Deurne, 2100
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg

    Genk, 3600
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Jan Palfijn

    Gent, 9000
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Maria Middelares

    Gent, 9000
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Ghent, 9000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Ghent, 9000
    Belgium

    Site Not Available

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Site Not Available

  • Jan Yperman Ziekenhuis

    Ieper, 8900
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel

    Jette, 1090
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • Universitaire Ziekenhuizen van de K.U. Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Sint Maarten

    Mechelen, 2800
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • AZ Nikolaas

    Sint-Niklaas, 9100
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Sint-Augustinus

    Veurne, 8630
    Belgium

    Site Not Available

  • O.L.V. van Lourdesziekenhuis

    Waregem, 8790
    Belgium

    Site Not Available

  • De Gasthuiszusters Antwerpen

    Wilrijk, 2610
    Belgium

    Site Not Available

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