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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Onze-Lieve-Vrouwziekenhuis Aalst
  • Antwerpen, Belgium
    • ZiekenhuisNetwerk Antwerpen
  • Deurne, Belgium, 2100
    • AZ Monica
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Gent, Belgium, 9000
    • Algemeen Ziekenhuis Jan Palfijn
  • Gent, Belgium, 9000
    • Algemeen ziekenhuis Maria Middelares
  • Ghent, Belgium, 9000
    • AZ Sint-Lucas
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis
  • Ieper, Belgium, 8900
    • Jan Yperman ziekenhuis
  • Jette, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • Kortrijk, Belgium, 8500
    • Algemeen Ziekenhuis Groeninge
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen van de K.U. Leuven
  • Mechelen, Belgium, 2800
    • Algemeen Ziekenhuis Sint Maarten
  • Roeselare, Belgium, 8800
    • Algemeen Ziekenhuis Delta
  • Sint-Niklaas, Belgium, 9100
    • AZ Nikolaas
  • Veurne, Belgium, 8630
    • Algemeen Ziekenhuis Sint-Augustinus
  • Waregem, Belgium, 8790
    • O.L.V. van Lourdesziekenhuis
  • Wilrijk, Belgium, 2610
    • De Gasthuiszusters Antwerpen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to intensive care unit, with fecal incontinence (a known risk for IAD Cat. 2 development) will be sampled. The presence of fecal incontinence (any type) will be used as the only variable for matching (as not to reduce the possibility to interfere with associated risk factors).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cases; Patients with IAD Category 2 (red skin with skin breakdown)
Controls; Patients with IAD Cat. 0 (at risk, no redness and skin intact)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: 3M

Publications and helpful links

General Publications

• Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.
• Beeckman D, Van Lancker A, Van Hecke A, Verhaeghe S. A systematic review and meta-analysis of incontinence-associated dermatitis, incontinence, and moisture as risk factors for pressure ulcer development. Res Nurs Health. 2014 Jun;37(3):204-18. doi: 10.1002/nur.21593. Epub 2014 Apr 3.

Helpful Links

• Website of the research group

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2016
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Prevention; Intensive care unit; Risk factor; Incontinence-associated dermatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Contact; Fecal Incontinence; Diaper Rash; Dermatitis, Irritant
• Other Study ID Numbers: 2016/0883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No