Clinical trial NCT02996357: Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence
Official title: Specific Factors Associated With the Development of Incontinence- Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence: Matched Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritant Contact Dermatitis
Diaper Rash
Incontinence-associated Dermatitis
Keywords: Incontinence-associated dermatitis
Risk factor
Intensive care unit
Prevention
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2016-12-19
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acute Physiology and Chronic Health Evaluation score (APACHE II)
timeFrame: 1 day
measure: Presence of mechanical ventilation
timeFrame: Up to six days
measure: Presence of dialysis
timeFrame: Up to six days
measure: Presence of infection
timeFrame: Up to six days
measure: Presence of fever
timeFrame: Up to six days
measure: Presence of inadequate arterial oxygen pressure
timeFrame: Up to six days
measure: Administration of antibiotics
timeFrame: Up to six days
measure: Administration of steroids
timeFrame: Up to six days
measure: Presence of malnutrition
timeFrame: Up to six days
measure: Presence of diabetes
timeFrame: Up to six days
measure: Use of continence products (diapers, underpads)
timeFrame: Up to six days
measure: Use of washing without water (wipes, skin cleansers)
timeFrame: Up to six days
measure: Presence of urinary incontinence
timeFrame: Up to six days
measure: Presence of diarrhea
timeFrame: Up to six days
measure: Presence of Clostridium difficile
timeFrame: Up to six days
measure: Presence of mechanical chafing
timeFrame: Up to six days
measure: Presence of low hemoglobin level
timeFrame: Up to six days
measure: Presence of enteral nutrition
timeFrame: Up to six days
measure: Presence of diminished cognitive awareness
timeFrame: Up to six days
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis Aalst
city: Antwerpen
country: Belgium
facility: ZiekenhuisNetwerk Antwerpen
city: Deurne
country: Belgium
facility: AZ Monica
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Jan Palfijn
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
city: Ghent
country: Belgium
facility: AZ Sint-Lucas
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Ieper
country: Belgium
facility: Jan Yperman Ziekenhuis
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Kortrijk
country: Belgium
facility: Algemeen Ziekenhuis Groeninge
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen van de K.U. Leuven
city: Mechelen
country: Belgium
facility: Algemeen Ziekenhuis Sint Maarten
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Veurne
country: Belgium
facility: Algemeen Ziekenhuis Sint-Augustinus
city: Waregem
country: Belgium
facility: O.L.V. van Lourdesziekenhuis
city: Wilrijk
country: Belgium
facility: De Gasthuiszusters Antwerpen
Study officials:
affiliation: University Ghent
name: Dimitri Beeckman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.