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

Diaper Rash Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996357
• Other study ID #: 2016/0883
• Status: Completed
• Phase: N/A
• First received: August 26, 2016
• Last updated: July 17, 2017
• Start date: October 4, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: July 2017
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact
• Diaper Rash
• Fecal Incontinence
• Incontinence-associated Dermatitis
• Irritant Contact Dermatitis

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouwziekenhuis Aalst	Aalst
Belgium	ZiekenhuisNetwerk Antwerpen	Antwerpen
Belgium	AZ Monica	Deurne
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Algemeen Ziekenhuis Jan Palfijn	Gent
Belgium	Algemeen Ziekenhuis Maria Middelares	Gent
Belgium	AZ Sint-Lucas	Ghent
Belgium	Universitair Ziekenhuis Gent	Ghent
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Jan Yperman Ziekenhuis	Ieper
Belgium	Universitair Ziekenhuis Brussel	Jette
Belgium	Algemeen Ziekenhuis Groeninge	Kortrijk
Belgium	Universitaire Ziekenhuizen van de K.U. Leuven	Leuven
Belgium	Algemeen Ziekenhuis Sint Maarten	Mechelen
Belgium	Algemeen Ziekenhuis Delta	Roeselare
Belgium	AZ Nikolaas	Sint-Niklaas
Belgium	Algemeen Ziekenhuis Sint-Augustinus	Veurne
Belgium	O.L.V. van Lourdesziekenhuis	Waregem
Belgium	De Gasthuiszusters Antwerpen	Wilrijk

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	3M

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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:CD011627. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Physiology and Chronic Health Evaluation score (APACHE II)		1 day
Primary	Presence of mechanical ventilation		Up to six days
Primary	Presence of dialysis		Up to six days
Primary	Presence of infection	Leucocyten count and white blood cell count	Up to six days
Primary	Presence of fever	temperature > 38.0°C	Up to six days
Primary	Presence of inadequate arterial oxygen pressure	PaO2 < 80mmHg	Up to six days
Primary	Administration of antibiotics		Up to six days
Primary	Administration of steroids		Up to six days
Primary	Presence of malnutrition	Measured by serum albumin level	Up to six days
Primary	Presence of diabetes		Up to six days
Primary	Use of continence products (diapers, underpads)		Up to six days
Primary	Use of washing without water (wipes, skin cleansers)		Up to six days
Primary	Presence of urinary incontinence		Up to six days
Primary	Presence of diarrhea	Measured by Bristol Stool Chart	Up to six days
Primary	Presence of Clostridium difficile		Up to six days
Primary	Presence of mechanical chafing		Up to six days
Primary	Presence of low hemoglobin level		Up to six days
Primary	Presence of enteral nutrition		Up to six days
Primary	Presence of diminished cognitive awareness	Measured by Glasgow Coma Scale	Up to six days

External Links

•   Website of the research group