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

NCT ID: NCT02996357

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 206 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-04
• Study Completion Date: 2017-05-31

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.

Conditions

Irritant Contact Dermatitis; Diaper Rash; Incontinence-associated Dermatitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cases

Patients with IAD Category 2 (red skin with skin breakdown)

No interventions assigned to this group

Controls

Patients with IAD Cat. 0 (at risk, no redness and skin intact)

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitri Beeckman, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Onze-Lieve-Vrouwziekenhuis Aalst

Aalst, , Belgium

ZiekenhuisNetwerk Antwerpen

Antwerp, , Belgium

AZ Monica

Deurne, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

Algemeen Ziekenhuis Jan Palfijn

Ghent, , Belgium

Algemeen Ziekenhuis Maria Middelares

Ghent, , 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, , Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 27841440 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24700170 (View on PubMed)

Related Links

http://www.ucvvgent.be

Website of the research group

Other Identifiers

2016/0883

Identifier Type: -

Identifier Source: org_study_id