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NCT Number: NCT02996357

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

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.

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Key information

Conditions

Irritant Contact Dermatitis Dermatitis Dermatitis, Contact Dermatitis, Irritant Diaper Rash Incontinence-associated Dermatitis Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Onze-Lieve-Vrouwziekenhuis Aalst, Aalst, Belgium

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About this study

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:

  • 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)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Acute Physiology and Chronic Health Evaluation score (APACHE II)

    Time frame: 1 day

  2. Presence of mechanical ventilation

    Time frame: Up to six days

  3. Presence of dialysis

    Time frame: Up to six days

  4. Presence of infection

    Time frame: Up to six days

    Leucocyten count and white blood cell count

  5. Presence of fever

    Time frame: Up to six days

    temperature > 38.0°C

  6. Presence of inadequate arterial oxygen pressure

    Time frame: Up to six days

    PaO2 < 80mmHg

  7. Administration of antibiotics

    Time frame: Up to six days

  8. Administration of steroids

    Time frame: Up to six days

  9. Presence of malnutrition

    Time frame: Up to six days

    Measured by serum albumin level

  10. Presence of diabetes

    Time frame: Up to six days

  11. Use of continence products (diapers, underpads)

    Time frame: Up to six days

  12. Use of washing without water (wipes, skin cleansers)

    Time frame: Up to six days

  13. Presence of urinary incontinence

    Time frame: Up to six days

  14. Presence of diarrhea

    Time frame: Up to six days

    Measured by Bristol Stool Chart

  15. Presence of Clostridium difficile

    Time frame: Up to six days

  16. Presence of mechanical chafing

    Time frame: Up to six days

  17. Presence of low hemoglobin level

    Time frame: Up to six days

  18. Presence of enteral nutrition

    Time frame: Up to six days

  19. Presence of diminished cognitive awareness

    Time frame: Up to six days

    Measured by Glasgow Coma Scale

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2016
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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