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

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ClinicalTrials.gov Identifier: NCT02996357
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
University Ghent

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.


Condition or disease
Irritant Contact Dermatitis Diaper Rash Incontinence-associated 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.

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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Specific Factors Associated With the Development of Incontinence- Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence: Matched Case Control Study
Actual Study Start Date : October 4, 2016
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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)



Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996357


Locations
Show Show 19 study locations
Sponsors and Collaborators
University Ghent
3M
Investigators
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Principal Investigator: Dimitri Beeckman, PhD University Ghent
Additional Information:
Publications:
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT02996357    
Other Study ID Numbers: 2016/0883
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Ghent:
Incontinence-associated dermatitis
Risk factor
Intensive care unit
Prevention
Additional relevant MeSH terms:
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Fecal Incontinence
Dermatitis
Dermatitis, Contact
Diaper Rash
Dermatitis, Irritant
Skin Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Skin Diseases, Eczematous