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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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 stu
Sponsor: University Ghent

Current Primary Outcome:

  • Acute Physiology and Chronic Health Evaluation score (APACHE II) [ Time Frame: 1 day ]
  • Presence of mechanical ventilation [ Time Frame: Up to six days ]
  • Presence of dialysis [ Time Frame: Up to six days ]
  • Presence of infection [ Time Frame: Up to six days ]
    Leucocyten count and white blood cell count
  • Presence of fever [ Time Frame: Up to six days ]
    temperature > 38.0°C
  • Presence of inadequate arterial oxygen pressure [ Time Frame: Up to six days ]
    PaO2 < 80mmHg
  • Administration of antibiotics [ Time Frame: Up to six days ]
  • Administration of steroids [ Time Frame: Up to six days ]
  • Presence of malnutrition [ Time Frame: Up to six days ]
    Measured by serum albumin level
  • Presence of diabetes [ Time Frame: Up to six days ]
  • Use of continence products (diapers, underpads) [ Time Frame: Up to six days ]
  • Use of washing without water (wipes, skin cleansers) [ Time Frame: Up to six days ]
  • Presence of urinary incontinence [ Time Frame: Up to six days ]
  • Presence of diarrhea [ Time Frame: Up to six da

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University Ghent

    Dates:
    Date Received: August 26, 2016
    Date Started: October 2016
    Date Completion: October 2017
    Last Updated: December 14, 2016
    Last Verified: December 2016