<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02996357</url>
  </required_header>
  <id_info>
    <org_study_id>2016/0883</org_study_id>
    <nct_id>NCT02996357</nct_id>
  </id_info>
  <brief_title>Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence</brief_title>
  <official_title>Specific Factors Associated With the Development of Incontinence- Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence: Matched Case Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to identify patient characteristics associated with the development of&#xD;
      Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence).&#xD;
&#xD;
      380 ICU patients suffering of fecal incontinence will be included in the study. Data on 19&#xD;
      possible risk factors will be collected at one point in time by the research team. Different&#xD;
      sources and methods will be used to collect patient data: skin assessment, patient record,&#xD;
      direct patient observation, routine blood samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Incontinence is a widespread problem in all health care settings. Prevalence figures of&#xD;
      incontinence vary around 20.0% of all hospitalized patients. In acute and critical care units&#xD;
      the proportion of patients with fecal incontinence may rise up to 33.0%.&#xD;
&#xD;
      One of the main complications of incontinence is inflammation of the skin in the genital and&#xD;
      anal region, also known as incontinence-associated dermatitis (IAD). IAD is defined as skin&#xD;
      inflammation manifested as redness with or without blistering, erosion, or loss of skin&#xD;
      barrier function that occurs as a consequence of chronically or repeated exposure of the skin&#xD;
      to urine or faeces.&#xD;
&#xD;
      A range of skin care products and procedures for the prevention of IAD exists. In order to&#xD;
      provide cost-effective IAD prevention, it's important to target preventive skin care&#xD;
      interventions to patients at risk of IAD.&#xD;
&#xD;
      The aims of this study are:&#xD;
&#xD;
        1. To identify specific factors associated with the development of Incontinence- Associated&#xD;
           Dermatitis (IAD) in a recognized high risk patient population (ICU patients suffering&#xD;
           from fecal incontinence)&#xD;
&#xD;
        2. To develop and statistically validate patient profiles being associated with high risk&#xD;
           for IAD development&#xD;
&#xD;
      This study is a matched case control study. The cases are defined as patients with IAD Cat. 2&#xD;
      (red skin with skin breakdown). The controls are defined as patients with IAD Cat. 0 (at&#xD;
      risk, no redness and skin intact). The patient will be matched for fecal incontinence.&#xD;
&#xD;
      In total, 380 ICU patients suffering from fecal incontinence will be included. 19 possible&#xD;
      risk factors will be studied.&#xD;
&#xD;
      All data will be collected at one point in time by the research team. Different sources and&#xD;
      methods will be used to collect patient data: skin assessment, patient record, direct patient&#xD;
      observation, routine blood samples.&#xD;
&#xD;
      Specific IAD risk factors will be determined by applying univariate and multivariate binary&#xD;
      logistic regression modeling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2016</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Physiology and Chronic Health Evaluation score (APACHE II)</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of mechanical ventilation</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of dialysis</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of infection</measure>
    <time_frame>Up to six days</time_frame>
    <description>Leucocyten count and white blood cell count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of fever</measure>
    <time_frame>Up to six days</time_frame>
    <description>temperature &gt; 38.0°C</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of inadequate arterial oxygen pressure</measure>
    <time_frame>Up to six days</time_frame>
    <description>PaO2 &lt; 80mmHg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Administration of antibiotics</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Administration of steroids</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of malnutrition</measure>
    <time_frame>Up to six days</time_frame>
    <description>Measured by serum albumin level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of diabetes</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of continence products (diapers, underpads)</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of washing without water (wipes, skin cleansers)</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of urinary incontinence</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of diarrhea</measure>
    <time_frame>Up to six days</time_frame>
    <description>Measured by Bristol Stool Chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of Clostridium difficile</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of mechanical chafing</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of low hemoglobin level</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of enteral nutrition</measure>
    <time_frame>Up to six days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of diminished cognitive awareness</measure>
    <time_frame>Up to six days</time_frame>
    <description>Measured by Glasgow Coma Scale</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">206</enrollment>
  <condition>Irritant Contact Dermatitis</condition>
  <condition>Diaper Rash</condition>
  <condition>Incontinence-associated Dermatitis</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Patients with IAD Category 2 (red skin with skin breakdown)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Patients with IAD Cat. 0 (at risk, no redness and skin intact)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to intensive care unit, with fecal incontinence (a known risk for IAD&#xD;
        Cat. 2 development) will be sampled. The presence of fecal incontinence (any type) will be&#xD;
        used as the only variable for matching (as not to reduce the possibility to interfere with&#xD;
        associated risk factors).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being admitted to the intensive care unit&#xD;
&#xD;
          -  Being fecal incontinent (=unintentional loss of stool)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being &lt; 18 years&#xD;
&#xD;
          -  No contact possible between skin en stool at the perianal region (e.g. due to enteral&#xD;
             stoma)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dimitri Beeckman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Onze-Lieve-Vrouwziekenhuis Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZiekenhuisNetwerk Antwerpen</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Monica</name>
      <address>
        <city>Deurne</city>
        <zip>2100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Jan Palfijn</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Maria Middelares</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Lucas</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jan Yperman Ziekenhuis</name>
      <address>
        <city>Ieper</city>
        <zip>8900</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Jette</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaire Ziekenhuizen van de K.U. Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Sint Maarten</name>
      <address>
        <city>Mechelen</city>
        <zip>2800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Delta</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Nikolaas</name>
      <address>
        <city>Sint-Niklaas</city>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Sint-Augustinus</name>
      <address>
        <city>Veurne</city>
        <zip>8630</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>O.L.V. van Lourdesziekenhuis</name>
      <address>
        <city>Waregem</city>
        <zip>8790</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>De Gasthuiszusters Antwerpen</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.ucvvgent.be</url>
    <description>Website of the research group</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>27841440</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24700170</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>July 17, 2017</last_update_submitted>
  <last_update_submitted_qc>July 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Incontinence-associated dermatitis</keyword>
  <keyword>Risk factor</keyword>
  <keyword>Intensive care unit</keyword>
  <keyword>Prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Dermatitis, Contact</mesh_term>
    <mesh_term>Diaper Rash</mesh_term>
    <mesh_term>Dermatitis, Irritant</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996357
org study id: 2016/0883
nct id: NCT02996357
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Acute Physiology and Chronic Health Evaluation score (APACHE II)
time frame: 1 day
measure: Presence of mechanical ventilation
time frame: Up to six days
measure: Presence of dialysis
time frame: Up to six days
measure: Presence of infection
time frame: Up to six days
description: Leucocyten count and white blood cell count
measure: Presence of fever
time frame: Up to six days
description: temperature > 38.0°C
measure: Presence of inadequate arterial oxygen pressure
time frame: Up to six days
description: PaO2 < 80mmHg
measure: Administration of antibiotics
time frame: Up to six days
measure: Administration of steroids
time frame: Up to six days
measure: Presence of malnutrition
time frame: Up to six days
description: Measured by serum albumin level
measure: Presence of diabetes
time frame: Up to six days
measure: Use of continence products (diapers, underpads)
time frame: Up to six days
measure: Use of washing without water (wipes, skin cleansers)
time frame: Up to six days
measure: Presence of urinary incontinence
time frame: Up to six days
measure: Presence of diarrhea
time frame: Up to six days
description: Measured by Bristol Stool Chart
measure: Presence of Clostridium difficile
time frame: Up to six days
measure: Presence of mechanical chafing
time frame: Up to six days
measure: Presence of low hemoglobin level
time frame: Up to six days
measure: Presence of enteral nutrition
time frame: Up to six days
measure: Presence of diminished cognitive awareness
time frame: Up to six days
description: Measured by Glasgow Coma Scale
arm group label: Cases
description: Patients with IAD Category 2 (red skin with skin breakdown)
arm group label: Controls
description: Patients with IAD Cat. 0 (at risk, no redness and skin intact)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dimitri Beeckman, PhD
role: Principal Investigator
affiliation: University Ghent
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
url: http://www.ucvvgent.be
description: Website of the research group
citation: 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.
PMID: 27841440
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.
PMID: 24700170
responsible party type: Sponsor
mesh term: Fecal Incontinence
mesh term: Dermatitis
mesh term: Dermatitis, Contact
mesh term: Diaper Rash
mesh term: Dermatitis, Irritant
sharing ipd: No