<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/NCT03023072</url>
  </required_header>
  <id_info>
    <org_study_id>CR-CWS2016-001</org_study_id>
    <nct_id>NCT03023072</nct_id>
  </id_info>
  <brief_title>Evaluation of an Incontinence Product</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hill-Rom</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hill-Rom</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the sponsor's Incontinence Product reduces&#xD;
      patient exposure time to a wet and/or soiled incontinence pad.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Site no longer met criteria&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient exposure time following an incontinence event</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction surveys</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Staff satisfaction surveys</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family/patient support member surveys</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of incontinence associated skin irritation and breakdown issues</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of pressure injuries</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">9</enrollment>
  <condition>Incontinence</condition>
  <arm_group>
    <arm_group_label>Phase 1</arm_group_label>
    <description>Subjects will use the incontinence pad with incontinence detection notifications turned on</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2</arm_group_label>
    <description>Subjects will use the incontinence pad with incontinence notification turned off</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Incontinence Detection System</intervention_name>
    <arm_group_label>Phase 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute Care Unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking/reading adults, age ≥ 18 years&#xD;
&#xD;
          -  Incontinent (fecal, urine, or dual incontinence)&#xD;
&#xD;
          -  Patients with dual incontinence who require use of a fecal management system (but no&#xD;
             urinary catheter)&#xD;
&#xD;
          -  Absence of skin irritation, breakdown, and pressure injuries present in the buttocks,&#xD;
             sacrum, and/or perineal areas at the time of enrollment; minor irritation may be&#xD;
             acceptable at the discretion of the Study Investigator&#xD;
&#xD;
          -  Willing and able to provide written informed consent or legal authorized&#xD;
             representative is willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of skin irritation and/or breakdown including but not limited to IAD or&#xD;
             pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time&#xD;
             of enrollment; minor irritation may be acceptable at the discretion of the study&#xD;
             Investigator&#xD;
&#xD;
          -  Require use of an absorbent undergarment (e.g. Depends) or catheter as the primary&#xD;
             incontinence management strategy&#xD;
&#xD;
          -  Is considered to be near death or requires hospice care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Parkview Regional Medical Center</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 6, 2018</last_update_submitted>
  <last_update_submitted_qc>February 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03023072
org study id: CR-CWS2016-001
nct id: NCT03023072
lead sponsor: 
has dmc: No
The purpose of this study is to determine if the sponsor's Incontinence Product reduces
      patient exposure time to a wet and/or soiled incontinence pad.
observational model: Case-Control
time perspective: Prospective
measure: Patient exposure time following an incontinence event
time frame: Through study completion, an average of 6 months
measure: Patient satisfaction surveys
time frame: Through study completion, an average of 6 months
measure: Staff satisfaction surveys
time frame: Through study completion, an average of 6 months
measure: Family/patient support member surveys
time frame: Through study completion, an average of 6 months
measure: Incidence of incontinence associated skin irritation and breakdown issues
time frame: Through study completion, an average of 6 months
measure: Incidence of pressure injuries
time frame: Through study completion, an average of 6 months
arm group label: Phase 1
description: Subjects will use the incontinence pad with incontinence detection notifications turned on
arm group label: Phase 2
description: Subjects will use the incontinence pad with incontinence notification turned off
intervention type: Other
intervention name: Incontinence Detection System
arm group label: Phase 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No