<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/NCT03257787</url>
  </required_header>
  <id_info>
    <org_study_id>CP265_15</org_study_id>
    <nct_id>NCT03257787</nct_id>
  </id_info>
  <brief_title>Evaluation of the Performance of a New Adhesive Strip</brief_title>
  <official_title>A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coloplast A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coloplast A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the performance of a new adhesive strip when impacted by output.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">September 23, 2017</completion_date>
  <primary_completion_date type="Actual">August 23, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trans epidermal water loss</measure>
    <time_frame>8 hours</time_frame>
    <description>The trans epidermal water loss is a measure of the skins barrier function. There is always a loss of water from the skin due to evaporation. However, when the barrier is damaged this evaporation increases. Thus, trans epidermal water loss can be used to assess damage to the skin.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Ileostomy - Stoma</condition>
  <arm_group>
    <arm_group_label>Test of a new adhesive strip</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A new adhesive strip has been developed and will be tested in this investigation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>new adhesive strip</intervention_name>
    <description>This is a strip made of a newly developed adhesive</description>
    <arm_group_label>Test of a new adhesive strip</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have given written informed consent&#xD;
&#xD;
          2. Be at least 18 years of age and have full legal capacity&#xD;
&#xD;
          3. Have had a stoma for more than one year&#xD;
&#xD;
          4. Have intact skin on the area used in the evaluation&#xD;
&#xD;
          5. Has a stoma with a diameter up to (≤) 35 mm&#xD;
&#xD;
          6. Have a peristomal area accessible for application of adhesive strips (assessed by&#xD;
             investigating scientist)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1 Currently receiving or have within the past 2 month received radio- and/or chemotherapy&#xD;
        2. Currently receiving or have within the past month received topical steroid treatment in&#xD;
        the peristomal skin area or systemic steroid (tablet/injection) treatment.&#xD;
&#xD;
        3. Are pregnant or breastfeeding 4. Having dermatological problems in the peristomal or&#xD;
        abdominal area (assessed by investigating scientist) 5. Actively participating in other&#xD;
        interventional clinical investigations or have previously participated in this&#xD;
        investigation.&#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>Lene F Nielsen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of preclinical department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Coloplast A/S</name>
      <address>
        <city>Humlebæk</city>
        <zip>3050</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>November 7, 2017</last_update_submitted>
  <last_update_submitted_qc>November 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03257787
org study id: CP265_15
nct id: NCT03257787
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the performance of a new adhesive strip when impacted by output.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Trans epidermal water loss
time frame: 8 hours
description: The trans epidermal water loss is a measure of the skins barrier function. There is always a loss of water from the skin due to evaporation. However, when the barrier is damaged this evaporation increases. Thus, trans epidermal water loss can be used to assess damage to the skin.
arm group label: Test of a new adhesive strip
arm group type: Experimental
description: A new adhesive strip has been developed and will be tested in this investigation.
intervention type: Other
intervention name: new adhesive strip
description: This is a strip made of a newly developed adhesive
arm group label: Test of a new adhesive strip
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lene F Nielsen
role: Principal Investigator
affiliation: Head of preclinical department
facility: 
country: Denmark
responsible party type: Sponsor