<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/NCT04449354</url>
  </required_header>
  <id_info>
    <org_study_id>CE-GAX-001-01 V4</org_study_id>
    <nct_id>NCT04449354</nct_id>
  </id_info>
  <brief_title>HidraWear AX HS Study</brief_title>
  <official_title>A Study to Evaluate the HS Specific Wound Dressing HidraWear AX in the Home Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HidraMed Solutions Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HidraMed Solutions Ltd</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>
      The product, HidraWear AX (www.hidrawear.com) is and adhesive free wound dressing system for&#xD;
      the every day home care of Hidradenitis Suppurativa (HS), a debilitating disease of the skin&#xD;
      for which there are limited wound dressing products.&#xD;
&#xD;
      This is a study to assess the use HidraWear Ax vs current product and method of use, and to&#xD;
      determine the impact on patients' quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective is to evaluate the ease of use of Hidrawear AX compared to the subject's&#xD;
      existing product use in 23 subjects with HS (Hidradenitis Suppurativa).&#xD;
&#xD;
      Secondary objectives are to evaluate if Hidrawear AX:&#xD;
&#xD;
        -  Is comfortable&#xD;
&#xD;
        -  Improves quality of life&#xD;
&#xD;
        -  Faster to use than the subject's existing product&#xD;
&#xD;
        -  Reduces dressing related pain&#xD;
&#xD;
        -  Secure dressing retention&#xD;
&#xD;
      This pilot study will evaluate usability - the safety, efficacy and performance of HidraWear&#xD;
      AX in the home setting. Quality of life, ease of use and comfort of Hidrawear AX will be&#xD;
      assessed.&#xD;
&#xD;
      The clinical effect of the wound pad will not be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2019</start_date>
  <completion_date type="Actual">October 3, 2020</completion_date>
  <primary_completion_date type="Actual">October 3, 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of Life (QoL) measured using the Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>3 weeks</time_frame>
    <description>Questionnaire determining the impact of dermatological disease on patient's quality of life. Scored out of 30, high score indicates impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Pain Analogue Scale Day 21 vs Day 0</measure>
    <time_frame>3 weeks</time_frame>
    <description>Patient reported pain, 10 point scale, high score indicates pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of Use Day 21 vs Day 0</measure>
    <time_frame>3 weeks</time_frame>
    <description>10 point scale, self reported . High score indicates difficulty using product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken to dress wounds</measure>
    <time_frame>3 weeks</time_frame>
    <description>10 point scale, high score indicating product is time consuming to use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Image visual analogue scale</measure>
    <time_frame>3 weeks</time_frame>
    <description>10 point scale, self reported, high score indicates poor body image</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <condition>Hidradenitis</condition>
  <arm_group>
    <arm_group_label>Quality of Life assessment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>HidraWear AX Garment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HidraWear Ax</intervention_name>
    <description>An adhesive free wound dressing fixation device for people living with Hidradenitis Suppurativa (HS), Hidrawear AX, designed to make dressing changes quick and easy for subjects. The unique features of the product completely remove the use of adhesives on the skin.The body conforming garment acts as a second skin and incorporates largely perforated panels over wound affected areas, minimising skin contact and aerating the area. The main function of the perforated is to act as a retaining device for the wound pads. The garment facilitates easy insertion, removal, precise positioning and adjustment of a non- adhesive wound dressing onto the effected wound space. The perforated section of the garment sits on the outer surface of the dressing providing provisional fixation. Next, an outer patch is placed on the outside of the garment on the footprint of the dressing. Through a hook and loop mechanism the dressing is now fully secured in place.</description>
    <arm_group_label>Quality of Life assessment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In order to be eligible to participate in this study, an individual must meet all of&#xD;
             the following criteria:&#xD;
&#xD;
               1. Provision of signed and dated informed consent form in English.&#xD;
&#xD;
               2. Stated willingness to comply with all study procedures and availability for the&#xD;
                  duration of the study&#xD;
&#xD;
               3. Female, aged &gt;18&#xD;
&#xD;
               4. Diagnosed with Hidradenitis Suppurativa&#xD;
&#xD;
               5. Hidradenitis Suppurativa affecting the axilla&#xD;
&#xD;
               6. Exuding lesion that requires wound dressings&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Recent surgery &lt;3 months in axilla 2. Psoriasis, Dermatitis or skin conditions/rash&#xD;
             other than Hidradenitis Suppurativa on or near affected area 3. Pregnancy or lactation&#xD;
             4. Known allergic reactions to components of Hidrawear AX&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Product is designed for females</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Trevor Duffy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hermitage Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hermitage Clinic</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</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/NCT04449354
org study id: CE-GAX-001-01 V4
nct id: NCT04449354
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The product, HidraWear AX (www.hidrawear.com) is and adhesive free wound dressing system for
      the every day home care of Hidradenitis Suppurativa (HS), a debilitating disease of the skin
      for which there are limited wound dressing products.

      This is a study to assess the use HidraWear Ax vs current product and method of use, and to
      determine the impact on patients' quality of life.
The objective is to evaluate the ease of use of Hidrawear AX compared to the subject's
      existing product use in 23 subjects with HS (Hidradenitis Suppurativa).

      Secondary objectives are to evaluate if Hidrawear AX:

        -  Is comfortable

        -  Improves quality of life

        -  Faster to use than the subject's existing product

        -  Reduces dressing related pain

        -  Secure dressing retention

      This pilot study will evaluate usability - the safety, efficacy and performance of HidraWear
      AX in the home setting. Quality of life, ease of use and comfort of Hidrawear AX will be
      assessed.

      The clinical effect of the wound pad will not be assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Quality of Life (QoL) measured using the Dermatology Life Quality Index (DLQI)
time frame: 3 weeks
description: Questionnaire determining the impact of dermatological disease on patient's quality of life. Scored out of 30, high score indicates impairment.
measure: Visual Pain Analogue Scale Day 21 vs Day 0
time frame: 3 weeks
description: Patient reported pain, 10 point scale, high score indicates pain
measure: Ease of Use Day 21 vs Day 0
time frame: 3 weeks
description: 10 point scale, self reported . High score indicates difficulty using product
measure: Time taken to dress wounds
time frame: 3 weeks
description: 10 point scale, high score indicating product is time consuming to use
measure: Body Image visual analogue scale
time frame: 3 weeks
description: 10 point scale, self reported, high score indicates poor body image
arm group label: Quality of Life assessment
arm group type: Other
description: HidraWear AX Garment
intervention type: Device
intervention name: HidraWear Ax
description: An adhesive free wound dressing fixation device for people living with Hidradenitis Suppurativa (HS), Hidrawear AX, designed to make dressing changes quick and easy for subjects. The unique features of the product completely remove the use of adhesives on the skin.The body conforming garment acts as a second skin and incorporates largely perforated panels over wound affected areas, minimising skin contact and aerating the area. The main function of the perforated is to act as a retaining device for the wound pads. The garment facilitates easy insertion, removal, precise positioning and adjustment of a non- adhesive wound dressing onto the effected wound space. The perforated section of the garment sits on the outer surface of the dressing providing provisional fixation. Next, an outer patch is placed on the outside of the garment on the footprint of the dressing. Through a hook and loop mechanism the dressing is now fully secured in place.
arm group label: Quality of Life assessment
criteria: 
gender: Female
gender based: Yes
gender description: Product is designed for females
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Trevor Duffy
role: Principal Investigator
affiliation: Hermitage Clinic
facility: 
country: Ireland
responsible party type: Sponsor
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
sharing ipd: No