<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/NCT03298113</url>
  </required_header>
  <id_info>
    <org_study_id>CLIN-PROT-EU-05-293312</org_study_id>
    <nct_id>NCT03298113</nct_id>
  </id_info>
  <brief_title>Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis</brief_title>
  <official_title>Effects of an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis Compared to Hospital Standard Care Practice: an Exploratory Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>3M</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin&#xD;
      Protectant in comparison to different local IAD care regimes in hospitals (IAD:&#xD;
      Incontinence-associated Dermatitis)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin&#xD;
      Protectant in comparison to different local IAD care regimes in hospitals (IAD:&#xD;
      incontinence-associated dermatitis). IAD is a skin damage caused by exposure to moisture and&#xD;
      irritants such as urine and/or stool. The clinical appearance ranges from painful erythema to&#xD;
      severe erosion and denudation/skin loss with or without secondary infection. The durable,&#xD;
      long lasting skin protectant (3M study device) is formulated to attach to moist or wet skin&#xD;
      surfaces (i.e., superficial, partial thickness skin loss) to provide better protection&#xD;
      against moisture and irritants under challenging conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    slow enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">November 17, 2017</start_date>
  <completion_date type="Actual">July 10, 2018</completion_date>
  <primary_completion_date type="Actual">July 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Central reader</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Healing of IAD</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Number and percentage of patients completely healed (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)&#xD;
Note: Due to the exploratory design no formal a priori hypothesis was defined for this study. The outcome measure type for all endpoints is &quot;other pre-specified&quot;. The effects were analyzed using descriptive statistics. No confirmatory statements can be made about the effects and no comparative statements are possible. The sponsor decided to early terminate the study after 20 evaluable patients for the intention-to-treat analysis. Reason for the early termination was the slow enrollment rate of patients and overall short length of stay in hospital.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Improvement of IAD Category</measure>
    <time_frame>Up to 21 days depending on length of hospitalization</time_frame>
    <description>Number and percentage of patients improved with regard to IAD category</description>
  </other_outcome>
  <other_outcome>
    <measure>Re-epithelialization of Skin Loss</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Number and percentage of patients with 100% re-epithelialization of skin loss based on structured skin assessment (skin loss: skin is moist, as the epidermal layer is missing).</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to Heal IAD</measure>
    <time_frame>Up to 21 days depending on length of hospitalization</time_frame>
    <description>Time to complete healing of IAD in the terms of days of treatment (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to Improve in IAD Category</measure>
    <time_frame>Up to 21 days depending on length of hospitalization</time_frame>
    <description>Time to improve in IAD category in the terms of days of treatment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Prevention of Skin Loss</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Protection of IAD category 1 patients from developing IAD category 2</description>
  </other_outcome>
  <other_outcome>
    <measure>Prevention of IAD Recurrence</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Protection of completely healed patients from recurrence of IAD during the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Product Cost: IAD 1A</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Mean average daily product cost per patient for IAD 1A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment.&#xD;
Note: One patient in the group treated with Cavilon Advanced Skin Protectant stayed only one day in the study due to an unrelated Severe Adverse Event at night. This had an impact on the product cost calculation. The application interval for Cavilon Advanced Skin Protectant in this study was three days (D1, D4, D7, D10, D13, D16, D19) , while the use of IAD products for standard hospital care was based on manufacturer recommendations, which could correspond to a daily interval with multiple applications.</description>
  </other_outcome>
  <other_outcome>
    <measure>Product Cost : IAD 2A</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Mean average daily cost per patient for IAD 2A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Use of Resources Involved in IAD Therapy</measure>
    <time_frame>Up to 21 days depending on length of hospitalization</time_frame>
    <description>Additional appointments with specialists involved in IAD therapy</description>
  </other_outcome>
  <other_outcome>
    <measure>Nursing Time Related to Cleansing</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Nursing time to clean up incontinence episode</description>
  </other_outcome>
  <other_outcome>
    <measure>Nursing Time Related to Product Application</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Nursing time to administer skin protectants for IAD treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Related to Cleansing: IAD 1A</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Pain scores related to clean up incontinence episode for IAD 1A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain. For cleansing, IAD 1A patients treated with Cavilon Advanced Skin Protectant saw no change in pain due to having no pain reported at baseline nor last visit.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patients able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2, 4, 6, 8, 10), with higher score indicating more pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Related to Cleansing: IAD 2A</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Pain scores related to clean up incontinence episode for IAD 2A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Related to Product Application: IAD 1A</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Pain scores related to application of skin protectants for IAD 1A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Related to Product Application: IAD 2A</measure>
    <time_frame>up to 21 days depending on length of hospitalization</time_frame>
    <description>Pain scores related to application of skin protectants for IAD 2A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline. More extreme negative values denote a larger reduction in pain.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Incontinence-associated Dermatitis</condition>
  <arm_group>
    <arm_group_label>Cavilon Advanced Skin Protectant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IAD Hospital Standard Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Marketed products are applied according to the IAD hospital standard care routine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cavilon Advanced Skin Protectant</intervention_name>
    <description>Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
    <arm_group_label>Cavilon Advanced Skin Protectant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IAD Hospital Standard Care</intervention_name>
    <description>Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
    <arm_group_label>IAD Hospital Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Is the patient 18 years or older?&#xD;
&#xD;
          2. Has the patient or their legally authorized representative signed the Informed Consent&#xD;
             Form?&#xD;
&#xD;
          3. Does the patient have IAD category 1A (IAD 1A: persistent redness without clinical&#xD;
             signs of infection) or IAD category 2A (IAD 2A: skin loss without clinical signs of&#xD;
             infection) in the study area (study area: the sacral region going down to the upper&#xD;
             thighs, bordered approximately 5 cm below the gluteal fold?&#xD;
&#xD;
          4. Is the patient incontinent and does stool and/or urine come into direct contact with&#xD;
             the skin?&#xD;
&#xD;
          5. Is the patient able to be turned/positioned with regard to skin assessment and photo&#xD;
             documentation?&#xD;
&#xD;
          6. Is there a reasonable expectation that the patient will remain in the hospital setting&#xD;
             for at least 7 days?&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is the patient pregnant or breast feeding?&#xD;
&#xD;
          2. Does the patient have a known hypersensitivity or allergy to acrylate or&#xD;
             cyanoacrylate?&#xD;
&#xD;
          3. Does the patient have a stage II, III, IV or unstageable pressure ulcer or other&#xD;
             suspected deep tissue injury in the study area?&#xD;
&#xD;
          4. Does the patient require topical treatment due to a fungal, bacterial or viral&#xD;
             infection in the study area?&#xD;
&#xD;
          5. Does the patient require treatment with topical medication or product other than IAD&#xD;
             treatment in the study area?&#xD;
&#xD;
          6. Does the patient have any other local dermatological disease or skin condition&#xD;
             interfering with this study?&#xD;
&#xD;
          7. Does the patient have any medical condition (e.g. end of life, planned elective&#xD;
             surgery) that in the opinion of the investigator should exclude him/her from&#xD;
             participating in the study?&#xD;
&#xD;
          8. Does the patient participate in another study with a known or implied effect on skin&#xD;
             barrier function?&#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>Matthew M. Cooper, MD</last_name>
    <role>Study Director</role>
    <affiliation>3M</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <state>East Flanders</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <results_first_submitted>July 8, 2019</results_first_submitted>
  <results_first_submitted_qc>September 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 24, 2019</results_first_posted>
  <last_update_submitted>September 4, 2019</last_update_submitted>
  <last_update_submitted_qc>September 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2019</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>Dermatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Protective Agents</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03298113/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cavilon Advanced Skin Protectant</title>
          <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
        </group>
        <group group_id="P2">
          <title>IAD Hospital Standard Care</title>
          <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10">10 subjects were treated w/ Cavilon Advanced Skin Protectant. Study terminated due to low enrollment</participants>
                <participants group_id="P2" count="10">10 subjects were treated with IAD Hospital Standard Care. Study terminated due to low enrollment.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>IAD 1A</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>IAD 2A</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients with Incontinence-associated Dermatitis</population>
      <group_list>
        <group group_id="B1">
          <title>Cavilon Advanced Skin Protectant</title>
          <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
        </group>
        <group group_id="B2">
          <title>IAD Hospital Standard Care</title>
          <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Healing of IAD</title>
        <description>Number and percentage of patients completely healed (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)&#xD;
Note: Due to the exploratory design no formal a priori hypothesis was defined for this study. The outcome measure type for all endpoints is &quot;other pre-specified&quot;. The effects were analyzed using descriptive statistics. No confirmatory statements can be made about the effects and no comparative statements are possible. The sponsor decided to early terminate the study after 20 evaluable patients for the intention-to-treat analysis. Reason for the early termination was the slow enrollment rate of patients and overall short length of stay in hospital.</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the intention-to-treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Healing of IAD</title>
          <description>Number and percentage of patients completely healed (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)&#xD;
Note: Due to the exploratory design no formal a priori hypothesis was defined for this study. The outcome measure type for all endpoints is &quot;other pre-specified&quot;. The effects were analyzed using descriptive statistics. No confirmatory statements can be made about the effects and no comparative statements are possible. The sponsor decided to early terminate the study after 20 evaluable patients for the intention-to-treat analysis. Reason for the early termination was the slow enrollment rate of patients and overall short length of stay in hospital.</description>
          <population>Analysis was done based on the intention-to-treat (ITT) population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Not completely healed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completely healed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Improvement of IAD Category</title>
        <description>Number and percentage of patients improved with regard to IAD category</description>
        <time_frame>Up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the intention-to-treat (ITT) population. In both treatment groups, there were two improvements in the IAD category for patients who started with IAD 2A (IAD 2A: skin loss without clinical signs of infection) and switched to IAD 1A (IAD 1A: persistent redness without clinical signs of infection).</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement of IAD Category</title>
          <description>Number and percentage of patients improved with regard to IAD category</description>
          <population>Analysis was done based on the intention-to-treat (ITT) population. In both treatment groups, there were two improvements in the IAD category for patients who started with IAD 2A (IAD 2A: skin loss without clinical signs of infection) and switched to IAD 1A (IAD 1A: persistent redness without clinical signs of infection).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worsened</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Remained the Same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Re-epithelialization of Skin Loss</title>
        <description>Number and percentage of patients with 100% re-epithelialization of skin loss based on structured skin assessment (skin loss: skin is moist, as the epidermal layer is missing).</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the IAD 2A patient population at start of study (IAD 2A: skin loss without clinical signs of infection)</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Re-epithelialization of Skin Loss</title>
          <description>Number and percentage of patients with 100% re-epithelialization of skin loss based on structured skin assessment (skin loss: skin is moist, as the epidermal layer is missing).</description>
          <population>Analysis was done based on the IAD 2A patient population at start of study (IAD 2A: skin loss without clinical signs of infection)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Not completely ephitelialized</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completely epithelialized</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time to Heal IAD</title>
        <description>Time to complete healing of IAD in the terms of days of treatment (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)</description>
        <time_frame>Up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the intention-to-treat (ITT) population. No healing event occured in the arm/group treated with Cavilon Advanced Skin Protectant in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Heal IAD</title>
          <description>Time to complete healing of IAD in the terms of days of treatment (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)</description>
          <population>Analysis was done based on the intention-to-treat (ITT) population. No healing event occured in the arm/group treated with Cavilon Advanced Skin Protectant in this study.</population>
          <units>Days</units>
          <param>Number</param>
          <units_analyzed>Healing Events</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Healing Events</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="13.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time to Improve in IAD Category</title>
        <description>Time to improve in IAD category in the terms of days of treatment.</description>
        <time_frame>Up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the intention-to-treat (ITT) population. In both treatment groups, there were two improvements in the IAD category for patients who started with IAD 2A (skin loss without clinical signs of infection) and switched to IAD 1A (persistent redness without clinical signs of infection).</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Improve in IAD Category</title>
          <description>Time to improve in IAD category in the terms of days of treatment.</description>
          <population>Analysis was done based on the intention-to-treat (ITT) population. In both treatment groups, there were two improvements in the IAD category for patients who started with IAD 2A (skin loss without clinical signs of infection) and switched to IAD 1A (persistent redness without clinical signs of infection).</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Improvement Events</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Improvement Events</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.50" spread="0.707"/>
                    <measurement group_id="O2" value="5.50" spread="2.121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Prevention of Skin Loss</title>
        <description>Protection of IAD category 1 patients from developing IAD category 2</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the IAD 1A patient population at start of study (IAD 1A: persistent redness without clinical signs of infection)</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Prevention of Skin Loss</title>
          <description>Protection of IAD category 1 patients from developing IAD category 2</description>
          <population>Analysis was done based on the IAD 1A patient population at start of study (IAD 1A: persistent redness without clinical signs of infection)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worsened</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Remained the Same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Prevention of IAD Recurrence</title>
        <description>Protection of completely healed patients from recurrence of IAD during the study.</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>The overall number of participants analyzed represents the number of patients completely healed during this study.&#xD;
No healing event occured in the group treated with Cavilon Advanced Skin Protectant and therefore prevention of IAD recurrence could no be assessed. One healing event occured in the group treated with IAD Hospital Standard Care.</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Prevention of IAD Recurrence</title>
          <description>Protection of completely healed patients from recurrence of IAD during the study.</description>
          <population>The overall number of participants analyzed represents the number of patients completely healed during this study.&#xD;
No healing event occured in the group treated with Cavilon Advanced Skin Protectant and therefore prevention of IAD recurrence could no be assessed. One healing event occured in the group treated with IAD Hospital Standard Care.</population>
          <units>IAD Recurrence Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Product Cost: IAD 1A</title>
        <description>Mean average daily product cost per patient for IAD 1A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment.&#xD;
Note: One patient in the group treated with Cavilon Advanced Skin Protectant stayed only one day in the study due to an unrelated Severe Adverse Event at night. This had an impact on the product cost calculation. The application interval for Cavilon Advanced Skin Protectant in this study was three days (D1, D4, D7, D10, D13, D16, D19) , while the use of IAD products for standard hospital care was based on manufacturer recommendations, which could correspond to a daily interval with multiple applications.</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the IAD 1A population at start of study (IAD1A: persistent redness without clinical signs of infection).</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Product Cost: IAD 1A</title>
          <description>Mean average daily product cost per patient for IAD 1A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment.&#xD;
Note: One patient in the group treated with Cavilon Advanced Skin Protectant stayed only one day in the study due to an unrelated Severe Adverse Event at night. This had an impact on the product cost calculation. The application interval for Cavilon Advanced Skin Protectant in this study was three days (D1, D4, D7, D10, D13, D16, D19) , while the use of IAD products for standard hospital care was based on manufacturer recommendations, which could correspond to a daily interval with multiple applications.</description>
          <population>Analysis was done based on the IAD 1A population at start of study (IAD1A: persistent redness without clinical signs of infection).</population>
          <units>Euro</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.56" spread="3.80"/>
                    <measurement group_id="O2" value="0.75" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Product Cost : IAD 2A</title>
        <description>Mean average daily cost per patient for IAD 2A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the IAD 2A population at start of study (IAD 2A: Skin loss without clinical signs of infection)</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Product Cost : IAD 2A</title>
          <description>Mean average daily cost per patient for IAD 2A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment</description>
          <population>Analysis was done based on the IAD 2A population at start of study (IAD 2A: Skin loss without clinical signs of infection)</population>
          <units>Euro</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.67" spread="2.53"/>
                    <measurement group_id="O2" value="1.21" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Use of Resources Involved in IAD Therapy</title>
        <description>Additional appointments with specialists involved in IAD therapy</description>
        <time_frame>Up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the intention-to-treat (ITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Resources Involved in IAD Therapy</title>
          <description>Additional appointments with specialists involved in IAD therapy</description>
          <population>Analysis was done based on the intention-to-treat (ITT) population</population>
          <units>Appointments</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Nursing Time Related to Cleansing</title>
        <description>Nursing time to clean up incontinence episode</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the intention-to-treat (ITT) population Note: One patient allocated to Cavilon Advanced Skin Protectant participated in the study for only one day. Therefore, the time required to clean up the incontinence episode could not be measured (n = 1 missing data set; only 9 data sets were available for analysis).</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Nursing Time Related to Cleansing</title>
          <description>Nursing time to clean up incontinence episode</description>
          <population>Analysis was done based on the intention-to-treat (ITT) population Note: One patient allocated to Cavilon Advanced Skin Protectant participated in the study for only one day. Therefore, the time required to clean up the incontinence episode could not be measured (n = 1 missing data set; only 9 data sets were available for analysis).</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.67" spread="7.99"/>
                    <measurement group_id="O2" value="12.41" spread="8.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Nursing Time Related to Product Application</title>
        <description>Nursing time to administer skin protectants for IAD treatment</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the intention-to-treat (ITT) population Note: For two patients allocated to Cavilon Advanced Skin Protectant the nursing time to administer the skin protectant was not recorded (n = 2 missing data sets; only 8 data sets were available for analysis).</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Nursing Time Related to Product Application</title>
          <description>Nursing time to administer skin protectants for IAD treatment</description>
          <population>Analysis was done based on the intention-to-treat (ITT) population Note: For two patients allocated to Cavilon Advanced Skin Protectant the nursing time to administer the skin protectant was not recorded (n = 2 missing data sets; only 8 data sets were available for analysis).</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.49" spread="3.20"/>
                    <measurement group_id="O2" value="2.02" spread="1.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pain Related to Cleansing: IAD 1A</title>
        <description>Pain scores related to clean up incontinence episode for IAD 1A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain. For cleansing, IAD 1A patients treated with Cavilon Advanced Skin Protectant saw no change in pain due to having no pain reported at baseline nor last visit.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patients able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2, 4, 6, 8, 10), with higher score indicating more pain.</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the IAD 1A study population at start of study (IAD 1A: persistent redness without clinical signs of infection) Note: One patient allocated to IAD Hospital Standard Care was not able to report pain (n = 1 missing data set; only n = 3 data sets were available for analysis)</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Related to Cleansing: IAD 1A</title>
          <description>Pain scores related to clean up incontinence episode for IAD 1A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain. For cleansing, IAD 1A patients treated with Cavilon Advanced Skin Protectant saw no change in pain due to having no pain reported at baseline nor last visit.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patients able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2, 4, 6, 8, 10), with higher score indicating more pain.</description>
          <population>Analysis was done based on the IAD 1A study population at start of study (IAD 1A: persistent redness without clinical signs of infection) Note: One patient allocated to IAD Hospital Standard Care was not able to report pain (n = 1 missing data set; only n = 3 data sets were available for analysis)</population>
          <units>Change in score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.000"/>
                    <measurement group_id="O2" value="-2.00" spread="3.464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pain Related to Cleansing: IAD 2A</title>
        <description>Pain scores related to clean up incontinence episode for IAD 2A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the IAD 2A population at start of study (IAD 2A: skin loss without clinical signs of infection) Note: One patient allocated to Cavilon Advanced Skin Protectant was not able to report pain (n = 1 missing data set; only n = 6 data sets were available for analysis)</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Related to Cleansing: IAD 2A</title>
          <description>Pain scores related to clean up incontinence episode for IAD 2A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.</description>
          <population>Analysis was done based on the IAD 2A population at start of study (IAD 2A: skin loss without clinical signs of infection) Note: One patient allocated to Cavilon Advanced Skin Protectant was not able to report pain (n = 1 missing data set; only n = 6 data sets were available for analysis)</population>
          <units>Change in score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.00" spread="4.147"/>
                    <measurement group_id="O2" value="-0.33" spread="4.274"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pain Related to Product Application: IAD 1A</title>
        <description>Pain scores related to application of skin protectants for IAD 1A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on the IAD 1A population at start of study (IAD 1A: persistent redness without clinical signs of infection) Note: One patient allocated to IAD Hospital Standard Care was not able to report pain (n = 1 missing data set, only n= 3 data sets were available for analysis)</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Related to Product Application: IAD 1A</title>
          <description>Pain scores related to application of skin protectants for IAD 1A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.</description>
          <population>Analysis was done based on the IAD 1A population at start of study (IAD 1A: persistent redness without clinical signs of infection) Note: One patient allocated to IAD Hospital Standard Care was not able to report pain (n = 1 missing data set, only n= 3 data sets were available for analysis)</population>
          <units>Change in score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.000"/>
                    <measurement group_id="O2" value="0.00" spread="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pain Related to Product Application: IAD 2A</title>
        <description>Pain scores related to application of skin protectants for IAD 2A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline. More extreme negative values denote a larger reduction in pain.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.</description>
        <time_frame>up to 21 days depending on length of hospitalization</time_frame>
        <population>Analysis was done based on IAD 2A population at start of study (IAD 2A: skin loss without clinical signs of infection) Note: One patient in the Cavilon Advanced Skin Protectant group and one patient in the IAD Hospital Standard care group were not able to report pain.</population>
        <group_list>
          <group group_id="O1">
            <title>Cavilon Advanced Skin Protectant</title>
            <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
          </group>
          <group group_id="O2">
            <title>IAD Hospital Standard Care</title>
            <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Related to Product Application: IAD 2A</title>
          <description>Pain scores related to application of skin protectants for IAD 2A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline. More extreme negative values denote a larger reduction in pain.&#xD;
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.</description>
          <population>Analysis was done based on IAD 2A population at start of study (IAD 2A: skin loss without clinical signs of infection) Note: One patient in the Cavilon Advanced Skin Protectant group and one patient in the IAD Hospital Standard care group were not able to report pain.</population>
          <units>Change in score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.33" spread="4.082"/>
                    <measurement group_id="O2" value="-1.20" spread="5.020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 months</time_frame>
      <desc>ISO 14155 Definitions (ISO: International Organization for Standardization)</desc>
      <group_list>
        <group group_id="E1">
          <title>Cavilon Advanced Skin Protectant</title>
          <description>Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.&#xD;
Cavilon Advanced Skin Protectant: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.</description>
        </group>
        <group group_id="E2">
          <title>IAD Hospital Standard Care</title>
          <description>Marketed products are applied according to the IAD hospital standard care routine.&#xD;
IAD Hospital Standard Care: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vaginal mycosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device adhesion issue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination due to slow enrollment rate and overall short length of hospital stay leading to small numbers of subjects analyzed (n = 20 ITT). No confirmatory and comparative statements can be made about the effects (exploratory study design).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Nancy Klinger, Clinical Manager</name_or_title>
      <organization>3M Healthcare Business Group</organization>
      <phone>651 736 ext 5825</phone>
      <email>nmklinger@mmm.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03298113
org study id: CLIN-PROT-EU-05-293312
nct id: NCT03298113
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin
      Protectant in comparison to different local IAD care regimes in hospitals (IAD:
      Incontinence-associated Dermatitis)
The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin
      Protectant in comparison to different local IAD care regimes in hospitals (IAD:
      incontinence-associated dermatitis). IAD is a skin damage caused by exposure to moisture and
      irritants such as urine and/or stool. The clinical appearance ranges from painful erythema to
      severe erosion and denudation/skin loss with or without secondary infection. The durable,
      long lasting skin protectant (3M study device) is formulated to attach to moist or wet skin
      surfaces (i.e., superficial, partial thickness skin loss) to provide better protection
      against moisture and irritants under challenging conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Central reader
measure: Healing of IAD
time frame: up to 21 days depending on length of hospitalization
description: Number and percentage of patients completely healed (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)
Note: Due to the exploratory design no formal a priori hypothesis was defined for this study. The outcome measure type for all endpoints is "other pre-specified". The effects were analyzed using descriptive statistics. No confirmatory statements can be made about the effects and no comparative statements are possible. The sponsor decided to early terminate the study after 20 evaluable patients for the intention-to-treat analysis. Reason for the early termination was the slow enrollment rate of patients and overall short length of stay in hospital.
measure: Improvement of IAD Category
time frame: Up to 21 days depending on length of hospitalization
description: Number and percentage of patients improved with regard to IAD category
measure: Re-epithelialization of Skin Loss
time frame: up to 21 days depending on length of hospitalization
description: Number and percentage of patients with 100% re-epithelialization of skin loss based on structured skin assessment (skin loss: skin is moist, as the epidermal layer is missing).
measure: Time to Heal IAD
time frame: Up to 21 days depending on length of hospitalization
description: Time to complete healing of IAD in the terms of days of treatment (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)
measure: Time to Improve in IAD Category
time frame: Up to 21 days depending on length of hospitalization
description: Time to improve in IAD category in the terms of days of treatment.
measure: Prevention of Skin Loss
time frame: up to 21 days depending on length of hospitalization
description: Protection of IAD category 1 patients from developing IAD category 2
measure: Prevention of IAD Recurrence
time frame: up to 21 days depending on length of hospitalization
description: Protection of completely healed patients from recurrence of IAD during the study.
measure: Product Cost: IAD 1A
time frame: up to 21 days depending on length of hospitalization
description: Mean average daily product cost per patient for IAD 1A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment.
Note: One patient in the group treated with Cavilon Advanced Skin Protectant stayed only one day in the study due to an unrelated Severe Adverse Event at night. This had an impact on the product cost calculation. The application interval for Cavilon Advanced Skin Protectant in this study was three days (D1, D4, D7, D10, D13, D16, D19) , while the use of IAD products for standard hospital care was based on manufacturer recommendations, which could correspond to a daily interval with multiple applications.
measure: Product Cost : IAD 2A
time frame: up to 21 days depending on length of hospitalization
description: Mean average daily cost per patient for IAD 2A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment
measure: Use of Resources Involved in IAD Therapy
time frame: Up to 21 days depending on length of hospitalization
description: Additional appointments with specialists involved in IAD therapy
measure: Nursing Time Related to Cleansing
time frame: up to 21 days depending on length of hospitalization
description: Nursing time to clean up incontinence episode
measure: Nursing Time Related to Product Application
time frame: up to 21 days depending on length of hospitalization
description: Nursing time to administer skin protectants for IAD treatment
measure: Pain Related to Cleansing: IAD 1A
time frame: up to 21 days depending on length of hospitalization
description: Pain scores related to clean up incontinence episode for IAD 1A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain. For cleansing, IAD 1A patients treated with Cavilon Advanced Skin Protectant saw no change in pain due to having no pain reported at baseline nor last visit.
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patients able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2, 4, 6, 8, 10), with higher score indicating more pain.
measure: Pain Related to Cleansing: IAD 2A
time frame: up to 21 days depending on length of hospitalization
description: Pain scores related to clean up incontinence episode for IAD 2A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain.
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.
measure: Pain Related to Product Application: IAD 1A
time frame: up to 21 days depending on length of hospitalization
description: Pain scores related to application of skin protectants for IAD 1A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline.
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.
measure: Pain Related to Product Application: IAD 2A
time frame: up to 21 days depending on length of hospitalization
description: Pain scores related to application of skin protectants for IAD 2A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline. More extreme negative values denote a larger reduction in pain.
Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.
arm group label: Cavilon Advanced Skin Protectant
arm group type: Experimental
description: Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.
arm group label: IAD Hospital Standard Care
arm group type: Other
description: Marketed products are applied according to the IAD hospital standard care routine.
intervention type: Device
intervention name: Cavilon Advanced Skin Protectant
description: Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.
arm group label: Cavilon Advanced Skin Protectant
intervention type: Device
intervention name: IAD Hospital Standard Care
description: Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.
arm group label: IAD Hospital Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew M. Cooper, MD
role: Study Director
affiliation: 3M
facility: 
facility: 
facility: 
country: Belgium
country: Germany
country: United Kingdom
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Protective Agents
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination due to slow enrollment rate and overall short length of hospital stay leading to small numbers of subjects analyzed (n = 20 ITT). No confirmatory and comparative statements can be made about the effects (exploratory study design).
point of contact: 