<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/NCT03815240</url>
  </required_header>
  <id_info>
    <org_study_id>CRC-SP-A-32</org_study_id>
    <nct_id>NCT03815240</nct_id>
  </id_info>
  <brief_title>Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin</brief_title>
  <official_title>Comparing the Effects of Three Different Dressings on the Cutaneous Response to Pressure and Shear of Sacral Skin: an Exploratory Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Skin functional parameters such as erythema or stratum corneum hydration have been&#xD;
      successfully used in PU prevention research. These parameters are able to discriminate&#xD;
      effects of different loading intensities and to measure PU preventive device performance.&#xD;
&#xD;
      The overall aim of this study is to measure the effects of Mepilex® Border Sacrum Dressing on&#xD;
      the skin structure and function during mechanical loading compared to (1) no dressing, (2)&#xD;
      ALLEVYN Life Sacrum Dressing and (3) Optifoam® Gentle Liquitrap Sacrum Dressing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pressure ulcers (PUs) are severe and unwanted cutaneous lesions and subcutaneous wounds&#xD;
      caused by prolonged skin and underlying soft tissue deformation. In the supine position they&#xD;
      predominantly occur near to bony prominences, like at the sacral area. The cornerstone of PU&#xD;
      prevention is repositioning, early mobilization and the use of special support surfaces. In&#xD;
      addition, empirical evidence suggests that the application of preventive dressings on PU&#xD;
      predilection sites helps to prevent PU development.&#xD;
&#xD;
      Skin functional parameters such as erythema or stratum corneum hydration have been&#xD;
      successfully used in PU prevention research. These parameters are able to discriminate&#xD;
      effects of different loading intensities and to measure PU preventive device performance.&#xD;
      Recently it could be shown that there are associations between structural and functional skin&#xD;
      changes at the sacral area during loading. The overall aim of this study is to measure the&#xD;
      effects of Mepilex® Border Sacrum Dressing on the skin structure and function during&#xD;
      mechanical loading compared to no dressing, ALLEVYN Life Sacrum and Optifoam® Gentle&#xD;
      Liquitrap Sacrum.&#xD;
&#xD;
      The procedure of one visit will be as follows:&#xD;
&#xD;
      After a skin acclimatization time of 30 minutes baseline measurements and Cyanoacrylate Skin&#xD;
      Surface (CSSS)-stripping will be performed. Then a randomization envelope will be opened and&#xD;
      the corresponding dressing will be applied or the skin will be left uncovered. The subject&#xD;
      will then lie in supine position on a standard hospital mattress for a loading period of 3.5&#xD;
      hours. Every 30 minutes the head of the bed will be elevated to 45° for five minutes. During&#xD;
      these five minutes, the participants will be instructed to bend their knees and to drag the&#xD;
      feet repeatedly forth and back 10 times in order to simulate shear forces. The whole exercise&#xD;
      will be done six times, after 0.5, 1, 1.5, 2, 2.5 and 3 hours. After 3.5 hours loading time&#xD;
      in supine position the subjects will move into prone position. The dressing (if present) will&#xD;
      be removed and all skin measurements and CSSS-stripping will be conducted again. The subjects&#xD;
      will come back for another three times completing the remaining interventions. At the end,&#xD;
      each volunteer will have received all three types of dressings once and once no dressing. In&#xD;
      between, there are at least 3 weeks to prevent possible carry over effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Actual">July 23, 2019</completion_date>
  <primary_completion_date type="Actual">July 23, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Skin Surface Temperature From Baseline</measure>
    <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
    <description>A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Stratum Corneum Hydration (SCH) From Baseline</measure>
    <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
    <description>Corneometer CM 825 (Courage and Khazaka Electronic GmbH) was used to measure the stratum corneum hydration (SCH) at the sacrum in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. The measurement is based on capacitance measurement of a dielectric medium. The change in the dielectric constant due to skin surface hydration by capacitance differences of a precision capacitor is measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Erythema Index (EI) From Baseline</measure>
    <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
    <description>Mexameter MX18 (Courage and Khazaka Electronic GmbH) was used to measure the Erythema index at the sacrum. This device uses specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin) and presents values from 0 to 999. Lower values represent less redness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Average Roughness (Rz) From Baseline</measure>
    <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
    <description>The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Arithmetic Average Roughness (Ra) From Baseline</measure>
    <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
    <description>The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Maximum Roughness (Rmax) From Baseline</measure>
    <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
    <description>The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Interleukin IL-1alpha Concentration From Baseline</measure>
    <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
    <description>Based on Cyanoacrylate Skin Surface (CSSS)-Stripping, corneocytes was collected in order to analyse changes regarding interleukin IL-1alpha concentrations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurence of Sacral Pain</measure>
    <time_frame>Captured from baseline until the end of the loading period after 3.5 hours at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
    <description>The occurrence of pain (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Until First Reporting of Sacral Pain</measure>
    <time_frame>Sacral pain was assessed from baseline up until 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
    <description>Time from baseline until the subject reported pain at sacrum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Erythema Score From Baseline</measure>
    <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
    <description>Erythema was assessed by visual inspection. A metric scale will be used: 0 = none 1 = mild (slight reddening), 2 = moderate (distinct redness), 3 = severe (strong redness, dark red)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Pressure Ulcer Prevention</condition>
  <arm_group>
    <arm_group_label>no dressing (A)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No dressing will be applied at sacrum before 3.5 hours loading period in supine position</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mepilex (B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>'Mepilex® Border Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Allevyn (C)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>'ALLEVYN Life Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Optifaom (D)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>'Optifoam® Gentle Sacrum' Dressing will be applied at sacrum before 3.5 hours loading period in supine position</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No dressing</intervention_name>
    <description>no dressing at sacrum</description>
    <arm_group_label>no dressing (A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mepilex® Border Sacrum</intervention_name>
    <description>adhesive sacrum dressing</description>
    <arm_group_label>Mepilex (B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ALLEVYN Life Sacrum</intervention_name>
    <description>adhesive sacrum dressing</description>
    <arm_group_label>Allevyn (C)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Optifoam® Gentle Sacrum</intervention_name>
    <description>adhesive sacrum dressing</description>
    <arm_group_label>Optifaom (D)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female volunteers&#xD;
&#xD;
          -  65 to 80 years&#xD;
&#xD;
          -  Body Mass Index 18.5 to 29.9 kg/m2&#xD;
&#xD;
          -  Non-smoker of at least one year (including electronic-cigarettes)&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Being free of any clinical dermatosis in the investigational area&#xD;
&#xD;
          -  Intact sacral skin without scars&#xD;
&#xD;
          -  Skin phototype I, II, or III (according to Fitzpatrick)&#xD;
&#xD;
          -  No regular use of leave-on products on the sacral skin&#xD;
&#xD;
          -  Willing and able to fulfil the study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disability to maintain in supine or prone Position&#xD;
&#xD;
          -  Acute diseases&#xD;
&#xD;
          -  Known hyper-sensibility or allergy to the study product or any of its ingredients&#xD;
&#xD;
          -  Extensive UV exposure 4 weeks before study inclusion&#xD;
&#xD;
          -  Use of topical treatment on the investigational areas or systemic Treatment within the&#xD;
             4 past weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids,&#xD;
             NSIDS etc.) that would interfere with assessment and/or investigational treatments&#xD;
&#xD;
          -  Medical history of skin cancer&#xD;
&#xD;
          -  History of established Diabetes mellitus, cardiac or renal insufficiency, COPD&#xD;
&#xD;
          -  Chronic inflammatory skin disorders such as atopic dermatitis, psoriasis, lichen&#xD;
             planus&#xD;
&#xD;
          -  Participation in another study 4 weeks prior to study start&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Charité-Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <results_first_submitted>April 6, 2020</results_first_submitted>
  <results_first_submitted_qc>April 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2020</results_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>PD Dr. Jan Kottner</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pressure Ulcer Prevention</keyword>
  <keyword>Preventive Dressings</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <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 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03815240/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study took place at the Clinical Research Center for Hair and Skin Science in Berlin, Germany from January 2019 to July 2019 and involved 12 healthy female volunteers</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>No Dressing, Mepilex, Allevyn, Optifoam</title>
          <description>Dressing application order:&#xD;
no dressing (A), Mepilex® Border Sacrum (B), ALLEVYN Life Sacrum (C), Optifoam® Gentle Sacrum (D)</description>
        </group>
        <group group_id="P2">
          <title>Mepilex, no Dressing, Optifoam, Allevyn</title>
          <description>Dressing application order:&#xD;
Mepilex® Border Sacrum (B), no dressing (A), Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C)</description>
        </group>
        <group group_id="P3">
          <title>No Dressing, Mepilex, Optifoam, Allevyn</title>
          <description>Dressing application order:&#xD;
no dressing (A), Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C)</description>
        </group>
        <group group_id="P4">
          <title>No Dressing, Allevyn, Mepilex, Optifoam</title>
          <description>Dressing application order:&#xD;
no dressing (A), ALLEVYN Life Sacrum (C), Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D)</description>
        </group>
        <group group_id="P5">
          <title>Optifoam, Allevyn, no Dressing, Mepilex</title>
          <description>Dressing application order:&#xD;
Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C), no dressing (A), Mepilex® Border Sacrum (B)</description>
        </group>
        <group group_id="P6">
          <title>Optifoam, Mepilex, Allevyn, no Dressing,</title>
          <description>Dressing application order:&#xD;
Optifoam® Gentle Sacrum (D), Mepilex® Border Sacrum (B), ALLEVYN Life Sacrum (C), no dressing (A)</description>
        </group>
        <group group_id="P7">
          <title>Mepilex, Optifoam, no Dressing, Allevyn</title>
          <description>Dressing application order:&#xD;
Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D), no dressing (A), ALLEVYN Life Sacrum (C)</description>
        </group>
        <group group_id="P8">
          <title>Allevyn, no Dressing, Mepilex, Optifoam</title>
          <description>Dressing application order:&#xD;
ALLEVYN Life Sacrum (C), no dressing (A), Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D)</description>
        </group>
        <group group_id="P9">
          <title>Optifoam, Allevyn, Mepilex, no Dressing</title>
          <description>Dressing application order:&#xD;
Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C), Mepilex® Border Sacrum (B), no dressing (A)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Intervention no Dressing</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Intervention Mepilex Dressing</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Intervention Allevyn Dressing</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Intervention Optifoam Dressing</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>12 female participants between 65 to 80 years.</population>
      <group_list>
        <group group_id="B1">
          <title>no Dressing, Mepilex, Allevyn, Optifoam (in Different Order)</title>
          <description>Cross-over study. Each of the 12 participants received each intervention once (no dressing, Mepilex® Border Sacrum, ALLEVYN Life Sacrum, Optifoam® Gentle Sacrum)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.2" spread="4.2"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Skin Surface Temperature From Baseline</title>
        <description>A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum</description>
        <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
        <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
        <group_list>
          <group group_id="O1">
            <title>no Dressing (A)</title>
            <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O2">
            <title>Mepilex (B)</title>
            <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O3">
            <title>Allevyn (C)</title>
            <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O4">
            <title>Optifaom (D)</title>
            <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Skin Surface Temperature From Baseline</title>
          <description>A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum</description>
          <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
          <units>°C</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="1.9" upper_limit="4.1"/>
                    <measurement group_id="O2" value="3.8" lower_limit="2.8" upper_limit="4.1"/>
                    <measurement group_id="O3" value="3.0" lower_limit="2.4" upper_limit="4.4"/>
                    <measurement group_id="O4" value="3.3" lower_limit="2.3" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Stratum Corneum Hydration (SCH) From Baseline</title>
        <description>Corneometer CM 825 (Courage and Khazaka Electronic GmbH) was used to measure the stratum corneum hydration (SCH) at the sacrum in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. The measurement is based on capacitance measurement of a dielectric medium. The change in the dielectric constant due to skin surface hydration by capacitance differences of a precision capacitor is measured.</description>
        <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
        <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
        <group_list>
          <group group_id="O1">
            <title>no Dressing (A)</title>
            <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O2">
            <title>Mepilex (B)</title>
            <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O3">
            <title>Allevyn (C)</title>
            <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O4">
            <title>Optifaom (D)</title>
            <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Stratum Corneum Hydration (SCH) From Baseline</title>
          <description>Corneometer CM 825 (Courage and Khazaka Electronic GmbH) was used to measure the stratum corneum hydration (SCH) at the sacrum in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. The measurement is based on capacitance measurement of a dielectric medium. The change in the dielectric constant due to skin surface hydration by capacitance differences of a precision capacitor is measured.</description>
          <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
          <units>arbitrary units</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="0.7" upper_limit="13.3"/>
                    <measurement group_id="O2" value="4.4" lower_limit="1.2" upper_limit="11.5"/>
                    <measurement group_id="O3" value="5.9" lower_limit="-0.4" upper_limit="9.2"/>
                    <measurement group_id="O4" value="7.3" lower_limit="3.6" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Erythema Index (EI) From Baseline</title>
        <description>Mexameter MX18 (Courage and Khazaka Electronic GmbH) was used to measure the Erythema index at the sacrum. This device uses specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin) and presents values from 0 to 999. Lower values represent less redness.</description>
        <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
        <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
        <group_list>
          <group group_id="O1">
            <title>no Dressing (A)</title>
            <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O2">
            <title>Mepilex (B)</title>
            <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O3">
            <title>Allevyn (C)</title>
            <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O4">
            <title>Optifaom (D)</title>
            <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Erythema Index (EI) From Baseline</title>
          <description>Mexameter MX18 (Courage and Khazaka Electronic GmbH) was used to measure the Erythema index at the sacrum. This device uses specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin) and presents values from 0 to 999. Lower values represent less redness.</description>
          <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
          <units>arbitrary units</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" lower_limit="19" upper_limit="49"/>
                    <measurement group_id="O2" value="7" lower_limit="-9" upper_limit="45"/>
                    <measurement group_id="O3" value="41" lower_limit="-2" upper_limit="63"/>
                    <measurement group_id="O4" value="4" lower_limit="-24" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Average Roughness (Rz) From Baseline</title>
        <description>The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.</description>
        <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
        <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
        <group_list>
          <group group_id="O1">
            <title>no Dressing (A)</title>
            <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O2">
            <title>Mepilex (B)</title>
            <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O3">
            <title>Allevyn (C)</title>
            <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O4">
            <title>Optifaom (D)</title>
            <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Average Roughness (Rz) From Baseline</title>
          <description>The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.</description>
          <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
          <units>micrometre</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" lower_limit="-7.6" upper_limit="1.8"/>
                    <measurement group_id="O2" value="-1" lower_limit="-5.3" upper_limit="2.8"/>
                    <measurement group_id="O3" value="-0.8" lower_limit="-2.0" upper_limit="0.9"/>
                    <measurement group_id="O4" value="-6.3" lower_limit="-9.4" upper_limit="-5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Arithmetic Average Roughness (Ra) From Baseline</title>
        <description>The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.</description>
        <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
        <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
        <group_list>
          <group group_id="O1">
            <title>no Dressing (A)</title>
            <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O2">
            <title>Mepilex (B)</title>
            <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O3">
            <title>Allevyn (C)</title>
            <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O4">
            <title>Optifaom (D)</title>
            <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Arithmetic Average Roughness (Ra) From Baseline</title>
          <description>The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.</description>
          <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
          <units>micrometre</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" lower_limit="-3.9" upper_limit="2.4"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-5.8" upper_limit="3.1"/>
                    <measurement group_id="O3" value="0.5" lower_limit="-0.5" upper_limit="2.3"/>
                    <measurement group_id="O4" value="-4.5" lower_limit="-6.9" upper_limit="-0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Maximum Roughness (Rmax) From Baseline</title>
        <description>The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.</description>
        <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
        <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
        <group_list>
          <group group_id="O1">
            <title>no Dressing (A)</title>
            <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O2">
            <title>Mepilex (B)</title>
            <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O3">
            <title>Allevyn (C)</title>
            <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O4">
            <title>Optifaom (D)</title>
            <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maximum Roughness (Rmax) From Baseline</title>
          <description>The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.</description>
          <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
          <units>micrometre</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-8.8" upper_limit="2.6"/>
                    <measurement group_id="O2" value="-1.8" lower_limit="-7.8" upper_limit="2.4"/>
                    <measurement group_id="O3" value="-1.3" lower_limit="-3.1" upper_limit="1.0"/>
                    <measurement group_id="O4" value="-8.0" lower_limit="-12.3" upper_limit="-5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Interleukin IL-1alpha Concentration From Baseline</title>
        <description>Based on Cyanoacrylate Skin Surface (CSSS)-Stripping, corneocytes was collected in order to analyse changes regarding interleukin IL-1alpha concentrations.</description>
        <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
        <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
        <group_list>
          <group group_id="O1">
            <title>no Dressing (A)</title>
            <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O2">
            <title>Mepilex (B)</title>
            <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O3">
            <title>Allevyn (C)</title>
            <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O4">
            <title>Optifaom (D)</title>
            <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Interleukin IL-1alpha Concentration From Baseline</title>
          <description>Based on Cyanoacrylate Skin Surface (CSSS)-Stripping, corneocytes was collected in order to analyse changes regarding interleukin IL-1alpha concentrations.</description>
          <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
          <units>picogramme/microgramme</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="-0.1" upper_limit="4.2"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-0.9" upper_limit="2.5"/>
                    <measurement group_id="O3" value="1.3" lower_limit="0.1" upper_limit="3.7"/>
                    <measurement group_id="O4" value="1.3" lower_limit="-0.8" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurence of Sacral Pain</title>
        <description>The occurrence of pain (yes/no)</description>
        <time_frame>Captured from baseline until the end of the loading period after 3.5 hours at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
        <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
        <group_list>
          <group group_id="O1">
            <title>no Dressing (A)</title>
            <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O2">
            <title>Mepilex (B)</title>
            <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O3">
            <title>Allevyn (C)</title>
            <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O4">
            <title>Optifoam (D)</title>
            <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
        </group_list>
        <measure>
          <title>Occurence of Sacral Pain</title>
          <description>The occurrence of pain (yes/no)</description>
          <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </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 group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Until First Reporting of Sacral Pain</title>
        <description>Time from baseline until the subject reported pain at sacrum</description>
        <time_frame>Sacral pain was assessed from baseline up until 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
        <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
        <group_list>
          <group group_id="O1">
            <title>no Dressing (A)</title>
            <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O2">
            <title>Mepilex (B)</title>
            <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O3">
            <title>Allevyn (C)</title>
            <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
          <group group_id="O4">
            <title>Optofoam (D)</title>
            <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
          </group>
        </group_list>
        <measure>
          <title>Time Until First Reporting of Sacral Pain</title>
          <description>Time from baseline until the subject reported pain at sacrum</description>
          <population>Cross-over study. Each of the 12 participants received each intervention once (total number is 12).</population>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">no participant experienced pain during the study visits</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">no participant experienced pain during the study visits</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">no participant experienced pain during the study visits</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">no participant experienced pain during the study visits</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Erythema Score From Baseline</title>
        <description>Erythema was assessed by visual inspection. A metric scale will be used: 0 = none 1 = mild (slight reddening), 2 = moderate (distinct redness), 3 = severe (strong redness, dark red)</description>
        <time_frame>Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>no Dressing (A)</title>
            <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position&#xD;
No dressing: no dressing at sacrum</description>
          </group>
          <group group_id="O2">
            <title>Mepilex (B)</title>
            <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position&#xD;
Mepilex® Border Sacrum: adhesive sacrum dressing</description>
          </group>
          <group group_id="O3">
            <title>Allevyn (C)</title>
            <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position&#xD;
ALLEVYN Life Sacrum: adhesive sacrum dressing</description>
          </group>
          <group group_id="O4">
            <title>Optifaom (D)</title>
            <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position&#xD;
Optifoam® Gentle Sacrum: adhesive sacrum dressing</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Erythema Score From Baseline</title>
          <description>Erythema was assessed by visual inspection. A metric scale will be used: 0 = none 1 = mild (slight reddening), 2 = moderate (distinct redness), 3 = severe (strong redness, dark red)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>no erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>mild erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>moderate erythema</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>during each visit (four visits per subject), 5.5 hours each</time_frame>
      <group_list>
        <group group_id="E1">
          <title>no Dressing (A)</title>
          <description>No dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
        </group>
        <group group_id="E2">
          <title>Mepilex (B)</title>
          <description>'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
        </group>
        <group group_id="E3">
          <title>Allevyn (C)</title>
          <description>'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
        </group>
        <group group_id="E4">
          <title>Optifoam (D)</title>
          <description>'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position</description>
        </group>
      </group_list>
      <serious_events>
        <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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Dr. Jan Kottner</name_or_title>
      <organization>Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergology Charité - Universitätsmedizin Berlin</organization>
      <phone>+49 30 450 518218</phone>
      <email>jan.kottner@charite.de</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/NCT03815240
org study id: CRC-SP-A-32
nct id: NCT03815240
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Skin functional parameters such as erythema or stratum corneum hydration have been
      successfully used in PU prevention research. These parameters are able to discriminate
      effects of different loading intensities and to measure PU preventive device performance.

      The overall aim of this study is to measure the effects of Mepilex® Border Sacrum Dressing on
      the skin structure and function during mechanical loading compared to (1) no dressing, (2)
      ALLEVYN Life Sacrum Dressing and (3) Optifoam® Gentle Liquitrap Sacrum Dressing.
Pressure ulcers (PUs) are severe and unwanted cutaneous lesions and subcutaneous wounds
      caused by prolonged skin and underlying soft tissue deformation. In the supine position they
      predominantly occur near to bony prominences, like at the sacral area. The cornerstone of PU
      prevention is repositioning, early mobilization and the use of special support surfaces. In
      addition, empirical evidence suggests that the application of preventive dressings on PU
      predilection sites helps to prevent PU development.

      Skin functional parameters such as erythema or stratum corneum hydration have been
      successfully used in PU prevention research. These parameters are able to discriminate
      effects of different loading intensities and to measure PU preventive device performance.
      Recently it could be shown that there are associations between structural and functional skin
      changes at the sacral area during loading. The overall aim of this study is to measure the
      effects of Mepilex® Border Sacrum Dressing on the skin structure and function during
      mechanical loading compared to no dressing, ALLEVYN Life Sacrum and Optifoam® Gentle
      Liquitrap Sacrum.

      The procedure of one visit will be as follows:

      After a skin acclimatization time of 30 minutes baseline measurements and Cyanoacrylate Skin
      Surface (CSSS)-stripping will be performed. Then a randomization envelope will be opened and
      the corresponding dressing will be applied or the skin will be left uncovered. The subject
      will then lie in supine position on a standard hospital mattress for a loading period of 3.5
      hours. Every 30 minutes the head of the bed will be elevated to 45° for five minutes. During
      these five minutes, the participants will be instructed to bend their knees and to drag the
      feet repeatedly forth and back 10 times in order to simulate shear forces. The whole exercise
      will be done six times, after 0.5, 1, 1.5, 2, 2.5 and 3 hours. After 3.5 hours loading time
      in supine position the subjects will move into prone position. The dressing (if present) will
      be removed and all skin measurements and CSSS-stripping will be conducted again. The subjects
      will come back for another three times completing the remaining interventions. At the end,
      each volunteer will have received all three types of dressings once and once no dressing. In
      between, there are at least 3 weeks to prevent possible carry over effects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Skin Surface Temperature From Baseline
time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
description: A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum
measure: Change in Stratum Corneum Hydration (SCH) From Baseline
time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
description: Corneometer CM 825 (Courage and Khazaka Electronic GmbH) was used to measure the stratum corneum hydration (SCH) at the sacrum in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. The measurement is based on capacitance measurement of a dielectric medium. The change in the dielectric constant due to skin surface hydration by capacitance differences of a precision capacitor is measured.
measure: Change in Erythema Index (EI) From Baseline
time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
description: Mexameter MX18 (Courage and Khazaka Electronic GmbH) was used to measure the Erythema index at the sacrum. This device uses specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin) and presents values from 0 to 999. Lower values represent less redness.
measure: Change in Average Roughness (Rz) From Baseline
time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
description: The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
measure: Change in Arithmetic Average Roughness (Ra) From Baseline
time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
description: The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
measure: Change in Maximum Roughness (Rmax) From Baseline
time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
description: The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
measure: Change in Interleukin IL-1alpha Concentration From Baseline
time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
description: Based on Cyanoacrylate Skin Surface (CSSS)-Stripping, corneocytes was collected in order to analyse changes regarding interleukin IL-1alpha concentrations.
measure: Occurence of Sacral Pain
time frame: Captured from baseline until the end of the loading period after 3.5 hours at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
description: The occurrence of pain (yes/no)
measure: Time Until First Reporting of Sacral Pain
time frame: Sacral pain was assessed from baseline up until 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
description: Time from baseline until the subject reported pain at sacrum
measure: Change in Erythema Score From Baseline
time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
description: Erythema was assessed by visual inspection. A metric scale will be used: 0 = none 1 = mild (slight reddening), 2 = moderate (distinct redness), 3 = severe (strong redness, dark red)
arm group label: no dressing (A)
arm group type: Other
description: No dressing will be applied at sacrum before 3.5 hours loading period in supine position
arm group label: Mepilex (B)
arm group type: Active Comparator
description: 'Mepilex® Border Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position
arm group label: Allevyn (C)
arm group type: Active Comparator
description: 'ALLEVYN Life Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position
arm group label: Optifaom (D)
arm group type: Active Comparator
description: 'Optifoam® Gentle Sacrum' Dressing will be applied at sacrum before 3.5 hours loading period in supine position
intervention type: Other
intervention name: No dressing
description: no dressing at sacrum
arm group label: no dressing (A)
intervention type: Other
intervention name: Mepilex® Border Sacrum
description: adhesive sacrum dressing
arm group label: Mepilex (B)
intervention type: Other
intervention name: ALLEVYN Life Sacrum
description: adhesive sacrum dressing
arm group label: Allevyn (C)
intervention type: Other
intervention name: Optifoam® Gentle Sacrum
description: adhesive sacrum dressing
arm group label: Optifaom (D)
criteria: 
gender: Female
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: PD Dr. Jan Kottner
investigator title: Principal Investigator
mesh term: Pressure Ulcer
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 