<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/NCT02224638</url>
  </required_header>
  <id_info>
    <org_study_id>R14-028</org_study_id>
    <nct_id>NCT02224638</nct_id>
  </id_info>
  <brief_title>Wound Management for Sacral Pressure Ulcers With Necrotic Tissue</brief_title>
  <official_title>Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medline Industries</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medline Industries</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer&#xD;
      wounds&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pressure ulcers on the sacral area will be applied with either a wound debridement product or&#xD;
      a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3&#xD;
      week period of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Wounds Healed</measure>
    <time_frame>3 weeks</time_frame>
    <description>Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>3 weeks</time_frame>
    <description>Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Pressure Ulcers</condition>
  <arm_group>
    <arm_group_label>TheraHoney HD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Honey product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SkinTegrity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Skin moisturizer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TheraHoney HD</intervention_name>
    <description>Honey</description>
    <arm_group_label>TheraHoney HD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SkinTegrity</intervention_name>
    <description>Hydrogel</description>
    <arm_group_label>SkinTegrity</arm_group_label>
    <other_name>Hydrogel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects of any age&#xD;
&#xD;
          -  Sacral wounds with necrotic tissue&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  3rd degree burns&#xD;
&#xD;
          -  know hypersensitivity to products&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy Chaiken, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swedish Covenant Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Swedish Covenant Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>606025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harmony Residential Facility</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>August 29, 2017</results_first_submitted>
  <results_first_submitted_qc>November 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 7, 2018</results_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>skin ulcers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TheraHoney HD</title>
          <description>Honey product&#xD;
TheraHoney HD: Honey</description>
        </group>
        <group group_id="P2">
          <title>SkinTegrity</title>
          <description>Skin moisturizer&#xD;
SkinTegrity: Hydrogel</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TheraHoney HD</title>
          <description>Honey product&#xD;
TheraHoney HD: Honey</description>
        </group>
        <group group_id="B2">
          <title>SkinTegrity</title>
          <description>Skin moisturizer&#xD;
SkinTegrity: Hydrogel</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="11"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Wounds Healed</title>
        <description>Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer</description>
        <time_frame>3 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TheraHoney HD</title>
            <description>Honey product</description>
          </group>
          <group group_id="O2">
            <title>SkinTegrity</title>
            <description>SkinTegrity: Hydrogel</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Wounds Healed</title>
          <description>Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer</description>
          <units>percentage of wounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.1" spread="38.4"/>
                    <measurement group_id="O2" value="6.1" spread="74.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.</description>
        <time_frame>3 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TheraHoney HD</title>
            <description>Honey product&#xD;
TheraHoney HD: Honey</description>
          </group>
          <group group_id="O2">
            <title>SkinTegrity</title>
            <description>Skin moisturizer&#xD;
SkinTegrity: Hydrogel</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.</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="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>wound treatment period of 34 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>TheraHoney HD</title>
          <description>Honey product&#xD;
TheraHoney HD: Honey</description>
        </group>
        <group group_id="E2">
          <title>SkinTegrity</title>
          <description>Skin moisturizer&#xD;
SkinTegrity: Hydrogel</description>
        </group>
      </group_list>
      <serious_events>
        <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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>AFIB</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ischemic Bowel Surgery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection/sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Periwound Maceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Increased Wound Size</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" 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>
    <point_of_contact>
      <name_or_title>Nancy Chaiken</name_or_title>
      <organization>Swedish Covenant Hospital</organization>
      <phone>847-372-3500</phone>
      <email>nchaiken@comcast.net</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/NCT02224638
org study id: R14-028
nct id: NCT02224638
lead sponsor: 
has dmc: No
Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer
      wounds
Pressure ulcers on the sacral area will be applied with either a wound debridement product or
      a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3
      week period of treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Wounds Healed
time frame: 3 weeks
description: Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer
measure: Number of Participants With Adverse Events
time frame: 3 weeks
description: Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.
arm group label: TheraHoney HD
arm group type: Active Comparator
description: Honey product
arm group label: SkinTegrity
arm group type: Active Comparator
description: Skin moisturizer
intervention type: Device
intervention name: TheraHoney HD
description: Honey
arm group label: TheraHoney HD
intervention type: Device
intervention name: SkinTegrity
description: Hydrogel
arm group label: SkinTegrity
other name: Hydrogel
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nancy Chaiken, RN
role: Principal Investigator
affiliation: Swedish Covenant Hospital
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pressure Ulcer
mesh term: Ulcer
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 