<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/NCT02223689</url>
  </required_header>
  <id_info>
    <org_study_id>R14-008</org_study_id>
    <nct_id>NCT02223689</nct_id>
  </id_info>
  <brief_title>Evaluation of Skin Affix in the Emergency Room</brief_title>
  <official_title>Evaluation of SkinAffix as a Topical Emergency Room Department Skin Incision Adhesive</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>
      Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects were approached for recruitment in the ED when discussing closure options by the&#xD;
      physician. Only subjects deemed appropriate for skin glue closures by their treating&#xD;
      physician were approached.Subjects were followed at 48 hours post-procedure, 5-10 days, and&#xD;
      at 14 days following the ED visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound Closure at Discharge</measure>
    <time_frame>14 days</time_frame>
    <description>Wounds remained closed following application of Skin Affix</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Following Application</measure>
    <time_frame>15 minutes Post Application</time_frame>
    <description>Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Wounds</condition>
  <arm_group>
    <arm_group_label>Skin Affix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgical adhesive</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Skin Affix</intervention_name>
    <arm_group_label>Skin Affix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Greater than 5 years of age&#xD;
&#xD;
          -  Requires the use of a surgical skin adhesive&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sensitivity to topical adhesive products or formaldehyde&#xD;
&#xD;
          -  Hx keloid formation, hypotension, diabetes, blood clotting disorders&#xD;
&#xD;
          -  Wound infections&#xD;
&#xD;
          -  mucosal surfaces or skin exposed to body fluids&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jon Schrock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Metro Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MetroHealth System</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>March 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>August 28, 2017</results_first_submitted>
  <results_first_submitted_qc>April 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 11, 2019</results_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SkinAffix</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Skin Affix</title>
          <description>Surgical adhesive (Skin Affix) applied during wound closure in ED</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Skin Affix</title>
          <description>Surgical adhesive&#xD;
Skin Affix</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.1" lower_limit="7" upper_limit="78"/>
                  </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="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </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="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Wound Closure at Discharge</title>
        <description>Wounds remained closed following application of Skin Affix</description>
        <time_frame>14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Skin Affix</title>
            <description>Surgical adhesive</description>
          </group>
        </group_list>
        <measure>
          <title>Wound Closure at Discharge</title>
          <description>Wounds remained closed following application of Skin Affix</description>
          <units>percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain Following Application</title>
        <description>Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.</description>
        <time_frame>15 minutes Post Application</time_frame>
        <population>Participants were asked 15 min after application to rate any change in pain as decreased, increased or no change.</population>
        <group_list>
          <group group_id="O1">
            <title>Change in Pain Following Application</title>
            <description>Pain assessed through a pain score 0-5. 0 = no pain, 5 = highest pain.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Following Application</title>
          <description>Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.</description>
          <population>Participants were asked 15 min after application to rate any change in pain as decreased, increased or no change.</population>
          <units>percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Increase in Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change in Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Skin Affix</title>
          <description>Surgical adhesive&#xD;
Skin Affix</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="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="9" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Procedural bleeding</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Dihiscence</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </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>Lori Rotolo</name_or_title>
      <organization>Medline Industries, Inc.</organization>
      <phone>8476434640</phone>
      <email>lrotolo@medline.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02223689
org study id: R14-008
nct id: NCT02223689
lead sponsor: 
has dmc: No
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
Subjects were approached for recruitment in the ED when discussing closure options by the
      physician. Only subjects deemed appropriate for skin glue closures by their treating
      physician were approached.Subjects were followed at 48 hours post-procedure, 5-10 days, and
      at 14 days following the ED visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Wound Closure at Discharge
time frame: 14 days
description: Wounds remained closed following application of Skin Affix
measure: Change in Pain Following Application
time frame: 15 minutes Post Application
description: Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.
arm group label: Skin Affix
arm group type: Experimental
description: Surgical adhesive
intervention type: Procedure
intervention name: Skin Affix
arm group label: Skin Affix
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: Jon Schrock, MD
role: Principal Investigator
affiliation: Metro Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 