<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/NCT01722929</url>
  </required_header>
  <id_info>
    <org_study_id>STU69718</org_study_id>
    <nct_id>NCT01722929</nct_id>
  </id_info>
  <brief_title>Study of Skin and Muscle Parameters Using a Skin Sensor</brief_title>
  <official_title>A Pilot Study of Skin and Muscle Parameters Using a Multifunctional Skin Sensor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the role of skin sensors in obtaining reliable and&#xD;
      accurate serial measurements of skin parameters in the context of cutaneous skin wound&#xD;
      healing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2013</start_date>
  <completion_date type="Actual">September 16, 2013</completion_date>
  <primary_completion_date type="Actual">September 16, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants had the skin sensor measure temperature both near a surgery site and also near a non-surgery site. There is one intervention (skin sensor) and the participants were assigned to both arms &quot;surgery side&quot; and &quot;non-surgery side&quot; in parallel.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure Temperature at 3 Time Points</measure>
    <time_frame>Baseline, 48 hours from baseline, and 2 weeks from baseline</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Skin Wounds</condition>
  <arm_group>
    <arm_group_label>Skin sensor on surgery side</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Skin sensor will be placed on the side that had surgery. This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skin sensor on non-surgery side</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Skin sensor will be placed on the contralateral side from surgery site.This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Skin sensor</intervention_name>
    <arm_group_label>Skin sensor on non-surgery side</arm_group_label>
    <arm_group_label>Skin sensor on surgery side</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and Females age 18 and over&#xD;
&#xD;
          -  Recent (post-operative day 0-90) skin surgery of the trunk,extremities, head or neck&#xD;
             for minor skin problems resulting in sutured wounds or open granulating wounds.&#xD;
&#xD;
          -  Otherwise good general health as assessed by the investigator&#xD;
&#xD;
          -  The subject has the willingness and the ability to understand and provide informed&#xD;
             consent for the use of their tissue and communicate with the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Pregnancy or Lactation&#xD;
&#xD;
          -  Subjects who are unable to understand the protocol or to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murad Alam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine, Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>September 13, 2017</results_first_submitted>
  <results_first_submitted_qc>October 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 4, 2017</results_first_posted>
  <last_update_submitted>December 2, 2021</last_update_submitted>
  <last_update_submitted_qc>December 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Murad Alam</investigator_full_name>
    <investigator_title>Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation</investigator_title>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Surgery Side and Non-surgery Side</title>
          <description>This is a split-body, parallel-designed study. All study participants had the skin sensor (the same intervention) placed near the site of their surgery wound, and also on a site without any surgery wound.&#xD;
Since this is split-body design with one intervention, participant flow will be limited to all study participants as one group to not double-count the number of participants.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </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>Surgery Side and Non-surgery Side</title>
          <description>All study participants had the skin sensor placed near the site of their surgery wound, and also on a site without any surgery wound.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
          </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="69.75" spread="12.21"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Measure Temperature at 3 Time Points</title>
        <time_frame>Baseline, 48 hours from baseline, and 2 weeks from baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Skin Sensor on Surgery Side</title>
            <description>Skin sensor will be placed on the side that had surgery.&#xD;
Sensor on surgery side.&#xD;
This is a split-body study. All participants will have the skin senor on both the surgery side and a non-surgery side.</description>
          </group>
          <group group_id="O2">
            <title>Skin Sensor on Non-surgery Side</title>
            <description>Skin sensor will be placed on the contralateral side from surgery site.&#xD;
Sensor on non-surgery side&#xD;
This is a split-body study. All participants will have the skin senor on both the surgery side and a non-surgery side.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure Temperature at 3 Time Points</title>
          <units>Degrees Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.89" spread="0.09"/>
                    <measurement group_id="O2" value="31.13" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hrs from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.87" spread="0.35"/>
                    <measurement group_id="O2" value="32.02" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Weeks from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.01" spread="0.03"/>
                    <measurement group_id="O2" value="33.45" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A mixed ANOVA was performed with the arms as a between factor and the three times as the within factor.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>p-value is for the main effect for the Treatment, Time, and Treatment*Time interaction.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Surgery Side and Non-surgery Side</title>
          <description>The skin sensor intervention was placed on both a surgery site and a non-surgery site in the same participant. This reflects all participants that received the intervention. The Arms/Groups &quot;Surgery Side&quot; and &quot;Non-surgery Side&quot; are combined because they both received the same intervention (skin sensor).</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="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </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="4"/>
              </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>Murad Alam, MD</name_or_title>
      <organization>Northwestern University</organization>
      <phone>312-695-4761</phone>
      <email>m-alam@northwestern.edu</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/NCT01722929
org study id: STU69718
nct id: NCT01722929
lead sponsor: 
has dmc: Yes
The aim of this study is to assess the role of skin sensors in obtaining reliable and
      accurate serial measurements of skin parameters in the context of cutaneous skin wound
      healing.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants had the skin sensor measure temperature both near a surgery site and also near a non-surgery site. There is one intervention (skin sensor) and the participants were assigned to both arms "surgery side" and "non-surgery side" in parallel.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measure Temperature at 3 Time Points
time frame: Baseline, 48 hours from baseline, and 2 weeks from baseline
arm group label: Skin sensor on surgery side
arm group type: Experimental
description: Skin sensor will be placed on the side that had surgery. This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body.
arm group label: Skin sensor on non-surgery side
arm group type: Active Comparator
description: Skin sensor will be placed on the contralateral side from surgery site.This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body.
intervention type: Device
intervention name: Skin sensor
arm group label: Skin sensor on non-surgery side
arm group label: Skin sensor on surgery side
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Murad Alam, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Murad Alam
investigator title: Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 