<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/NCT03034694</url>
  </required_header>
  <id_info>
    <org_study_id>2015H0393</org_study_id>
    <nct_id>NCT03034694</nct_id>
  </id_info>
  <brief_title>The Effect of Dermatology and Teledermatology Consultations on Length of Hospital Admission, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic Inpatient Setting</brief_title>
  <official_title>The Effect of Dermatology and Teledermatology Consultations on Length of Hospital Admission, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic Inpatient Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of teledermatology on length of hospital admission, length of stay, 30 day&#xD;
      readmission rate, and antibiotic use in patients presenting with cellulitis vs&#xD;
      pseudocellulitis in an academic emergency department setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Routine Care vs The use of teledermatology</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of Hospitalization</measure>
    <time_frame>60 Days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency/Use of antibiotics</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Cellulitis</condition>
  <arm_group>
    <arm_group_label>Routine Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The first group will be randomized to routine care of receiving or not receiving a dermatology consult in the hospitalized setting based on the clinical decision of the hospitalist. The patients will see the research coordinator who will take images and for a teledermatology assessment, however, these assessments will not be placed in the chart and the treating hospitalist will not know.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Teledermatology INtervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The second arm will be patient randomized to teledermatology intervention. These patients will be imaged by the research coordinator, then the assessment will be placed in the chart for the hospitalist to see although final treatment decisions are still made by the hospitalist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>teledermatology consult</intervention_name>
    <description>teledermatology consult</description>
    <arm_group_label>Teledermatology INtervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine Care</intervention_name>
    <description>The patient will undergo imaging but this report will not be put into the chart.</description>
    <arm_group_label>Routine Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18&#xD;
&#xD;
          -  Admission for cellulitis-like symptoms, including but not limited to the following:&#xD;
             tenderness, redness, swelling, expansive lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin H Kaffenberger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OSU Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>June 4, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 16, 2018</last_update_submitted>
  <last_update_submitted_qc>January 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Benjamin Kaffenberger</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cellulitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03034694
org study id: 2015H0393
nct id: NCT03034694
lead sponsor: 
has dmc: No
The effect of teledermatology on length of hospital admission, length of stay, 30 day
      readmission rate, and antibiotic use in patients presenting with cellulitis vs
      pseudocellulitis in an academic emergency department setting.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Routine Care vs The use of teledermatology
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Length of Hospitalization
time frame: 60 Days
measure: Readmission rate
time frame: 30 Days
measure: Frequency/Use of antibiotics
time frame: 30 days
arm group label: Routine Care
arm group type: Placebo Comparator
description: The first group will be randomized to routine care of receiving or not receiving a dermatology consult in the hospitalized setting based on the clinical decision of the hospitalist. The patients will see the research coordinator who will take images and for a teledermatology assessment, however, these assessments will not be placed in the chart and the treating hospitalist will not know.
arm group label: Teledermatology INtervention
arm group type: Experimental
description: The second arm will be patient randomized to teledermatology intervention. These patients will be imaged by the research coordinator, then the assessment will be placed in the chart for the hospitalist to see although final treatment decisions are still made by the hospitalist.
intervention type: Other
intervention name: teledermatology consult
description: teledermatology consult
arm group label: Teledermatology INtervention
intervention type: Other
intervention name: Routine Care
description: The patient will undergo imaging but this report will not be put into the chart.
arm group label: Routine Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Benjamin H Kaffenberger, MD
role: Principal Investigator
affiliation: OSU Dermatology
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Benjamin Kaffenberger
investigator title: Assistant Professor
mesh term: Cellulitis
sharing ipd: Yes