<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/NCT03785834</url>
  </required_header>
  <id_info>
    <org_study_id>2018H0147</org_study_id>
    <nct_id>NCT03785834</nct_id>
  </id_info>
  <brief_title>The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis and Pseudocellulitis</brief_title>
  <official_title>The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis and Pseudocellulitis</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Investigators wish to study the value of dermatologic testing assessments in&#xD;
      differentiating between cellulitis and pseudocellulitis in the inpatient setting. The&#xD;
      Investigators propose that by utilizing cutaneous biopsies and tissue cultures in patients&#xD;
      that have been admitted to inpatient internal medicine teams, the investigators may be able&#xD;
      to improve multiple measures of hospital efficiency in patients presenting with&#xD;
      cellulitis-like symptoms, by more accurately recognizing cellulitis from pseudocellulitis.&#xD;
      The patient will undergo encrypted digital imaging for his or her condition. This image will&#xD;
      then be sent to the study investigators, along with basic clinical information on the skin&#xD;
      evaluation form. The study investigators will develop a differential diagnosis and then the&#xD;
      patient will undergo a skin biopsy. The patient will then be randomized to one of two arms&#xD;
      using a random number generator: A) Skin biopsies and tissue cultures recorded and published&#xD;
      in patient's medical chart as they would be in a standard of care procedure B) Skin biopsies&#xD;
      and tissue cultures consultation performed but not published in the patient's medical chart&#xD;
      unless medically necessary. Information will be collected from medical records in IHIS.&#xD;
      Patients will be contacted by phone 30 days after discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 25, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The feasibility of conducting a larger study will be conducted, by establishing patient enrollment rates</measure>
    <time_frame>At study completion, around 2 years after study start</time_frame>
    <description>According to the NIH: The goal of pilot work is not to test hypotheses about the effects of an intervention, but rather, to assess the feasibility/acceptability of an approach to be used in a larger scale study. We will use descriptive statistics to monitor patient enrollment and pilot data on additional secondary outcomes for inferential statistics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in antibiotic use (antibiotics/day administered) over the course of the hospitalizations</measure>
    <time_frame>1 year</time_frame>
    <description>Cellulitis is a common type of bacterial skin infection. Pseudocellulitis is a skin infection that is very similar to cellulitis and is often misdiagnosed as cellulitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of participant readmission within 30 days</measure>
    <time_frame>1 year</time_frame>
    <description>The investigators will examine 30 day readmission rates between standard care and interventional care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospitalization as measured in days</measure>
    <time_frame>1 year</time_frame>
    <description>The investigators will examine hospital length-of-stay in patients randomized to interventional vs standard care</description>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cellulitis</condition>
  <condition>Pseudocellulitis</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Punch Biopsy</intervention_name>
    <description>The patient will undergo two 6 mm punch biopsies into the affected extremity at the most proximal portion of the redness.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient's ages 18 to 99 years that present in the ED with pseudocellulitis or cellulitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admitted inpatient to The Ohio State University Wexner Medical Center Internal&#xD;
             Medicine ward with cellulitis-like symptoms, including but not limited to the&#xD;
             following: tenderness, redness, swelling, expansive lesion.&#xD;
&#xD;
          -  Affecting one or more extremities&#xD;
&#xD;
          -  are at least 90 days post any associated operation of the extremity&#xD;
&#xD;
          -  are above the age of 18&#xD;
&#xD;
          -  Participants will be patients with cellulitis or pseudocellulitis.&#xD;
&#xD;
          -  Patients who have recurrent cellulitis will be eligible for enrollment into the study,&#xD;
             but only once.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients may not have trauma, ulcer, or puncture wound to the area&#xD;
&#xD;
          -  May not be transferred from another hospital&#xD;
&#xD;
          -  May not be admitted to the Cancer Hospital or with a known active solid organ or&#xD;
             hematologic cancer other than nonmelanoma skin cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>The Ohio State University Dermatology</name>
      <address>
        <city>Gahanna</city>
        <state>Ohio</state>
        <zip>43230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Ben H Kaffenberger</investigator_full_name>
    <investigator_title>Associate Professor-Clinical Dermatology</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>No</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/NCT03785834
org study id: 2018H0147
nct id: NCT03785834
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Investigators wish to study the value of dermatologic testing assessments in
      differentiating between cellulitis and pseudocellulitis in the inpatient setting. The
      Investigators propose that by utilizing cutaneous biopsies and tissue cultures in patients
      that have been admitted to inpatient internal medicine teams, the investigators may be able
      to improve multiple measures of hospital efficiency in patients presenting with
      cellulitis-like symptoms, by more accurately recognizing cellulitis from pseudocellulitis.
      The patient will undergo encrypted digital imaging for his or her condition. This image will
      then be sent to the study investigators, along with basic clinical information on the skin
      evaluation form. The study investigators will develop a differential diagnosis and then the
      patient will undergo a skin biopsy. The patient will then be randomized to one of two arms
      using a random number generator: A) Skin biopsies and tissue cultures recorded and published
      in patient's medical chart as they would be in a standard of care procedure B) Skin biopsies
      and tissue cultures consultation performed but not published in the patient's medical chart
      unless medically necessary. Information will be collected from medical records in IHIS.
      Patients will be contacted by phone 30 days after discharge.
observational model: Cohort
time perspective: Prospective
measure: The feasibility of conducting a larger study will be conducted, by establishing patient enrollment rates
time frame: At study completion, around 2 years after study start
description: According to the NIH: The goal of pilot work is not to test hypotheses about the effects of an intervention, but rather, to assess the feasibility/acceptability of an approach to be used in a larger scale study. We will use descriptive statistics to monitor patient enrollment and pilot data on additional secondary outcomes for inferential statistics.
measure: Change in antibiotic use (antibiotics/day administered) over the course of the hospitalizations
time frame: 1 year
description: Cellulitis is a common type of bacterial skin infection. Pseudocellulitis is a skin infection that is very similar to cellulitis and is often misdiagnosed as cellulitis
measure: The rate of participant readmission within 30 days
time frame: 1 year
description: The investigators will examine 30 day readmission rates between standard care and interventional care
measure: Length of hospitalization as measured in days
time frame: 1 year
description: The investigators will examine hospital length-of-stay in patients randomized to interventional vs standard care
intervention type: Procedure
intervention name: Punch Biopsy
description: The patient will undergo two 6 mm punch biopsies into the affected extremity at the most proximal portion of the redness.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Ben H Kaffenberger
investigator title: Associate Professor-Clinical Dermatology
mesh term: Cellulitis
sharing ipd: No