<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/NCT01706913</url>
  </required_header>
  <id_info>
    <org_study_id>DermFound-2008A058574</org_study_id>
    <nct_id>NCT01706913</nct_id>
  </id_info>
  <brief_title>Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis</brief_title>
  <official_title>A Randomized Controlled Study to Assess the Impact of Dermatology Consultations on the Hospital Course of Patients Admitted for Cellulitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dermatology Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, controlled study to compare patients evaluated and managed by internal&#xD;
      medicine hospitalists alone versus patients who are additionally evaluated by a dermatologist&#xD;
      when they are admitted to the hospital, aiming to demonstrate that hospital admissions for&#xD;
      cellulitis that involve early dermatology consultation will reduce hospital length of stay,&#xD;
      readmission rates, prevalence of pseudocellulitis, cost, and antibiotic usage. The hypothesis&#xD;
      of this study is that obtaining inpatient dermatology consultations, within 24 hours of a&#xD;
      patient being admitted to the hospital for cellulitis, will reduce the length of stay,&#xD;
      readmission rate, cost, and antibiotic usage of the patient&quot;s admission as well as properly&#xD;
      evaluate and diagnose patients with pseudocellulitis. The primary objective will be to&#xD;
      measure the difference in the length of stay for patients who are randomized to a dermatology&#xD;
      consultation within 24 hours of hospital admission (active arm) versus being managed by an&#xD;
      internal medicine hospitalist alone, as is the standard of care (control arm). The length of&#xD;
      stay for each arm will be assessed once the study has been completed. The secondary endpoint&#xD;
      will be to measure readmission rates for cellulitis after patients are discharged from the&#xD;
      hospital. An additional endpoint will be to determine if antibiotic usage differs between&#xD;
      patients randomized to a dermatology consultation and those not. Exploratory analyses will&#xD;
      assess the percentage of patients with a concomitant known predisposing factor for recurrent&#xD;
      cellulitis such as lymphedema, leg ulceration, tinea pedis, or onychomycosis, as well as the&#xD;
      association of fever &gt;100.5 F and a history of a prior episode of cellulitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Antibiotic usage</measure>
    <time_frame>2 weeks after discharge from hospital stay</time_frame>
    <description>We will be measuring the difference between antibiotic usage in patients in the control group as compared with the treatment group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Will be measured at day of patient discharge</time_frame>
    <description>We will be comparing the length of admission between the control group and the treatment group to assess whether a dermatology consult has any impact on the length of a patient's hospital stay.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Readmission rate</measure>
    <time_frame>2 weeks after patient discharge</time_frame>
    <description>We will be measuring the readmission rate among patients in both groups in order to discover whether a dermatology consult has an impact on readmission rates among patients with cellultis.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">246</enrollment>
  <condition>Cellulitis</condition>
  <arm_group>
    <arm_group_label>No consult</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Those who are in the control group will follow internal medicine hospitalist recommendations alone which will include when and what type of post-discharge follow-up appointments the patient will have. We would like to emphasize that as part of the standard of care, patients in the control arm may still receive a dermatology consult if it is deemed necessary and/or requested. We will not prevent patients or the patient's team of caregivers from requesting a dermatology consultation during the course of hospitalization. A follow-up phone call will be performed two weeks after discharge for patients in the control group in order to confirm the patient's outcome. There will also be a medical record review one month after the patient's initial discharge from the hospital to assess for readmission</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dermatology Consult</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients randomized to the treatment group will obtain a dermatology evaluation within 24 hours of being admitted to MGH for their cellulitis. The skin and lymph node exam performed by the dermatologist on patients in the treatment group will be documented in the LMR for the subjects' medical records. Patients who are readmitted for cellulitis within one month of being discharged from the hospital will be considered treatment failures. Patients in the treatment group will have a follow-up visit in dermatology clinic within two weeks after being discharged. There will also be a medical record review performed one month after the patient's initial discharge from the hospital to assess for readmission.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dermatology consult</intervention_name>
    <arm_group_label>Dermatology Consult</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand and sign informed consent&#xD;
&#xD;
          -  Able to complete study and comply with study procedures&#xD;
&#xD;
          -  Presumed clinical diagnosis of cellulitis by medicine team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a known postoperative site infection or abscess&#xD;
&#xD;
          -  Have a human/animal bite&#xD;
&#xD;
          -  Have known osteomyelitis&#xD;
&#xD;
          -  Have a hardware/line infection&#xD;
&#xD;
          -  Are under the age of 18&#xD;
&#xD;
          -  Have a history of transplantation less than six months after initial transplant and/or&#xD;
             if they have had an episode of acute rejection in the last 90 days&#xD;
&#xD;
          -  Known use of antithymocyte globulin or campath in the last 6 months or more than 20&#xD;
             mg/day of prednisone for more than 30 days -&#xD;
&#xD;
          -  Are a known prisoner.&#xD;
&#xD;
          -  Are decisionally-impaired.&#xD;
&#xD;
          -  Have abnormal vital signs defined as systolic blood pressure &lt;90 mmHg, diastolic blood&#xD;
             pressure &lt;80 mmHg, heart rate greater than 90 beats per minute or less than 50 beats&#xD;
             per minute, respiratory rate greater than 20, or temperature &gt; 100.5 F.&#xD;
&#xD;
          -  Are known to be pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniela Kroshinsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Daniela Kroshinsky</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cellulitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01706913
org study id: DermFound-2008A058574
nct id: NCT01706913
lead sponsor: 
collaborator: 
has dmc: No
This is a randomized, controlled study to compare patients evaluated and managed by internal
      medicine hospitalists alone versus patients who are additionally evaluated by a dermatologist
      when they are admitted to the hospital, aiming to demonstrate that hospital admissions for
      cellulitis that involve early dermatology consultation will reduce hospital length of stay,
      readmission rates, prevalence of pseudocellulitis, cost, and antibiotic usage. The hypothesis
      of this study is that obtaining inpatient dermatology consultations, within 24 hours of a
      patient being admitted to the hospital for cellulitis, will reduce the length of stay,
      readmission rate, cost, and antibiotic usage of the patient"s admission as well as properly
      evaluate and diagnose patients with pseudocellulitis. The primary objective will be to
      measure the difference in the length of stay for patients who are randomized to a dermatology
      consultation within 24 hours of hospital admission (active arm) versus being managed by an
      internal medicine hospitalist alone, as is the standard of care (control arm). The length of
      stay for each arm will be assessed once the study has been completed. The secondary endpoint
      will be to measure readmission rates for cellulitis after patients are discharged from the
      hospital. An additional endpoint will be to determine if antibiotic usage differs between
      patients randomized to a dermatology consultation and those not. Exploratory analyses will
      assess the percentage of patients with a concomitant known predisposing factor for recurrent
      cellulitis such as lymphedema, leg ulceration, tinea pedis, or onychomycosis, as well as the
      association of fever >100.5 F and a history of a prior episode of cellulitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Antibiotic usage
time frame: 2 weeks after discharge from hospital stay
description: We will be measuring the difference between antibiotic usage in patients in the control group as compared with the treatment group
measure: Length of hospital stay
time frame: Will be measured at day of patient discharge
description: We will be comparing the length of admission between the control group and the treatment group to assess whether a dermatology consult has any impact on the length of a patient's hospital stay.
measure: Readmission rate
time frame: 2 weeks after patient discharge
description: We will be measuring the readmission rate among patients in both groups in order to discover whether a dermatology consult has an impact on readmission rates among patients with cellultis.
arm group label: No consult
arm group type: No Intervention
description: Those who are in the control group will follow internal medicine hospitalist recommendations alone which will include when and what type of post-discharge follow-up appointments the patient will have. We would like to emphasize that as part of the standard of care, patients in the control arm may still receive a dermatology consult if it is deemed necessary and/or requested. We will not prevent patients or the patient's team of caregivers from requesting a dermatology consultation during the course of hospitalization. A follow-up phone call will be performed two weeks after discharge for patients in the control group in order to confirm the patient's outcome. There will also be a medical record review one month after the patient's initial discharge from the hospital to assess for readmission
arm group label: Dermatology Consult
arm group type: Active Comparator
description: The patients randomized to the treatment group will obtain a dermatology evaluation within 24 hours of being admitted to MGH for their cellulitis. The skin and lymph node exam performed by the dermatologist on patients in the treatment group will be documented in the LMR for the subjects' medical records. Patients who are readmitted for cellulitis within one month of being discharged from the hospital will be considered treatment failures. Patients in the treatment group will have a follow-up visit in dermatology clinic within two weeks after being discharged. There will also be a medical record review performed one month after the patient's initial discharge from the hospital to assess for readmission.
intervention type: Other
intervention name: Dermatology consult
arm group label: Dermatology Consult
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniela Kroshinsky, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Daniela Kroshinsky
investigator title: Principal Investigator
mesh term: Cellulitis