<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/NCT01671423</url>
  </required_header>
  <id_info>
    <org_study_id>HN 4372</org_study_id>
    <nct_id>NCT01671423</nct_id>
  </id_info>
  <brief_title>Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis</brief_title>
  <official_title>Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein Healthcare Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albert Einstein Healthcare Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cellulitis is the medical term for an infection of the skin, with symptoms including redness,&#xD;
      swelling, warmth, and pain. This group of symptoms is called inflammation, and is caused by&#xD;
      the body's immune system responding to the infection. Standard care for cellulitis is using&#xD;
      antibiotics to destroy the infection, but the inflammation can persist and cause a great deal&#xD;
      of pain. The hypothesis of this study is that adding a single dose of an oral steroid&#xD;
      (prednisone), which tempers the immune response, will reduce inflammation, reduce pain, and&#xD;
      speed recovery. This hypothesis will be examined by recruiting a group of patients with&#xD;
      cellulitis, and randomizing them to two sub-groups: one group will receive a dose of&#xD;
      prednisone, while the other group will receive a placebo. Neither group will know what they&#xD;
      received unless there is a problem. These subjects will be followed up at the 48 hour mark&#xD;
      and the 7 day mark, and will have their results compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study will be conducted in a prospective, double-blinded, placebo-controlled,&#xD;
      randomized fashion using a convenience sample of 100 subjects who come to the ED with signs&#xD;
      and symptoms of cellulitis. Initial medical assessment will be made by an attending/senior&#xD;
      resident according with established clinical procedures, including the history, physical&#xD;
      examination, and vital signs. If by clinical assessment the patients meet eligibility&#xD;
      criteria, then they will be approached by a research associate for screening, informed&#xD;
      consent process, enrollment in the study, and data collection.&#xD;
&#xD;
      After the subjects understand and sign the informed consent form, they will be randomized to&#xD;
      either the placebo group or treatment group. The EMCP pharmacy will be in charge of the&#xD;
      randomization process. Once randomized, a standard source document (see data management&#xD;
      section and appendix C for details) will be filled with information given by the subjects and&#xD;
      in their charts. While study medication is given (time zero), subjects will receive a Visual&#xD;
      Analog Scale (VAS) to rate their pain upon initial presentation along with determination of&#xD;
      size of the cellulitic area. This will be done by determining the longest axis of the&#xD;
      cellulitic area and measuring it (in mm) from the most proximal/lateral end towards the most&#xD;
      distal/medial end, excluding any lymphangitic spread. The most proximal and distal area of&#xD;
      erythema will be outlined.&#xD;
&#xD;
      While the standard treatment of care for cellulitis will be circumscribed according to&#xD;
      already established protocols, the class of antibiotics and pain control that patients&#xD;
      receive will depend on their disposition:&#xD;
&#xD;
      If discharged:&#xD;
&#xD;
        1. Antibiotic prescriptions will be TMP/SMX 160/800 mg (Bactrim DS), 2 pills PO BID and&#xD;
           Cephalexin 500 mg PO qid; if allergic, Clindamycin 300 mg PO QID.&#xD;
&#xD;
        2. Pain control: during stay in the ED subjects will receive, according to their allergic&#xD;
           history and as long as the treating physician determines it is necessary to address the&#xD;
           pain, two tablets of either Percocet 5/325 mg,Vicodin 5/500 mg (if allergic to&#xD;
           Percocet), or Acetaminophen 500 mg as an only dose. Once discharged they will receive,&#xD;
           according to their allergic history and the physician's clinical judgement, a&#xD;
           prescription of 12 tablets of either Percocet 5/325 mg, Vicodin 5/500 mg (if allergic to&#xD;
           Percocet), Tylenol #3 300/30 mg, or Acetaminophen 500 mg, one tablet PO q6 and PRN for&#xD;
           pain. Pain medication must not include NSAIDs.&#xD;
&#xD;
      If admitted to observation unit: antibiotics will be IV Clindamycin 300 mg q6 hours; if&#xD;
      allergic, IV Vancomycin 1 g q12 hours should be given. For pain control: Morphine 4 mg IV q4&#xD;
      hours and PRN pain; if allergic, Dilaudid 1 mg IV q4 hours and PRN if pain. Pain medication&#xD;
      must not include NSAIDs. Once discharged, they will receive the same prescription as the&#xD;
      discharged group of subjects.&#xD;
&#xD;
      In addition to the standard of care described and any additional medications deemed&#xD;
      appropriate by the attending physician that do not represent a confounding factor to the&#xD;
      study (NSAIDs, other antibiotics), subjects will also receive an additional pill which will&#xD;
      be either prednisone 60 mg or placebo. If the treating physician feels it is in the best&#xD;
      interest of the subject to break the protocol, the subject's participation in study&#xD;
      procedures will end. Data that has already been collected will be kept, and may be analyzed&#xD;
      separately. Once the subjects have received the study medications, they will follow their&#xD;
      dispositions (either be discharged or be admitted in the observation's unit). To assure&#xD;
      treatment compliance, the Research Associate will provide the subjects with antibiotics and&#xD;
      pain medication treatment corresponding to the first 48 hours. After this landmark, the&#xD;
      subjects will cover the rest of their treatment. Subjects will be instructed not to take any&#xD;
      medication outside the prescription during the length of the study. If the subjects take&#xD;
      NSAIDs during the first 48 hours, this could be considered a confounding factor. As such,&#xD;
      subjects who take NSAIDs within the first 48 hours will have their participation in study&#xD;
      procedures ended. Their already collected data will be kept and may be analyzed separately;&#xD;
      however, if they take NSAIDs after the 48-hour visit their study participation will continue.&#xD;
&#xD;
      Subjects will be required to return to the ED after 48 hours and bring the remaining&#xD;
      prescribed pain medications. They will meet a Research Associate for re-evaluation, which&#xD;
      will be done by using a VAS, measuring the cellulitic area, and assessing the degree of usage&#xD;
      of the prescribed pain medications. This second visit is not part of the standard of care so&#xD;
      patients won't be required to receive a formal evaluation by an ED doctor nor register in&#xD;
      triage. Financial compensation will be provided on completion of the 48 hour follow-up visit&#xD;
      for all patients. A seventh (± one) day follow-up call will be done to assess pain severity,&#xD;
      degree of symptomatic recovery and disappearance of the erythema, and need of additional&#xD;
      medical assistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours</measure>
    <time_frame>Assessed once at day 1 and then once during the 48 hour follow-up</time_frame>
    <description>The level of pain as measured by a Visual Analog Scale(VAS) measured once at day 1 and once during the 48th hour follow-up visit. Minimum value 0, maximum value 100mm, higher scores corresponds to more pain/worse outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount of Pain Medication - Day 1 to 48 Hours</measure>
    <time_frame>Assessed once during the 48 hour follow-up</time_frame>
    <description>Number of times the subject needed to use pain medication between day 1 and the 48 hour follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Pain Medication - Day 1 to 7 Days</measure>
    <time_frame>Assessed once during the 7 day follow-up</time_frame>
    <description>Total amount of pain medication used between day 1 and the 7 day follow-up call.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Pain Medication - 48 Hours to 7 Days</measure>
    <time_frame>Assessed at the 48 hour follow-up and at the 7 day follow-up</time_frame>
    <description>Amount of pain medication the subject needed to use between the 48 hour follow-up and the 7 day follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring Additional Medical Assistance Post-Randomization</measure>
    <time_frame>Assessed continuously from day 1 to the day 7 follow-up call</time_frame>
    <description>Need for additional medical intervention to treat the current episode of cellulitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disposition Trend</measure>
    <time_frame>Assessed once during day 1</time_frame>
    <description>Disposition of the subject at the end of the initial visit on day 1; &quot;Disposition Trend&quot; refers to whether the subject was discharged to home or admitted to observation unit in the hospital. This Outcome Measure intends to assess improvement from baseline following intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AE)</measure>
    <time_frame>Assessed continuously from day 1 to day 7 follow-up</time_frame>
    <description>Development of adverse events during study period such as: allergic reaction, development of severe sepsis or septic shock, crepitus, change in mentation, fever greater than or equal to 39 degrees Celsius, tachycardia (heart rate over 120 beats per minute)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Erythema Size - Day 1 to 48 Hours</measure>
    <time_frame>Calculated once at 48 hrs</time_frame>
    <description>Change in erythema size - day 1 to 48 hours = (Mean erythema at Day 1) - (Mean erythema at 48 hrs) Erythema is measured in millimeters using the most proximal and distal area of the erythema. Higher values represent worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Cellulitis</condition>
  <arm_group>
    <arm_group_label>Prednisone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>See &quot;Prednisone&quot; arm description</description>
    <arm_group_label>Prednisone</arm_group_label>
    <other_name>Deltasone</other_name>
    <other_name>Prednicot</other_name>
    <other_name>Sterapred</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>See &quot;Placebo&quot; arm description</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Sugar Pill</other_name>
    <other_name>Inactive Drug</other_name>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 70 years&#xD;
&#xD;
          -  Current episode of cellulitis&#xD;
&#xD;
               1. Erythema greater than 5 centimeters in any dimension&#xD;
&#xD;
               2. Pain, swelling, warmth, and tenderness in the area without elevated borders&#xD;
&#xD;
          -  Dispositioned for discharge from the Emergency Department or Observation&#xD;
&#xD;
          -  Able to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Steroid use in the past 2 weeks&#xD;
&#xD;
          -  History of adrenal insufficiency&#xD;
&#xD;
          -  Any infection treated with antibiotics in the past 2 weeks&#xD;
&#xD;
          -  Allergy to:&#xD;
&#xD;
               1. Steroids&#xD;
&#xD;
               2. Acetaminophen&#xD;
&#xD;
               3. Trimethoprim-Sulphamethoxazole (TMP/SMX), Cephalexin, and Clindamycin (must be&#xD;
                  allergic to all three for exclusion)&#xD;
&#xD;
               4. Oxycodone and Hydrocodone (must be allergic to both for exclusion)&#xD;
&#xD;
          -  If subject is going to the Observation unit, allergy to:&#xD;
&#xD;
               1. Clindamycin and Vancomycin (must be allergic to both for exclusion)&#xD;
&#xD;
               2. Morphine and Hydromorphone (must be allergic to both for exclusion)&#xD;
&#xD;
          -  Suspicion or presence of abscess&#xD;
&#xD;
          -  Suspicion or presence of deep vein thrombosis&#xD;
&#xD;
          -  Suspicion or presence of severe sepsis, as defined by:&#xD;
&#xD;
               1. Sepsis&#xD;
&#xD;
               2. Hypotension (systolic pressure &lt; 90 mmHg or reduction of 40 mmHg from baseline)&#xD;
&#xD;
               3. Failure of single end organ&#xD;
&#xD;
          -  Suspicion or presence of septic shock, as defined by:&#xD;
&#xD;
               1. Severe sepsis&#xD;
&#xD;
               2. Hypotension that is refractory to fluid management&#xD;
&#xD;
               3. Failure or more than one end organ&#xD;
&#xD;
          -  Crepitus&#xD;
&#xD;
          -  Change in mentation&#xD;
&#xD;
          -  Tachycardia greater than 120 beats per minute&#xD;
&#xD;
          -  Fever greater than or equal to 39 degrees Celsius&#xD;
&#xD;
          -  Hospital admission&#xD;
&#xD;
          -  Under 18 years of age, or over 70 years of age&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Police custody or prisoner&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Inability to consent&#xD;
&#xD;
          -  Nursing home residents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Goldstein, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein Healthcare Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Albert Einstein Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bergkvist PI, Sjobeck K. Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study. Scand J Infect Dis. 1997;29(4):377-82. doi: 10.3109/00365549709011834.</citation>
    <PMID>9360253</PMID>
  </reference>
  <reference>
    <citation>Kiderman A, Yaphe J, Bregman J, Zemel T, Furst AL. Adjuvant prednisone therapy in pharyngitis: a randomised controlled trial from general practice. Br J Gen Pract. 2005 Mar;55(512):218-21.</citation>
    <PMID>15808038</PMID>
  </reference>
  <reference>
    <citation>Qi D, Pulinilkunnil T, An D, Ghosh S, Abrahani A, Pospisilik JA, Brownsey R, Wambolt R, Allard M, Rodrigues B. Single-dose dexamethasone induces whole-body insulin resistance and alters both cardiac fatty acid and carbohydrate metabolism. Diabetes. 2004 Jul;53(7):1790-7. doi: 10.2337/diabetes.53.7.1790.</citation>
    <PMID>15220203</PMID>
  </reference>
  <reference>
    <citation>Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.</citation>
    <PMID>8604867</PMID>
  </reference>
  <reference>
    <citation>Yen MT, Yen KG. Effect of corticosteroids in the acute management of pediatric orbital cellulitis with subperiosteal abscess. Ophthalmic Plast Reconstr Surg. 2005 Sep;21(5):363-6; discussion 366-7. doi: 10.1097/01.iop.0000179973.44003.f7.</citation>
    <PMID>16234700</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <results_first_submitted>May 14, 2020</results_first_submitted>
  <results_first_submitted_qc>January 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 10, 2021</results_first_posted>
  <last_update_submitted>January 22, 2021</last_update_submitted>
  <last_update_submitted_qc>January 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein Healthcare Network</investigator_affiliation>
    <investigator_full_name>Scott Goldstein, DO</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>Cellulitis</keyword>
  <keyword>Skin infection</keyword>
  <keyword>Prednisone</keyword>
  <keyword>Steroid</keyword>
  <keyword>Anti-inflammatory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cellulitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>42 participants agreed to participate in the study. Following completion of informed consent process, 1 participant withdrew of their own volition, 1 participant was excluded from analysis for taking NSAID within the first 48 hrs.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Prednisone</title>
          <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo</population>
      <group_list>
        <group group_id="B1">
          <title>Prednisone</title>
          <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40" lower_limit="21" upper_limit="58"/>
                    <measurement group_id="B2" value="40" lower_limit="18" upper_limit="66"/>
                    <measurement group_id="B3" value="40" lower_limit="18" upper_limit="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours</title>
        <description>The level of pain as measured by a Visual Analog Scale(VAS) measured once at day 1 and once during the 48th hour follow-up visit. Minimum value 0, maximum value 100mm, higher scores corresponds to more pain/worse outcomes.</description>
        <time_frame>Assessed once at day 1 and then once during the 48 hour follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours</title>
          <description>The level of pain as measured by a Visual Analog Scale(VAS) measured once at day 1 and once during the 48th hour follow-up visit. Minimum value 0, maximum value 100mm, higher scores corresponds to more pain/worse outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VAS at Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.64" spread="14.89"/>
                    <measurement group_id="O2" value="56.45" spread="30.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS at 48 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.71" spread="34.5"/>
                    <measurement group_id="O2" value="25.91" spread="33.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Pain Medication - Day 1 to 48 Hours</title>
        <description>Number of times the subject needed to use pain medication between day 1 and the 48 hour follow-up</description>
        <time_frame>Assessed once during the 48 hour follow-up</time_frame>
        <population>Data is not available on all participants</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Pain Medication - Day 1 to 48 Hours</title>
          <description>Number of times the subject needed to use pain medication between day 1 and the 48 hour follow-up</description>
          <population>Data is not available on all participants</population>
          <units>medications taken</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="0" upper_limit="16"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Pain Medication - Day 1 to 7 Days</title>
        <description>Total amount of pain medication used between day 1 and the 7 day follow-up call.</description>
        <time_frame>Assessed once during the 7 day follow-up</time_frame>
        <population>Data was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Pain Medication - Day 1 to 7 Days</title>
          <description>Total amount of pain medication used between day 1 and the 7 day follow-up call.</description>
          <population>Data was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Pain Medication - 48 Hours to 7 Days</title>
        <description>Amount of pain medication the subject needed to use between the 48 hour follow-up and the 7 day follow-up.</description>
        <time_frame>Assessed at the 48 hour follow-up and at the 7 day follow-up</time_frame>
        <population>Data was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Pain Medication - 48 Hours to 7 Days</title>
          <description>Amount of pain medication the subject needed to use between the 48 hour follow-up and the 7 day follow-up.</description>
          <population>Data was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring Additional Medical Assistance Post-Randomization</title>
        <description>Need for additional medical intervention to treat the current episode of cellulitis.</description>
        <time_frame>Assessed continuously from day 1 to the day 7 follow-up call</time_frame>
        <population>Data was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring Additional Medical Assistance Post-Randomization</title>
          <description>Need for additional medical intervention to treat the current episode of cellulitis.</description>
          <population>Data was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disposition Trend</title>
        <description>Disposition of the subject at the end of the initial visit on day 1; &quot;Disposition Trend&quot; refers to whether the subject was discharged to home or admitted to observation unit in the hospital. This Outcome Measure intends to assess improvement from baseline following intervention.</description>
        <time_frame>Assessed once during day 1</time_frame>
        <population>Data is not available on all participants</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</description>
          </group>
        </group_list>
        <measure>
          <title>Disposition Trend</title>
          <description>Disposition of the subject at the end of the initial visit on day 1; &quot;Disposition Trend&quot; refers to whether the subject was discharged to home or admitted to observation unit in the hospital. This Outcome Measure intends to assess improvement from baseline following intervention.</description>
          <population>Data is not available on all participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Discharged to Home</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Data not available/not collected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events (AE)</title>
        <description>Development of adverse events during study period such as: allergic reaction, development of severe sepsis or septic shock, crepitus, change in mentation, fever greater than or equal to 39 degrees Celsius, tachycardia (heart rate over 120 beats per minute)</description>
        <time_frame>Assessed continuously from day 1 to day 7 follow-up</time_frame>
        <population>Data not collected on this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events (AE)</title>
          <description>Development of adverse events during study period such as: allergic reaction, development of severe sepsis or septic shock, crepitus, change in mentation, fever greater than or equal to 39 degrees Celsius, tachycardia (heart rate over 120 beats per minute)</description>
          <population>Data not collected on this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Erythema Size - Day 1 to 48 Hours</title>
        <description>Change in erythema size - day 1 to 48 hours = (Mean erythema at Day 1) - (Mean erythema at 48 hrs) Erythema is measured in millimeters using the most proximal and distal area of the erythema. Higher values represent worse outcome.</description>
        <time_frame>Calculated once at 48 hrs</time_frame>
        <population>Data not collected on this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Erythema Size - Day 1 to 48 Hours</title>
          <description>Change in erythema size - day 1 to 48 hours = (Mean erythema at Day 1) - (Mean erythema at 48 hrs) Erythema is measured in millimeters using the most proximal and distal area of the erythema. Higher values represent worse outcome.</description>
          <population>Data not collected on this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events collected upto 7 day follow up.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prednisone</title>
          <description>In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.&#xD;
Prednisone: See &quot;Prednisone&quot; arm description</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.&#xD;
Placebo: See &quot;Placebo&quot; arm description</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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>
    <limitations_and_caveats>Small sample size</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Scott Goldstein</name_or_title>
      <organization>Einstein Medical Center</organization>
      <phone>2154561836</phone>
      <email>goldstes@einstein.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/NCT01671423
org study id: HN 4372
nct id: NCT01671423
lead sponsor: 
has dmc: Yes
Cellulitis is the medical term for an infection of the skin, with symptoms including redness,
      swelling, warmth, and pain. This group of symptoms is called inflammation, and is caused by
      the body's immune system responding to the infection. Standard care for cellulitis is using
      antibiotics to destroy the infection, but the inflammation can persist and cause a great deal
      of pain. The hypothesis of this study is that adding a single dose of an oral steroid
      (prednisone), which tempers the immune response, will reduce inflammation, reduce pain, and
      speed recovery. This hypothesis will be examined by recruiting a group of patients with
      cellulitis, and randomizing them to two sub-groups: one group will receive a dose of
      prednisone, while the other group will receive a placebo. Neither group will know what they
      received unless there is a problem. These subjects will be followed up at the 48 hour mark
      and the 7 day mark, and will have their results compared.
This pilot study will be conducted in a prospective, double-blinded, placebo-controlled,
      randomized fashion using a convenience sample of 100 subjects who come to the ED with signs
      and symptoms of cellulitis. Initial medical assessment will be made by an attending/senior
      resident according with established clinical procedures, including the history, physical
      examination, and vital signs. If by clinical assessment the patients meet eligibility
      criteria, then they will be approached by a research associate for screening, informed
      consent process, enrollment in the study, and data collection.

      After the subjects understand and sign the informed consent form, they will be randomized to
      either the placebo group or treatment group. The EMCP pharmacy will be in charge of the
      randomization process. Once randomized, a standard source document (see data management
      section and appendix C for details) will be filled with information given by the subjects and
      in their charts. While study medication is given (time zero), subjects will receive a Visual
      Analog Scale (VAS) to rate their pain upon initial presentation along with determination of
      size of the cellulitic area. This will be done by determining the longest axis of the
      cellulitic area and measuring it (in mm) from the most proximal/lateral end towards the most
      distal/medial end, excluding any lymphangitic spread. The most proximal and distal area of
      erythema will be outlined.

      While the standard treatment of care for cellulitis will be circumscribed according to
      already established protocols, the class of antibiotics and pain control that patients
      receive will depend on their disposition:

      If discharged:

        1. Antibiotic prescriptions will be TMP/SMX 160/800 mg (Bactrim DS), 2 pills PO BID and
           Cephalexin 500 mg PO qid; if allergic, Clindamycin 300 mg PO QID.

        2. Pain control: during stay in the ED subjects will receive, according to their allergic
           history and as long as the treating physician determines it is necessary to address the
           pain, two tablets of either Percocet 5/325 mg,Vicodin 5/500 mg (if allergic to
           Percocet), or Acetaminophen 500 mg as an only dose. Once discharged they will receive,
           according to their allergic history and the physician's clinical judgement, a
           prescription of 12 tablets of either Percocet 5/325 mg, Vicodin 5/500 mg (if allergic to
           Percocet), Tylenol #3 300/30 mg, or Acetaminophen 500 mg, one tablet PO q6 and PRN for
           pain. Pain medication must not include NSAIDs.

      If admitted to observation unit: antibiotics will be IV Clindamycin 300 mg q6 hours; if
      allergic, IV Vancomycin 1 g q12 hours should be given. For pain control: Morphine 4 mg IV q4
      hours and PRN pain; if allergic, Dilaudid 1 mg IV q4 hours and PRN if pain. Pain medication
      must not include NSAIDs. Once discharged, they will receive the same prescription as the
      discharged group of subjects.

      In addition to the standard of care described and any additional medications deemed
      appropriate by the attending physician that do not represent a confounding factor to the
      study (NSAIDs, other antibiotics), subjects will also receive an additional pill which will
      be either prednisone 60 mg or placebo. If the treating physician feels it is in the best
      interest of the subject to break the protocol, the subject's participation in study
      procedures will end. Data that has already been collected will be kept, and may be analyzed
      separately. Once the subjects have received the study medications, they will follow their
      dispositions (either be discharged or be admitted in the observation's unit). To assure
      treatment compliance, the Research Associate will provide the subjects with antibiotics and
      pain medication treatment corresponding to the first 48 hours. After this landmark, the
      subjects will cover the rest of their treatment. Subjects will be instructed not to take any
      medication outside the prescription during the length of the study. If the subjects take
      NSAIDs during the first 48 hours, this could be considered a confounding factor. As such,
      subjects who take NSAIDs within the first 48 hours will have their participation in study
      procedures ended. Their already collected data will be kept and may be analyzed separately;
      however, if they take NSAIDs after the 48-hour visit their study participation will continue.

      Subjects will be required to return to the ED after 48 hours and bring the remaining
      prescribed pain medications. They will meet a Research Associate for re-evaluation, which
      will be done by using a VAS, measuring the cellulitic area, and assessing the degree of usage
      of the prescribed pain medications. This second visit is not part of the standard of care so
      patients won't be required to receive a formal evaluation by an ED doctor nor register in
      triage. Financial compensation will be provided on completion of the 48 hour follow-up visit
      for all patients. A seventh (± one) day follow-up call will be done to assess pain severity,
      degree of symptomatic recovery and disappearance of the erythema, and need of additional
      medical assistance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours
time frame: Assessed once at day 1 and then once during the 48 hour follow-up
description: The level of pain as measured by a Visual Analog Scale(VAS) measured once at day 1 and once during the 48th hour follow-up visit. Minimum value 0, maximum value 100mm, higher scores corresponds to more pain/worse outcomes.
measure: Amount of Pain Medication - Day 1 to 48 Hours
time frame: Assessed once during the 48 hour follow-up
description: Number of times the subject needed to use pain medication between day 1 and the 48 hour follow-up
measure: Amount of Pain Medication - Day 1 to 7 Days
time frame: Assessed once during the 7 day follow-up
description: Total amount of pain medication used between day 1 and the 7 day follow-up call.
measure: Amount of Pain Medication - 48 Hours to 7 Days
time frame: Assessed at the 48 hour follow-up and at the 7 day follow-up
description: Amount of pain medication the subject needed to use between the 48 hour follow-up and the 7 day follow-up.
measure: Number of Participants Requiring Additional Medical Assistance Post-Randomization
time frame: Assessed continuously from day 1 to the day 7 follow-up call
description: Need for additional medical intervention to treat the current episode of cellulitis.
measure: Disposition Trend
time frame: Assessed once during day 1
description: Disposition of the subject at the end of the initial visit on day 1; "Disposition Trend" refers to whether the subject was discharged to home or admitted to observation unit in the hospital. This Outcome Measure intends to assess improvement from baseline following intervention.
measure: Adverse Events (AE)
time frame: Assessed continuously from day 1 to day 7 follow-up
description: Development of adverse events during study period such as: allergic reaction, development of severe sepsis or septic shock, crepitus, change in mentation, fever greater than or equal to 39 degrees Celsius, tachycardia (heart rate over 120 beats per minute)
measure: Change in Erythema Size - Day 1 to 48 Hours
time frame: Calculated once at 48 hrs
description: Change in erythema size - day 1 to 48 hours = (Mean erythema at Day 1) - (Mean erythema at 48 hrs) Erythema is measured in millimeters using the most proximal and distal area of the erythema. Higher values represent worse outcome.
arm group label: Prednisone
arm group type: Active Comparator
description: In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.
arm group label: Placebo
arm group type: Placebo Comparator
description: In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
intervention type: Drug
intervention name: Prednisone
description: See "Prednisone" arm description
arm group label: Prednisone
other name: Deltasone
other name: Prednicot
other name: Sterapred
intervention type: Drug
intervention name: Placebo
description: See "Placebo" arm description
arm group label: Placebo
other name: Sugar Pill
other name: Inactive Drug
other name: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Scott Goldstein, DO
role: Principal Investigator
affiliation: Albert Einstein Healthcare Network
facility: 
country: United States
citation: Bergkvist PI, Sjobeck K. Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study. Scand J Infect Dis. 1997;29(4):377-82. doi: 10.3109/00365549709011834.
PMID: 9360253
citation: Kiderman A, Yaphe J, Bregman J, Zemel T, Furst AL. Adjuvant prednisone therapy in pharyngitis: a randomised controlled trial from general practice. Br J Gen Pract. 2005 Mar;55(512):218-21.
PMID: 15808038
citation: Qi D, Pulinilkunnil T, An D, Ghosh S, Abrahani A, Pospisilik JA, Brownsey R, Wambolt R, Allard M, Rodrigues B. Single-dose dexamethasone induces whole-body insulin resistance and alters both cardiac fatty acid and carbohydrate metabolism. Diabetes. 2004 Jul;53(7):1790-7. doi: 10.2337/diabetes.53.7.1790.
PMID: 15220203
citation: Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.
PMID: 8604867
citation: Yen MT, Yen KG. Effect of corticosteroids in the acute management of pediatric orbital cellulitis with subperiosteal abscess. Ophthalmic Plast Reconstr Surg. 2005 Sep;21(5):363-6; discussion 366-7. doi: 10.1097/01.iop.0000179973.44003.f7.
PMID: 16234700
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein Healthcare Network
investigator full name: Scott Goldstein, DO
investigator title: Attending Physician
mesh term: Cellulitis
mesh term: Prednisone
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size
point of contact: 