<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20201204049598N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-08</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Naproxen in the treatment of cellulitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of Cefazolin and Naproxen with Cefazolin only in the treatment of cellulitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53636</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a table of random numbers, patients are randomly divided into two groups of intervention and control, and receive the medication of the same group, Blinding description: First, written informed consent is obtained from patients. Based on the list prepared by the researcher, the clinician prescribes two types of medication regimens for patients: the intervention group receives Cefazolin (1-1.5 gram intravenously every 8 hours) and Naproxen (500 milligram orally every 12 hours), and the control group receives Cefazolin only (1-1.5 gram intravenously every 8 hours). An individual, then evaluates the clinical outcome. In this study, patients and clinical outcome assessors are not aware of the names of the intervention and control groups.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Cellulitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group received Cefazolin (1.5-1 g intravenously every 8 hours) and Naproxen (500 mg orally every 12 hours) until the end of hospitalization. The drugs used are the product of Dr. Abidi. Intervention 2: Control group: The control group received Cefazolin only (1.5-1 g intravenously every 8 hours) until the end of hospitalization.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sadaf Saket</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 24, Gol Ave., Shahid Araghi St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1664943813</zip>
        <telephone>+98 21 2231 3681</telephone>
        <email>dasdd272@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadaf Saket</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 24, Gol Ave., Shahid Araghi St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1664943813</zip>
        <telephone>+98 21 2231 3681</telephone>
        <email>dasdd272@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Hospitalized patients with a diagnosis of cellulitis
Age over 18 years
Willingness to participate in this clinical trial</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy to Penicillin, Cefazolin or Naproxen
Pregnant women
Immunodeficiency
Patients with mucocutaneous diseases
Patients with kidney diseases
Patients with vascular catheters
Patients suspected of having septic arthritis or osteomyelitis
Patients with infected diabetic foot ulcers
Bite or the presence of a foreign body in the wound
Perianal cellulitis
Injecting substance abuse
Hospitalization during the last three months
Chronic hemodialysis patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cellulitis and acute lymphangitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group received Cefazolin (1.5-1 g intravenously every 8 hours) and Naproxen (500 mg orally every 12 hours) until the end of hospitalization. The drugs used are the product of Dr. Abidi.</i_keyword>
      <i_keyword>Control group: The control group received Cefazolin only (1.5-1 g intravenously every 8 hours) until the end of hospitalization.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Erythema. Timepoint: Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention. Method of measurement: Trained doctor report.</prim_outcome>
      <prim_outcome>Warmth. Timepoint: Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention. Method of measurement: Trained doctor report.</prim_outcome>
      <prim_outcome>Tenderness. Timepoint: Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention. Method of measurement: Trained doctor report.</prim_outcome>
      <prim_outcome>Body temperature. Timepoint: Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention. Method of measurement: Using a mercury thermometer.</prim_outcome>
      <prim_outcome>Reduce exudate secretion from the wound. Timepoint: Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention. Method of measurement: Trained doctor report.</prim_outcome>
      <prim_outcome>Hospitalization duration. Timepoint: Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention. Method of measurement: Medical record.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Epigastric pain. Timepoint: Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention. Method of measurement: Trained doctor report.</sec_outcome>
      <sec_outcome>Diarreha. Timepoint: Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention. Method of measurement: Trained doctor report.</sec_outcome>
      <sec_outcome>Itching. Timepoint: Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention. Method of measurement: Trained doctor report.</sec_outcome>
      <sec_outcome>Skin rash. Timepoint: Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention. Method of measurement: Trained doctor report.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-05</approval_date>
        <contact_name>Research ethics committees of school of medicine; Shahid Beheshti university of medical sciences</contact_name>
        <contact_address>School of medicine of Shahid Beheshti university of medical sciences, Koudakyar Ave., Daneshjoo Blvd., Velenjak. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
