<?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>IRCT20220702055349N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-05</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Swalin  ointment and 1% silver sulfadiazine on deep 2nd degree burns</public_title>
      <acronym>Swalin (SW)  Silver Sulfadiazine (SSD)</acronym>
      <scientific_title>Comparison of the effect of Swalin  ointment and 1% Silver sulfadiazine on the repair of 2nd degree deep burns</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64791</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study is done through block randomization with 6 blocks. The randomization unit is an individual type. The randomization tool of this study is Excel software and this software is also used to create a random sequence. For concealment, an experienced person who is not one of the project collaborators, in a separate center after registering the participants' information, defines the ointment code separately for each patient and informs the research team about the corresponding code, Blinding description: In this study, the researcher, doctor and data analyst, who is responsible for collecting information, do not know the type of drug used, all patients are fully informed about the type of ointment used, and a written consent form is completed for each of them, and all treatment steps are also It will be under the supervision of the center's specialist doctor.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Burns. Condition 2: Burns. Condition 3: Burns. Condition 4: Burn.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Patients with deep 2nd degree burns and treated with Swalin ointment. Intervention 2: Control group: Patients with deep 2nd degree burns and treated with 1% silver sulfadiazine ointment.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The research team and partners have not reached the conclusion.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrdad Bakhtiyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 8862 2689</telephone>
        <email>mehr_bakhtiyari@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Alizadeotaghvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahhari Burn Hospital, Rashid-Yasemi Ave, Valieasr Ave, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۷۱۴۳۵۳</zip>
        <telephone>021-88770031-36</telephone>
        <email>drhralizade@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 15-45 years, 2nd degree thermal burn wound of 1% to 2% depth of the body, less than 24 hours have passed since the burn, good general condition and no pregnancy, no underlying disease such as diabetes, no history of autoimmune diseases, No HIV infection, no immune system deficiency, no history of taking immunosuppressant drugs, no history of psychiatric disorders, no history of electrical chemical thermal burns, no history of allergies and sensitivities.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other types of burns, such as chemical, electrical, etc., wound stained with polluting substances, using any substance other than drinking water on the wound before entering the study, untreated active infection in different parts of the body, patients with underlying diseases and immune system defects such as cancer, AIDS, diabetes, high blood pressure, etc., burns on the face and genital areas, pregnant and lactating women,</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T22</hc_code>
      <hc_code>T23</hc_code>
      <hc_code>T24</hc_code>
      <hc_code>T25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn and corrosion of shoulder and upper limb, except wrist and hand</hc_keyword>
      <hc_keyword>Burn and corrosion of wrist and hand</hc_keyword>
      <hc_keyword>Burn and corrosion of lower limb, except ankle and foot</hc_keyword>
      <hc_keyword>Burn and corrosion of ankle and foot</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:Patients with deep 2nd degree burns and treated with Swalin ointment</i_keyword>
      <i_keyword>Control group: Patients with deep 2nd degree burns and treated with 1% silver sulfadiazine ointment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The size of the burn surface. Timepoint: Days 1, 7, 14, 21 and 28. Method of measurement: Photo image using imageJ software.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Angiogenesis factors. Timepoint: fourteenth day. Method of measurement: ELISA assay.</sec_outcome>
      <sec_outcome>Inflammatory factors. Timepoint: Days 3, 7 and 14. Method of measurement: ELISA assay.</sec_outcome>
      <sec_outcome>The amount of collagen. Timepoint: fourteenth day. Method of measurement: Masson's Trichrome Stain.</sec_outcome>
      <sec_outcome>Number of vascular sections. Timepoint: fourteenth day. Method of measurement: H&amp;E Staining.</sec_outcome>
      <sec_outcome>Epithelialization. Timepoint: fourteenth day. Method of measurement: H&amp;E Staining.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-15</approval_date>
        <contact_name>Research Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
