<?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>IRCT20141208020249N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-23</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the healing effects of a natural oint based on herbal oil, honey and egg yolk on 1st and 2nd degree burn wounds</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the healing effects of a natural oint based on herbal oil, honey and egg yolk on 1st and 2nd degree burn wounds</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77848</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: We divide the burn site into two parts (half medial) A and (half lateral) B and use the drug under study as follows. The part of the burn that does not receive the study drug will be partially controlled.
0001: A 0007: B 0013: B 0019: A 0025: A 0031: B
0002: B 0008: A 0014: A 0020: B 0026: B 0032: B
0003: A 0009: B 0015: B 0021: B 0027: B 0033: B
0004: A 0010: B 0016: A 0022: B 0028: B 0034: A
0005: A 0011: A 0017: A 0023: B 0029: A 0035: B
0006: A 0012: A 0018: A 0024: A 0030: A, Blinding description: This study will be double-blind, so that the doctor responsible for measuring the outcome/intervention and the patient will be blind to the type of intervention received.</study_design>
      <phase>1-2</phase>
      <hc_freetext>1st and 2nd degree burns.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Treatment with burn ointment (based on natural oils, honey and eggs), which is performed on the left side in horizontal wounds, upper side in vertical wounds, and right side in oblique wounds.Gauze impregnated with burn ointment is used at the intervention site. Intervention 2: Control group: The usual clinical procedures (mefenaid ointment) are performed on the right side in horizontal wounds, the bottom in vertical wounds and the left side in oblique wounds. (The wound is divided into two equal parts in terms of the largest dimension). It is used for the control surface.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All the original data will be published in the form of an article, and supplementary data can be obtained from the responsible author upon reasonable request.

When:
2025 spring

To whom:
Official academic researchers or working in commercial research and development units

Conditions:
Scientific research uses

Where to obtain:
Researchers can request documents or data files by sending an email to the person responsible for the scientific responsibility of the study. The exact response time is not known. The email address and details of the person responsible for responding are as follows:
The full name of the responsible person: Behzad Khalafi
Email: khalafi.behzad70@gmail.com
Phone +98 87 3377 7925
Address: Pasdaran Street, Shahada Salamat Blvd., Kawsar Hospital
Postal code 6617784817

How to obtain:
First, the researchers send an e-mail to the person responsible for the scientific response(The full name of the responsible person: Behzad Khalafi
Email: khalafi.behzad70@gmail.com) and specify which of the data they want. The information (except for the personal information of the participants) will be available to the said person after reviewing the request through e-mail.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behzad Khalafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kawsar Hospital, Shohadaye Salamat Blvd, Pasdaran St.,</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617784817</zip>
        <telephone>+98 87 3377 7925</telephone>
        <email>khalafi.behzad70@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behzad Khalafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran St.,</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617784817</zip>
        <telephone>+98 45 3344 9697</telephone>
        <email>khalafi.behzad70@muk.ac.ir</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1st and 2nd degree burn patients referred to Kowsar Sanandaj Hospital who consent to participate in the research project.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction of patients in participating in the study
Death of patients
Stopping treatment in patients who have problems with wound healing</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn and corrosion, body region unspecified</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:Treatment with burn ointment (based on natural oils, honey and eggs), which is performed on the left side in horizontal wounds, upper side in vertical wounds, and right side in oblique wounds.Gauze impregnated with burn ointment is used at the intervention site</i_keyword>
      <i_keyword>Control group: The usual clinical procedures (mefenaid ointment) are performed on the right side in horizontal wounds, the bottom in vertical wounds and the left side in oblique wounds. (The wound is divided into two equal parts in terms of the largest dimension). It is used for the control surface.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Surgical Site Infection score. Timepoint: Before starting the study and 2 and 5 days after the intervention. Method of measurement: In this measure, Surgical Site Infection (SSI) indicators based on CDC guidelines are used to evaluate the risk of wound infection.</prim_outcome>
      <prim_outcome>Early Healing Score. Timepoint: Before starting the study and 2 and 5 days after the intervention. Method of measurement: EHS evaluation consists of clinical signs of re-epithelization (CSR), clinical signs of haemostasis (CSH) and clinical signs of inflammation (CSI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-19</approval_date>
        <contact_name>Ethics Committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Abider Street Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
