<?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>IRCT20190614043889N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-13</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of  between amniotic membrane and conventional dressing outcomes  in burned skin graft Donor site</public_title>
      <acronym></acronym>
      <scientific_title>comparison of short-term outcomes between amniotic membrane and conventional dressing in skin graft Donor site in patients hospitalized in the burn ward of Imam Khomeini Hospital of Urmia in 2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40280</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Burn. Donor Graft Side.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the patient's left side will be dressed biologically with amniotic membrane. Intervention 2: Control group:The right side of the patient is dressed with Nitrofurazone impregnated gas and 2 grams of ointment will be used for each percentage of the graft site.</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:
Data related to the primary and secondary outcomes  will be provided to clinical researchers in full detail after unidentifiable individuals and articles are published.

When:
Up to 6 months after publishing resultes

To whom:
Researchers, Ethics Committee

Conditions:
cite of clinical results in other similar researches and collaborating with other large multi center clinical trials with approval ethical commite and IRCT center.

Where to obtain:
The results are available in the form of articles and seminars to applicants and can be contacted by Dr. Jafar Kazemzadeh, Imam Hospital Burn Unit.
Urmia.Imam Hospital. Burn Section.Jafar Kazemzadeh. Contact No. 098 44 33459539

How to obtain:
The applicant can access the results of the study by written request or by contacting the center within a maximum of 10 working days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jafar Kazemzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ershad ave emam khomeini hospital</address>
        <city>URMIA</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715718516</zip>
        <telephone>+98 44 3198 8111</telephone>
        <email>jafar.kazemzade48@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jafar Kazemzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ershad ave emam khomeini Hospital</address>
        <city>URMIA</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715718516</zip>
        <telephone>+98 44 3198 8111</telephone>
        <email>jafar.kazemzade48@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patient age 1-66 years old
Patient accept biologic dressing
Burns require skin grafts regardless of burning percent</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>66 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>have underlying disease such as diabetes mellitus renal failure hepatitis vascular in sufficiency and heart disease
patient have other trauma</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T30.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn of unspecified body region, unspecified degree</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the patient's left side will be dressed biologically with amniotic membrane.</i_keyword>
      <i_keyword>Control group:The right side of the patient is dressed with Nitrofurazone impregnated gas and 2 grams of ointment will be used for each percentage of the graft site</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Epithelialization and scar in donor graft site. Timepoint: effect of Biologic dressing in donor graft site on days 7, 14 and 30. Method of measurement: Information Gathering Form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Local infection rate. Timepoint: over a period of one month. Method of measurement: observed local infection.</sec_outcome>
      <sec_outcome>Amount of pain. Timepoint: during  a period of one month. Method of measurement: Visual  Analogue Scale.</sec_outcome>
      <sec_outcome>Patients' rate of co-operation in dressing replacement. Timepoint: during  a period of one month. Method of measurement: observation.</sec_outcome>
      <sec_outcome>Duration of recovery time. Timepoint: over a period of one month. Method of measurement: week.</sec_outcome>
      <sec_outcome>Itching rate. Timepoint: during  a period of one month. Method of measurement: to measure  with Nominal Scale (yes/no).</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-02</approval_date>
        <contact_name>Ethics Research Commity Of Urmia Medical university</contact_name>
        <contact_address>ershad ave emam khomeini hospital born ward Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
