<?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>IRCT20181006041252N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-26</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of amniotic membrane on wound healing</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of human amniotic membrane on wound healing of donor site in burn patients compared with standard treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41634</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was performed using the card in a way that 35 cards were produced and divided into 17 with proximal and 18 with distal name. These cards were poured into a bowl and shuffled, then the cards drew without replacement from the bowl and aligned from 1 to 35 respectively. By drawing each card and identifying the proximal or distal part as the intervention, the other part was considered as a control, Blinding description: The study was a double-blind study in which no patients and outcome evaluators were aware of the study procedure and placement of the study groups and each person in the study will be assigned to "A" and "B" code that only the researcher will know about the type of group.</study_design>
      <phase>3</phase>
      <hc_freetext>Burn.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: donor site in this group was covered with amniotic membranes made by Royan Cells Co 10 x 15 cm, Vaseline gauze, and wet dressing. Intervention 2: Control group: The patients' graft site was just covered with Vaseline gauze and wet dressing.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Sahebkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617913114</zip>
        <telephone>+98 51 4401 8337</telephone>
        <email>Mohammad.sahebkar66@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mojtaba Vaheb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617913114</zip>
        <telephone>+98 51 4401 1604</telephone>
        <email>Drvaheb2017@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 2-60 years
Grade 2 and 3 burn patients require autologous skin graft (STSG) and surgery</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Connective tissue diseases, diabetes, malnutrition, septicemia, heart disease, kidney failure, cancer, chemotherapy and the use of corticosteroid drugs.
Dissatisfaction patients to participate in the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M61.30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calcification and ossification of muscles associated with burns, unspecified site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: donor site in this group was covered with amniotic membranes made by Royan Cells Co 10 x 15 cm, Vaseline gauze, and wet dressing.</i_keyword>
      <i_keyword>Control group: The patients' graft site was just covered with Vaseline gauze and wet dressing.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determination of pigmentation. Timepoint: Measurement of pigmentation on days 10, 20 and 30 after the intervention. Method of measurement: Photographic Morphometry.</prim_outcome>
      <prim_outcome>Determination of epithelization. Timepoint: Measurement of epithelization on days 10, 20 and 30 after the intervention. Method of measurement: Photographic Morphometry.</prim_outcome>
      <prim_outcome>Determination of superficial vascularity. Timepoint: Measurement of superficial vascularity on days 10, 20 and 30 after the intervention. Method of measurement: Photographic Morphometry.</prim_outcome>
      <prim_outcome>Determination of granulation. Timepoint: Measurement of granulation on days 10, 20 and 30 after the intervention. Method of measurement: Photographic Morphometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determine the amount of pain. Timepoint: Measurement of pain on days 10, 20 and 30 after the intervention. Method of measurement: Visual Analogue Scale of Pain Questionnaire.</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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-25</approval_date>
        <contact_name>Ethics committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
