<?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>IRCT20131112015390N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-06</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of skin grafts on the platelet level of burn patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of skin grafts on the platelet level of patients after surgery in Imam Khomeini Hospital of Urmia in the first 6 months of 2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>220</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74084</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Burn.</hc_freetext>
      <i_freetext>In patients with relatively deep or deep burns that penetrate the reticular dermis layer, blood vessels, and skin appendages, surgical debridement, and skin graft were performed to repair the burn site. For this purpose, excision and skin graft were performed in one session after the patient's initial resuscitation. In this surgical procedure, the ischemic and necrotic burnt tissue was removed layer by layer by a dermatome. Until the wound bed began to bleed, which indicated that there was blood supply from this layer and that it was not involved in a burn. After the hemostasis of bleeding, skin grafts were taken from healthy body parts that had not suffered burns. The skin grafts were taken  around the thighs, and in case of the thigh's involvement, the grafts were taken from the legs, arms, forearms, and trunk. The depth of the skin removal was adjusted on the Dermatome, based on the patient’s’ need; the skin was removed on the required area, which was debrided, placed, and sutured with a stapler. At the end of the operation, the grafted area was dressed with sterile vaseline gases, and it was not opened for five days to one week. The skin that was left in place guaranteed the graft's success. The place that suffered a deep burn was repaired by replacing the person's healthy skin (autograft)..</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 data is potentially shareable after de-identifying individuals

When:
Six months after the results are published

To whom:
All researchers who need data.

Conditions:
All researchers who use the data for research can apply.

Where to obtain:
The data will be accessible via the following email. jafarkazemzade48@gmail.com

How to obtain:
The ethics code of the current study will be sufficient for data delivery.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jafar Kazemzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayat Allah Madras Blvd., Ershad Blvd., Imam Khomeini Teaching Hospital, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81351-57157</zip>
        <telephone>+98 44 3345 9538</telephone>
        <email>jafarkazemzade48@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jafar Kazemzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayat Allah Madras Blvd., Ershad Blvd., Imam Khomeini Teaching Hospital, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81351-57157</zip>
        <telephone>+98 44 3345 9538</telephone>
        <email>jafarkazemzade48@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Burn patients who needed skin graft surgery.
Patients who were willing to participate in the study.
Parents who consented to the participation of their minor patient.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who had no history of smoking.
Patients who had no history of diabetes.
Patients who did not have skin infections.
Patients who did not use drugs affecting platelet factors.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In patients with relatively deep or deep burns that penetrate the reticular dermis layer, blood vessels, and skin appendages, surgical debridement, and skin graft were performed to repair the burn site. For this purpose, excision and skin graft were performed in one session after the patient's initial resuscitation. In this surgical procedure, the ischemic and necrotic burnt tissue was removed layer by layer by a dermatome. Until the wound bed began to bleed, which indicated that there was blood supply from this layer and that it was not involved in a burn. After the hemostasis of bleeding, skin grafts were taken from healthy body parts that had not suffered burns. The skin grafts were taken  around the thighs, and in case of the thigh's involvement, the grafts were taken from the legs, arms, forearms, and trunk. The depth of the skin removal was adjusted on the Dermatome, based on the patient’s’ need; the skin was removed on the required area, which was debrided, placed, and sutured with a stapler. At the end of the operation, the grafted area was dressed with sterile vaseline gases, and it was not opened for five days to one week. The skin that was left in place guaranteed the graft's success. The place that suffered a deep burn was repaired by replacing the person's healthy skin (autograft).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The mean platelet counts. Timepoint: Blood samples were taken from patients during surgery and on the third and fifth days after transplantation to determine the patient's platelet count (Primary outcome). Method of measurement: Sysmex KX-21N Hematology Analyzer.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-22</approval_date>
        <contact_name>Urmia University of Medical Sciences ethics committee</contact_name>
        <contact_address>Emergency alley, Resalat Blvd.,  Urmia Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
