<?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>IRCT20190618043934N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-14</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of overlapping wound edges with skin graft in reducing hypertrophic scar formation</public_title>
      <acronym>همپوشانی لبه های زخم با گرافت جلدی در کاهش ایجاد اسکار</acronym>
      <scientific_title>Evaluation of the effect of overlapping wound edges with skin graft in reducing hypertrophic scar formation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72928</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients in two areas of the total number of burns in the body of patients who are similar in terms of percentage of burns will be selected and will be repaired by two graft methods: 1. Overlapping and 2. Equal to the edges of the burn wound. The selection of the site and repair method is simple random and in a blocked method inside a closed and sealed envelope, which includes the burn site and repair with a graft using the overlapping method (A) or a burn site with a graft using the same method as the edges of the burn wound (A). B) is divided. In this way, various quadruple blocks were created first (AABB, BBAA, ABAB, BABA, ABBA and BABA). One of these blocks is randomly selected and the patients are divided into one of two groups A or B. Then randomization is done for other patients as well.</study_design>
      <phase>N/A</phase>
      <hc_freetext>burn.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group 1, patients hospitalized in the burn department, candidates for graft transplantation, Imam Reza Birjand Hospital, where the burn site and repair with graft will be done by overlapping method. Intervention 2: Intervention group: Intervention group 2 patients admitted to the burn ward of Imam Reza Birjand Hospital, who are candidates for graft transplantation, where the burn site will be treated with a graft in the same way as the edges of the burn wound.</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 There is no need to publish individual patient information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zabihullah Mohaghegh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717934888</zip>
        <telephone>+98 56 3232 3232</telephone>
        <email>zabihullahmohaghegh@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mahdi Ghoncheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Surgery, School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717811674</zip>
        <telephone>+98 56 3232 3232</telephone>
        <email>mahdighoncheh@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>2nd and 3rd degree burns
Patient consent to enter the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnancy
History of chemotherapy
diabetes
Drug abuse
Receiving systemic medications such as glucocorticosteroids</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M61.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calcification and ossification of muscles associated with burns</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: Intervention group 1, patients hospitalized in the burn department, candidates for graft transplantation, Imam Reza Birjand Hospital, where the burn site and repair with graft will be done by overlapping method.</i_keyword>
      <i_keyword>Intervention group: Intervention group 2 patients admitted to the burn ward of Imam Reza Birjand Hospital, who are candidates for graft transplantation, where the burn site will be treated with a graft in the same way as the edges of the burn wound.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: The beginning of the study, 1 month and 6 months after the start of the study. Method of measurement: Using a visual pain scale.</prim_outcome>
      <prim_outcome>Burn scar. Timepoint: The beginning of the study, 1 month and 6 months after the start of the study. Method of measurement: Using the Vancouver scar scale including four vascular indices, flexibility, pigmentation and the height of the wound edges are evaluated.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-28</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
