<?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>IRCT20170114031928N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-16</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effects of Partial Thickness Skin Graft Harvesting from Scalp for Scalp Skin Defects</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Outcome of Partial Thickness Skin Graft Harvesting from Scalp with the Calf for Scalp Skin Defects</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24993</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Patients of all ages and sexes were randomly assigned into two groups of 20 patients and 20 patients receiving routine treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Scalp skin defect. Condition 2: Scalp skin defect. Condition 3: Scalp skin defect. Condition 4: Scalp skin defect. Condition 5: Scalp skin defect.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Partial thickness skin graft from healthy areas of the adjacent scalp and scalp defect/ electric dermatome D80 or D42 or manual dermatome for the preparation of middle-thickness skin grafts (0.04 inch ) / Marking the skin of scalp in Temporal, parietal or occipital areas with methylene blue / the designed area swells with infusion of some normal saline solution/defects up to 50% of the scalp can be reconstituted with 50% of the rest of the skull's healthy skin. The donor area is covered by a gas and jelly layer followed by a dry gaseous layer/ the graft in the receptor is covered in accordance with the principles of plastic surgery with "tie-over dressing" and then the entire scalp including the receiver and donor area is enclosed with Sergi Fix. Intervention 2: Control group: Twenty-one patients with scalp defects that are treated with the routine and commonly used skin graft (leg skin graft) are selected as a control group.</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 I have not decided yet. After the final analysis of the data and the writing of the article, a final decision will be made.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrdad Taghipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khaje Rashid Crossroads - Ayatollah Kashani Blvd.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48138</zip>
        <telephone>+98 81 3262 4331</telephone>
        <email>m.taghipour@edu.umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Eskandarlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Besat hospital, Shahid beheshti blvd.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48137</zip>
        <telephone>+98 81 3264 0030</telephone>
        <email>Dr.eskandarlou@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients of any age and gender with scalp defect requiring repair of the skin graft primarily for the present defect or secondary to the defect in order to repair the defect result from flap rotation in the scalp.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction, scarring or skin disease that prevents skin graft from the scalp, such as eczema, folliculitis, tumor or pre-cancerous lesions such as keratosis, scalp scar due to severe scalp burn or severe atrophy, or radiation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T20</hc_code>
      <hc_code>C43.4</hc_code>
      <hc_code>D23.4</hc_code>
      <hc_code>S08</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn and corrosion of head, face, and neck</hc_keyword>
      <hc_keyword>Malignant melanoma of scalp and neck</hc_keyword>
      <hc_keyword>Other benign neoplasm of skin of scalp and neck</hc_keyword>
      <hc_keyword>Avulsion and traumatic amputation of part of head</hc_keyword>
      <hc_keyword></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: Partial thickness skin graft from healthy areas of the adjacent scalp and scalp defect/ electric dermatome D80 or D42 or manual dermatome for the preparation of middle-thickness skin grafts (0.04 inch ) / Marking the skin of scalp in Temporal, parietal or occipital areas with methylene blue / the designed area swells with infusion of some normal saline solution/defects up to 50% of the scalp can be reconstituted with 50% of the rest of the skull's healthy skin. The donor area is covered by a gas and jelly layer followed by a dry gaseous layer/ the graft in the receptor is covered in accordance with the principles of plastic surgery with "tie-over dressing" and then the entire scalp including the receiver and donor area is enclosed with Sergi Fix.</i_keyword>
      <i_keyword>Control group: Twenty-one patients with scalp defects that are treated with the routine and commonly used skin graft (leg skin graft) are selected as a control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in VAS index. Timepoint: measuring of the pain based on VAS score during the days 5, 16,35 and 90. Method of measurement: VAS score checklist.</prim_outcome>
      <prim_outcome>Graft take based on Likert index. Timepoint: graft take during the days 5,16,35 and 90. Method of measurement: Likert score checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient Satisfaction. Timepoint: At the end of the study. Method of measurement: Likert index.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-30</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Blvd, Besat Hospital Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
