<?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>IRCT2014110413259N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-01</date_registration>
      <primary_sponsor>Vice chancellor for research, Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>evaluation of skin grafts harvested from wrist area versus groin area</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of skin grafts harvested from wrist area versus groin area in patients with finger tip injury referring to Imam Reza Hospital during the year 2014 to 2015</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13174</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The patients will be randomized to a Wrist group or Groin group with a number allocated by Research Randomizer Program.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Injuries to the wrist and hand.</hc_freetext>
      <i_freetext>Intervention 1: Skin grafts from wrist area (group1):  We harvested the adjusted skin graft from the wrist area in elliptical form to incorporate to the size of the loss region in finger tips and tried to remove the subcutaneous fat completely to increase the odds of successful grafting. No meshing procedure were used, Grafts were fixed with absorbable 4.0 (Vicryl, Ethicon Inc, New Jersey) running sutures. Then dressing was applied on by 4-layered sterile gauze in a moderately tight fashion. and due to the low risk of hematoma formation the grafts were seen after 5-7days. Intervention 2: Skin grafts from groin area (group2): We harvested the adjusted skin graft from the groin area in elliptical form to incorporate to the size of the loss region in finger tips and tried to remove the subcutaneous fat completely to increase the odds of successful grafting. No meshing procedure were used, Grafts were fixed with absorbable 4.0 (Vicryl, Ethicon Inc, New Jersey) running sutures. Then dressing was applied on by 4-layered sterile gauze in a moderately tight fashion. and due to the low risk of hematoma formation the grafts were seen after 5-7days.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzam Mokarami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Etemad Zadeh St., West Fatemi St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>Farzam_m2001@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Sharifzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Etemad Zadeh St., West Fatemi St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>Reza.sharifzadeh@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-The inclusion criteria: normal sensation and judgment, and age between twenty and seventy years old.&#13;
-The exclusion criteria: patients with neuropathic disorders including diabetes,  autoimmune diseases (eg; sclerodermia), congestive heart failure, chronic liver diseases, chronic renal failure, peripheral vascular diseases and smokers</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S60, S61, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Superficial injury of wrist and hand, Open wound of wrist and hand , Crushing injury of wrist and hand , Other and unspecified injuries of wrist and hand</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>Skin grafts from wrist area (group1):  We harvested the adjusted skin graft from the wrist area in elliptical form to incorporate to the size of the loss region in finger tips and tried to remove the subcutaneous fat completely to increase the odds of successful grafting. No meshing procedure were used, Grafts were fixed with absorbable 4.0 (Vicryl, Ethicon Inc, New Jersey) running sutures. Then dressing was applied on by 4-layered sterile gauze in a moderately tight fashion. and due to the low risk of hematoma formation the grafts were seen after 5-7days.</i_keyword>
      <i_keyword>Skin grafts from groin area (group2): We harvested the adjusted skin graft from the groin area in elliptical form to incorporate to the size of the loss region in finger tips and tried to remove the subcutaneous fat completely to increase the odds of successful grafting. No meshing procedure were used, Grafts were fixed with absorbable 4.0 (Vicryl, Ethicon Inc, New Jersey) running sutures. Then dressing was applied on by 4-layered sterile gauze in a moderately tight fashion. and due to the low risk of hematoma formation the grafts were seen after 5-7days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Skin Color. Timepoint: Before surgery and at least six months afterwards. Method of measurement: Brightness of the skin will be measured by PhotoShop software after taking photos of the grafted area and data will be collected in a questionnaire.</prim_outcome>
      <prim_outcome>Contracture. Timepoint: Before surgery and at least six months afterwards. Method of measurement: The proportion of the grafted area to the area of the primary injury will be calculated and data will be collected in a questionnaire.</prim_outcome>
      <prim_outcome>Light Touch. Timepoint: Before surgery and at least six months afterwards. Method of measurement: Semmes-Weinstein monofilaments aesthesiometer with different thicknesses data will be collected in a questionnaire.</prim_outcome>
      <prim_outcome>Hair Follicle Counts. Timepoint: Before surgery and at least six months afterwards. Method of measurement: The counts of hair follicles in the grafted area and data will be collected in a questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice chancellor for research, Artesh University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Shiraz University of Medical Sciences</source_name>
      <source_name>Vice chancellor for research, Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-14</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Palestine St., Zand Blvd. Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
