<?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>IRCT201201298861N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-03-15</date_registration>
      <primary_sponsor>Researach deputy of Tehran university of medical sciences, Faculty of medicine</primary_sponsor>
      <public_title>Soft tissue distraction using pentagonal frame in long standing traumatic flexion deformity of interphalangeal joints</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between treatment outcomes of soft tissue distraction in addition to Z-plasty and Z-plasty alone after skin graft in patients with chronic flexion contracture of interphalangeal joints due to previous traumatic abrasive injuries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9334</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Flexion contracture of proximal and distal interphalangeal finger joints.</hc_freetext>
      <i_freetext>Intervention 1: Group A (intervention) : Soft tissue distraction will be performed using pentagonal frame technique.  In this method, primarily, scars and contractures will be released using single or multiple Z or zigzag incisions for lengthening. A Kirschner wire size 1–1.5 mm (matching the patient’s distal phalanx thickness) will be used for anchorage. The wire wll be passed horizontally, under direct fluoroscopic control, through the head of the phalanx and then bent like a pentagon. Before closing the wire ends, a rubber band will be inserted inside the frame. The frame will be shaped such that only the horizontal wire segment exerts the ‘‘distraction,’’ and no vascular compromise or soft tissue encroachment will be created. An external fixation device will then be used to distract the finger. Intervention 2: Group B (Control) : In this group, scars and contracture will be release using single or multiple Z or zigzag incisions for lengthening. Then, a splint will be used to hold the finger in full extension position.</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>Dr. Mohammad Reza Keramati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Apt.43, No.32, Parastoo St., Kamraniye Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1951955531</zip>
        <telephone>+98 21 2283 3381</telephone>
        <email>mr-keramati@razi.tums.ac.ir</email>
        <affiliation>Tehran university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Reza Keramati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Apt.43, No.32, Parastoo St., Kamraniye Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1951955531</zip>
        <telephone>+98 21 2283 3381</telephone>
        <email>mr-keramati@razi.tums.ac.ir</email>
        <affiliation>Tehran university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients with long-standing scars on fingers for more than 6 months after the trauma with a history of unsuccessful medical treatment for the past 6 months.  Exclusion criteria: history of muscular and/or bone injuries of the fingers (only pure cutaneous and subcutaneous traumatic injuries resulting scar formation will be studied); Bone fracture (using X-rays); acute inflammation or granulation tissue; History of other medical comorbidities including medical or surgical problems, immune-suppression; previous history of surgery in the involved hand; any previous traumatic injuries of the hand; physical exam revealing any sensory, motor or vascular problem within the hand.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M20.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Deformity of finger(s)</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>Group A (intervention) : Soft tissue distraction will be performed using pentagonal frame technique.  In this method, primarily, scars and contractures will be released using single or multiple Z or zigzag incisions for lengthening. A Kirschner wire size 1–1.5 mm (matching the patient’s distal phalanx thickness) will be used for anchorage. The wire wll be passed horizontally, under direct fluoroscopic control, through the head of the phalanx and then bent like a pentagon. Before closing the wire ends, a rubber band will be inserted inside the frame. The frame will be shaped such that only the horizontal wire segment exerts the ‘‘distraction,’’ and no vascular compromise or soft tissue encroachment will be created. An external fixation device will then be used to distract the finger.</i_keyword>
      <i_keyword>Group B (Control) : In this group, scars and contracture will be release using single or multiple Z or zigzag incisions for lengthening. Then, a splint will be used to hold the finger in full extension position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Degree of flexion contracture of proximal interphalangeal finger joints. Timepoint: before surgery, six months after surgery. Method of measurement: Degree using measure.</prim_outcome>
      <prim_outcome>Degree of flexion contracture of distal interphalangeal finger joints. Timepoint: before surgery, six months after surgery. Method of measurement: Degree using measure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion of proximal interphalangeal finger joint. Timepoint: before surgery, six months after surgery. Method of measurement: degree using measure.</sec_outcome>
      <sec_outcome>Range of motion of distal interphalangeal finger joint. Timepoint: before surgery, six months after surgery. Method of measurement: degree using measure.</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>Researach deputy of Tehran university of medical sciences, Faculty of medicine</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-08-01</approval_date>
        <contact_name>Tehran university of medical sciences</contact_name>
        <contact_address>6th floor, Central building of Tehran university of medical sciences, Ghods St., Keshavarz Ave. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
