<?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>IRCT20181216041994N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-20</date_registration>
      <primary_sponsor>Vice-chancellors of Research and Technology, Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of Diode 940 nm on reduction of nasal tip edema</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of Diode 940 nm laser on reduction of post-rhinoplasty nasal tip edema</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37418</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly devided into Intervention and control group via quadri-blocks. concealment will be done through Sealed Envelope, Blinding description: In the control group (Sham laser group), the device will be turned off and the handpiece will be moved on the nose and nasal holes. Meanwhile, at the time of laser and sham laser radiation, headphones will be placed on the ears of the patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>nose tip edema after rhinoplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 940nm Diod laser( Biolase,USA) is radiated to patient's  face on eight zones of nose and nasal nostrils and also on Submandibular   and jugular-digastric. Laser radiation will be continuous. Energy density: 4 J/cm2, spot size: 2.27 cm2, outputpower: 0.1 mW and the ray is radiated to each zone for 91 seconds. energy in each zone is 9.08 j. power density: 44 mW/cm2. Intervention 2: Control group: In control group( Sham laser group) the device will be turned off and the handpiece will be moved on nose and nasal nostrils.</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 The clinical results of the study will generally be published in the form of an article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hanie Tavasoliara</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 29, third Siahrang alley, Fatemie street, Saeedie Blvd., Hamedan Town</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516945381</zip>
        <telephone>+98 81 3822 6487</telephone>
        <email>Hanie_tavasoliara@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Jamalpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan university of medical scinces, Shahid Fahmideh Blvd., Hamedan Town</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838677</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>jamalpour1972@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>primary rhinoplasty candidate
ASA I patients  ( no systemic disease)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with lip and nasal cleft
Patients under pharmaceutical treatment
Patients with the history of rhinoplasty</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R60.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Localized edema</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 940nm Diod laser( Biolase,USA) is radiated to patient's  face on eight zones of nose and nasal nostrils and also on Submandibular   and jugular-digastric. Laser radiation will be continuous. Energy density: 4 J/cm2, spot size: 2.27 cm2, outputpower: 0.1 mW and the ray is radiated to each zone for 91 seconds. energy in each zone is 9.08 j. power density: 44 mW/cm2</i_keyword>
      <i_keyword>Control group: In control group( Sham laser group) the device will be turned off and the handpiece will be moved on nose and nasal nostrils.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nose tip edema. Timepoint: 8 days after surgery; every week until 2 months after surgery. Method of measurement: photoshop software.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nose tip projection. Timepoint: 8 days after surgery; every week until 2 months after surgery. Method of measurement: photoshop.</sec_outcome>
      <sec_outcome>Supratip depression. Timepoint: 8 days after surgery; every week until 2 months after surgery. Method of measurement: photoshop.</sec_outcome>
      <sec_outcome>Amount of Columella exposure. Timepoint: 8 days after surgery; every week until 2 months after surgery. Method of measurement: photoshop.</sec_outcome>
      <sec_outcome>Nose tip retraction. Timepoint: 8 days after surgery; every week until 2 months after surgery. Method of measurement: photoshop.</sec_outcome>
      <sec_outcome>Nosal width in middle of Columella. Timepoint: 8 days after surgery; every week until 2 months after surgery. Method of measurement: photoshop.</sec_outcome>
      <sec_outcome>Nasal width in pinnacle of nostrils. Timepoint: 8 days after surgery; every week until 2 months after surgery. Method of measurement: photoshop.</sec_outcome>
      <sec_outcome>Nasal width between pinnacle of nostrils and nose tip. Timepoint: 8 days after surgery; every week until 2 months after surgery. Method of measurement: photoshop.</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>Vice-chancellors of Research and Technology, Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-28</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Hamedan university of medical sciences, Shahid Fahmideh Blvd., Hamedan Town Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
