<?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>IRCT2013052613460N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-09-07</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences Branch</primary_sponsor>
      <public_title>Effective cryo therapy in reduce bruising and Swelling</public_title>
      <acronym></acronym>
      <scientific_title>Assay effective cryo therapy in reduce bruising and Swelling nose and sub optic in Patients undergoing operation  surgery rhinoplasty in Martyr Rajai Hospital gachsaran2013</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-07-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13331</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Swelling and bruising.</hc_freetext>
      <i_freetext>Intervention 1: This study is a clinical trial in 35 patients from the hospital martyr Rajai GACHSARAN for rhinoplasty (intervention group) were performed. Demographic data questionnaire, registration form and information about how to measure edema and ecchymosis were specific for each patient separately regulated. All patients received general anesthesia, closed rhinoplasty procedure was identical. For, before, during and after surgery were cryotherapy, all patients received the same postoperative care rhinoplasty.. Calibrated using the standard tools of ecchymosis and swelling were scored, and the data were recorded in the registration form. The amount of swelling and bruising in the intervention and control groups on both the right and left eyes at intervals of 0/5, 1, 6 and 24 hours after surgery was measured. The data collected by statistical software spss version 20 and independent t-test and test Greenhouse - Gysr were analyzed. Intervention 2: This study is a clinical trial in 35 patients from the hospital martyr Rajai GACHSARAN for rhinoplasty (control group) was performed. Demographic data questionnaire, registration form and information about how to measure edema and ecchymosis were specific for each patient separately regulated. All patients received general anesthesia, closed rhinoplasty procedure was identical. For, before, during and after surgery cryotherapy not used, all patients received the same postoperative care rhinoplasty. Calibrated using the standard tools of ecchymosis and swelling were scored, and the data were recorded in the registration form. Control the amount of swelling and bruising on both the right and left eyes at intervals of 0/5, 1, 6 and 24 hours after surgery was measured. The data collected by statistical software spss version 20 and independent t-test and test Greenhouse - Gysr were analyzed.</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>Hossein Kavyani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Azad University khorasgan unit</address>
        <city>Khorasgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>75818-16664</zip>
        <telephone>+98 31 1535 4018</telephone>
        <email>hosseinkavyani7@yahoo.com; h.kavyani@khuisf.ac.ir</email>
        <affiliation>Isfahan Azad University khorasgan unit</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Babak Paryavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Martyr Rajai Hospital Gachsaran</address>
        <city>Gachsaran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 74 2222 4711</telephone>
        <email>mahdiamohammadi2@yahoo.com</email>
        <affiliation>Iasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Exclusion criteria: 1 - In the study, patients had to be admitted to the hospital martyr Rajai Gachsaran.&#13;
2 - Patients should be settled Gachsaran 24 hours after surgery or rhinoplasty are staying in the city Gachsaran.&#13;
3 - Patients must be willing to participate in the study.&#13;
4 - Minimum 20 years and maximum age of patients is 40 years. 5 - Patients who do not express any disease that might interfere with rhinoplasty surgery. 6 - patients are referred for surgery rhinoplasty. 7 - Ability to answer the questions.&#13;
Exclusion criteria: 1 - requests that the subjects withdrew from the study during the preoperative rhinoplasty questionnaire to analyze the data. 2 - Failure to comply with the instructions given to the patients before treatment and after rhinoplasty.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study is a clinical trial in 35 patients from the hospital martyr Rajai GACHSARAN for rhinoplasty (intervention group) were performed. Demographic data questionnaire, registration form and information about how to measure edema and ecchymosis were specific for each patient separately regulated. All patients received general anesthesia, closed rhinoplasty procedure was identical. For, before, during and after surgery were cryotherapy, all patients received the same postoperative care rhinoplasty.. Calibrated using the standard tools of ecchymosis and swelling were scored, and the data were recorded in the registration form. The amount of swelling and bruising in the intervention and control groups on both the right and left eyes at intervals of 0/5, 1, 6 and 24 hours after surgery was measured. The data collected by statistical software spss version 20 and independent t-test and test Greenhouse - Gysr were analyzed.</i_keyword>
      <i_keyword>This study is a clinical trial in 35 patients from the hospital martyr Rajai GACHSARAN for rhinoplasty (control group) was performed. Demographic data questionnaire, registration form and information about how to measure edema and ecchymosis were specific for each patient separately regulated. All patients received general anesthesia, closed rhinoplasty procedure was identical. For, before, during and after surgery cryotherapy not used, all patients received the same postoperative care rhinoplasty. Calibrated using the standard tools of ecchymosis and swelling were scored, and the data were recorded in the registration form. Control the amount of swelling and bruising on both the right and left eyes at intervals of 0/5, 1, 6 and 24 hours after surgery was measured. The data collected by statistical software spss version 20 and independent t-test and test Greenhouse - Gysr were analyzed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Place of ecchymosis. Timepoint: 0.5, 1 ,6 ,24 hours. Method of measurement: The method of determining the degree of ecchymosis around the eyes and under the terms of the observed.</prim_outcome>
      <prim_outcome>Edema or swelling around the nose and under the eyes. Timepoint: 5.0,1,6,24  hours. Method of measurement: Indentation of millimeters.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Swelling and edema. Timepoint: 5.0, 1, 6, 24 hours. Method of measurement: Indentation of millimeters.</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>Isfahan University of Medical Sciences Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-06-26</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan - Gate Shiraz - Isfahan University of Medical Sciences Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
