<?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>IRCT20151123025202N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-07</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>correction of old nasal bone deviation</public_title>
      <acronym></acronym>
      <scientific_title>New technique for correction of old nasal bone deviation during nasal fracture reduction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43988</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Nose deviation.</hc_freetext>
      <i_freetext>Intervention group: In this study, patients with nasal fractures with a history of nasal deviation before recent trauma were enrolled. After induction of general anesthesia and oro-tracheal tube insertion, the nasal dislocation is first surgically located. To correct the old deviation, first place a two-layer 3 x 3 cm vibrile piece on the most prominent lateral part of the dorsum (to prevent skin injury) and the non-dominant thumb parallel to the eyebrow, gently and without pressure on The eye to protect the eye from accidental impact). At this point, the surgeon uses a surgical hammer with a 30 ° recoil to the horizontal line of the face and from 15 to 20 cm from the nose, simply by moving the wrist (while the arm and elbow are fixed) to strike the vibrating, The most prominent lateral part of the dorsum enters the convex side. The blows can be repeated to break the old fragment. Then according to the conventional method, if the fragment is unstable (convex or concave), a tetracycline impregnated mesh 4 to 6 cm long between the septum and the moving fragment It is placed in the direction of stability. Then the nose is stabilized by casting.After 5 to 7 days the mesh impregnated with tetracycline and casting is removed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data can be shared except for authors names

When:
From 2021 onwards it is permissible

To whom:
Researchers in all fields

Conditions:
To develop research and science

Where to obtain:
Correspond to the email address of the scientific responsible for the study

How to obtain:
Send and receive email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan, Shahid Fahmideh Avenue, Medical School, Department of Social Medicine</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6515974544</zip>
        <telephone>+98 81 3838 0097</telephone>
        <email>a.moradi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Rohollah Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Blv</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6514845411</zip>
        <telephone>+98 81 3264 0030</telephone>
        <email>r.abbasi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with new nasal bone fractures with old nose bone deviation
Ages 18-50 years for women and 18-60 years for men.
Patient satisfaction to correct old nose bone deviation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of CSF leak
History of seizures
History of neurosurgery, maxillofacial surgery in the middle and upper third of the face
A history of coagulopathy
Post-operative trauma history, cartilage deformity, nasal fracture</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Deviated nasal septum</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, patients with nasal fractures with a history of nasal deviation before recent trauma were enrolled. After induction of general anesthesia and oro-tracheal tube insertion, the nasal dislocation is first surgically located. To correct the old deviation, first place a two-layer 3 x 3 cm vibrile piece on the most prominent lateral part of the dorsum (to prevent skin injury) and the non-dominant thumb parallel to the eyebrow, gently and without pressure on The eye to protect the eye from accidental impact). At this point, the surgeon uses a surgical hammer with a 30 ° recoil to the horizontal line of the face and from 15 to 20 cm from the nose, simply by moving the wrist (while the arm and elbow are fixed) to strike the vibrating, The most prominent lateral part of the dorsum enters the convex side. The blows can be repeated to break the old fragment. Then according to the conventional method, if the fragment is unstable (convex or concave), a tetracycline impregnated mesh 4 to 6 cm long between the septum and the moving fragment It is placed in the direction of stability. Then the nose is stabilized by casting.After 5 to 7 days the mesh impregnated with tetracycline and casting is removed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Correction of old nasal bone deviation. Timepoint: Before inserting a new fracture, after removing the mesh and casting, three months after surgery. Method of measurement: Take a photo of the nose.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improve patient nasal breathing. Timepoint: Before surgery and three months after surgery. Method of measurement: with NOSE questionnaire.</sec_outcome>
      <sec_outcome>Patient satisfaction of nose beauty. Timepoint: Before surgery and three months after surgery. Method of measurement: use of ROE questionnaire.</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>2018-06-08</approval_date>
        <contact_name>Ethics committee of Hamadan Univercity of Medical Science</contact_name>
        <contact_address>Shahid Fahmideh َ Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
