<?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>IRCT20230412057887N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-26</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Laser effect on surgical incision site</public_title>
      <acronym></acronym>
      <scientific_title>The effect of early fractional CO2 Laser  in post surgical incision treatment  in patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69625</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomized 
To select people for laser surgery on the left or right side, it is done using a table of random numbers, if an even number occurs for them, the laser will be on the right side, and for those with an odd number, the laser will be on the left side, Blinding description: Patient ;  In bilateral incisions, on both sides and in incisions larger than fifteen centimeters, the laser prop is placed on the entire incision so that the patient does not notice the direction of the laser part.
 Evaluating doctors;  Other doctors, when the patient goes to them and conducts a clinical examination and compares the incisions on both sides, or compares the left side with the right side of the wound based on the vss table, points are given without knowing the lasered and non-laser side.
 analyzer;  The person who analyzes the tables and statistics does not know the side that was lasered for each patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Plastic Surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, there are 20 patients who, after bilateral cosmetic surgery (a surgery that leaves scars on both sides of the body), are lasered in two stages of their surgical incision by fractional CO2 laser, so that its effect can be compared with the other side, which is healed naturally. . This intervention in two stages; It will be done in the first and fourth week after surgery. During the laser, the laser prop is placed on all incisions so that the patient does not notice the direction of the laser. After six months, the patient is examined in the clinic and the scar condition of the incisions is compared. Intervention 2: Control group: In this group, there are 20 patients who, after bilateral cosmetic surgery (a surgery that leaves scars on both sides of the body), were only touched by the laser probe in the two stages of the surgery, and the laser was not performed on the other side, which healed naturally. This intervention in two stages; It will be done in the first and fourth week after surgery. During the laser, the laser prop is placed on all incisions so that the patient does not notice the direction of the laser. After six months, the patient is examined in the clinic and the scar condition of the incisions is compared.</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 According to the final meaningful results, a decision will be made and there is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahan ara street,  forty one avenue   , no 3</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1436643891</zip>
        <telephone>+98 21 6522 4891</telephone>
        <email>Abbas.nas57@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahan ara street,  forty one avenue  , no 3</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1436643891</zip>
        <telephone>+98 21 6522 4891</telephone>
        <email>Abbas.nas57@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Cosmetic surgery with incisions on both sides of the body or incisions larger than 15 cm</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History or current skin disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for cosmetic surgery</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>Intervention group: In this group, there are 20 patients who, after bilateral cosmetic surgery (a surgery that leaves scars on both sides of the body), are lasered in two stages of their surgical incision by fractional CO2 laser, so that its effect can be compared with the other side, which is healed naturally. . This intervention in two stages; It will be done in the first and fourth week after surgery. During the laser, the laser prop is placed on all incisions so that the patient does not notice the direction of the laser. After six months, the patient is examined in the clinic and the scar condition of the incisions is compared.</i_keyword>
      <i_keyword>Control group: In this group, there are 20 patients who, after bilateral cosmetic surgery (a surgery that leaves scars on both sides of the body), were only touched by the laser probe in the two stages of the surgery, and the laser was not performed on the other side, which healed naturally. This intervention in two stages; It will be done in the first and fourth week after surgery. During the laser, the laser prop is placed on all incisions so that the patient does not notice the direction of the laser. After six months, the patient is examined in the clinic and the scar condition of the incisions is compared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pigmentation. Timepoint: Six month after laser. Method of measurement: The Vancouver scar scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vascularity. Timepoint: Six months after laser. Method of measurement: The Vancouver scar scale.</sec_outcome>
      <sec_outcome>Pilability. Timepoint: Six months after laser. Method of measurement: The Vancouver scar scale.</sec_outcome>
      <sec_outcome>Height of Scar. Timepoint: Six months after laser. Method of measurement: The Vancouver scar scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-14</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Tehran  , highway hemmat , Next to Milad Tower ، Iran university of medical science Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
