<?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>IRCT20221218056851N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-19</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the VitaNit method on upper limb orthopedic surgery wounds</public_title>
      <acronym></acronym>
      <scientific_title>The effect of VitaNit wound healing method in cosmetic outcomes and healing of upper limb orthopedics surgical wound</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71336</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization using the block method using blocks of four, 68 people were randomized into two groups in blocks of four and were assigned to intervention and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Orthopedics surgical wound.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The combination of vitamin C and TNG spray is used. How to make the product is as follows: to make a nitroglycerin spray, about 50 mg of nitroglycerin is poured into a spray and one puff is used for every 10 cm wound (each puff contains one to two mg of nitroglycerin). And to make vitamin C spray, 10 injection vials of vitamin C with a volume of 5 ml containing 500 mg of vitamin C are poured into the syringe and one puff of the spray is used for every 10 cm of the wound (each puff contains 20 to 40 mg of vitamin C). Patients use sprays after being taught how to use them after the operation (on the day of discharge). Patients need to use this spray 4 times a day (every 6 hours) during the first 2 weeks. The wound area is sprayed (one puff for every ten centimeters) so that the surface is completely covered, and then vitamin C spray is sprayed on the wound (one puff for every 10 centimeters), and after an hour, the drape is removed and normal dressing is applied. is done 6 hours later, this work is done again, and in the next two weeks, the patient uses both sprays once every hour in the order mentioned, but there is no need for dressing. Intervention 2: Control group: receives only routine treatment (repeated dressing and washing with normal saline).</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 Considering that the study is not finished, we have not decided to publish it yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mona Hamedi Tabar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak Univercity of Medical Science, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176341</zip>
        <telephone>+98 86 3417 3639</telephone>
        <email>hamedimona.1996@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammadreza Bozorgmanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr square, Valiasr Hospital, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>086-32222003-8</telephone>
        <email>Mhmmdrz_bzrgmnsh@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Upper limb surgery except clavicle surgery .
Age between 18-60 years old
Residence in Arak city or the possibility of patient presence for all visits.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z47.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Orthopaedic follow-up care, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The combination of vitamin C and TNG spray is used. How to make the product is as follows: to make a nitroglycerin spray, about 50 mg of nitroglycerin is poured into a spray and one puff is used for every 10 cm wound (each puff contains one to two mg of nitroglycerin). And to make vitamin C spray, 10 injection vials of vitamin C with a volume of 5 ml containing 500 mg of vitamin C are poured into the syringe and one puff of the spray is used for every 10 cm of the wound (each puff contains 20 to 40 mg of vitamin C). Patients use sprays after being taught how to use them after the operation (on the day of discharge). Patients need to use this spray 4 times a day (every 6 hours) during the first 2 weeks. The wound area is sprayed (one puff for every ten centimeters) so that the surface is completely covered, and then vitamin C spray is sprayed on the wound (one puff for every 10 centimeters), and after an hour, the drape is removed and normal dressing is applied. is done 6 hours later, this work is done again, and in the next two weeks, the patient uses both sprays once every hour in the order mentioned, but there is no need for dressing.</i_keyword>
      <i_keyword>Control group: receives only routine treatment (repeated dressing and washing with normal saline).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound size. Timepoint: Immediately and 1, 2, 3, 4 weeks later. Method of measurement: Wound area is measured using ImitoMeasure v:2.0.0.18 mobile application.</prim_outcome>
      <prim_outcome>Speed ​​of wound healing. Timepoint: Immediately and 1, 2, 3, 4 weeks later. Method of measurement: Measured using ImitoMeasure v:2.0.0.18 mobile application.</prim_outcome>
      <prim_outcome>Wound appeariance. Timepoint: Immediately and 1, 2, 3, 4 weeks later. Method of measurement: With REEDA scoring system.</prim_outcome>
      <prim_outcome>Scar size. Timepoint: Immediately and 1, 2, 3, 4 weeks later. Method of measurement: If a scar is created, it is measured using the ImitoMeasure v:2.0.0.18 mobile application.</prim_outcome>
      <prim_outcome>Appearance features of Oscar. Timepoint: Immediately and 1, 2, 3, 4 weeks later. Method of measurement: With VSS scoring system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-30</approval_date>
        <contact_name>Research ethics committees of Arak University of Medical Sciences</contact_name>
        <contact_address>Arak Univercity of Medical Science, Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
