<?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>IRCT2015110624905N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-09</date_registration>
      <primary_sponsor>Zanjan University of Medical Science</primary_sponsor>
      <public_title>The effect of alpha ointment in treatment of burned patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between effect of Alpha and Silver Sulfadiazine ointments in treatment of burned patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20935</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Burning.</hc_freetext>
      <i_freetext>Intervention 1: Patients in the burning ward, was treated accidentally with Alpha ointment which made in Rejoderm company and Silver Sulfadiazine ointment which made in Sina Darou company. In this study we choose patients with two burned limbs and if they were compatible with our criterias, the intervention was done in two separate limbs where one limb dressed with Alpha and the other limb was dressed with Silver Sulfadiazine. Dressing of wounds was done daily after washing of the wounds with sterile Normal Saline serum. Every one percent of wounds was macerated with twenty Gram of Alpha or Silver Sulfadiazine ointment. We used vaseline gauzes to cover the Alpha ointment dressings and sterile gauzes to cover the Silver Sulfadiazine dressings. Then these dressings was fixed with cotton bands. Dressing of wounds was continued until epithelialization of whole wounds. Intervention 2: Because this study was done over patients with two burned limbs, in all patients one limb accidentally was dressed with Alpha ointment and the other limb was dressed with Silver Sulfadiazine ointment.</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>Payman Sadri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Mousavi Hospital, Gavazang road, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3310 0001</telephone>
        <email>Sadrip@zums.ac.ir; Payman169@yahoo.com</email>
        <affiliation>Zanjan University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hossein Moghimi M.D</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Mousavi Hospital, Gavazang road, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3310 0001</telephone>
        <email>Mohammadhoseinmoghimi@yahoo.com</email>
        <affiliation>Zanjan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Second degree heat burned patients; burning surface area between 10% and 20%&#13;
Exclusion criteria:Iisolated head and neck burning; burning of genitalia; pregnant women; first and third and fourth degree burning; unstable patients; burning surface area above 20% or under 10%; patients with history of neurocycotic diseases who are under treatment; addiction to opioids; smokers; patients with history of cardiac, renal or hepatic diseases; diabetic patients; malnutrished patients; patients under treatment of corticosteroids or other immune suppressive treatments; inhalative burnings; sulfunamid toxicity; old burnings</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>X10; X11; </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Contact with hot drinks, food, fats and cooking oils; Contact with hot tap-water; Contact with other hot fluids</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in the burning ward, was treated accidentally with Alpha ointment which made in Rejoderm company and Silver Sulfadiazine ointment which made in Sina Darou company. In this study we choose patients with two burned limbs and if they were compatible with our criterias, the intervention was done in two separate limbs where one limb dressed with Alpha and the other limb was dressed with Silver Sulfadiazine. Dressing of wounds was done daily after washing of the wounds with sterile Normal Saline serum. Every one percent of wounds was macerated with twenty Gram of Alpha or Silver Sulfadiazine ointment. We used vaseline gauzes to cover the Alpha ointment dressings and sterile gauzes to cover the Silver Sulfadiazine dressings. Then these dressings was fixed with cotton bands. Dressing of wounds was continued until epithelialization of whole wounds.</i_keyword>
      <i_keyword>Because this study was done over patients with two burned limbs, in all patients one limb accidentally was dressed with Alpha ointment and the other limb was dressed with Silver Sulfadiazine ointment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rate of ulcer healing. Timepoint: Seventh, 14th, 30th day. Method of measurement: Evaluation of patient in the admission time and evaluation of ulcers in 7th and 14th day of admission and out patient in day 30th. In every visit photography of ulcers was done.</prim_outcome>
      <prim_outcome>The rate of scar. Timepoint: Thirtieth day. Method of measurement: Two other colleagues who were not aware of our protocol, visited patients in 30th day and scored rate of scar in 4 qualitative scale item like excellent, good, intermediate, poor. And the remaining scar was reported in percentage.</prim_outcome>
      <prim_outcome>The rate of positive culture. Timepoint: First, 7th, 14th day. Method of measurement: The cuture of wound swap in the first, 7th and 14th day of admission.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The rate of patients' pain. Timepoint: Daily. Method of measurement: VAS (visual analogue scale) in first 14 day.</sec_outcome>
      <sec_outcome>Dose of recieved analgesia. Timepoint: Daily. Method of measurement: Evaluation of pethidine consumption in firs 14 day.</sec_outcome>
      <sec_outcome>Days of admission. Timepoint: Daily. Method of measurement: Questionnarie.</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>Zanjan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-14</approval_date>
        <contact_name>Zanjan University of Medical Science</contact_name>
        <contact_address>Central office of Zanjan University of Medical Science, Azadi Blvd, Zanjan, Iran Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
