<?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>IRCT20090613002027N18</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-06</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of timolol gel on wound healing in patients with skin transplantation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of efficacy and safety of timolol gel versus placebo in wound healing of patients with split-thickness skin grafts</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39738</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For allocation concealment, a 5 numbers digital code obtained from Excel software will be assigned for each patient. Participants will be randomly assigned to the study groups according to block randomization with 4 patients in each block. Random allocation software will be used for block randomization, Blinding description: For blinding purpose, instead of labels A or B, each participant will be assigned a unique fore-digit code obtained by the Excel program. Both timolol gel and placebo will be prepared in containers with equal appearance. Participants, physicians and assessor will be blinded regarding the grouping of participants.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Candidate Patients Receiving Skin Transplant.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention: patients receiving 0.25% timolol gel                             The first dose will be applied immediately after the operation. The gel will be used twice daily for the first 48 hr and then daily until 14 days. The first four doses will be applied when the patient is in the hospital and then twelve single-dose units will be given for home use. Intervention 2: Second Intervention: patients receiving gel base without timolol                             The first dose will be applied immediately after the operation. The gel will be used twice daily for the first 48 hr and then daily until 14 days. The first four doses will be applied when the patient is in the hospital and then twelve single-dose units will be given for home use.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no plan for publishing the protocol of the study because it is accessible in IRCT.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Salehifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818893716</zip>
        <telephone>+98 11 3354 3083</telephone>
        <email>esalehifar52@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sari University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818893716</zip>
        <telephone>+98 11 3354 3083</telephone>
        <email>esalehifar52@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age ≥18 years of age
Undergoing a procedure which results in the need of a STSG
Willing to provide written informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant women and breastfeeding
Use of systemic beta blockers drugs or topical except timolol
Hypersensitivity to timolol or other beta blockers
Severe, uncontrolled systemic comorbidities, such as diabetes, asthma, Chronic obstructive pulmonary disease
Use of systemic drugs that can impede wound healing, such retinoids or immune-suppressive drugs
Severe coagulation disorders including a lack of coagulation factors and immunologic thrombocytopenic purpura</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention: patients receiving 0.25% timolol gel                             The first dose will be applied immediately after the operation. The gel will be used twice daily for the first 48 hr and then daily until 14 days. The first four doses will be applied when the patient is in the hospital and then twelve single-dose units will be given for home use.</i_keyword>
      <i_keyword>Second Intervention: patients receiving gel base without timolol                             The first dose will be applied immediately after the operation. The gel will be used twice daily for the first 48 hr and then daily until 14 days. The first four doses will be applied when the patient is in the hospital and then twelve single-dose units will be given for home use.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of wound epithelization in donor site of the transplant. Timepoint: The evaluation of wound on days 0 and 3 and 7 and 14 after surgery. Method of measurement: Clinical observation regarding the wound epithelization.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain severity. Timepoint: The evaluation times include days 0 (time of skin removal),3 ,7, 14 and 3 months after surgery. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>ٍEvaluation of the scar status. Timepoint: Three months after surgery. Method of measurement: Vancouver Scar Scale (VSS) and The Patient and Observer Scar Assessment Scale (POSAS).</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-01</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar Square, Sari, Mazandaran Province Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
