<?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>IRCT20220730055580N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-17</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of herbal vitamin cream on preventing scarring</public_title>
      <acronym></acronym>
      <scientific_title>The effect of stop scar cream on the prevention of scar formation in sutured wounds caused by biopsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65028</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this randomized clinical trial, the randomized block method is used in which we use double blocks (there are equal numbers of each group in each group), the desired cases of people with wounds caused by punch biopsy (with diameter 3 mm) using the online tool Sealed Envelope Ltd, random blocks and the order of allocation of treatment groups have been determined. Scarstop cream with A and zinc oxide ointment with B are shown in blocks. The samples will be assigned to two treatment groups according to the order of entering the center, if they have expressed their consent to enter the study in writing and the treatments based on the list predetermined by the online tool. The intended intervention is the use of Scar Stop cream, which is made by a clinical pharmacist. In this study, the participants are divided into two intervention and control groups. Scar Top cream is used for the intervention group and zinc oxide ointment is used for the control group, Blinding description: This research will be conducted in a single blind (assessor blind) in such a way that the medicine packaging containers are unnamed and have the same shape, color and appearance and are named as A, B, And the people who evaluate the scar after the wound, as well as the patients, will not know whether they are using zinc oxide or cream, on the contrary, the people who give medicine know the type of ingredients and cream.</study_design>
      <phase>3</phase>
      <hc_freetext>Scars caused by wounds (keloid, hypertrophic, atrophic).</hc_freetext>
      <i_freetext>Intervention 1: Scar Top cream (made by a clinical pharmacist in the laboratory) is used for the intervention group and zinc oxide ointment is used for the control group. Then the common cream and treatment are coded as (B, A). Intervention group: At the beginning of the intervention, the wound site is completely washed and disinfected with normal saline, and after that, the desired site is completely dried using sterile gas. In the next step, a layer of the produced cream is placed on the wound site of the intervention group samples (for 2 times a day) and there is no need to massage and cover the wound surface. All cases are taught to the cases in a training session) and this work will be done every day for 3 weeks. 3 weeks and 6 weeks after the start of scar treatment, the lesion site is evaluated by a person who is not aware of the type of treatment. . Evaluation methods include: photography and POSAS criteria. Intervention 2: Control group: At the beginning of the intervention, the wound site is completely washed with normal saline and disinfected, and after that, the desired site is completely dried using sterile gas. In the next step, on the wound site of the control group samples (under common treatment), a layer of zinc oxide (Raha Pharmaceutical Company) is placed on the wound site (and it is placed on 2 times a day as well There is no need to massage and cover the wound surface and this will be done every day for 3 weeks.</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 For now, we only intend to print the article</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mohamad parsa tabar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safi Abad, Bahnar St</address>
        <city>dezfull</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6463164467</zip>
        <telephone>+98 61 4238 8491</telephone>
        <email>mohamadparsatbar@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mohamad parsa tabar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safi Abad, Bahnar St</address>
        <city>dezfull</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6463164467</zip>
        <telephone>+98 61 4238 8491</telephone>
        <email>mohamadparsatbar@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. People aged 18-60 years                                                         2.Not suffering from acute or chronic diseases (any diseases such as diabetes, etc.)                                                                       3. No history of active skin disease                                                  4. Insensitivity to herbal medicines                                                   5. Not using drugs that interfere with wound healing, such as corticosteroids                                                                                    6. No history of diseases interfering with wound healing               7. Willingness to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Patients with oozing wounds with tissue loss                            ２. Malnourished patients                                                                  3. Patients with various malignancies                                              4. Patients with a history of radiotherapy                                         5. Use of corticosteroids for more than a week                               6. Non-cooperation in intervention such as non-cooperation in regular and timely use of cream                                                      ７. Unwillingness to continue participating in the study for any reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L91.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertrophic scar</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Scar Top cream (made by a clinical pharmacist in the laboratory) is used for the intervention group and zinc oxide ointment is used for the control group. Then the common cream and treatment are coded as (B, A). Intervention group: At the beginning of the intervention, the wound site is completely washed and disinfected with normal saline, and after that, the desired site is completely dried using sterile gas. In the next step, a layer of the produced cream is placed on the wound site of the intervention group samples (for 2 times a day) and there is no need to massage and cover the wound surface. All cases are taught to the cases in a training session) and this work will be done every day for 3 weeks. 3 weeks and 6 weeks after the start of scar treatment, the lesion site is evaluated by a person who is not aware of the type of treatment. . Evaluation methods include: photography and POSAS criteria</i_keyword>
      <i_keyword>Control group: At the beginning of the intervention, the wound site is completely washed with normal saline and disinfected, and after that, the desired site is completely dried using sterile gas. In the next step, on the wound site of the control group samples (under common treatment), a layer of zinc oxide (Raha Pharmaceutical Company) is placed on the wound site (and it is placed on 2 times a day as well There is no need to massage and cover the wound surface and this will be done every day for 3 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vascularity. Timepoint: On the day of the intervention and the day of the end of the study. Method of measurement: Patient and Observer Scar Assessment Scale.</prim_outcome>
      <prim_outcome>Pigment:. Timepoint: On the day of the intervention and the day of the end of the study. Method of measurement: POSAS scale.</prim_outcome>
      <prim_outcome>Thickness. Timepoint: On the day of the intervention and the day of the end of the study. Method of measurement: POSAS scale.</prim_outcome>
      <prim_outcome>Flexibility. Timepoint: On the day of the intervention and the day of the end of the study. Method of measurement: POSAS scale.</prim_outcome>
      <prim_outcome>Surface area. Timepoint: On the day of the intervention and the day of the end of the study. Method of measurement: POSAS scale.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-16</approval_date>
        <contact_name>Tehran Faculty of Nursing and Midwifery and Rehabilitation Faculty of Medical Sciences</contact_name>
        <contact_address>Tawheed Square, Dr. Mirkhani St. (East Nusrat) tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
