<?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>IRCT20220119053762N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-18</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of propolis on surgical wound healing</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of using bee propolis solution on the speed of surgical wound healing</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83287</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Given that both products used, i.e. placebo (normal saline) and propolis solution, are used in the same person, half of the wound is washed with one solution and half with the other. And the name of the containers containing the solution is coded. The patient is unaware of the allocation. Moreover, each person is his or her own control. And receives placebo and intervention simultaneously, all aspects of bias are eliminated.</study_design>
      <phase>2</phase>
      <hc_freetext>Surgical wound.</hc_freetext>
      <i_freetext>Intervention 1: In the patient, half of the surgical incision is considered as the intervention site. To avoid bias in horizontal incisions, the right side of the wound is considered as the intervention site, and in vertical incisions, the upper half of the wound is considered as the intervention site. The intervention site is washed twice daily with a 2% ethanol-based propolis solution. The intervention lasts for one week. Propolis will be supplied from Shahd Mom Pars Company. Intervention 2: Control group: In the present study, half of the surgical incision area was considered as the control site in each patient, such that in horizontal surgical incisions, the left side was considered as the control site and in vertical surgical incisions, the lower half was considered as the control site. The control group received routine care and treatment, which included intravenous antimicrobial treatment and dressing the site in case of discharge with normal saline solution manufactured by Samen Pharmaceutical Company (placebo), which was done daily for one week.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aramesh Rezaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, Mashhad, Razavi Khorasan Province, Iran</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٩١٧٧٩۴٩۰٢۵</zip>
        <telephone>+98 51 3882 9278</telephone>
        <email>rezaeiana@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aramesh Rezaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, Mashhad, Razavi Khorasan Province, Iran</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٩١٧٧٩۴٩۰٢۵</zip>
        <telephone>+98 51 3882 9278</telephone>
        <email>rezaeiana@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- The surgery must have an incision,
2- The surgeon's consent to the patient's participation in the study,
3- Patient consent to participate in the study
4- The possibility of removing the operating room dressing on the second day after surgery,
5- Age over 18 years.
6- No history of allergy to bee products.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the patient, half of the surgical incision is considered as the intervention site. To avoid bias in horizontal incisions, the right side of the wound is considered as the intervention site, and in vertical incisions, the upper half of the wound is considered as the intervention site. The intervention site is washed twice daily with a 2% ethanol-based propolis solution. The intervention lasts for one week. Propolis will be supplied from Shahd Mom Pars Company.</i_keyword>
      <i_keyword>Control group: In the present study, half of the surgical incision area was considered as the control site in each patient, such that in horizontal surgical incisions, the left side was considered as the control site and in vertical surgical incisions, the lower half was considered as the control site. The control group received routine care and treatment, which included intravenous antimicrobial treatment and dressing the site in case of discharge with normal saline solution manufactured by Samen Pharmaceutical Company (placebo), which was done daily for one week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Speed ​​of wound healing. Timepoint: Before the intervention and then daily until the seventh day after the start of the intervention. Method of measurement: Taking pictures of the wound site.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-12</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Avenue, Mashad, Khoorasan Razavi , Iran Mashad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
