<?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>IRCT20230621058552N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-13</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing collagen superabsorbent powder containing silver nanoparticles 15 ppm and 1% silver sulfadiazine ointment</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the therapeutic effect of collagen superabsorbent powder containing silver nanoparticles 15 ppm and 1% silver sulfadiazine ointment on the healing of bedsore.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70823</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: They are divided into two intervention and comparison groups through the table of random numbers. These tables have random numbers in both row and column directions, which usually reach 99 rows and columns, and the numbers of the rows and columns are in blocks of five digits next to each other and in a separated form to facilitate its use. Then we find out the exact number of people in the community and give them a code or machine gun number respectively. To select sample people from the table, we randomly start from a point of the table (by closing the eyes and placing a finger or the tip of the pen on the table) in the direction of the row or column. The chosen small number is actually the code of an individual from the community that is chosen as a sample. This work continues until a small number can be selected for the number of sample people. After the sample volume is complete, the sampling work ends.</study_design>
      <phase>3</phase>
      <hc_freetext>Bed Sore.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After washing the wound with 0.9% sterile saline, the wound is placed in the open air for 5 minutes so that its surface is completely dry, then a few puffs of Nivasha nano silver spray (with a concentration of 15 ppm and health code 9655068437941620, manufactured by Nano Alvand Arad Company) is applied on the surface of the wounds to sterilize the surface of the wounds. After that, collagen superabsorbent powder containing silver nanoparticles (with a concentration of 15 ppm, manufactured by Nano Alvand Arad company) is poured on the wounds and a layer of Vaseline and sterile gauze is placed on the wounds and bandaged. The wound dressing is changed every 48 hours until the wound heals completely. Intervention 2: Control group: After washing the wound with 0.9% sterile saline, the wound is placed in the open air for 5 minutes so that its surface is completely dry, then a few puffs of Nivasha nano silver spray (with a concentration of 15 ppm and health code 9655068437941620, manufactured by Nano Alvand Arad Company) is applied on the surface of the wounds to sterilize the surface of the wounds. After that, 1% silver sulfadiazine ointment (with the trade name Flamexin, manufactured by Emad Darman Pars Pharmaceutical Company) is used, and a layer of Vaseline and sterile gauze is placed on the wounds and bandaged. Wound dressings are changed daily until the wound heals completely.</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>Maryam Aghaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sedigheh Tahereh hospital . Khoram Street. Jomhori Square.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81876-98191</zip>
        <telephone>+98 31 3339 0100</telephone>
        <email>maryam.aghaei2008@gmai.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zabihollah Shahmoradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Leishmaniasis And Skin Diseases Research Center, Sedighe And Tahereh Clinic,  Khoram Street, Jomhoori Square.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81876-98191</zip>
        <telephone>+98 31 3339 0100</telephone>
        <email>emrc@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 35-80 years with at least 30-day-old ulcers.         The wound should be defined as a cavitary bed wound, Wagner grade 3-4.                                                                                           No local or systemic signs of infection,                                        with normal CRP and leukocyte levels</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>80 years</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After washing the wound with 0.9% sterile saline, the wound is placed in the open air for 5 minutes so that its surface is completely dry, then a few puffs of Nivasha nano silver spray (with a concentration of 15 ppm and health code 9655068437941620, manufactured by Nano Alvand Arad Company) is applied on the surface of the wounds to sterilize the surface of the wounds. After that, collagen superabsorbent powder containing silver nanoparticles (with a concentration of 15 ppm, manufactured by Nano Alvand Arad company) is poured on the wounds and a layer of Vaseline and sterile gauze is placed on the wounds and bandaged. The wound dressing is changed every 48 hours until the wound heals completely.</i_keyword>
      <i_keyword>Control group: After washing the wound with 0.9% sterile saline, the wound is placed in the open air for 5 minutes so that its surface is completely dry, then a few puffs of Nivasha nano silver spray (with a concentration of 15 ppm and health code 9655068437941620, manufactured by Nano Alvand Arad Company) is applied on the surface of the wounds to sterilize the surface of the wounds. After that, 1% silver sulfadiazine ointment (with the trade name Flamexin, manufactured by Emad Darman Pars Pharmaceutical Company) is used, and a layer of Vaseline and sterile gauze is placed on the wounds and bandaged. Wound dressings are changed daily until the wound heals completely.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency distribution of improvement rate in patients treated with collagen superabsorbent powder and silver sulfadiazine ointment. Timepoint: Measurement of the wound surface at the beginning of the study (before the start of the intervention) and every 48 hours after starting the use of collagen superabsorbent powder and silver sulfadiazine ointment. Method of measurement: Using caliper software with a unit of mm.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-14</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar jarib Street. Azadai Square, Isfahan. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
