<?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>IRCT20211127053186N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-23</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of chitosan wound dressing in the treatment of infected wounds</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect of chitosan wound dressing containing antibiotics on recovering process of the infected wounds</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74471</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done in a simple way and the table of random numbers will be used as a tool. Even numbers are for the intervention group and odd numbers are for the control group. Then, according to the number of the studied sample, the corresponding numbers are extracted from the table of random numbers or using a computer, and each number is written on a card and placed in an envelope, and the envelopes are sealed, and on each envelope the number The patient is written. The first patient who is enrolled in the study and enters the study will be given the envelope related to patient number 1, patient number 2 will be given envelope number 2 and so on, and this will continue until the end of the study sample. In order to maintain randomization, the person who prepares the envelopes will be different from the person who registers the patients and provides the envelopes to the patients, Blinding description: Only study participants are blinded. This means that only the participants do not know which group they have been placed in and whether they have been prescribed a drug or a placebo.
It is tried that the patients do not meet each other during their visits, and their appointments are made separately at different times. During wound dressing, all patients will be told that the same dressings will be used for them.</study_design>
      <phase>3</phase>
      <hc_freetext>Infected wounds.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The wound dressing is prepared in the laboratory of Medical Biomaterials Research Center (MBRC) in Tehran University of Medical Sciences. Patients referred to Farmanieh Hospital are selected by a specialist doctor. A chitosan dressing containing antibiotics will be placed on the affected wound. The wound dressing is changed and controlled by the attending physician every day for a week. Intervention 2: Control group: Wound dressing is prepared in the laboratory of Medical Biomaterial Research Center (MBRC) in Tehran University of Medical Sciences. Patients referred to Farmanieh Hospital are selected by a specialist doctor. A chitosan dressing will be placed on the affected wound. The wound dressing is changed and controlled by the attending physician every day for a 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data from this study will be published as an article or a report.

When:
The access period starts 6 months after the results are published

To whom:
The resulting data will be available for researchers working in academic and scientific and clinical institutions

Conditions:
There are no special conditions.

Where to obtain:
To receive the data, applicants can refer to Tehran University of Medical Sciences, located on 16 Azar St.

How to obtain:
Researchers can access the data by searching the Internet.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Handali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Englebal, 16 Azar, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8163 3619</telephone>
        <email>handali_s81@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Handali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Englebal, 16 Azar, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8163 3619</telephone>
        <email>handali_s81@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>"Patients with surgical wounds" are eligible for the study.
"Patients with ulcers caused by bedsores" are eligible for the study.
"Patients with diabetic foot ulcers" are eligible for the study.
"Patients with wounds caused by infectious " are eligible for the study.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>"Patients who have a deep wound with abscess, osteomyelitis, the presence of local or extensive non-debrideable gangrene" are not eligible for the study.
"Patients with venous ulcers and evidence of malignancy in the wound area" are not eligible for the study.
"Pregnant women diagnosed by a specialist doctor" are not eligible to enter the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S01.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Open wound of scalp</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: The wound dressing is prepared in the laboratory of Medical Biomaterials Research Center (MBRC) in Tehran University of Medical Sciences. Patients referred to Farmanieh Hospital are selected by a specialist doctor. A chitosan dressing containing antibiotics will be placed on the affected wound. The wound dressing is changed and controlled by the attending physician every day for a week.</i_keyword>
      <i_keyword>Control group: Wound dressing is prepared in the laboratory of Medical Biomaterial Research Center (MBRC) in Tehran University of Medical Sciences. Patients referred to Farmanieh Hospital are selected by a specialist doctor. A chitosan dressing will be placed on the affected wound. The wound dressing is changed and controlled by the attending physician every day for a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound healing percentage. Timepoint: The wound healing process is monitored every day for a week. Method of measurement: Taking a photo of the wound and comparing the photo of the first day with the photo of the seventh day.</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>2023-12-14</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Englebal, 16 Azar St., Tehran University of Medical Sciences1417653761 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
