<?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>IRCT20220703055358N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-30</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of using wet dressing with normal saline on infection, scar and healing process of surgical wound</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of using wet dressing with normal saline on infection, scar and healing process of surgical wound in patients undergoing orthopedic surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64583</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is designed as a simple randomization with an individual random unit, and the randomization tool is a table of random numbers, Blinding description: The person who prepares the culture samples does not know whether the patient is in the intervention group or the control group.</study_design>
      <phase>3</phase>
      <hc_freetext>infection.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: From the day of surgery to the seventh, during the dressing change, a gauze is used that is completely soaked in normal saline (0.9% isotonic solution of chlorsodium) and then the excess liquid is removed with full compliance with aseptic principles. The wound will be evaluated by the doctor and the researcher on the 3rd, 7th, 13th and 21st days after the surgery. and to evaluate the checklists for checking the scar (Vancouver) and the checklist for checking the recovery process (REEDA) also in relation to the definite diagnosis of infection, sampling from inflamed and exuding wounds directly and through sterile methods using sterile swaps and from the environments Blood, EMB and chocolate agar will be used to check for microbial contamination. Intervention 2: Control group: From the day of surgery to the seventh day during the dressing change, the routine method (cleaning the wound using betadine and then drying it)is used for dressing the surgical wound. The wound will be evaluated by the doctor and the researcher on the 3rd, 7th, 13th and 21st days after the surgery. and to evaluate the checklists for checking the scar (Vancouver) and the checklist for checking the recovery process (REEDA) also in relation to the definite diagnosis of infection, from inflamed and exuding wounds directly and through sterile methods by sterile swap sampling and from the environments Blood, EMB and chocolate agar will be used to check for microbial contamination.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>،Faculty of Nursing and Midwifery،Shahryar St.</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9678694176</zip>
        <telephone>00955832297096</telephone>
        <email>f.imani@nkums.ac.ir</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery،Shahryar St</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>94176-96786</zip>
        <telephone>+98 58 3229 7096</telephone>
        <email>f.imani@nkums.ac.ir</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Absence of symptoms of infection in the surgical area before the intervention
not having history of drug abuse
not having diabetes
definitive diagnosis of orthopedic surgery for patientsno</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Surgical site infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B99.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified infectious disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: From the day of surgery to the seventh, during the dressing change, a gauze is used that is completely soaked in normal saline (0.9% isotonic solution of chlorsodium) and then the excess liquid is removed with full compliance with aseptic principles. The wound will be evaluated by the doctor and the researcher on the 3rd, 7th, 13th and 21st days after the surgery. and to evaluate the checklists for checking the scar (Vancouver) and the checklist for checking the recovery process (REEDA) also in relation to the definite diagnosis of infection, sampling from inflamed and exuding wounds directly and through sterile methods using sterile swaps and from the environments Blood, EMB and chocolate agar will be used to check for microbial contamination.</i_keyword>
      <i_keyword>Control group: From the day of surgery to the seventh day during the dressing change, the routine method (cleaning the wound using betadine and then drying it)is used for dressing the surgical wound. The wound will be evaluated by the doctor and the researcher on the 3rd, 7th, 13th and 21st days after the surgery. and to evaluate the checklists for checking the scar (Vancouver) and the checklist for checking the recovery process (REEDA) also in relation to the definite diagnosis of infection, from inflamed and exuding wounds directly and through sterile methods by sterile swap sampling and from the environments Blood, EMB and chocolate agar will be used to check for microbial contamination.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Infection. Timepoint: Sampling from the surgical wound at the beginning of the study and days 3, 7, 13 and 21 after intervention. Method of measurement: Sampling by sterile swap and from blood, EMB and chocolate agar media.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Oscar. Timepoint: At the beginning of the study, days 3, 7, 13 and 21 after the intervention. Method of measurement: Oscar Checklist (Vancouver).</sec_outcome>
      <sec_outcome>Recovery process. Timepoint: At the beginning of the study, days 3, 7, 13 and 21 after the intervention. Method of measurement: Recovery Checklist (REEDA).</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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-04</approval_date>
        <contact_name>Ethics committee of Bojnurd University of Medical Sciences</contact_name>
        <contact_address>College of Nursing and Midwifery،Shahryar St., Bojnurd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
