<?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>IRCT20170712035044N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-20</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Antiseptic effect on bacteriuria of patients with catheterization</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Effect of Betadine and Chlorhexidine for periurethral cleaning before Catheterization on Bacteriuria and pyuria in female patients hospitalized in emergency of Alzahra hospital of Isfahan University of Medical Sciences   2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40179</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, the sampels  divided into two intervention groups A and B by  using random numbers and Randomizer software. group A with iodine and group B with Chlorhexidine was done  periurethral cleaning before Catheterization , Blinding description: In this study, the researcher specifies the type of solution in each group and at the time of sampling the participant is asked about the susceptibility to both solutions, but at the time of the intervention the participant is not aware of the type of solution used.(One-way blind to the patient).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bacteriuria.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In this group, 36 female patients needed Foley Catheter  and conditions for entry into the study, the urethra and perinea area were washed with iodine, and the urine specimen in the 3 periods immediately after the catheter was 72 hours Next and 5 days later. Intervention 2: Intervention group2: Intervention group 1: In this group, 36 female patients needed Foley Catheter  and conditions for entry into the study, the urethra and perinea area were washed with Chlorhexidine, and the urine specimen in the 3 periods immediately after the catheter was 72 hours Next and 5 days later.</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 Confidentiality of patient information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somaye Ghafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib St., Isfahan University of Medical Sciences, Nursing and Midwifery Faculty</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۶۵</zip>
        <telephone>+98 31 3792 7544</telephone>
        <email>somayehghafari@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Ghafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HezarJarib St., Isfahan University of Medical Sciences, Nursing and Midwifery Faculty</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۶۵</zip>
        <telephone>+98 31 3792 7544</telephone>
        <email>somayehghafari@nm.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 need a Foley catheter for at least 5 days.
There is no obvious tissue damage to the mucosa and skin of the genital area in the patient.
There are no symptoms of urinary tract infection including fever above 38 °, pain in the suprapubic area, frequent urination, burning in the urine.
Absence of foley catheter at admission
No history of hypersensitivity to betadine and Chlorhexidine substances.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness of the patient and family to continue participating in the study.
Need to leave the patient's catheter sooner than 5 days</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Urinary tract infection, site not specified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In this group, 36 female patients needed Foley Catheter  and conditions for entry into the study, the urethra and perinea area were washed with iodine, and the urine specimen in the 3 periods immediately after the catheter was 72 hours Next and 5 days later.</i_keyword>
      <i_keyword>Intervention group2: Intervention group 1: In this group, 36 female patients needed Foley Catheter  and conditions for entry into the study, the urethra and perinea area were washed with Chlorhexidine, and the urine specimen in the 3 periods immediately after the catheter was 72 hours Next and 5 days later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bacteriuria in patients with Foley catheter. Timepoint: Immediately after catheterization, bacteriuria  were evaluated 72 hours and 5 days after catheterization. Method of measurement: By sending a urine test and culture the urine in the Blood Agar environment.</prim_outcome>
      <prim_outcome>Pyuria in patients with Foley catheter. Timepoint: Immediately after catheterization, pyuria were evaluated 72 hours and 5 days after catheterization. Method of measurement: By sending a urine test and culture in the Blood Agar environment.</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>2019-01-23</approval_date>
        <contact_name>National Ethics Committee for Biomedical Research</contact_name>
        <contact_address>Tehran-Ghods Town (West) - Between South Falamak and Zarafshan, Iran's Sims Avenue-Headquarters of the Ministry of Health and Medical Education, block A, thirteenth floor Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
