<?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>IRCT138903254190N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-12-29</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Antibacterial effects of chlorhexidine , persica  and saline mouthwashes</public_title>
      <acronym>persica</acronym>
      <scientific_title>Comparison of the immediate Antibacterial Effects of persica , Chlorhexidine and normal saline Mouthwash in ICU patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4416</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In this double blind randomized clinical trial samples in the three groups will be labeled by letters A, B and C and Laboratory staffs are unaware of the intervention groups. Patients are also blind as they are unconscious at the time of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: ventilator associated pneumonia. Condition 2: ventilator associated pneumonia.</hc_freetext>
      <i_freetext>Intervention 1: In first group, will used chlorhexidine gluconate 0.2% mouthwash, manufactured by pharmaceutical company of drug city (Tehran – Iran).all surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of mouthwashes (chlorhexidine gluconate 0.2%) for 6 minutes. Immediately before and after using of mouthwashes, salivary sample without any stimulation was taken for culturing S.aureus and pneumoccocus. Intervention 2: In second group, will used persica 10% mouthwash, manufactured by pharmaceutical company of pursina. all surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of mouthwashes (persica 10%) for 6 minutes. Immediately before and after using of mouthwashes, salivary sample without any stimulation was taken for culturing S.aureus and pneumoccocus. Intervention 3: In third group, will used normal salin mouthwash. all surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of mouthwashes (normal salin) for 6 minutes. Immediately before and after using of mouthwashes, salivary sample without any stimulation was taken for culturing S.aureus and pneumoccocus.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadi Darvishi Khezri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibe faculty of nursing and midwifery</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48175-866</zip>
        <telephone>+98 15132612458</telephone>
        <email>H.darvishi@mazums.ac.ir ; Hadidarvishi87@yahoo.com</email>
        <affiliation>Mazandaran University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohre taraqi-Assistant professor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibe faculty of nursing and midwifery</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48175-866</zip>
        <telephone>+98 15 1226 7343</telephone>
        <email>z.taraqi@mazums.ac.ir ; ztarair@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Age between 15-65 years, Third and fourth day of admission in ICU, Intubation and mechanical ventilation for 3 to 4 days, having NG tube for 3 to 4 Exclusion Criteria: Re-intubation, History of antibiotic therapy before admission, Oral anticoagulation therapy,Respiratory and systemic infection, Autoimmune diseases and malignancies, History of allergy to mouthwash, asthma, allergic rhinitis and dermatitis, History of radiation therapy and immunosuppressive therapy including corticosteroid, Use of any kind of antimicrobial mouthwash within 2 months before admission, Diseases of oral mucosa and severe periodontitis, History of splenectomy and  Tonsillectomy , Negative cultures of S.aureus and pneumoccocus before use of mouthwash, Occurrence of any reaction to Mouthwashes</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J13</hc_code>
      <hc_code>J15.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pneumonia due to Streptococcus pneumoniae</hc_keyword>
      <hc_keyword>Pneumonia due to staphylococcus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In first group, will used chlorhexidine gluconate 0.2% mouthwash, manufactured by pharmaceutical company of drug city (Tehran – Iran).all surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of mouthwashes (chlorhexidine gluconate 0.2%) for 6 minutes. Immediately before and after using of mouthwashes, salivary sample without any stimulation was taken for culturing S.aureus and pneumoccocus.</i_keyword>
      <i_keyword>In second group, will used persica 10% mouthwash, manufactured by pharmaceutical company of pursina. all surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of mouthwashes (persica 10%) for 6 minutes. Immediately before and after using of mouthwashes, salivary sample without any stimulation was taken for culturing S.aureus and pneumoccocus.</i_keyword>
      <i_keyword>In third group, will used normal salin mouthwash. all surfaces of mouth, gingiva, tongue, throat and teeth will be swapped carefully by 10 cc of mouthwashes (normal salin) for 6 minutes. Immediately before and after using of mouthwashes, salivary sample without any stimulation was taken for culturing S.aureus and pneumoccocus.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of colony of S.aureus and pneumoccocus. Timepoint: Immediately before and after using mouthwashes. Method of measurement: CFU(Colony-forming unit).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Any reaction to Mouthwashes. Timepoint: after using of mouthwashes. Method of measurement: inspection.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-29</approval_date>
        <contact_name>Deputy of research of Mazandaran University of medical sciences</contact_name>
        <contact_address>Moalem Square, Deputy of research of Mazandaran University of medical sciences Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
