<?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>IRCT2012070910217N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-10-02</date_registration>
      <primary_sponsor>Vice chancellor for research &amp; technology, Hamadan university of medical sciences</primary_sponsor>
      <public_title>Impact of nursing care on pressure ulcer prevention</public_title>
      <acronym></acronym>
      <scientific_title>study of homecare’s effects on prevention of the pressure ulcer in craniospinal injury  patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10690</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Evaluation the skin of pressure ulcers.</hc_freetext>
      <i_freetext>Intervention 1: In the control group does not interfere and the patient's family will receive training from the hospital. these patients survey from incidence and degree of Bedsores every 72 hours. Intervention 2: In the intervention group, researcher go to patients home daily, and assess the health of the skin and pressure ulcer prevention protocol carries out. Protocols including skin care, use of support surfaces such as pillows and changing position every 2 hours.  Floating mats are used in both.</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>mohammad vali kian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517678835</zip>
        <telephone>+98 81 1264 4888</telephone>
        <email>m.kian@umsha.ac.ir</email>
        <affiliation>Hamadan university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mohammad vali kian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517678835</zip>
        <telephone>+98 81 1264 4888</telephone>
        <email>m.kian@umsha.ac.ir</email>
        <affiliation>Hamadan university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Immediately after the discharge of patients with craniospinal injury; Patients should not have pressure ulcers; Predicting pressure ulcer patients based on the Borden scale with scores below 18 are; Patients must be aged between 40-75 years.&#13;
Exclusion Criteria: Need for hospital readmission; Disaffiliate the patient and family; Having a history of diabetes; Having advanced vascular disease&#13;
serum albumin level less than 3/5 g/dL.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L-89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Decubitus ulcer and pressure area</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the control group does not interfere and the patient's family will receive training from the hospital. these patients survey from incidence and degree of Bedsores every 72 hours</i_keyword>
      <i_keyword>In the intervention group, researcher go to patients home daily, and assess the health of the skin and pressure ulcer prevention protocol carries out. Protocols including skin care, use of support surfaces such as pillows and changing position every 2 hours.  Floating mats are used in both.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pressure ulcer. Timepoint: one month. Method of measurement: View and apply pressure ulcer scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of pressure ulcer. Timepoint: one month. Method of measurement: View and apply pressure ulcer scale.</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>Vice chancellor for research &amp; technology, Hamadan university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-08-12</approval_date>
        <contact_name>Hamadan university of medical sciences</contact_name>
        <contact_address>Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
