<?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>IRCT20230711058739N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-19</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of zinc oxide and vaseline in preventing pressure ulcer</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between effect of Zinc Oxide and Vaseline in prevention pressure ulcer in patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71275</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients who meet the criteria for inclusion in the study were selected by random sampling method and divided into four groups: 1- Zinc oxide with dressing, 2- Vaseline with dressing, 3- Zinc oxide without dressing, 4- Vaseline without dressing and the control group. will be placed. The selection of the ball from the bag will be done by one of the ward nurses who is not aware of the study. Due to the fact that in the present study, an attempt has been made to prevent the occurrence of pressure injuries in all vulnerable points, therefore, the use of zinc oxide and Vaseline will support all pressure points of the body. Since according to studies, the average duration of pressure injury in patients hospitalized in the intensive care unit is the first 10 days, in group 1 and 2 patients, the skin of the patients was examined twice a day for 10 days and using Zing. Oxide will cover all pressure points of the body twice a day in the morning and at night with this medicine. The amount of medicine used varies according to the fitness of the patient, and it is important that all pressure points are well covered with this medicine. In group 1, zinc oxide will be used directly on the skin of patients, and in group 2, gas impregnated with zinc will be used on the skin of patients. Patients in groups 3 and 4, for 10 days and twice a day, the skin of the patients will be examined and all pressure points will be covered with Vaseline. In group 3, Vaseline will be used directly on the skin of patients, and in group 4, gauze impregnated with Vaseline will be used on the skin of patients. The amount of medicine used in this group will also be different according to the size of the patient, and the important thing is that all pressure points are covered with medicine. Treatment centers will be conducted and there will be no intervention in routine nursing care. The skin of the patients was examined by the research team twice within 24 hours and each time when the condition of the patients changed in terms of occurrence of pressure injuries using standard tools and in case of ulcers, the degree, size, location and other cases were recorded in the special file for each patient. The present study will be designed and registered. The members of the research team will carry out the relevant interventions on the patients' beds in order to maintain ethical issues according to the purpose of the research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bedsores in the intensive care unit.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: zinc oxide receptor group without dressing. Intervention 2: Intervention group: Vaseline receiving group without dressing. Intervention 3: Intervention group: Zinc oxide with dressing. Intervention 4: Intervention group: Vaseline with dressing. Intervention 5: Control group: Not using zinc and vaseline and doing routine care.</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>Fatima Safari Al-Muti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Haft Shehamat Alley, Kausar, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3471646118</zip>
        <telephone>+98 28 3377 8507</telephone>
        <email>fatemesafarii75@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>farnoosh rashvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin - Qazvin University of Medical Sciences, Faculty of Nursing and Midwifery</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3471646118</zip>
        <telephone>+98 28 3377 8507</telephone>
        <email>n.rashvand@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent of the patient or the patient's family to participate in the research
Patients with medium and high risk based on the score they get from Braden's criteria upon entering the department.
Age (18-70) years (because Braden's criterion is for people over 18).
Absence of underlying disease (diabetes, skin diseases, vascular diseases)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from a pressure injury at the time of entering the ward
2- Circumstances in which a change in the patient's condition is indicated.
3- Age less than 18 years or more than 70 years
4- Having diabetes and various skin and vascular diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: zinc oxide receptor group without dressing</i_keyword>
      <i_keyword>Intervention group: Vaseline receiving group without dressing</i_keyword>
      <i_keyword>Intervention group: Zinc oxide with dressing</i_keyword>
      <i_keyword>Intervention group: Vaseline with dressing</i_keyword>
      <i_keyword>Control group: Not using zinc and vaseline and doing routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Prevention of bedsores. Timepoint: Before reading - every time you change position - twice in 24 hours in 10 days. Method of measurement: Braden tool - pressure injury grading tool - checklist of demographic variables.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The effect of zinc oxide and vaseline. Timepoint: 2 times within 24 hours and within 10 days. Method of measurement: Compressive damage grading tool - Braden tool.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-28</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin, Kausar town, South Miyad St., 7 Shahamat alley, No. 5, 2nd floor Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
