<?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>IRCT20190326043114N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-09</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>effect of aloe vera and honey prophylactic dressings on the incidence of pressure injury</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between effect of aloe vera and honey prophylactic dressings on the incidence of pressure injury among Elderly Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38934</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: for random allocation in this study will be use Bowl and individual methods It will be placed 90 small beads in a non-transparent container On the beads, the number will be one to 90 labels.
The numbers 1 to 30 belong to the AloeVera group and the numbers 31 to 60 belong to the honey group and the numbers 61 to 90 belong to the placebo group.
After each patient is admitted to the intensive care unit, a bead will be randomly removed from the container.
And determine which the patient will belong to, of the three groups And the nut will be removed and will not be returned to the container.</study_design>
      <phase>3</phase>
      <hc_freetext>pressure ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patient sacrum area is evaluated for 7 days, twice daily, for the onset of compression ulcers. In the absence of a pressure ulcer, the skin of the sacrum area is first washed with a normal saline solution. Then, 5 cc of the Aloe Vera gel is applied to the sacrum skin, and then a simple dressing gauze with 10 * 10 cm dimensions is placed on it and will be kept with a mattress glue on the skin. Intervention 2: Intervention group 2: Sacrum area of the patient is evaluated for the duration of 7 days, twice daily, for the incidence of compression ulcers. In the absence of a pressure ulcer, the skin of the sacrum area is first washed with a normal saline solution. Then 5 cc of honey is rubbed into the skin of the sacrum area, and then a simple dressing gauze placed 10 x 10 cm in size and will be kept firmly fixed on the skin with a mattress glue. Intervention 3: Control group: The skin of the sacrum area of the patient will be examined twice a day by the nurse for the occurrence of pressure ulcers twice daily for a maximum of seven days.In the absence of pressure ulcer as soon as it enters the icu unit, the skin of the sacrum area is first washed and cleaned by the researcher with normal saline solution, and a simple dressing gas of 10 x 10 cm is applied on it and glued on. It will be fixed on the skin.glued.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information will be published in the form of a paper

When:
After the end of the data collection

To whom:
There is no limit

Conditions:
Any person or organization that needs to receive information can send the email to the person in charge of receiving the information

Where to obtain:
Responsible person - Dr. Farnoosh Rashvand

How to obtain:
send mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farnoosh Rashvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Qazvin Shahid Bahonar Blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>59811 -34197</zip>
        <telephone>+98 28 3333 8034</telephone>
        <email>n.rashvand@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnoosh Rashvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences,  Shahid Bahonar Blvd, qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>59811 -34197</zip>
        <telephone>+98 28 3333 8034</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>not having pressure ulcer at the time of admission to the ICU
Patients with a high and medium risk score based on the Braden criterion at the start of the ICU (Score Bradden adjusted to 14 and lower).
Age over 60 years old</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>There is an absolute motion limitation requested by the physician and prevents the patient from moving.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>l89</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>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patient sacrum area is evaluated for 7 days, twice daily, for the onset of compression ulcers. In the absence of a pressure ulcer, the skin of the sacrum area is first washed with a normal saline solution. Then, 5 cc of the Aloe Vera gel is applied to the sacrum skin, and then a simple dressing gauze with 10 * 10 cm dimensions is placed on it and will be kept with a mattress glue on the skin.</i_keyword>
      <i_keyword>Intervention group 2: Sacrum area of the patient is evaluated for the duration of 7 days, twice daily, for the incidence of compression ulcers. In the absence of a pressure ulcer, the skin of the sacrum area is first washed with a normal saline solution. Then 5 cc of honey is rubbed into the skin of the sacrum area, and then a simple dressing gauze placed 10 x 10 cm in size and will be kept firmly fixed on the skin with a mattress glue.</i_keyword>
      <i_keyword>Control group: The skin of the sacrum area of the patient will be examined twice a day by the nurse for the occurrence of pressure ulcers twice daily for a maximum of seven days.In the absence of pressure ulcer as soon as it enters the icu unit, the skin of the sacrum area is first washed and cleaned by the researcher with normal saline solution, and a simple dressing gas of 10 x 10 cm is applied on it and glued on. It will be fixed on the skin.glued</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of incidece pressure ulcer. Timepoint: Daily check up spot of medication use. Method of measurement: observation.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-12</approval_date>
        <contact_name>Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences.Qazvin. Shahid Bahonar Blvd. qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
