<?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>IRCT20211128053199N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-25</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of pistachio cream on grade one pressure ulcers in hospitalized patients.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of pistachio cream on grade one pressure ulcers in patients admitted to Ali Ebn Abitaleb Hospital.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63049</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants of the intervention and control groups are first selected among the intensive care unit patients with grade one pressure ulcers, using the convenience sampling method with the sample size of 35 participants. Then they are classified based on body mass index, (BMI ≤25 and BMI&gt;25) and age (20-40 years, 41-60 years, 61-90 years). The first participant is randomized in the intervention or control group. Next participants enter the group with lower total BMI.</study_design>
      <phase>3</phase>
      <hc_freetext>Pressure Ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: To measure the size of the wound, the largest longitudinal and transverse diameter of the wound (using a caliper with an accuracy of one millimeter) is measured and multiplied together, and the size of the wound is recorded in square centimeters. The amount of wound secretions with the factors score zero: no exudation, score one: low exudation (the sterile gauze was not wet), score two: moderate exudation (one sterile gauze was wet) and score three: high exudation (2 gauzes were wet). And the degree of tissue improvement based on the first degree: epithelial tissue, second degree: granular tissue, third degree: progenitor tissue, and the fourth degree of necrotic tissue. The highest score in Posh system is 17 and the lowest score is 3. Lower scores indicate low severity and higher scores indicate greater severity of the wound. Then, the recorded size is scored based on the PUSH scale and considering that the first stage pressure ulcer has no exudate and tissue disorder, these two items are assigned a score of zero. Each time the scores are compared and the healing process of the wound is determined based on it, and after allocating people to groups, the intervention will be implemented by the main researcher. The green and fresh skin of the ripe Uhdi pistachio variety is separated by hand and dried in the shade and at room temperature. Then the dried skin is ground and turned into powder. Finally, 150 grams of this powder is soaked in 600 ml of hydroethanolic solution for 96 hours at room temperature. After filtering with a cloth and then Whatman No. 1 filter paper, the extract solution under the filter is dried in an oven at a temperature of 40 °C. The obtained dry extract is kept at -20°C until consumption. It should be mentioned that the formulation is done in clean conditions by Barij Essans Daru Company in Kashan. In the intervention group, daily and for seven days after changing the position and washing the wound with physiological serum, pistachio skin extract with a thickness of (2-3) mm was applied to the wound using a sterile abslang and covered with a sterile gauze. can be In order to ensure that the patient is not allergic to pistachio skin extract, before the intervention, a layer of this extract will be rubbed on the inner part of the patient's arm and the patient's reaction will be checked within 30 minutes after use. Intervention 2: Control group: In the control group, routine care includes changing the position every 2-3 hours and washing with physiological serum daily.</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:
Only a part of the data, such as the information related to the main result or the like, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
It will be available for researchers working in academic and scientific institutions, or people who are also working in industry can apply for them.

Conditions:
It will be available for researchers working in academic and scientific institutions, or people who are also working in the industry can apply for them.

Where to obtain:
For information, people can contact the responsible author by calling 09103131606 and by e-mail at mahinghiyasi.nurse@gmail.com and at the address of Rafsanjan, Nurse Street, Nursing School.

How to obtain:
Whenever a person requests information, she can communicate with the email and contact number, and she will receive the information after 24 hours.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahin Ghiyasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Blvd</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3428 0000</telephone>
        <email>mahinghiyasi.nurse@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme  khoshoei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Blvd</address>
        <city>Rafasanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3428 0000</telephone>
        <email>fatemekhoshoei8@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Immobile patients
Moderate to severe loss of consciousness ( Glasgow Coma Scale&lt;8)
Not having diabetes (based on the patient's medical history)
Absence of skin disorders such as dermatitis
Not taking corticosteroid drugs</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have second degree pressure and higher</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pressure ulcer</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: To measure the size of the wound, the largest longitudinal and transverse diameter of the wound (using a caliper with an accuracy of one millimeter) is measured and multiplied together, and the size of the wound is recorded in square centimeters. The amount of wound secretions with the factors score zero: no exudation, score one: low exudation (the sterile gauze was not wet), score two: moderate exudation (one sterile gauze was wet) and score three: high exudation (2 gauzes were wet). And the degree of tissue improvement based on the first degree: epithelial tissue, second degree: granular tissue, third degree: progenitor tissue, and the fourth degree of necrotic tissue. The highest score in Posh system is 17 and the lowest score is 3. Lower scores indicate low severity and higher scores indicate greater severity of the wound. Then, the recorded size is scored based on the PUSH scale and considering that the first stage pressure ulcer has no exudate and tissue disorder, these two items are assigned a score of zero. Each time the scores are compared and the healing process of the wound is determined based on it, and after allocating people to groups, the intervention will be implemented by the main researcher. The green and fresh skin of the ripe Uhdi pistachio variety is separated by hand and dried in the shade and at room temperature. Then the dried skin is ground and turned into powder. Finally, 150 grams of this powder is soaked in 600 ml of hydroethanolic solution for 96 hours at room temperature. After filtering with a cloth and then Whatman No. 1 filter paper, the extract solution under the filter is dried in an oven at a temperature of 40 °C. The obtained dry extract is kept at -20°C until consumption. It should be mentioned that the formulation is done in clean conditions by Barij Essans Daru Company in Kashan. In the intervention group, daily and for seven days after changing the position and washing the wound with physiological serum, pistachio skin extract with a thickness of (2-3) mm was applied to the wound using a sterile abslang and covered with a sterile gauze. can be In order to ensure that the patient is not allergic to pistachio skin extract, before the intervention, a layer of this extract will be rubbed on the inner part of the patient's arm and the patient's reaction will be checked within 30 minutes after use.</i_keyword>
      <i_keyword>Control group: In the control group, routine care includes changing the position every 2-3 hours and washing with physiological serum daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Type 1 pressure ulcer. Timepoint: In both groups, three days after the intervention and one week later. Method of measurement: Wound healing process using the PUSH scale(PUSH) Pressure   Ulcer Scale   for Healing.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-12</approval_date>
        <contact_name>Rafsanjan University of Medical Sciences (RUMS)</contact_name>
        <contact_address>Emam Ali Blvd,Rafsanjan City Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
