<?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>IRCT20220308054222N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-02</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>A Survey of the effectiveness of  Arnebia euchroma Ointment and Silver nanoparticles dressing  on pain and Pressure Ulcer healing</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Arnebia euchroma Ointment and Silver nanoparticles dressing  on pain and Pressure Ulcer healing</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62410</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization is first done by random sequence generation. A simple randomization method will be used to generate a random sequence. The method of simple randomization in this study is the use of a random number table. A random number table is a set of numbers that are generated without a specific pattern or order and in a completely random form and has become a table. In order to use the table of random numbers, we first preset the table to read the numbers (from left to right). Then the numbers are considered for the study groups so that even numbers will be considered for the experimental group and odd numbers will be considered for the control group. The second step is the concealment of the randomization allocation because the assigned group will not be specified before the individual is assigned. In this study, due to the fact that sampling is multicenter, the central randomization method will be used to hide the allocation. In this method, the random sequence is given to a person in the school of Nursing and sampling is performed in two centers. Based on the order in which the participants entered the study, the researcher contacted the mentioned person in the School of Nursing and asked about the random assignment of the participant to the experimental or control group. Communication method include the use of telephone, Blinding description: This study is Single blind. The outcome evaluator don't knows the groups  and is unaware of type of treatment in each group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>pressure ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Control group: For 12 days, After Washing the Wound with Sodium Chloride Irrigation Solution 0.9%, the Wound is Dressed with Silver nanoparticle Dressing (AGICOAT)  Once Every Three Days. And on the First, Seventh, and Twelfth Days, The Condition of The Wound and the Level of Pain Experienced Will be Measured. Intervention 2: Intervention group: For 12 days, After Washing the Wound with Sodium Chloride Irrigation Solution 0.9%, the Wound is Dressed with Arnebia Euchroma Ointment  (GOUROH Ointment) and  Sterile Gauze Pads Once Every Two Days. And on the First, Seventh, and Twelfth Days, The Condition of The Wound and the Level of Pain Experienced Will be Measured.</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:
Part of the data is related to the main outcome and the secondary outcome can be shared.

When:
The access period starts 3 months after the results are published

To whom:
The data is available to researchers working in academic and scientific institutions as well as people working in the industry.

Conditions:
Use as a reference

Where to obtain:
DR.Simin sharifi, 
siminsharifi1@gmail.com

How to obtain:
After making a call via email or phone, the desired data will be sent using email or post.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sajjad Mohammadzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahedan Mashahir Square The school of Nursing and Midwifery</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9716913396</zip>
        <telephone>+98 910 563 9024</telephone>
        <email>mohamamdzadehs911@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Simin Sharifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahedan Mashahir Square The school of Nursing and Midwifery</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9716913396</zip>
        <telephone>+98 54 3344 2481</telephone>
        <email>siminsharif1@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with pressure ulcers grade 2 ,3 and 4
nonverbal patient
Using a wavy mattress
Albumin level above 3 mg/dL
Presence of pain in the area</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A history of any allergy to Arnebia euchroma  and silver
Use of other dressings during the intervention</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: For 12 days, After Washing the Wound with Sodium Chloride Irrigation Solution 0.9%, the Wound is Dressed with Silver nanoparticle Dressing (AGICOAT)  Once Every Three Days. And on the First, Seventh, and Twelfth Days, The Condition of The Wound and the Level of Pain Experienced Will be Measured.</i_keyword>
      <i_keyword>Intervention group: For 12 days, After Washing the Wound with Sodium Chloride Irrigation Solution 0.9%, the Wound is Dressed with Arnebia Euchroma Ointment  (GOUROH Ointment) and  Sterile Gauze Pads Once Every Two Days. And on the First, Seventh, and Twelfth Days, The Condition of The Wound and the Level of Pain Experienced Will be Measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound Healing. Timepoint: The first, seventh, and twelfth day. Method of measurement: Pressure Ulcer Scale for Healing (PUSH Tool).</prim_outcome>
      <prim_outcome>Pain. Timepoint: The first, seventh, and twelfth day. Method of measurement: Nonverbal Pain Scale (NVPS).</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-24</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
