<?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>IRCT20220718055487N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-26</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of using a special waterproof layer under the tourniquet cuff on the burn incidence and pain intensity after surgery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of using a special waterproof layer under the tourniquet cuff on the burn incidence and pain intensity after surgery in the patient and the level of satisfaction of operating room staff in knee arthroscopic surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64825</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Randomization description: Randomization method: simple
  In this study, considering that the distribution of patients will be done by the day of surgery (patients on even and odd days), therefore, there is no tool for randomization, Blinding description: This study is conducted in the form of a randomized clinical trial study of a blinded statistical analyst;  This means that the statistical analyzer will remain unaware of the division of groups and groups of each patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Burns of the patient after surgery caused by the use of monopolar cautery - pain after surgery of the patient at the place of closure of the tourniquet.</hc_freetext>
      <i_freetext>Intervention group: Using a special waterproof drip under the tourniquet cuff (17 people): After preparing the patient and inducing anesthesia, an inflatable tourniquet is used under which a special tourniquet drape will be used to protect the skin..</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:
The report of the results of the personnel satisfaction questionnaire for the use of a special tourniquet and the report of the results of the checklist for burns and pain after surgery in patients.

When:
Access starts 6 months after the results are published

To whom:
Researchers affiliated with universities and scientific institutions

Conditions:
The results of the data in order to find new solutions to reduce complications caused by the use of tourniquets

Where to obtain:
Nafise Rahimi
Telephone Number : 00989059856560
Email: Nafiserahimi7@gmail.com
Address: No.10, mojgan alley, east yeganeh alley, bahar ave, marzdaran blv, tehran

How to obtain:
Email the identification card related to the scientific institute or university to Nafiserahimi7@gmail.com.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nafise rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.10,mojgan alley, east yeganeh alley, bahar ave, marzdaran blv, tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461844371</zip>
        <telephone>+98 21 4425 4561</telephone>
        <email>Nafiserahimi7@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nafise rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.10, mojgan alley, east yeganeh alley, bahar ave, marzdaran blv, tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461844378</zip>
        <telephone>+98 21 4425 4561</telephone>
        <email>Nafiserahimi7@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 and over
Informed consent to participate in the study
Arthroscopic knee surgery with the need to use a tourniquet
The surgery is not an emergency
Absence of fractures in other body organs based on the information in the patient's file
No history of cardiovascular diseases such as congestive heart failure, cardiac arrhythmias, high blood pressure, diabetes based on patient file information
Non-use of drugs or continuous use of alcohol or cigarettes more than 5 packs per year based on the person's self-report
The absence of trauma to the chest, head or abdomen based on the person's self-report
No need for other surgeries, in addition to orthopedic surgery, based on the patient's file information
Absence of coagulation diseases or the need to take anti-coagulation drugs based on the person's medical and medical history</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Using a special waterproof drip under the tourniquet cuff (17 people): After preparing the patient and inducing anesthesia, an inflatable tourniquet is used under which a special tourniquet drape will be used to protect the skin.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patients who suffer from monopolar cautery burns after surgery. Timepoint: Before surgery, immediately after surgery. Method of measurement: Direct observation by the student and completion of the relevant checklist.</prim_outcome>
      <prim_outcome>Pain after surgery of patients in the place of tourniquet. Timepoint: Immediately after surgery, up to 24 hours after the patient enters recovery (every 8 hours). Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Personnel satisfaction with the waterproof tourniquet cover. Timepoint: Immediately after the intervention. Method of measurement: Satisfaction questionnaire.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-09</approval_date>
        <contact_name>Ethical Committee of Isfahan University of Medical Sciences - Al-Zahra Research Center</contact_name>
        <contact_address>No.10, mojgan alley, east yeganeh alley, bahar ave, marzdaran blv, tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
