<?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>IRCT20231108059996N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-05</date_registration>
      <primary_sponsor>Zabol University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of aloe vera gel and chlorhexidine gluconate       solution2 %  on the prevention of phlebitis caused by peripheral vein catheters in patients admitted to the cardiac intensive care units</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of aloe vera gel and chlorhexidine gluconate       solution2 %  on the prevention of phlebitis caused by peripheral vein catheters in patients admitted to the cardiac intensive care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73679</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, first, a list of patients who meet the research inclusion criteria will be prepared, and then the first person will be selected in the first intervention group, the second person will be in the third intervention group, and the third person will be selected in the random allocation method. A control will be placed and this work will continue until all research samples are placed in one of the two intervention or control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>phlebitis.</hc_freetext>
      <i_freetext>Intervention 1: IntervenAfter washing your hands for 30 seconds with soap and water and wearing non-sterile gloves to protect yourself, preparing the intravenous fluid and serum set in a sterile way and choosing the appropriate vein, disinfection in the first group is done with 70% ethyl alcohol. And after the venous catheter is dried and inserted, then the upper part of the catheter insertion site is fixed with angioket adhesive, which has a pad embedded in its upper part, dipped in half a cc of 2% chlorhexidine gluconate solution. Intervention 2: In the second group, the catheter insertion site is first disinfected with 70% ethyl alcohol, then the selected area, after drying and entering the venous catheter, is then smeared with half a cc of aloe vera gel with angioket adhesive, which has a pad embedded in its upper part. The upper part of the catheter entry point is fixed. Intervention 3: In the control group, only the insertion site of the catheter is disinfected with 70% ethyl alcohol and the catheter is fixed using glue in a standard way. The date, time and name of the researcher are recorded. Every 12 hours to 72 hours, the site is checked and recorded for signs and degree of phlebitis. The serum set in 3 groups is changed every 24 hours and the duration of maintenance of the venous catheter is 72 hours.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is -</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Herati Nesab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shilat Square - Motahari Street</address>
        <city>zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861664656</zip>
        <telephone>+98 54 3223 6156</telephone>
        <email>mahdiyehharati742@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Naderi Far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sistan and Baluchestan province, Zabul city - 11 Ferdowsi St.</address>
        <city>zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861734184</zip>
        <telephone>+98 54 3222 3947</telephone>
        <email>mahin.naderifar@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Voluntary participation in the study
Age 20 to 70 years
Having a healthy upper limb
Absence of phlebitis at the site before catheter placement
Not taking anticoagulants
No history of skin diseases, acute and chronic infection, severe anemia, glaucoma, hypotension (systolic pressure less than 100 mm Hg)
Lack of immune system defects
No chemotherapy
Lack of intravenous nutrition</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Discharge from the hospital three days before the start of the intervention
Unwillingness to continue cooperation
Rupture or removal of the catheter before 72 hours
pregnancy
Sickness of the patient for any reason
Having diabetes
Simultaneous use of two or more antibiotics
Vasculitis and vascular involvement</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Phlebitis and thrombophlebitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>IntervenAfter washing your hands for 30 seconds with soap and water and wearing non-sterile gloves to protect yourself, preparing the intravenous fluid and serum set in a sterile way and choosing the appropriate vein, disinfection in the first group is done with 70% ethyl alcohol. And after the venous catheter is dried and inserted, then the upper part of the catheter insertion site is fixed with angioket adhesive, which has a pad embedded in its upper part, dipped in half a cc of 2% chlorhexidine gluconate solution.</i_keyword>
      <i_keyword>In the second group, the catheter insertion site is first disinfected with 70% ethyl alcohol, then the selected area, after drying and entering the venous catheter, is then smeared with half a cc of aloe vera gel with angioket adhesive, which has a pad embedded in its upper part. The upper part of the catheter entry point is fixed.</i_keyword>
      <i_keyword>In the control group, only the insertion site of the catheter is disinfected with 70% ethyl alcohol and the catheter is fixed using glue in a standard way. The date, time and name of the researcher are recorded. Every 12 hours to 72 hours, the site is checked and recorded for signs and degree of phlebitis. The serum set in 3 groups is changed every 24 hours and the duration of maintenance of the venous catheter is 72 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Phlebitis. Timepoint: Every 12 hours. Method of measurement: Phlebitis checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Phlebitis. Timepoint: Every 12 hours. Method of measurement: Phlebitis checklist.</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>Zabol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-28</approval_date>
        <contact_name>Ethics Committee of Zabul University of Medical Sciences</contact_name>
        <contact_address>Shilat Square - Motahari Street - Motahari corner 2 زابل Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
