<?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>IRCT20210412050938N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-28</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>the effect of dressing  on the infection  rate of  hemodialysis catheters in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of using silver nanoparticles dressings and alcoholic chlorhexidine impregnated dressings and conventional dressings on the rate of infection of temporary hemodialysis catheters in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56353</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be divided into three groups using a simple randomization method based on a table of random numbers. According to the sample size (120 patients), patients will first be given a code from 1 to 120 (given that the number of patients is three digits). Therefore, the given codes will be three digits: 001, 002, ......, 120) Then a number will be randomly selected from the table and we will go from top to bottom in a column in the table until the sample size is examined. To be completed. In this case, patients between 001 and 040 will be in group one, 041 to 080 in group 2 and 081 to 120 in group 3, Blinding description: Blinding in this study will be done in several steps as follows
1- Preparing 120 dressing packages that are the same in terms of appearance, type of packaging and color.
2- Using a table of random numbers to assign dressing packages to three treatment groups at random.
3- After assigning the dressings to three groups, we mark them with a label of 1 to 120.
4- The researcher delivers the dressing packages to the therapist and the therapist gives the patients from 1 to 120, respectively (only the researcher is aware of the number of dressings and which treatment group each dressing package belongs to, and therefore is blind. The study is valid because the therapist and patient are unaware of the nature of the treatment and dressing).</study_design>
      <phase>N/A</phase>
      <hc_freetext>hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: The catheter site is disinfected with 10% povidone iodine and then washed and dried with normal saline, covered with a sterile dressing. The time required for rinsing with povidone iodine is 2 minutes. It will be washed and bandaged three times at intervals of 48 hours, and at each time the symptoms of local infection will be checked with a checklist, and then the correct way to take care of the catheter dressing and to observe the hygiene of the area will be taught. one liter povidone iodine from Pejhan Shimi Yazd Company will be used. Intervention 2: Intervention group: To do the dressing with silver, according to the product catalog, first wash and dry the catheter site with washing serum and then wet the silver dressing with sterile water to have more and better silver release, then place it in the catheter site sterile and fix we do. Each group will be washed and bandaged three times at intervals of 48 hours. At each time, the symptoms of local infection will be checked with a checklist, and then the correct way to take care of the catheter dressing and observe the hygiene of the area will be taught. Eurofarm Silvermed adhesive silver absorbent dressing will be used. Intervention 3: Intervention group:Rinse the catheter site with 2% chlorhexidine in 70% isopropyl for 30 seconds and wait for it to dry. It will then be sterilely dressed.Each group will be washed and bandaged three times at intervals of 48 hours. At each time, the symptoms of local infection will be checked with a checklist, and then the correct way to take care of the catheter dressing and observe the hygiene of the area will be taught. body prep solution from Behban Shimi company  will be used that contains 2% chlorhexidine in 70% isopropyl alcohol.</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:
Unidentifiable data of individuals and related information available to others
Researchers will be placed. Study protocol, data analysis program and
Etc. will also be shared

When:
3 months after article publication

To whom:
Health care professionalists

Conditions:
Data can be used to research and provide new solutions by citing the source

Where to obtain:
Refer to this mail:
pourmehr.omid@umsu.ac.ir
Omid Pourmehr

How to obtain:
Email to the applicant - Request from the Vice Chancellor for Research - If the information to the applicant is positive

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Omid Pourmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.72 , Maad Alley, Ghandi Ave., Ahar Town</address>
        <city>Ahar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5451665433</zip>
        <telephone>+98 41 4422 0369</telephone>
        <email>omidpourmehr@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Omid Pourmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.72 , Maad Alley, Ghandi Ave., Ahar Town</address>
        <city>Ahar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5451665433</zip>
        <telephone>+98 41 4422 0369</telephone>
        <email>omidpourmehr@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in research
Patients with renal insufficiency with temporary temporal and subclavian catheters
Patients with negative skin culture
No respiratory, pulmonary and blood infectious diseases (file review)
Patients who do not receive intravenous or oral antibiotics
Patients who do not take immunosuppressive drugs</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue the research process</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z99.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dependence on renal dialysis</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>The catheter site is disinfected with 10% povidone iodine and then washed and dried with normal saline, covered with a sterile dressing. The time required for rinsing with povidone iodine is 2 minutes. It will be washed and bandaged three times at intervals of 48 hours, and at each time the symptoms of local infection will be checked with a checklist, and then the correct way to take care of the catheter dressing and to observe the hygiene of the area will be taught. one liter povidone iodine from Pejhan Shimi Yazd Company will be used.</i_keyword>
      <i_keyword>Intervention group: To do the dressing with silver, according to the product catalog, first wash and dry the catheter site with washing serum and then wet the silver dressing with sterile water to have more and better silver release, then place it in the catheter site sterile and fix we do. Each group will be washed and bandaged three times at intervals of 48 hours. At each time, the symptoms of local infection will be checked with a checklist, and then the correct way to take care of the catheter dressing and observe the hygiene of the area will be taught. Eurofarm Silvermed adhesive silver absorbent dressing will be used.</i_keyword>
      <i_keyword>Intervention group:Rinse the catheter site with 2% chlorhexidine in 70% isopropyl for 30 seconds and wait for it to dry. It will then be sterilely dressed.Each group will be washed and bandaged three times at intervals of 48 hours. At each time, the symptoms of local infection will be checked with a checklist, and then the correct way to take care of the catheter dressing and observe the hygiene of the area will be taught. body prep solution from Behban Shimi company  will be used that contains 2% chlorhexidine in 70% isopropyl alcohol</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Catheter site infection. Timepoint: Three times at 48-hour intervals(At the time of initial dressing, the second and fourth day of dressing). Method of measurement: checklist.</prim_outcome>
      <prim_outcome>Bacterial colonization. Timepoint: Before intervention start and after 3rd time dressing. Method of measurement: skin culture from catheter location.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-09</approval_date>
        <contact_name>Urmia University Of Medical sciences</contact_name>
        <contact_address>No. 72 , Maad Alley , Ghandi Ave Ahar East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
