<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02263196</url>
  </required_header>
  <id_info>
    <org_study_id>921839</org_study_id>
    <nct_id>NCT02263196</nct_id>
  </id_info>
  <brief_title>The Efficacy of Alcohol After Betadine and Combination of Alcohol and Betadine on Inflammation Vascular Access</brief_title>
  <official_title>Mashhad University of Medical Sciences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mashhad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mashhad University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to compare the efficacy of combination of alcohol and povidone&#xD;
      iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to&#xD;
      vascular access area in hemodialysis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      These cases were identified from patient that lack of specific diseases; Non-use of&#xD;
      antibiotics or immunosuppressive drugs. That the participants will be selected using&#xD;
      convenience sampling method and randomly divided into three groups: combination of alcohol&#xD;
      and povidone iodine 10%, Alcohol after and control groups. In the Intervention in one group&#xD;
      the vascular access site disinfected with Alcohol(group1) and in group 2, Alcohol and&#xD;
      povidone iodine 10% was used to separate were disinfected. Then the patient in a month of&#xD;
      inflammation and infection of the vascular access will be monitor. Exclusion criteria:&#xD;
      inflammation or fistula failure during the study for any reason other than infection. Sample&#xD;
      size determination: Through the pilot study. Date: 02.10.2014 till 02.11.2014 Outcome:&#xD;
      Washing with both solution affected on reduce the inflammation and infection of the patient.&#xD;
&#xD;
      the efficacy of Alcohol after Betadine and combination of alcohol and Betadine on&#xD;
      inflammation and infection related to Vascular access hemodialysis patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>effected of betadin and alcohol on inflammation and infection of the patient</measure>
    <time_frame>up to one month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Complication of Hemodialysis</condition>
  <arm_group>
    <arm_group_label>alcohol and povidone iodine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the efficacy of combination of alcohol and povidone iodine on inflammation related to vascular access</description>
  </arm_group>
  <arm_group>
    <arm_group_label>combination of alcohol and betadin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the efficacy of combination of alcohol and povidone iodine on infection related to vascular access</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Alcohol and povidone iodine</intervention_name>
    <description>using from Alcohol and povidone iodine for prevention of inflammation</description>
    <arm_group_label>alcohol and povidone iodine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>combination of alcohol and betadin</intervention_name>
    <description>using from combination Alcohol and povidone iodine for prevention of inflammation</description>
    <arm_group_label>combination of alcohol and betadin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  absence of inflammatory vascular access site&#xD;
&#xD;
          -  three dialysis sessions per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient dies&#xD;
&#xD;
          -  patient withdrew from the partnership&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>mohmmad rajabpoor, student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Msc Student, Faculty of Nursing and Midwifery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ali bazzi, MSc student</last_name>
    <phone>09113723582</phone>
    <email>bazzia911@mums.ac.ir</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ali Bazzi</name>
      <address>
        <city>Mashhad</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>maryam bagheri, instructor</last_name>
      <phone>09153031112</phone>
      <email>bagherim@mums.ac.ir</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <link>
    <url>http://ncbi.nlm.nih.gov/pubmed/?term=hemodialysis+and+infection</url>
    <description>that is a article from pubmed</description>
  </link>
  <reference>
    <citation>Branas P, Morales E, Rios F, Sanz F, Gutierrez E, Quintanilla N, Orellana MA, Sanchez M, Rodriguez-Aranda A, Chaves F. Usefulness of endoluminal catheter colonization surveillance cultures to reduce catheter-related bloodstream infections in hemodialysis. Am J Infect Control. 2014 Nov;42(11):1182-7. doi: 10.1016/j.ajic.2014.07.022. Epub 2014 Sep 22.</citation>
    <PMID>25248485</PMID>
  </reference>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>April 7, 2015</last_update_submitted>
  <last_update_submitted_qc>April 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mashhad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>rajabpoor</investigator_full_name>
    <investigator_title>Mashhad University of Medical Sciences</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02263196
org study id: 921839
nct id: NCT02263196
lead sponsor: 
has dmc: Yes
The purpose of this study was to compare the efficacy of combination of alcohol and povidone
      iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to
      vascular access area in hemodialysis patients.
These cases were identified from patient that lack of specific diseases; Non-use of
      antibiotics or immunosuppressive drugs. That the participants will be selected using
      convenience sampling method and randomly divided into three groups: combination of alcohol
      and povidone iodine 10%, Alcohol after and control groups. In the Intervention in one group
      the vascular access site disinfected with Alcohol(group1) and in group 2, Alcohol and
      povidone iodine 10% was used to separate were disinfected. Then the patient in a month of
      inflammation and infection of the vascular access will be monitor. Exclusion criteria:
      inflammation or fistula failure during the study for any reason other than infection. Sample
      size determination: Through the pilot study. Date: 02.10.2014 till 02.11.2014 Outcome:
      Washing with both solution affected on reduce the inflammation and infection of the patient.

      the efficacy of Alcohol after Betadine and combination of alcohol and Betadine on
      inflammation and infection related to Vascular access hemodialysis patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: effected of betadin and alcohol on inflammation and infection of the patient
time frame: up to one month
arm group label: alcohol and povidone iodine
arm group type: Experimental
description: the efficacy of combination of alcohol and povidone iodine on inflammation related to vascular access
arm group label: combination of alcohol and betadin
arm group type: Experimental
description: the efficacy of combination of alcohol and povidone iodine on infection related to vascular access
intervention type: Other
intervention name: Alcohol and povidone iodine
description: using from Alcohol and povidone iodine for prevention of inflammation
arm group label: alcohol and povidone iodine
intervention type: Other
intervention name: combination of alcohol and betadin
description: using from combination Alcohol and povidone iodine for prevention of inflammation
arm group label: combination of alcohol and betadin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: mohmmad rajabpoor, student
role: Principal Investigator
affiliation: Msc Student, Faculty of Nursing and Midwifery
last name: ali bazzi, MSc student
phone: 09113723582
email: bazzia911@mums.ac.ir
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
url: http://ncbi.nlm.nih.gov/pubmed/?term=hemodialysis+and+infection
description: that is a article from pubmed
citation: Branas P, Morales E, Rios F, Sanz F, Gutierrez E, Quintanilla N, Orellana MA, Sanchez M, Rodriguez-Aranda A, Chaves F. Usefulness of endoluminal catheter colonization surveillance cultures to reduce catheter-related bloodstream infections in hemodialysis. Am J Infect Control. 2014 Nov;42(11):1182-7. doi: 10.1016/j.ajic.2014.07.022. Epub 2014 Sep 22.
PMID: 25248485
responsible party type: Principal Investigator
investigator affiliation: Mashhad University of Medical Sciences
investigator full name: rajabpoor
investigator title: Mashhad University of Medical Sciences
mesh term: Ethanol
mesh term: Povidone-Iodine
mesh term: Povidone