<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/NCT02217046</url>
  </required_header>
  <id_info>
    <org_study_id>DISINFECTION II</org_study_id>
    <nct_id>NCT02217046</nct_id>
  </id_info>
  <brief_title>Decrease Implantation Site INFECTION : a Randomized Controlled Trial</brief_title>
  <official_title>Phase 1 Study of Prevention of Cardiac Device Replacement Site Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yong Seog Oh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul St. Mary's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular implantable electronic device (CIED) infections have been increasing out of&#xD;
      proportion to the number of devices implanted the investigators investigated recent trends&#xD;
      and possible causes of the increasing numbers of Cardiovascular implantable electronic device&#xD;
      infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are many studies on the preventive use of Antibiotics or povidone iodine to&#xD;
      Cardiovascular implantable electronic device (CIED) infections.&#xD;
&#xD;
      But, studies of posterior pocket capsule removal is still limited.&#xD;
&#xD;
      The investigators had planned research on effects of posterior pocket capsule removal before&#xD;
      cardiac devices replacement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>freedom of cardiac device-related infection</measure>
    <time_frame>1 year after precedure</time_frame>
    <description>check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>freedom of endocarditis</measure>
    <time_frame>1 year after precedure</time_frame>
    <description>check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG</description>
  </secondary_outcome>
  <other_outcome>
    <measure>freedom of general infection</measure>
    <time_frame>1 year after procedure</time_frame>
    <description>check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">352</enrollment>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>device replacement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>remove previously inserted cardiac device and the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>device replacement(pocket capsule removal)</intervention_name>
    <description>remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze</description>
    <arm_group_label>device replacement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for cardiac devices replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under the age of 18&#xD;
&#xD;
          -  take an antibiotic&#xD;
&#xD;
          -  history of infection within 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong Seog Oh, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yong Seog Oh, Ph.D</last_name>
    <phone>82-10-7101-3810</phone>
    <email>oys@catholic.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul St Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seo Ch-gu</state>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sung Hwan Kim, MD</last_name>
      <phone>82-10-9109-8957</phone>
      <email>sunghwan@catholic.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Yong Seog Oh, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>April 4, 2019</last_update_submitted>
  <last_update_submitted_qc>April 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Yong Seog Oh</investigator_full_name>
    <investigator_title>Ph.D</investigator_title>
  </responsible_party>
  <keyword>Infection</keyword>
  <keyword>prevention</keyword>
  <keyword>cardiac devices</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_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/NCT02217046
org study id: DISINFECTION II
nct id: NCT02217046
lead sponsor: 
has dmc: Yes
Cardiovascular implantable electronic device (CIED) infections have been increasing out of
      proportion to the number of devices implanted the investigators investigated recent trends
      and possible causes of the increasing numbers of Cardiovascular implantable electronic device
      infections.
There are many studies on the preventive use of Antibiotics or povidone iodine to
      Cardiovascular implantable electronic device (CIED) infections.

      But, studies of posterior pocket capsule removal is still limited.

      The investigators had planned research on effects of posterior pocket capsule removal before
      cardiac devices replacement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: freedom of cardiac device-related infection
time frame: 1 year after precedure
description: check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG
measure: freedom of endocarditis
time frame: 1 year after precedure
description: check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG
measure: freedom of general infection
time frame: 1 year after procedure
description: check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG
arm group label: device replacement
arm group type: Experimental
description: remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
arm group label: control group
arm group type: No Intervention
description: remove previously inserted cardiac device and the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
intervention type: Procedure
intervention name: device replacement(pocket capsule removal)
description: remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
arm group label: device replacement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yong Seog Oh, Ph.D
role: Study Chair
affiliation: Seoul St. Mary's Hospital
last name: Yong Seog Oh, Ph.D
phone: 82-10-7101-3810
email: oys@catholic.ac.kr
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Yong Seog Oh
investigator title: Ph.D
mesh term: Infections
mesh term: Communicable Diseases