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Decrease Implantation Site INFECTION : a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02217046
Recruitment Status : Recruiting
First Posted : August 15, 2014
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infection Procedure: device replacement(pocket capsule removal) Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Prevention of Cardiac Device Replacement Site Infection
Study Start Date : December 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: device replacement
remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
Procedure: device replacement(pocket capsule removal)
remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze

No Intervention: control group
remove previously inserted cardiac device and the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze



Primary Outcome Measures :
  1. freedom of cardiac device-related infection [ Time Frame: 1 year after precedure ]
    check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG


Secondary Outcome Measures :
  1. freedom of endocarditis [ Time Frame: 1 year after precedure ]
    check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG


Other Outcome Measures:
  1. freedom of general infection [ Time Frame: 1 year after procedure ]
    check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for cardiac devices replacement

Exclusion Criteria:

  • under the age of 18
  • take an antibiotic
  • history of infection within 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217046


Contacts
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Contact: Yong Seog Oh, Ph.D 82-10-7101-3810 oys@catholic.ac.kr

Locations
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Korea, Republic of
Seoul St Mary's Hospital Recruiting
Seoul, Seo Ch-gu, Korea, Republic of, 137-701
Contact: Sung Hwan Kim, MD    82-10-9109-8957    sunghwan@catholic.ac.kr   
Principal Investigator: Yong Seog Oh, Ph.D         
Sponsors and Collaborators
Yong Seog Oh
Investigators
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Study Chair: Yong Seog Oh, Ph.D Seoul St. Mary's Hospital

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Responsible Party: Yong Seog Oh, Ph.D, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02217046     History of Changes
Other Study ID Numbers: DISINFECTION II
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Keywords provided by Yong Seog Oh, Seoul St. Mary's Hospital:
Infection
prevention
cardiac devices

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents