Decrease Implantation Site INFECTION : a Randomized Controlled Trial

Overview

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.

Full Title of Study: “Phase 1 Study of Prevention of Cardiac Device Replacement Site Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2025

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • scheduled for cardiac devices replacement Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yong Seog Oh
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Yong Seog Oh, Ph.D – Seoul St. Mary’s Hospital
  • Overall Official(s)
    • Yong Seog Oh, Ph.D, Study Chair, Seoul St. Mary’s Hospital
  • Overall Contact(s)
    • Yong Seog Oh, Ph.D, 82-10-7101-3810, oys@catholic.ac.kr

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