Decrease Implantation Site INFECTION : a Randomized Controlled Trial

April 4, 2019 updated by: Yong Seog Oh

Phase 1 Study of Prevention of Cardiac Device Replacement Site Infection

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Seo Ch-gu
      • Seoul, Seo Ch-gu, Korea, Republic of, 137-701
        • Recruiting
        • Seoul St Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • scheduled for cardiac devices replacement

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year after precedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year after precedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yong Seog Oh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2025

Study Completion (ANTICIPATED)

October 1, 2025

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (ESTIMATE)

August 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DISINFECTION II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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