Decrease Implantation Site INFECTION : a Randomized Controlled Trial

NCT ID: NCT02217046

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

device replacement(pocket capsule removal)

Intervention Type PROCEDURE

remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze

control group

remove previously inserted cardiac device and the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* scheduled for cardiac devices replacement

Exclusion Criteria

* under the age of 18
* take an antibiotic
* history of infection within 30 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yong Seog Oh

OTHER

Sponsor Role lead

Responsible Party

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Yong Seog Oh

Ph.D

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yong Seog Oh, Ph.D

Role: STUDY_CHAIR

Seoul St. Mary's Hospital

Locations

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Seoul St Mary's Hospital

Seoul, Seo Ch-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong Seog Oh, Ph.D

Role: CONTACT

82-10-7101-3810

Facility Contacts

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Sung Hwan Kim, MD

Role: primary

82-10-9109-8957

Other Identifiers

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DISINFECTION II

Identifier Type: -

Identifier Source: org_study_id

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