Decrease Implantation Site INFECTION (DISINFECTION I): a Randomized Controlled Trial

NCT ID: NCT02035410

Last Updated: 2020-04-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2019-10-31

Brief Summary

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Cardiovascular implantable electronic device (CIED) infections have been increasing out of proportion to the number of devices implanted We 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 prophylactic use of hydrogen peroxide is still limited.

We had planned research on effects of preventive using hydrogen peroxide before cardiac devices insertion.

Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Hydrogen peroxide pretreatment group

Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.

Group Type ACTIVE_COMPARATOR

Hydrogen peroxide pretreatment group

Intervention Type PROCEDURE

Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.

Control group

No intervention group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hydrogen peroxide pretreatment group

Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* scheduled for cardiac devices Implantation

Exclusion Criteria

* under the age of 18
* Hydrogen peroxide allergy
* 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

Countries

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South Korea

Other Identifiers

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DISINFECTION I

Identifier Type: -

Identifier Source: org_study_id

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