NCT02035410

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

5.7 years

First QC Date

January 12, 2014

Last Update Submit

April 20, 2020

Conditions

Infection

Keywords

cardiac devicespreventioninfection

Outcome Measures

Primary Outcomes (1)

  • freedom of cardiac device-related infection

    check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG

    1 year after precedure

Study Arms (2)

Hydrogen peroxide pretreatment group

ACTIVE COMPARATOR

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

Procedure: Hydrogen peroxide pretreatment group

Control group

NO INTERVENTION

No intervention group

Interventions

Hydrogen peroxide pretreatment groupPROCEDURE

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

Hydrogen peroxide pretreatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for cardiac devices Implantation

You may not qualify if:

  • under the age of 18
  • Hydrogen peroxide allergy
  • take an antibiotic
  • History of infection within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St Mary's Hospital

Seoul, Seo Ch-gu, 137-701, South Korea

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Yong Seog Oh, Ph.D

    Seoul St. Mary's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ph.D

Study Record Dates

First Submitted

January 12, 2014

First Posted

January 14, 2014

Study Start

December 1, 2013

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)