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

April 20, 2020 updated by: Yong Seog Oh

Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection

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.

Study Overview

Status

Completed

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 prophylactic use of hydrogen peroxide is still limited.

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

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Korea, Republic of
    • Seo Ch-gu
      • Seoul, Seo Ch-gu, Korea, Republic of, 137-701
        • 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 Implantation

Exclusion Criteria:

  • under the age of 18
  • Hydrogen peroxide allergy
  • 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hydrogen peroxide pretreatment group
Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.
Procedure: Hydrogen peroxide pretreatment group
Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.
No Intervention: Control group
No intervention group

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

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 (Actual)

August 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

January 12, 2014

First Submitted That Met QC Criteria

January 12, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DISINFECTION I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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