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

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.

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Key information

Conditions

Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St Mary's Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrogen peroxide pretreatment group

Procedure

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Yong Seog Oh

Other

Registry information

Official study title

Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection

Important dates

Study start: 2013
Primary completion: 2019
Study completion: 2019
First posted: Jan 14, 2014
Registry last updated: Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed