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NCT02035410 Clinical Trial

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

Infection Clinical Trial

Official title:
Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02035410
Other study ID # DISINFECTION I
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date October 2019

Study information
Verified date April 2020
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 352
Est. completion date October 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hydrogen peroxide pretreatment group
Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.

Locations
Country Name City State
Korea, Republic of Seoul St Mary's Hospital Seoul Seo Ch-gu

Sponsors (1)
Lead Sponsor Collaborator
Yong Seog Oh

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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