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NCT02217046 Clinical Trial

Decrease Implantation Site INFECTION : a Randomized Controlled Trial

Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02217046
Other study ID # DISINFECTION II
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date October 2025

Study information
Verified date April 2019
Source Seoul St. Mary's Hospital
Contact Yong Seog Oh, Ph.D
Phone 82-10-7101-3810
Email oys@catholic.ac.kr
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 the investigators 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 posterior pocket capsule removal is still limited.

The investigators had planned research on effects of posterior pocket capsule removal before cardiac devices replacement.

Recruitment information / eligibility
Status Recruiting
Enrollment 352
Est. completion date October 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- scheduled for cardiac devices replacement

Exclusion Criteria:

- under the age of 18

- take an antibiotic

- history of infection within 30 days

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• device replacement(pocket capsule removal)
remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked 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
Other freedom of general infection check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG 1 year after procedure
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
Secondary freedom of endocarditis 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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