Decrease Implantation Site INFECTION : a Randomized Controlled Trial

Phase 1 Study of Prevention of Cardiac Device Replacement Site Infection

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02217046

Enrollment

352

Registered

2014-08-15

Start date

2013-12-31

Completion date

2025-10-31

Last updated

2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

Infection, prevention, cardiac devices

Brief 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.

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

Interventions

PROCEDUREdevice 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* scheduled for cardiac devices replacement

Exclusion criteria

* under the age of 18 * take an antibiotic * history of infection within 30 days

Design outcomes

Primary

Measure	Time frame	Description
freedom of cardiac device-related infection	1 year after precedure	check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG

Secondary

Measure	Time frame	Description
freedom of endocarditis	1 year after precedure	check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG

Other

Measure	Time frame	Description
freedom of general infection	1 year after procedure	check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG

Countries

South Korea

Contacts

Primary ContactYong Seog Oh, Ph.D

oys@catholic.ac.kr82-10-7101-3810

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026