Decrease Implantation Site INFECTION : a Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Infection
• Interventions: Procedure: device replacement(pocket capsule removal)

• Registration Number: NCT02217046
• Lead Sponsor: Yong Seog Oh

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-05
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 352

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
device replacement	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul St Mary's Hospital; 🇰🇷 Seoul, Seo Ch-gu, Korea, Republic of