NCT02217046

Decrease Implantation Site INFECTION : a Randomized Controlled Trial

Phase 1 Study of Prevention of Cardiac Device Replacement Site Infection

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 352 (estimated)
• Sponsor: Yong Seog Oh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-12-01
• Primary completion: 2025-08-01
• Completion: 2025-10-01
• First posted: 2014-08-15
• Last updated: 2019-04-05

Locations

1 site across 1 country: South Korea