Decrease Implantation Site INFECTION : a Randomized Controlled Trial

Yong Seog Oh

Status: Enrolling

Conditions: Infection

Treatments: Procedure: device replacement(pocket capsule removal)

Study type: Interventional

Funder types: Other

Identifiers

NCT02217046

DISINFECTION II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 352 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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352 participants in 2 patient groups

device replacement

Experimental group

Description:

remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze

Treatment:

Procedure: device replacement(pocket capsule removal)

control group

No Intervention group

Description:

remove previously inserted cardiac device and the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze