Decrease Implantation Site INFECTION (DISINFECTION I): a Randomized Controlled Trial

Yong Seog Oh

Status: Completed

Conditions: Infection

Treatments: Procedure: Hydrogen peroxide pretreatment group

Study type: Interventional

Funder types: Other

Identifiers

NCT02035410

DISINFECTION I

Details and patient eligibility

About

Cardiovascular implantable electronic device (CIED) infections have been increasing out of proportion to the number of devices implanted We 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 prophylactic use of hydrogen peroxide is still limited.

We had planned research on effects of preventive using hydrogen peroxide before cardiac devices insertion.

Enrollment: 352 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled for cardiac devices Implantation

Exclusion criteria

• under the age of 18
• Hydrogen peroxide allergy
• take an antibiotic
• History of infection within 30 days

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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352 participants in 2 patient groups

Hydrogen peroxide pretreatment group

Active Comparator group

Description:

Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.

Treatment:

Procedure: Hydrogen peroxide pretreatment group

Control group

No Intervention group

Description:

No intervention group