Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 352
- Locations
- 1
- Primary Endpoint
- freedom of cardiac device-related infection
Study Overview
Brief Summary
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.
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 prophylactic use of hydrogen peroxide is still limited.
We had planned research on effects of preventive using hydrogen peroxide before cardiac devices insertion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Hydrogen peroxide pretreatment group
Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.
Intervention: Hydrogen peroxide pretreatment group (Procedure)
Control group
No intervention group
Outcomes
Primary Outcomes
freedom of cardiac device-related infection
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Yong Seog Oh
ph.D
Seoul St. Mary's Hospital