Decrease Implantation Site INFECTION (DISINFECTION I): a Randomized Controlled Trial
- Conditions
- Infection
- Interventions
- Procedure: Hydrogen peroxide pretreatment group
- Registration Number
- NCT02035410
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
- scheduled for cardiac devices Implantation
- under the age of 18
- Hydrogen peroxide allergy
- take an antibiotic
- History of infection within 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hydrogen peroxide pretreatment group Hydrogen peroxide pretreatment group Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide 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
Trial Locations
- Locations (1)
Seoul St Mary's Hospital
🇰🇷Seoul, Seo Ch-gu, Korea, Republic of