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

Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02035410
Enrollment
352
Registered
2014-01-14
Start date
2013-12-31
Completion date
2019-10-31
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

cardiac devices, prevention, infection

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.

Interventions

PROCEDUREHydrogen peroxide pretreatment group

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

Sponsors

Yong Seog Oh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
freedom of cardiac device-related infection1 year after precedurecheck the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026