Back to resultsDecrease Implantation Site INFECTION (DISINFECTION I): a Randomized Controlled Trial
Primary Purpose
Infection
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hydrogen peroxide pretreatment group
Sponsored by
About this trial
This is an interventional prevention trial for Infection focused on measuring cardiac devices, prevention, infection
Eligibility Criteria
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
Sites / Locations
- Seoul St Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Hydrogen peroxide pretreatment group
Control group
Arm Description
Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.
No intervention group
Outcomes
Primary Outcome Measures
freedom of cardiac device-related infection
check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02035410
Brief Title
Decrease Implantation Site INFECTION (DISINFECTION I): a Randomized Controlled Trial
Official Title
Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Seog Oh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
cardiac devices, prevention, infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
352 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrogen peroxide pretreatment group
Arm Type
Active Comparator
Arm Description
Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention group
Intervention Type
Procedure
Intervention Name(s)
Hydrogen peroxide pretreatment group
Intervention Description
Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.
Primary Outcome Measure Information:
Title
freedom of cardiac device-related infection
Description
check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG
Time Frame
1 year after precedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Seog Oh, Ph.D
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul St Mary's Hospital
City
Seoul
State/Province
Seo Ch-gu
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Decrease Implantation Site INFECTION (DISINFECTION I): a Randomized Controlled Trial
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