Back to resultsDecrease Implantation Site INFECTION : a Randomized Controlled Trial
Primary Purpose
Infection
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
device replacement(pocket capsule removal)
Sponsored by
About this trial
This is an interventional treatment trial for Infection focused on measuring Infection, prevention, cardiac devices
Eligibility Criteria
Inclusion Criteria:
- scheduled for cardiac devices replacement
Exclusion Criteria:
- under the age of 18
- take an antibiotic
- history of infection within 30 days
Sites / Locations
- Seoul St Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
device replacement
control group
Arm Description
remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
remove previously inserted cardiac device and the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
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
freedom of endocarditis
check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02217046
Brief Title
Decrease Implantation Site INFECTION : a Randomized Controlled Trial
Official Title
Phase 1 Study of Prevention of Cardiac Device Replacement Site Infection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
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 the investigators 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 posterior pocket capsule removal is still limited.
The investigators had planned research on effects of posterior pocket capsule removal before cardiac devices replacement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Infection, prevention, cardiac devices
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
352 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
device replacement
Arm Type
Experimental
Arm Description
remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
Arm Title
control group
Arm Type
No Intervention
Arm Description
remove previously inserted cardiac device and the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
Intervention Type
Procedure
Intervention Name(s)
device replacement(pocket capsule removal)
Intervention Description
remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked 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
Secondary Outcome Measure Information:
Title
freedom of endocarditis
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
Other Pre-specified Outcome Measures:
Title
freedom of general 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 procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
scheduled for cardiac devices replacement
Exclusion Criteria:
under the age of 18
take an antibiotic
history of infection within 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Seog Oh, Ph.D
Phone
82-10-7101-3810
Email
oys@catholic.ac.kr
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Hwan Kim, MD
Phone
82-10-9109-8957
Email
sunghwan@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Yong Seog Oh, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Decrease Implantation Site INFECTION : a Randomized Controlled Trial
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