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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Seoul St. Mary's Hospital
Sponsor:
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT02035410
First received: January 12, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Infection
Procedure: Hydrogen peroxide pretreatment group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection

Resource links provided by NLM:


Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • freedom of cardiac device-related infection [ Time Frame: 1 year after precedure ] [ Designated as safety issue: No ]
    check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG


Estimated Enrollment: 2
Study Start Date: December 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hydrogen peroxide pretreatment group
Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.
Procedure: Hydrogen peroxide pretreatment group
Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.
No Intervention: Control group
No intervention group

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035410

Contacts
Contact: Youg Seog Oh, Ph.D 82-10-7101-3810 oys@catholic.ac.kr

Locations
Korea, Republic of
Seoul St Mary's Hospital Recruiting
Seoul, Seo Ch-gu, Korea, Republic of, 137-701
Contact: Sung Hwan Kim, MD    82-10-9109-8957    sunghwan@catholic.ac.kr   
Sponsors and Collaborators
Seoul St. Mary's Hospital
Investigators
Study Chair: Yong Seog Oh, Ph.D Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Yong Seog Oh, ph.D, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02035410     History of Changes
Other Study ID Numbers: DISINFECTION I
Study First Received: January 12, 2014
Last Updated: January 12, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul St. Mary's Hospital:
cardiac devices
prevention
infection

Additional relevant MeSH terms:
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014