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

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ClinicalTrials.gov Identifier: NCT02035410
Recruitment Status : Recruiting
First Posted : January 14, 2014
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital

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.

Condition or disease Intervention/treatment Phase
Infection Procedure: Hydrogen peroxide pretreatment group Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection
Study Start Date : December 2013
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. freedom of cardiac device-related infection [ Time Frame: 1 year after precedure ]
    check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Yong Seog Oh
Investigators
Study Chair: Yong Seog Oh, Ph.D Seoul St. Mary's Hospital

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
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yong Seog Oh, Seoul St. Mary's Hospital:
cardiac devices
prevention
infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents