Reducing infections during cardiac device replacement
Phase 1 Study of Prevention of Cardiac Device Replacement Site Infection
NA · Seoul St. Mary's Hospital · NCT02217046
This study is testing if removing the pocket capsule before replacing heart devices can help prevent infections better than just using antibiotics and antiseptics.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seoul St. Mary's Hospital (other) |
| Locations | 1 site (Seoul, Seo Ch-gu) |
| Trial ID | NCT02217046 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of posterior pocket capsule removal prior to the replacement of cardiovascular implantable electronic devices (CIEDs) in preventing infections. The study aims to address the rising trend of CIED infections by comparing traditional methods of infection prevention, such as antibiotics and povidone iodine, with the surgical approach of removing the pocket capsule. Participants scheduled for device replacement will be randomly assigned to either the intervention or control group to assess the outcomes related to infection rates. The trial seeks to provide insights into a potentially novel method for reducing infection risks associated with cardiac devices.
Who should consider this trial
Good fit: Ideal candidates for this study are adults scheduled for cardiac device replacement who meet the inclusion criteria.
Not a fit: Patients under 18, those currently taking antibiotics, or with a history of infection within the last 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the incidence of infections in patients undergoing cardiac device replacement.
How similar studies have performed: While there have been studies on antibiotic use and povidone iodine for infection prevention, the approach of posterior pocket capsule removal is relatively novel and has limited prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * scheduled for cardiac devices replacement Exclusion Criteria: * under the age of 18 * take an antibiotic * history of infection within 30 days
Where this trial is running
Seoul, Seo Ch-gu
- Seoul St Mary's Hospital — Seoul, Seo Ch-gu, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Yong Seog Oh, Ph.D
- Email: oys@catholic.ac.kr
- Phone: 82-10-7101-3810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infection, prevention, cardiac devices