Prophylaxis of infection after cardiac implanted device replacement

Not Applicable

Completed

• Conditions: Injury, poisoning and certain other consequences of external causes

• Registration Number: KCT0004121
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Of the 195 patients included (mean age 70.2 ± 13.6years, 55.4% women), with an average follow-up period of 54.3±28.9 months. The primary outcome occurred in 4 (2.1%), and there was no significant difference between the two groups (3.1% vs 1.0%, p=0.606). Hematoma was occurred in 10 patients (3.1% vs 7.1%, p=0.338), one of them required wound revision. In multivariable analysis, the occurrence of hematoma was the only independent risk factor associated with device infection. (HR 13.6, 95% CI 1.02-181.15, p=0.048)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-05-10
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

over 19 years
Planned generator exchange procedure for implanted cardiac electronic device (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy)

Exclusion Criteria

Taking antibiotics due to infectious disease not related to generator pocket

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac device related infection

Secondary Outcome Measures

Name	Time	Method
systemic infection