Prevention of Arrhythmia Device Infection Trial (PADIT)

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of the pilot study is to compare whether a centre-wide policy of incremental antibiotic therapy will reduce pacemaker infection compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This pilot study will provide feasibility information for a larger cluster randomized crossover design (CRCD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Bacitracin; Cefazolin; Cephalexin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Vancomycin

Criteria

Inclusion Criteria:

• > 18 years

• received one of the following procedures:

1. a second or subsequent procedure on the arrhythmia device pocket: i. ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement. ii. pocket or lead revision iii. system upgrade (insertion or attempted insertion of leads)

2. new cardiac resynchronization therapy device implant (pacemaker or ICD)

Exclusion Criteria:

• life expectancy < 12 months in the opinion of the local investigator.

• allergy or unable to tolerate cefazolin or clindamycin or vancomycin.

• allergy or unable to tolerate intracavitary bacitracin identified per-operatively.

• pre-operative identification that the patient has infection.