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Arrhythmia | Prevention of Arrhythmia Device Infection Trial (PADIT)

Arrhythmia research study

What is the primary objective of this study?

The goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce CIED infection rate compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics used are approved for use and readily available.

Who is eligible to participate?

Inclusion Criteria: 1. Age >= 18 years 2. Received one of the following procedures: 1. A second or subsequent procedure on the arrhythmia device pocket: ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement 2. Pocket or lead revision 3. System upgrade (insertion or attempted insertion of leads) 4. New cardiac resynchronization therapy device implant (pacemaker or ICD) 3. Patient is not known to have device infection at the time of the surgery

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Arrhythmia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:IncrementalSingle dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.

Drug:ConventionalCefazolin preoperative

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ConventionalPreoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.

IncrementalPreoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.

Study Status

Active, not recruiting

Start Date: December 2012

Completed Date: January 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Hospitalization attributed to device infection

Secondary Outcome: 1. Proven device infection not requiring surgical intervention (medically treated device infection).

Study sponsors, principal investigator, and references

Principal Investigator: Andrew Krahn, MD

Lead Sponsor: Population Health Research Institute

Collaborator: Canadian Institutes of Health Research (CIHR)

More information:https://clinicaltrials.gov/show/NCT01628666

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