Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown
rapidly over the past two decades. CIED infections, defined as infections involving the
generator implant site (pocket) and/or intravascular leads, have become increasingly
prevalent, with the rate of growth in infections outpacing that of CIED procedures. The odds
of both short term and long term mortality are at least doubled in patients who suffer CIED
infections, and long term survival is particularly poor in women. Optimal strategies to
prevent CIED infections in high-risk patients are largely unproven. However, recent
observational studies of an antibiotic-coated envelope implanted at the time of CIED
procedure have shown that this strategy is associated with a low incidence of CIED
infections. Other interventions to prevent CIED infections, including the use of antibiotic
irrigant used to wash the pocket during implantation and postoperative oral antibiotics, are
commonly used but not supported by rigorous controlled studies. The Specific Aim of this
study is to test the hypothesis that the use of the antibacterial envelope alone is
noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial
irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device
infections in patients with ≥2 risk factors for infection.
Phase:
Phase 3
Details
Lead Sponsor:
Vanderbilt University Vanderbilt University Medical Center
Collaborators:
Medtronic The Cooper Health System Thomas Jefferson University Valley Health System