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Infections often occur after ventricular assist devices (VADs) are placed. These infections can be very serious. The goal of this study is to understand why these infections occur. Bacteria (germs) normally live on our skin and in our noses. After surgery, they can infect the VAD. The investigators will collect cultures of your skin and nose before and after surgery. The investigators will compare these bacteria to bacteria that cause infections. Their genes will be compared to see which ones help the bacteria cause infection.
Infections are one of the most serious of ventricular assist device (VAD) related complications. Many of these infections are associated with significant patient morbidity and mortality. Diagnosis of these infections is often difficult due to the complicated nature of the patient's medical problems, the need for rapid institution of empiric antibiotic therapy and the lack of established criteria that define infection. Staphylococci are among the most common causes of VAD infections. The basis for this high incidence is not well understood but is believed to be in part due to inoculation of staphylococcal commensal flora into wound sites at the time of surgery or thereafter. The goals of this observational study are to develop a better understanding of the pathogenesis and epidemiology of Staphylococcus aureus and epidermidis-VAD infections as well as to develop a set of criteria that can be used to help diagnose the presence or absence of a VAD related infection. This is a prospective, multi-center, observational study to identify risk factors associated with the development of VAD-related infections. Patients will be followed for up to one year following VAD implantation, time of death or transplantation, whichever comes first. There will be no randomization for this observational study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham
Birmingham, Alabama, United States
Sharp Memorial Hospital
San Diego, California, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Jewish Hospital
Louisville, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
LDS Hospital
Salt Lake City, Utah, United States
Start Date
January 1, 2006
Primary Completion Date
January 1, 2009
Completion Date
January 1, 2009
Last Updated
November 16, 2011
150
ACTUAL participants
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07101289