Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis
Information source: CAMC Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: MRSA Infections
Intervention: Ancef (Antibiotic Prophylaxis) (Drug); Vancomycin and Cefazolin (Antibiotic Prophylaxis) (Drug); Daptomycin and Cefazolin (Antibiotic Prophylaxis) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: CAMC Health System Official(s) and/or principal investigator(s):
Patrick Stone, M.D., Principal Investigator, Affiliation: CAMC Medical Staff-with admitting privileges
Summary
This study prospectively selects the patients to examine the effectiveness of the
investigators' current standard of prophylaxis prior to vascular surgery and to compare the
effectiveness of vancomycin and daptomycin plus cefazolin in reducing infections in vascular
surgical patients.
Clinical Details
Official title: Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: To examine the effectiveness of our current standard of prophylaxis with Ancef.
Secondary outcome: To compare the effectiveness of vancomycin and daptomycin plus cefazolin in reducing infections in vascular surgical patients.
Detailed description:
According to Medqic. org (site for the Surgical Care Improvement Project) the current
recommended drug of choice for prophylaxis prior to vascular surgery is Cefazolin (Ancef).
The exception would be to allow the use of Vancomycin as an acceptable antibiotic for
patients undergoing cardiac, vascular or orthopedic surgery due to the increasing risk of
MRSA. The significance of the study is to demonstrate that MRSA coverage is needed in
vascular surgery with prosthetic graft placement in areas of the body that is at high risk
for infection. By decreasing post surgical site and prosthetic infections, we could
significantly reduce vascular surgery mortality and morbidity. Cost and amputation rates we
feel could also be reduced. patients will be randomized in three groups such as
cefazolin,vancomycin and cefazolin, daptomycin and cefazolin and then patients will be
monitored per usual post-operative course (30 days and 90 days follow-up) with wound and
incision evaluation. Outcome measures include hospital length of stay, the presence of a
graft infection, skin infection at incision site, vascular procedure failure secondary to
infection, cost, thirty day readmits, amputation, and mortality.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients greater than 18 years of age undergoing vascular surgery including carotid
procedures and a vascular access procedure (Fistula or Graft).
Exclusion Criteria:
- Patients with an allergy to daptomycin or vancomycin.
- Patients with chronic wounds.
- Prior colonization of MRSA.
- Increased MRSA rate facility wide.
- Continuous inpatient stay >27 hrs prior to surgical procedure.
- Patients with active infection requiring antibiotics preoperatively.
- Patients with a history of MRSA colonization or infection, HIV, admission for >3
months in an acute care center or long-term care center, penicillin allergy or
penicillin allergy and on dialysis.
- Dialysis patients.
Locations and Contacts
Vascular Center of Excellence, Charleston, West Virginia 25304, United States
Additional Information
Starting date: August 2007
Last updated: July 31, 2012
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