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Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Stone, MD, CAMC Health System
ClinicalTrials.gov Identifier:
NCT00967941
First received: August 27, 2009
Last updated: July 31, 2012
Last verified: August 2009

August 27, 2009
July 31, 2012
August 2007
June 2009   (final data collection date for primary outcome measure)
To examine the effectiveness of our current standard of prophylaxis with Ancef. [ Time Frame: 30 and 90 days post-operative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00967941 on ClinicalTrials.gov Archive Site
To compare the effectiveness of vancomycin and daptomycin plus cefazolin in reducing infections in vascular surgical patients. [ Time Frame: 30 and 90 days post-operative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis
Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
MRSA Infections
  • Drug: Ancef (Antibiotic Prophylaxis)
    Comparing the antibiotic treatment related to surgery
  • Drug: Vancomycin and Cefazolin (Antibiotic Prophylaxis)
    Comparing the antibiotic treatment related to surgery
  • Drug: Daptomycin and Cefazolin (Antibiotic Prophylaxis)
    Comparing the antibiotic treatment related to surgery
  • Active Comparator: Ancef
    Intervention: Drug: Ancef (Antibiotic Prophylaxis)
  • Active Comparator: Vancomycin and Cefazolin
    Intervention: Drug: Vancomycin and Cefazolin (Antibiotic Prophylaxis)
  • Active Comparator: Daptomycin and Cefazolin
    Intervention: Drug: Daptomycin and Cefazolin (Antibiotic Prophylaxis)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
August 2010
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00967941
06-11-1879
No
Patrick Stone, MD, CAMC Health System
CAMC Health System
Not Provided
Principal Investigator: Patrick Stone, M.D. CAMC Medical Staff-with admitting privileges
CAMC Health System
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP