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
  Purpose

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.


Condition Intervention Phase
MRSA Infections
Drug: Ancef (Antibiotic Prophylaxis)
Drug: Vancomycin and Cefazolin (Antibiotic Prophylaxis)
Drug: Daptomycin and Cefazolin (Antibiotic Prophylaxis)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

Resource links provided by NLM:


Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 201
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ancef Drug: Ancef (Antibiotic Prophylaxis)
Comparing the antibiotic treatment related to surgery
Active Comparator: Vancomycin and Cefazolin Drug: Vancomycin and Cefazolin (Antibiotic Prophylaxis)
Comparing the antibiotic treatment related to surgery
Active Comparator: Daptomycin and Cefazolin Drug: Daptomycin and Cefazolin (Antibiotic Prophylaxis)
Comparing the antibiotic treatment related to surgery

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967941

Locations
United States, West Virginia
Vascular Center of Excellence
Charleston, West Virginia, United States, 25304
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: Patrick Stone, M.D. CAMC Medical Staff-with admitting privileges
  More Information

No publications provided

Responsible Party: Patrick Stone, MD, Patrick Stone, MD,, CAMC Health System
ClinicalTrials.gov Identifier: NCT00967941     History of Changes
Other Study ID Numbers: 06-11-1879
Study First Received: August 27, 2009
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
Vascular Surgery

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Cefazolin
Vancomycin
Daptomycin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 28, 2014