Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

CAMC Health System

Status: Completed

Conditions: MRSA Infections

Study type: Observational

Funder types: Other

Identifiers

NCT00967941

06-11-1879

Details and patient eligibility

About

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.

Full 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 methicillin-resistantStaphylococcus aureus (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.

Enrollment: 169 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

169 participants in 3 patient groups

Ancef

Vancomycin and Cefazolin

Daptomycin and Cefazolin