Overview

Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)

Status:
Unknown status
Trial end date:
2013-10-01
Target enrollment:
0
Participant gender:
All
Summary
The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive bacteria, and some gram-negative bacteria which may not be adequate antibiotic treatment at the time of vascular surgery and result in an increased hospital length of stay, increased cost of care, and an increased risk of morbidity and mortality as a consequence of surgical site infections. Thus, the investigators want to compare whether Methicillin-resistant Staphylococcus Aureaus (MRSA) antibiotic prophylaxis with Cefazolin plus Daptomycin is superior to Cefazolin plus Vancomycin in the reduction of surgical site infection (SSI) following open arterial revascularization procedures requiring a groin plus lower extremity incision. The investigators hypothesis is that Cefazolin plus Daptomycin is superior to Cefazolin plus Vancomycin in the prevention of SSI for high risk patients undergoing open groin plus lower extremity procedures.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
CAMC Health System
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Cefazolin
Daptomycin
Vancomycin
Criteria
Inclusion Criteria:

- Age greater than 18 years

- Any elective arterial revascularization procedure involving one or more groin plus
lower extremity incisions

- Further, patient's considered at high risk because of history of MRSA colonization or
infection, HIV, admission for >3 months in an acute care center or long-term care
center will be included in the study.

Exclusion Criteria:

- Patient with an allergy to Cefazolin, Daptomycin or Vancomycin.

- Patients allergic to Penicillin.

- Patients enrolled in another IRB approved biomedical study.

- Patients with active infection requiring antibiotics preoperatively.