drugset / Trial / NCT01612052

Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)

NCT01612052

Phase 4 Unknown 200 enrolled CAMC Health System
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2011-05
Primary completion
2013-03
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Daptomycin Other / unclassified
Comparator Vancomycin Other / unclassified
Comparator Cefazolin Small molecule