Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)
Status unconfirmed · Phase 4
Conditions studied: MRSA - Methicillin Resistant Staphylococcus Aureus Infection
In brief
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.
Key facts
- Study ID
- NCT01612052
- Run by
- CAMC Health System
- People needed
- 200
- Starts
- 2011-05-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2013-02-20
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Vascular Center of Excellence — Charleston, West Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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