Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | May 2011 |
| End Date: | October 2013 |
| Contact: | Patrick Stone, M.D. |
| Phone: | 304-388-8250 |
Double Blinded Prospective Randomized Controlled Trial Comparing Cefazolin Plus Vancomycin Versus Cefazolin Plus Daptomycin for Vascular Surgery Prophylaxis
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.
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.
There is an increase in surgical site infection (SSI) due to MRSA. 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. 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, the
investigators are initiating a second study of patients undergoing groin plus lower
extremity procedures by using combination antibiotics such as Cefazolin plus Daptomycin,
Cefazolin plus Vancomycin. By decreasing post surgical site and prosthetic infections, the
investigators could significantly reduce vascular surgery mortality and morbidity. Cost and
amputation rates the investigators feel could also be reduced. Patients will be randomized
in two groups -- Cefazolin plus Daptomycin, Cefazolin plus Vancomycin and will be evaluated
during post procedure before discharge or within 30 days and between 30 and 360 days, for
postoperative complications including cellulitis, graft infection, sepsis, limb loss, graft
failure, and length of stay. If a patient is re-hospitalized, reason for the return and
whether it is related to the procedure will be evaluated. Additionally, is there a graft
failure, amputation, infection, hematoma, pseudoanurysm will be assessed. In case of a wound
infection, the type of organism and finally, length of this hospitalization will be
recorded.
antibiotic, Cefazolin, treatment for vascular surgery, provides coverage only for
Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive bacteria, and some
gram-negative bacteria. 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, the
investigators are initiating a second study of patients undergoing groin plus lower
extremity procedures by using combination antibiotics such as Cefazolin plus Daptomycin,
Cefazolin plus Vancomycin. By decreasing post surgical site and prosthetic infections, the
investigators could significantly reduce vascular surgery mortality and morbidity. Cost and
amputation rates the investigators feel could also be reduced. Patients will be randomized
in two groups -- Cefazolin plus Daptomycin, Cefazolin plus Vancomycin and will be evaluated
during post procedure before discharge or within 30 days and between 30 and 360 days, for
postoperative complications including cellulitis, graft infection, sepsis, limb loss, graft
failure, and length of stay. If a patient is re-hospitalized, reason for the return and
whether it is related to the procedure will be evaluated. Additionally, is there a graft
failure, amputation, infection, hematoma, pseudoanurysm will be assessed. In case of a wound
infection, the type of organism and finally, length of this hospitalization will be
recorded.
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.
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