Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)
Information source: CAMC Health System
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Intervention: Antibiotic Prophylaxis (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: CAMC Health System Official(s) and/or principal investigator(s): Patrick Stone, M.D., Principal Investigator, Affiliation: CAMC Medical Staff-with admitting privileges
Overall contact: Patrick Stone, M.D., Phone: 304-388-8250, Ext: 9901
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.
Clinical Details
Official title: Double Blinded Prospective Randomized Controlled Trial Comparing Cefazolin Plus Vancomycin Versus Cefazolin Plus Daptomycin for Vascular Surgery Prophylaxis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Difference between number of patients with MRSA infection between two groups
Secondary outcome: Difference between number of patients with post-op complications between two groups
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Patrick Stone, M.D., Phone: 304-388-8250, Ext: 9901
Vascular Center of Excellence, Charleston, West Virginia 25304, United States; Recruiting Patrick Stone, M.D., Phone: 304-388-8250, Ext: 9901 Steven Hass, M.D., Sub-Investigator Albier Mousa, M.D., Sub-Investigator Ali F AbuRhama, M.D., Sub-Investigator
Additional Information
Starting date: May 2011
Last updated: February 18, 2013
|