Clinical trial NCT01612052: Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)
Official title: Double Blinded Prospective Randomized Controlled Trial Comparing Cefazolin Plus Vancomycin Versus Cefazolin Plus Daptomycin for Vascular Surgery Prophylaxis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Keywords: Vascular Surgery
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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.

Primary outcomes:
measure: Difference between number of patients with MRSA infection between two groups
timeFrame: post procedure at 30 days
Secondary outcomes:
measure: Difference between number of patients with post-op complications between two groups
timeFrame: post procedure at 360 days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Vascular Center of Excellence
state: West Virginia
Study officials:
affiliation: CAMC Medical Staff-with admitting privileges
name: Patrick Stone, M.D.
role: PRINCIPAL_INVESTIGATOR
References: