Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)

This study is currently recruiting participants.
Verified February 2013 by CAMC Health System
Sponsor:
Information provided by (Responsible Party):
Patrick Stone, MD, CAMC Health System
ClinicalTrials.gov Identifier:
NCT01612052
First received: September 1, 2011
Last updated: February 18, 2013
Last verified: February 2013

September 1, 2011
February 18, 2013
May 2011
March 2013   (final data collection date for primary outcome measure)
Difference between number of patients with MRSA infection between two groups [ Time Frame: post procedure at 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01612052 on ClinicalTrials.gov Archive Site
Difference between number of patients with post-op complications between two groups [ Time Frame: post procedure at 360 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Drug: Antibiotic Prophylaxis
Comparing the antibiotic treatment related to surgery
  • Active Comparator: Cefazolin plus Daptomycin
    Intervention: Drug: Antibiotic Prophylaxis
  • Active Comparator: Cefazolin plus Vancomycin
    Intervention: Drug: Antibiotic Prophylaxis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
October 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact: Patrick Stone, M.D. 304-388-8250 ext 9901
United States
 
NCT01612052
1997028
No
Patrick Stone, MD, CAMC Health System
CAMC Health System
Not Provided
Principal Investigator: Patrick Stone, M.D. CAMC Medical Staff-with admitting privileges
CAMC Health System
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP