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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

Page last updated: August 20, 2015

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