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.

Study Overview

• Status: Unknown
• Conditions: MRSA - Methicillin Resistant Staphylococcus Aureus Infection
• Intervention / Treatment: Drug: Antibiotic Prophylaxis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Patrick Stone, M.D.; Phone Number: 9901 304-388-8250

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Recruiting
      • Vascular Center of Excellence
      • Contact: Patrick Stone, M.D.; Phone Number: 9901 304-388-8250
      • Sub-Investigator: Steven Hass, M.D.
      • Sub-Investigator: Albier Mousa, M.D.
      • Sub-Investigator: Ali F AbuRhama, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cefazolin plus Daptomycin	Drug: Antibiotic Prophylaxis; Comparing the antibiotic treatment related to surgery
Active Comparator: Cefazolin plus Vancomycin	Drug: Antibiotic Prophylaxis; Comparing the antibiotic treatment related to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between number of patients with MRSA infection between two groups	post procedure at 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference between number of patients with post-op complications between two groups	post procedure at 360 days

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Patrick Stone, M.D., CAMC Medical Staff-with admitting privileges

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: September 1, 2011
• First Submitted That Met QC Criteria: June 2, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 18, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Vascular Surgery
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 1997028