Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)

MRSA - Methicillin Resistant Staphylococcus Aureus Infection Clinical Trial

Official title:

Double Blinded Prospective Randomized Controlled Trial Comparing Cefazolin Plus Vancomycin Versus Cefazolin Plus Daptomycin for Vascular Surgery Prophylaxis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01612052
• Other study ID #: 1997028
• Status: Recruiting
• Phase: Phase 4
• First received: September 1, 2011
• Last updated: February 18, 2013
• Start date: May 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2013
• Source: CAMC Health System
• Contact: Patrick Stone, M.D.
• Phone: 304-388-8250
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• MRSA - Methicillin Resistant Staphylococcus Aureus Infection
• Staphylococcal Infections

Intervention

Drug:
• Antibiotic Prophylaxis
Comparing the antibiotic treatment related to surgery

Locations

Country	Name	City	State
United States	Vascular Center of Excellence	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between number of patients with MRSA infection between two groups		post procedure at 30 days	No
Secondary	Difference between number of patients with post-op complications between two groups		post procedure at 360 days	No