Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

NCT ID: NCT00967941

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 169 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-08-31

Brief Summary

This study prospectively selects the patients to examine the effectiveness of the investigators' current standard of prophylaxis prior to vascular surgery and to compare the effectiveness of vancomycin and daptomycin plus cefazolin in reducing infections in vascular surgical patients.

Detailed Description

According to Medqic.org (site for the Surgical Care Improvement Project) the current recommended drug of choice for prophylaxis prior to vascular surgery is Cefazolin (Ancef). The exception would be to allow the use of Vancomycin as an acceptable antibiotic for patients undergoing cardiac, vascular or orthopedic surgery due to the increasing risk of methicillin-resistantStaphylococcus aureus (MRSA). The significance of the study is 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. By decreasing post surgical site and prosthetic infections, we could significantly reduce vascular surgery mortality and morbidity. Cost and amputation rates we feel could also be reduced. patients will be randomized in three groups such as cefazolin,vancomycin and cefazolin, daptomycin and cefazolin and then patients will be monitored per usual post-operative course (30 days and 90 days follow-up) with wound and incision evaluation. Outcome measures include hospital length of stay, the presence of a graft infection, skin infection at incision site, vascular procedure failure secondary to infection, cost, thirty day readmits, amputation, and mortality.

Conditions

MRSA Infections

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Ancef

No interventions assigned to this group

Vancomycin and Cefazolin

No interventions assigned to this group

Daptomycin and Cefazolin

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients greater than 18 years of age undergoing vascular surgery including carotid procedures and a vascular access procedure (Fistula or Graft).

Exclusion Criteria

• Patients with an allergy to daptomycin or vancomycin.
• Patients with chronic wounds.
• Prior colonization of MRSA.
• Increased MRSA rate facility wide.
• Continuous inpatient stay >27 hrs prior to surgical procedure.
• Patients with active infection requiring antibiotics preoperatively.
• Patients with a history of MRSA colonization or infection, HIV, admission for >3 months in an acute care center or long-term care center, penicillin allergy or penicillin allergy and on dialysis.
• Dialysis patients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

Patrick Stone, MD

Patrick Stone, MD,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Stone, M.D.

Role: PRINCIPAL_INVESTIGATOR

CAMC Medical Staff-with admitting privileges

Locations

Vascular Center of Excellence

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

06-11-1879

Identifier Type: -

Identifier Source: org_study_id