Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

February 16, 2020 updated by: Patrick Stone, MD, CAMC Health System
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Vascular Center of Excellence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients 18 years of age and older undergoing a vascular surgery and or vascular access (vascular fistula or vascular graft) procedure were eligible for enrollment in the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ancef
Vancomycin and Cefazolin
Daptomycin and Cefazolin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.
Time Frame: 30 days post-operative
30 days post-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Groin Procedures in Patients With and Without Any Infection.
Time Frame: 30 days post-operative
30 days post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CAMC Health System

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 27, 2009

First Submitted That Met QC Criteria

August 27, 2009

First Posted (Estimate)

August 28, 2009

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 16, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06-11-1879

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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