Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

MRSA Infections Clinical Trial

Official title:

Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967941
• Other study ID #: 06-11-1879
• Status: Completed
• Start date: August 2007
• Est. completion date: August 2010

Study information

• Verified date: February 2020
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: August 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• MRSA Infections

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	Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.		30 days post-operative
Secondary	Overall Groin Procedures in Patients With and Without Any Infection.		30 days post-operative