Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

NCT00967941 | Completed Results

• 1 other identifier: 06-11-1879
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

MRSA Infections

Keywords

Vascular Surgery

Outcome Measures

Primary Outcomes (1)

• Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.

  30 days post-operative

Secondary Outcomes (1)

• Overall Groin Procedures in Patients With and Without Any Infection.

  30 days post-operative

Study Arms (3)

Ancef

Vancomycin and Cefazolin

Daptomycin and Cefazolin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Vascular Center of Excellence

Charleston, West Virginia, 25304, United States

Location

Limitations and Caveats

We did not have standardization of skin preparation. Additionally, we did not have a specific protocol for dressing use and time of dressing removal. We excluded high-risk patients for MRSA infection in our study.

Results Point of Contact

• Title: Patrick Stone, MD
• Organization: CAMC Health System

pstone0627@yahoo.com

304-388-8250

Study Officials

• Patrick Stone, M.D.

  CAMC Medical Staff-with admitting privileges

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patrick Stone, MD,

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: August 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2010
• Last Updated: February 28, 2020
• Results First Posted: February 28, 2020

Record last verified: 2020-02

Locations

US (1)