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OpenTrials
Completed

NCT Number: NCT00967941

Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vascular Center of Excellence

Charleston, West Virginia, 25304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 30 days post-operative

Secondary outcomes

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

    Time frame: 30 days post-operative

Sponsors and collaborators

Lead sponsor

CAMC Health System

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Aug 28, 2009
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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