Clinical trial NCT00967941: Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis
Official title: Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MRSA Infections
Keywords: Vascular Surgery
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2009-08-28
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.
timeFrame: 30 days post-operative
Secondary outcomes:
measure: Overall Groin Procedures in Patients With and Without Any Infection.
timeFrame: 30 days post-operative
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Vascular Center of Excellence
state: West Virginia
Study officials:
affiliation: CAMC Medical Staff-with admitting privileges
name: Patrick Stone, M.D.
role: PRINCIPAL_INVESTIGATOR
References: