MRSA Infections
Conditions
Keywords
Vascular Surgery
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.
Interventions
None listed
Sponsors
CAMC Health System
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections. | 30 days post-operative |
Secondary
| Measure | Time frame |
|---|---|
| Overall Groin Procedures in Patients With and Without Any Infection. | 30 days post-operative |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPatrick Stone, M.D.
CAMC Medical Staff-with admitting privileges
Participant flow
Recruitment details
recruitment was done during the period August 2007 through June 2009 at vascular center.
Pre-assignment details
12 patients were excluded from study for being ineligible due to active infection, dialysis, allergy to penicillin,NO procedure, withdrew from surgery.
Participants by arm
| Arm | Count |
|---|---|
| Ancef Ancef (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery | 67 |
| Daptomycin and Cefazolin Daptomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery | 54 |
| Vancomycin and Cefazolin Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery | 60 |
| Total | 181 |
Baseline characteristics
| Characteristic | Ancef | Daptomycin and Cefazolin | Vancomycin and Cefazolin | Total |
|---|---|---|---|---|
| Age, Continuous | 64.37 years STANDARD_DEVIATION 11.78 | 66.78 years STANDARD_DEVIATION 11.81 | 64.36 years STANDARD_DEVIATION 11.12 | 65.17 years STANDARD_DEVIATION 11.57 |
| Sex: Female, Male Female | 26 Participants | 20 Participants | 20 Participants | 66 Participants |
| Sex: Female, Male Male | 41 Participants | 34 Participants | 40 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.
Time frame: 30 days post-operative
Population: Patients with MRSA infections.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ancef | Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections. | 2 participants |
| Daptomycin and Cefazolin | Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections. | 0 participants |
| Vancomycin and Cefazolin | Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections. | 4 participants |
Secondary
Overall Groin Procedures in Patients With and Without Any Infection.
Time frame: 30 days post-operative
Population: Patients with groin procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ancef | Overall Groin Procedures in Patients With and Without Any Infection. | 14 Participants |
| Daptomycin and Cefazolin | Overall Groin Procedures in Patients With and Without Any Infection. | 83 Participants |