Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
MRSA Infections |
Drug: Ancef (Antibiotic Prophylaxis) Drug: Vancomycin and Cefazolin (Antibiotic Prophylaxis) Drug: Daptomycin and Cefazolin (Antibiotic Prophylaxis) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis |
- To examine the effectiveness of our current standard of prophylaxis with Ancef. [ Time Frame: 30 and 90 days post-operative ] [ Designated as safety issue: No ]
- To compare the effectiveness of vancomycin and daptomycin plus cefazolin in reducing infections in vascular surgical patients. [ Time Frame: 30 and 90 days post-operative ] [ Designated as safety issue: No ]
| Enrollment: | 201 |
| Study Start Date: | August 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Ancef |
Drug: Ancef (Antibiotic Prophylaxis)
Comparing the antibiotic treatment related to surgery
|
| Active Comparator: Vancomycin and Cefazolin |
Drug: Vancomycin and Cefazolin (Antibiotic Prophylaxis)
Comparing the antibiotic treatment related to surgery
|
| Active Comparator: Daptomycin and Cefazolin |
Drug: Daptomycin and Cefazolin (Antibiotic Prophylaxis)
Comparing the antibiotic treatment related to surgery
|
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 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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| United States, West Virginia | |
| Vascular Center of Excellence | |
| Charleston, West Virginia, United States, 25304 | |
| Principal Investigator: | Patrick Stone, M.D. | CAMC Medical Staff-with admitting privileges |
More Information
No publications provided
| Responsible Party: | Patrick Stone, MD, Patrick Stone, MD,, CAMC Health System |
| ClinicalTrials.gov Identifier: | NCT00967941 History of Changes |
| Other Study ID Numbers: | 06-11-1879 |
| Study First Received: | August 27, 2009 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by CAMC Health System:
|
Vascular Surgery |
Additional relevant MeSH terms:
|
Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Anti-Bacterial Agents Cefazolin |
Vancomycin Daptomycin Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013