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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancef | |||
| Vancomycin and Cefazolin | |||
| Daptomycin and Cefazolin |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections. | 30 days post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Groin Procedures in Patients With and Without Any Infection. | 30 days post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Stone, M.D. | CAMC Medical Staff-with admitting privileges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Center of Excellence | Charleston | West Virginia | 25304 | United States |
12 patients were excluded from study for being ineligible due to active infection, dialysis, allergy to penicillin,NO procedure, withdrew from surgery.
recruitment was done during the period August 2007 through June 2009 at vascular center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ancef | Ancef (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery |
| FG001 | Daptomycin and Cefazolin | Daptomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery |
| FG002 | Vancomycin and Cefazolin | Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ancef | Ancef (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery |
| BG001 | Daptomycin and Cefazolin | Daptomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections. | Patients with MRSA infections. | Posted | Number | participants | 30 days post-operative |
|
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Adverse Events were not collected and assessed as a part of this protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | The adverse event was counted for all patients instead of groups. Ideally no unexpected adverse events. All were known risks in vascular procedures. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Stone, MD | CAMC Health System | 304-388-8250 | 9901 | pstone0627@yahoo.com |
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| BG002 | Vancomycin and Cefazolin | Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
|
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| Secondary | Overall Groin Procedures in Patients With and Without Any Infection. | Patients with groin procedures. | Posted | Number | Participants | 30 days post-operative |
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| 0 |
| 0 |
| 0 |
| 0 |
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