Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)
Primary Purpose
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Antibiotic Prophylaxis
Sponsored by
About this trial
This is an interventional prevention trial for MRSA - Methicillin Resistant Staphylococcus Aureus Infection focused on measuring Vascular Surgery
Eligibility Criteria
Inclusion Criteria:
- Age greater than 18 years
- Any elective arterial revascularization procedure involving one or more groin plus lower extremity incisions
- Further, patient's considered at high risk because of history of MRSA colonization or infection, HIV, admission for >3 months in an acute care center or long-term care center will be included in the study.
Exclusion Criteria:
- Patient with an allergy to Cefazolin, Daptomycin or Vancomycin.
- Patients allergic to Penicillin.
- Patients enrolled in another IRB approved biomedical study.
- Patients with active infection requiring antibiotics preoperatively.
Sites / Locations
- Vascular Center of ExcellenceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cefazolin plus Daptomycin
Cefazolin plus Vancomycin
Arm Description
Outcomes
Primary Outcome Measures
Difference between number of patients with MRSA infection between two groups
Secondary Outcome Measures
Difference between number of patients with post-op complications between two groups
Full Information
NCT ID
NCT01612052
First Posted
September 1, 2011
Last Updated
February 18, 2013
Sponsor
CAMC Health System
1. Study Identification
Unique Protocol Identification Number
NCT01612052
Brief Title
Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)
Official Title
Double Blinded Prospective Randomized Controlled Trial Comparing Cefazolin Plus Vancomycin Versus Cefazolin Plus Daptomycin for Vascular Surgery Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CAMC Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive bacteria, and some gram-negative bacteria which may not be adequate antibiotic treatment at the time of vascular surgery and result in an increased hospital length of stay, increased cost of care, and an increased risk of morbidity and mortality as a consequence of surgical site infections. Thus, the investigators want to compare whether Methicillin-resistant Staphylococcus Aureaus (MRSA) antibiotic prophylaxis with Cefazolin plus Daptomycin is superior to Cefazolin plus Vancomycin in the reduction of surgical site infection (SSI) following open arterial revascularization procedures requiring a groin plus lower extremity incision. The investigators hypothesis is that Cefazolin plus Daptomycin is superior to Cefazolin plus Vancomycin in the prevention of SSI for high risk patients undergoing open groin plus lower extremity procedures.
Detailed Description
There is an increase in surgical site infection (SSI) due to MRSA. The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive bacteria, and some gram-negative bacteria. 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, the investigators are initiating a second study of patients undergoing groin plus lower extremity procedures by using combination antibiotics such as Cefazolin plus Daptomycin, Cefazolin plus Vancomycin. By decreasing post surgical site and prosthetic infections, the investigators could significantly reduce vascular surgery mortality and morbidity. Cost and amputation rates the investigators feel could also be reduced. Patients will be randomized in two groups -- Cefazolin plus Daptomycin, Cefazolin plus Vancomycin and will be evaluated during post procedure before discharge or within 30 days and between 30 and 360 days, for postoperative complications including cellulitis, graft infection, sepsis, limb loss, graft failure, and length of stay. If a patient is re-hospitalized, reason for the return and whether it is related to the procedure will be evaluated. Additionally, is there a graft failure, amputation, infection, hematoma, pseudoanurysm will be assessed. In case of a wound infection, the type of organism and finally, length of this hospitalization will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Keywords
Vascular Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cefazolin plus Daptomycin
Arm Type
Active Comparator
Arm Title
Cefazolin plus Vancomycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Antibiotic Prophylaxis
Intervention Description
Comparing the antibiotic treatment related to surgery
Primary Outcome Measure Information:
Title
Difference between number of patients with MRSA infection between two groups
Time Frame
post procedure at 30 days
Secondary Outcome Measure Information:
Title
Difference between number of patients with post-op complications between two groups
Time Frame
post procedure at 360 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age greater than 18 years
Any elective arterial revascularization procedure involving one or more groin plus lower extremity incisions
Further, patient's considered at high risk because of history of MRSA colonization or infection, HIV, admission for >3 months in an acute care center or long-term care center will be included in the study.
Exclusion Criteria:
Patient with an allergy to Cefazolin, Daptomycin or Vancomycin.
Patients allergic to Penicillin.
Patients enrolled in another IRB approved biomedical study.
Patients with active infection requiring antibiotics preoperatively.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Stone, M.D.
Phone
304-388-8250
Ext
9901
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Stone, M.D.
Organizational Affiliation
CAMC Medical Staff-with admitting privileges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular Center of Excellence
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Stone, M.D.
Phone
304-388-8250
Ext
9901
First Name & Middle Initial & Last Name & Degree
Steven Hass, M.D.
First Name & Middle Initial & Last Name & Degree
Albier Mousa, M.D.
First Name & Middle Initial & Last Name & Degree
Ali F AbuRhama, M.D.
12. IPD Sharing Statement
Learn more about this trial
Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)
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