Vascular Surgical Antibiotic Prophylaxis Study (VSAPS 2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by CAMC Health System
Sponsor:
Information provided by (Responsible Party):
Patrick Stone, MD, CAMC Health System
ClinicalTrials.gov Identifier:
NCT01612052
First received: September 1, 2011
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Drug: Antibiotic Prophylaxis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Double Blinded Prospective Randomized Controlled Trial Comparing Cefazolin Plus Vancomycin Versus Cefazolin Plus Daptomycin for Vascular Surgery Prophylaxis

Resource links provided by NLM:


Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • Difference between number of patients with MRSA infection between two groups [ Time Frame: post procedure at 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between number of patients with post-op complications between two groups [ Time Frame: post procedure at 360 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cefazolin plus Daptomycin Drug: Antibiotic Prophylaxis
Comparing the antibiotic treatment related to surgery
Active Comparator: Cefazolin plus Vancomycin Drug: Antibiotic Prophylaxis
Comparing the antibiotic treatment related to surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612052

Contacts
Contact: Patrick Stone, M.D. 304-388-8250 ext 9901

Locations
United States, West Virginia
Vascular Center of Excellence Recruiting
Charleston, West Virginia, United States, 25304
Contact: Patrick Stone, M.D.    304-388-8250 ext 9901      
Sub-Investigator: Steven Hass, M.D.         
Sub-Investigator: Albier Mousa, M.D.         
Sub-Investigator: Ali F AbuRhama, M.D.         
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: Patrick Stone, M.D. CAMC Medical Staff-with admitting privileges
  More Information

No publications provided

Responsible Party: Patrick Stone, MD, CAMC Medical Staff-with admitting privileges, CAMC Health System
ClinicalTrials.gov Identifier: NCT01612052     History of Changes
Other Study ID Numbers: 1997028
Study First Received: September 1, 2011
Last Updated: February 18, 2013
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
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on October 19, 2014