Recruiting

Observational Study

Sponsor:

CAMC Health System

Code:

NCT01612052

Conditions

MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Antibiotic Prophylaxis

Study Details

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.

Conditions

MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Study ID

NCT01612052

Start date

May, 2011

Status verified date

Feb, 2013

Completion date

Oct, 2013

Anticipated

Primary completion date

Mar, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Cefazolin plus Daptomycin

active comparator: Cefazolin plus Vancomycin

Interventions

Antibiotic Prophylaxis

Comparing the antibiotic treatment related to surgery

Primary outcome measure

  • Difference between number of patients with MRSA infection between two groups [ Time Frame: post procedure at 30 days ]

Central Contacts and Locations

Central contacts

Patrick Stone, M.D.

304-388-8250

Locations

Vascular Center of Excellence

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Patrick Stone, M.D.

304-388-8250

More Information

Sponsor

CAMC Health System

Last update posted

Feb 20, 2013

Last verified

Feb, 2013

Keywords

  • Vascular Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CAMC Health System on 2013-02-20.