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Prevention of Infection in Surgical Treatment of Closed Fractures: Comparative of Cefazolin vs Vancomycin

This study is currently recruiting participants.
Verified June 2011 by University of Tennessee
Sponsor:
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01029457
First received: December 9, 2009
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

With the growing incidence of MRSA in the hospital and community setting it would be hypothesized that Vancomycin would decrease the risk of infection in patients requiring surgical treatment of closed fracture as compared to Cefazolin.


Condition
Closed Fractures

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by University of Tennessee:

Estimated Enrollment: 600
Study Start Date: February 2010
Estimated Study Completion Date: February 2013
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

male and female patients ages 18-85 years old treated with closed fractures requiring surgical intervention

Criteria

Inclusion Criteria:

Over 18 years of age or less than 85 years of age Ability to understand and agree to informed consent Qualifying fracture requiring surgical intervention on one day.

Exclusion Criteria:

under 18 years of age or older than 85 years of age Unable to understand and agree to informed consent Documented allergy to Cefazolin or Vancomycin Use of antibiotics within 2 weeks before or after injury Previous of MRSA infection Fractures requiring multiple operations on various days Previous surgery on the injured extremity within 1 year

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029457

Contacts
Contact: Jeremy Bruce, M.D. 423-778-9202 bruce_jeremy@hotmail.com
Contact: Elaine Pugh 423-778-5663 elaine.pugh@erlanger.org

Locations
United States, Tennessee
Erlanger Medical Center Recruiting
Chattanooga,, Tennessee, United States, 37403
Contact: Joseph N Rudd, PhD     423-778-6072     joe.rudd@erlanger.org    
Principal Investigator: Peter J Nowotarski, M.D            
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Peter J Nowotarski, MD University of Tennessee
  More Information

No publications provided

Responsible Party: Elaine Pugh Research Assistant, UTennessee
ClinicalTrials.gov Identifier: NCT01029457     History of Changes
Other Study ID Numbers: 1
Study First Received: December 9, 2009
Last Updated: June 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Infection closed fractures

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Closed
Wounds and Injuries
Cefazolin
Vancomycin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013