Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
University of Tennessee Identifier:
First received: January 2, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

The purpose of this study is to compare the incidence rate of infection in surgical patients with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the peri-operative period.

The hypothesis of this study is that patients undergoing surgical treatment for closed fractures who are treated prophylactically with Vancomycin will have a lower incidence rate of infection than patients who are treated prophylactically with Cefazolin.

Condition Intervention
Closed Fractures
Drug: Cefazolin
Drug: Vancomycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin

Resource links provided by NLM:

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • incidence of infection [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2009
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cefazolin
intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
Drug: Cefazolin
Active Comparator: Vancomycin
intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
Drug: Vancomycin


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Between 18 years old and 85 years old
  • Closed fracture
  • Fracture treatment plan is for one operation on one day (one surgical setting)
  • Likely to follow-up with surgeon until fracture is healed
  • Ability to understand and agree to Informed Consent

Exclusion Criteria:

  • Under 18 years old or over 85 years old
  • Open fracture(s)
  • Fracture requires multiple operations
  • Other injuries requiring operations
  • Documented allergy to Cefazolin or Vancomycin
  • Previous history of Methicillin-resistant Staphylococcus aureus infection
  • Previous surgery on the injured extremity within 1 year
  • Use of antibiotics within 2 weeks before or after injury
  • Use of antibiotics within 2 weeks before surgery
  • Unlikely to follow-up until fracture is healed
  • Unable to understand and agree to Informed Consent
  Contacts and Locations
Please refer to this study by its identifier: NCT02027532

United States, Tennessee
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University of Tennessee
Principal Investigator: Peter J Nowotarski, M.D. UTCOM Chattanooga/Erlanger Health System
  More Information

No publications provided

Responsible Party: University of Tennessee Identifier: NCT02027532     History of Changes
Obsolete Identifiers: NCT01029457
Other Study ID Numbers: 09-060
Study First Received: January 2, 2014
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Closed
Wounds and Injuries
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 15, 2014