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Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by University of Tennessee.
Recruitment status was:  Enrolling by invitation
Information provided by (Responsible Party):
University of Tennessee Identifier:
First received: January 2, 2014
Last updated: July 6, 2015
Last verified: March 2015

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
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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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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

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: July 6, 2015

Additional relevant MeSH terms:
Communicable Diseases
Fractures, Bone
Fractures, Closed
Wounds and Injuries
Anti-Bacterial Agents
Anti-Infective Agents processed this record on April 26, 2017