Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT02027532
First received: January 2, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

January 2, 2014
January 2, 2014
October 2009
December 2015   (final data collection date for primary outcome measure)
incidence of infection [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin
Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Infection
  • Closed Fractures
  • Drug: Cefazolin
  • Drug: Vancomycin
  • Active Comparator: Cefazolin
    intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
    Intervention: Drug: Cefazolin
  • Active Comparator: Vancomycin
    intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
    Intervention: Drug: Vancomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
600
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02027532
09-060
No
University of Tennessee
University of Tennessee
Not Provided
Principal Investigator: Peter J Nowotarski, M.D. UTCOM Chattanooga/Erlanger Health System
University of Tennessee
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP