We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
ClinicalTrials.gov Identifier:
NCT02027532
First Posted: January 6, 2014
Last Update Posted: July 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Tennessee
January 2, 2014
January 6, 2014
July 8, 2015
October 2009
December 2015   (Final data collection date for primary outcome measure)
incidence of infection [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT02027532 on ClinicalTrials.gov Archive Site
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02027532
09-060
No
Not Provided
Not Provided
University of Tennessee
University of Tennessee
Not Provided
Principal Investigator: Peter J Nowotarski, M.D. UTCOM Chattanooga/Erlanger Health System
University of Tennessee
March 2015

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