Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin
Information source: University of Tennessee
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection; Closed Fractures
Intervention: Cefazolin (Drug); Vancomycin (Drug)
Phase: N/A
Status: Enrolling by invitation
Sponsored by: University of Tennessee Official(s) and/or principal investigator(s):
Peter J Nowotarski, M.D., Principal Investigator, Affiliation: UTCOM Chattanooga/Erlanger Health System
Summary
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.
Clinical Details
Official title: Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: incidence of infection
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Erlanger Health System, Chattanooga, Tennessee 37403, United States
Additional Information
Starting date: October 2009
Last updated: July 6, 2015
|
