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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02027532
Enrollment
430
Registered
2014-01-06
Start date
2009-10-31
Completion date
2017-12-31
Last updated
2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closed Fractures, Infection

Brief 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.

Interventions

DRUGCefazolin
DRUGVancomycin

Sponsors

University of Tennessee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frame
incidence of infectionone year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026