Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

Not Applicable

Terminated

• Conditions: Infection; Closed Fractures
• Interventions: Drug: Vancomycin; Drug: Cefazolin

• Registration Number: NCT02027532
• Lead Sponsor: University of Tennessee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-06
• Primary Completion: 2015-06
• Status Verified: 2017-05
• Study Completion: 2017-12
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 430

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin	Vancomycin	intravenous, weight-based dose (1gm\<80kg, 2gm\>80kg), perioperatively
Cefazolin	Cefazolin	intravenous, weight-based dose (1gm\<80kg, 2gm\>80kg), perioperatively

Primary Outcome Measures

Name	Time	Method
incidence of infection	one year

Trial Locations

Locations (1)

Erlanger Health System; 🇺🇸 Chattanooga, Tennessee, United States