Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

University of Tennessee

Status: Terminated

Conditions: Infection; Closed Fractures

Treatments: Drug: Cefazolin; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02027532

09-060

Details and patient eligibility

About

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.

Enrollment: 430 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

Cefazolin

Active Comparator group

Description:

intravenous, weight-based dose (1gm\<80kg, 2gm\>80kg), perioperatively

Treatment:

Drug: Cefazolin

Vancomycin

Active Comparator group

Description:

intravenous, weight-based dose (1gm\<80kg, 2gm\>80kg), perioperatively

Treatment:

Drug: Vancomycin