Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infection Closed Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cefazolin

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

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

Vancomycin

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

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Interventions

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Cefazolin

Intervention Type DRUG

Vancomycin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No