Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

N/ATerminatedNCT02027532

University of Tennessee430 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

430

Conditions

Infection Closed Fractures

Interventions

CefazolinDRUG

VancomycinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 (1)

Erlanger Health System

Chattanooga, Tennessee, United States

Outcomes

Primary Outcomes

incidence of infection

Time frame: one year

Data from ClinicalTrials.gov

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