Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

July 9, 2018 updated by: University of Tennessee

Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cefazolin
intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
Drug: Cefazolin
Active Comparator: Vancomycin
intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
Drug: Vancomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of infection
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Investigators

  • Principal Investigator: Peter J Nowotarski, M.D., UTCOM Chattanooga/Erlanger Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 2, 2014

First Posted (Estimate)

January 6, 2014

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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