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Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

Primary Purpose

Infection, Closed Fractures

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cefazolin
Vancomycin
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Erlanger Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cefazolin

Vancomycin

Arm Description

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

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

Outcomes

Primary Outcome Measures

incidence of infection

Secondary Outcome Measures

Full Information

First Posted
January 2, 2014
Last Updated
July 9, 2018
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT02027532
Brief Title
Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin
Official Title
Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Could not complete study due to administrative challenges
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Closed Fractures

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cefazolin
Arm Type
Active Comparator
Arm Description
intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Description
intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Primary Outcome Measure Information:
Title
incidence of infection
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Nowotarski, M.D.
Organizational Affiliation
UTCOM Chattanooga/Erlanger Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States

12. IPD Sharing Statement

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Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

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