ClinicalTrials.gg
TerminatedNCT02027532Updated Jul 11, 2018

Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

An interventional study of Cefazolin and Vancomycin in Infection and Closed Fractures, sponsored by University of Tennessee. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-07-11.

Sponsored by University of Tennessee · Not applicable, Interventional, and Prevention

Why this study was terminated
Could not complete study due to administrative challenges
Phase
Not applicable
Study type
Interventional
Enrollment
430
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Infection
  • Closed Fractures
03

In context

Infections

2,093 studies on the registry are indexed under Infections; 364 are open to participants now.

This study's enrollment of 430 is above the median of 113 across 1,304 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University of Tennessee is the lead sponsor of 142 studies on the registry; 21 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
430 participants (actual)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. incidence of infection

    Time frame: one year

07

Study locations

1 site
  • Erlanger Health System
    Chattanooga, Tennessee 37403, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Jun 2015 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2014
First posted
Jan 6, 2014
Start
Oct 2009
Primary completionActual
Jun 2015
CompletionActual
Dec 2017
Last update
Jul 11, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02027532
Responsible party
Sponsor
First posted
Jan 6, 2014
Start date
Oct 2009
Primary completion
Jun 2015
Completion
Dec 2017
Last update
Jul 11, 2018

Study contacts

Peter J Nowotarski, M.D.
principal investigator · UTCOM Chattanooga/Erlanger Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Cefazolin · Vancomycin

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