The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

November 8, 2012 updated by: University of Arkansas

The purpose of the research is to perform a quality assurance evaluation using randomized prospective analysis the rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.

The investigators goal is to show the use of prophylactic antibiotics in orbital blowout fractures does not significantly decrease the rate of orbital cellulitis and is thus not indicated.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Orbital fractures are a common occurrence in association with a wide variety of blunt trauma injuries to the face. One type of fracture is that involving the orbital floor, or an isolated blowout fracture. One common current practice is to use prophylactic antibiotics in these cases to prevent the theoretical occurrence of an orbital cellulitis originating from sinus flora, though there is no current standard of care regarding this practice. Many surgeons may elect to not use antibiotics for this very reason.

The use of prophylactic antibiotics in isolated blowout fractures where there is no occlusion of the ostium is not defined, and no prospective controlled study has been undertaken to suggest the most appropriate course of action to take. Our goal in this study is to determine a correct course of action for these patients.

Study Type

Interventional

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
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

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

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Isolated orbital blow out fracture in patients between the ages 5 to 99 years old

Exclusion Criteria:

  • Involvement of the orbital rim in the floor fracture requiring the use of antibiotics
  • Involvement of the orbital rim in the floor fracture
  • Radiographic evidence of occlusion of the maxillary sinus ostium
  • Determined need for surgical intervention or prior use of synthetic implanted material in or around the involved maxillary sinus
  • Any symptoms of sinonasal disease in the preceding 3 month for any reason
  • Any use of oral or IV antibiotics in the preceding 3 month for any reason
  • Documented allergy to penicillin or amoxicillin prohibiting its use
  • Any currently immunosuppressed state, including actively treated autoimmune disease; use of steroids, immunomodulatory medication, or chemotherapy within the last year; diagnosis of active cancer within the last year

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
Other: Prophylactic Antibotics
Amoxicillin/clavulanic acid
Other: Treatment
Adults: ≥40 kg:250mg every eight hours Children: <40kg: 20mg/kg/day divided in three doses (up to 250mg) every eight hours Suspension form 250mg/ml
Other Names:
  • Amoxcillin/cavulanic acid
No Intervention: Non Treatment
Subjects will be followed without the use of antibiotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orbital Cellulitis
Time Frame: Two weeks
The rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.
Two weeks

Collaborators and Investigators

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

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Christopher Westfall, M.D., University of Arkansas
  • Principal Investigator: Bradley Thuro, M.D., University of Arkansas
  • Principal Investigator: John Pemberton, D.O., University of Arkansas

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

January 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 4, 2012

First Posted (Estimate)

January 5, 2012

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 134357

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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