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The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

NCT ID: NCT01504568

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Orbital Fractures Orbital Cellulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prophylactic Antibotics

Amoxicillin/clavulanic acid

Group Type OTHER

Treatment

Intervention Type OTHER

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

Non Treatment

Subjects will be followed without the use of antibiotics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Amoxcillin/cavulanic acid

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Westfall, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Bradley Thuro, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

John Pemberton, D.O.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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134357

Identifier Type: -

Identifier Source: org_study_id