The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

Study Overview
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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.

Official Title
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The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

Conditions
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Orbital Fractures, Orbital Cellulitis

Intervention / Treatment
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* Other: Treatment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prophylactic Antibotics<br>Amoxicillin/clavulanic acid | Other: Treatment<br>* 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<br>* Other names: Amoxcillin/cavulanic acid;|
| No Intervention: Non Treatment<br>Subjects will be followed without the use of antibiotics. | |

What is the study measuring?
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Primary Outcome Measures

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