The Use of Prophylactic Antibiotics in Isolated Blowout Fractures



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:January 2012
End Date:January 2014
Contact:Bradley Thuro, M.D.
Phone:501-686-5150

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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.


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.

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
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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mi
from
Little Rock, AR
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