The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
Withdrawn before enrolling · Not applicable
Conditions studied: Orbital Fractures, Orbital Cellulitis
In brief
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.
Key facts
- Study ID
- NCT01504568
- Run by
- University of Arkansas
- People needed
- 0
- Starts
- 2012-01-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2012-11-09
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Isolated orbital blow out fracture in patients between the ages 5 to 99 years old
You may not qualify if…
- 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
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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