Status:
WITHDRAWN
The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
Lead Sponsor:
University of Arkansas
Conditions:
Orbital Fractures
Orbital Cellulitis
Eligibility:
All Genders
5+ years
Phase:
NA
Brief Summary
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 ...
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 frac...
Eligibility Criteria
Inclusion
- Isolated orbital blow out fracture in patients between the ages 5 to 99 years old
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01504568
Start Date
January 1 2012
End Date
November 1 2012
Last Update
November 9 2012
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205