Clinical trial NCT01504568: The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
Official title: The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Orbital Fractures
Orbital Cellulitis
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Orbital Cellulitis
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Christopher Westfall, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Bradley Thuro, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: John Pemberton, D.O.
role: PRINCIPAL_INVESTIGATOR
References: