The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

University of Arkansas

Status

Withdrawn

Conditions

Orbital Fractures

Orbital Cellulitis

Treatments

Other: Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01504568

134357

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

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