WithdrawnNot Applicable

The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

Stopped: No subjects enrolled

United States0Started 2012-01

Plain-language 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.

Who can participate

Age range5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Orbital Cellulitis

Timeframe: Two weeks

Trial details

NCT IDNCT01504568

SponsorUniversity of Arkansas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Orbital Fractures trials