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 range

5 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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