The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Orbital Cellulitis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated orbital blow out fracture in patients between the ages 5 to 99 years old
排除标准
- •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
结局指标
主要结局
Orbital Cellulitis
时间窗: Two weeks
The rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.
次要结局
未报告次要终点