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临床试验/NCT04925531
NCT04925531已完成不适用

Antibiotic Use in Facial Fracture Post Injury

Methodist Health System2 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2016年7月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
2
主要终点
Injury associated infectious complications within 30-days of injury

研究概览

简要总结

Facial fractures make up a significant proportion of injuries in trauma patients (1, 2). Approximately 3 million individuals suffer craniofacial trauma in the United States on a yearly basis, and approximately 50% of all wounds presenting to emergency rooms involve the head and neck (1, 2). Treatment of these fractures often results in standard surgical interventions. While up to the early 1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its efficacy is well accepted today (3). Previous research work showed that the administration of antibiotics one hour preoperatively and eight hours after the intervention reduces the incidence of infectious complications in facial fractures from 42.2% to 8.9% (4). However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis in facial fractures varies from single-shot up to duration of 7 and even ten days postoperatively. The use of antibiotics can be associated with allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial resistance (5). In addition some authors assume that a prolonged administration of antibiotics might increase the risk of infectious complications via superinfection. On the other hand a short term or single shot administration might not be enough to prevent the onset of a postoperative infection. Up to date there is no standard to support the duration of antibiotic administration after surgical repair of a facial fracture. In this proposal, Investigators are aiming to investigate if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures.

详细描述

This proposed research is a retrospective chart review to examine if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures.

Records of trauma patients who were admitted to Methodist Health System (MHS) between January1st 2010 and December 31st 2015 will be retrieved to review the clinical charts according to our inclusion and exclusion criteria.

Patients will be segregated in to two groups according to the duration of antibiotic use, group 1 (less than 3days) and group 2 (5 days).

Basic demographics and clinical outcomes parameters as noted above will be attained from the patient's medical records.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patient's ≥ 18 years of age.
  • Blunt and penetration injury.

排除标准

  • Pregnant and breast feeding women.

研究组 & 干预措施

Antibiotic use for <3 days

a retrospective chart review to examine if either the utility of antibiotics administered for 3 days make a difference in the clinical outcomes after facial fractures

干预措施: Antibiotics (Drug)

Antibiotic use for 5 days

a retrospective chart review to examine if either the utility of antibiotics administered for 5 days make a difference in the clinical outcomes after facial fractures

干预措施: Antibiotics (Drug)

结局指标

主要结局

Injury associated infectious complications within 30-days of injury

时间窗: 3 days post trauma

This will help to determine if specific intervals of prophylactic antibiotic use for facial fracture patients decreases the incidence of fracture-associated infections.

次要结局

  • Demographics(through study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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