Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures (Mandibular Fractures, Zygomaticoorbital Fractures, Isolated Orbital Blow-out Fractures and LeFort I/II/III Fractures): 1 Day vs. 5 Days: a Prospective, Randomized, Double Blind and Placebo Controlled Study (Phase IV)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Number of patients with infection
研究概览
简要总结
Facial fractures make up a significant proportion of injuries in trauma patients. 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. Chole and his team could show 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%. However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis in facial fractures varies from single-shot 6-7 up to a duration of 7 and even ten days postoperatively 8-10. The use of antibiotics can be associated with allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial resistance. 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 an postoperative infection. Up to date there is no standard to support the administration of antibiotics after surgical repair of a facial fracture.
The purpose of this prospective, randomized double-blinded trial is to investigate the utility of antibiotics administered in the postoperative period after surgical revision of facial fractures.
Hypothesis: a short-term antibiotic prophylaxis of 1 day postoperatively is equally effective as a long-term administration of 5 days in facial fractures.
详细描述
Background
While up to the early 1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial its efficacy is well accepted today. Chole et al. showed that the administration of antibiotics reduces the incidence of infectious complications in facial fractures from 42,2% to 8.9%.
However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis varies from single-shot up to 7 and even ten days postoperatively.
Antibiotic use is costly and associated with allergic reactions, toxic reactions, adverse effects, drug interactions and increasing bacterial resistance. Additionally some authors assume that a prolonged administration of antibiotics might even increase the risk of infectious complications via superinfection. On the other hand one might risk an increase of postoperative infections with a short term or single shot administration.
In a medline search only few studies could be found which deal with antimicrobial prophylaxis in maxillofacial surgery and in facial trauma surgery in particular.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated orbital fracture, zygomatic fracture, mandibular fracture, or LeFort I/II/III fracture which requires surgical treatment
- •Written informed consent obtained
- •Exclusion Criteria
- •Need of intensive care treatment
- •Presence of an acute bacterial infection
- •Gunshot wounds
- •Pathological fracture
- •Skull base fracture with rhinoliquorrhea or intracranial emphysema
- •History of malignancy or radiation to the head and neck area
- •Known hypersensitivity, allergy to penicillin or other beta-lactam antibiotics
- •Reduced body weight (<40kg or BMI<17), severe renal insufficiency (stage 4 according to the Kidney Disease Outcomes Quality Initiative (KDOQI))
- •Insufficient patient compliance
排除标准
- 未提供
研究组 & 干预措施
1
Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 1 then receives amoxicillin/clavulanic acid 625 mg orally every eight hours for four days.
干预措施: Amoxicillin/clavulanic acid (Drug)
2
Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 2 receives oral placebo using the same schedule for the same duration as group 1.
干预措施: Amoxicillin plus placebo (Drug)
结局指标
主要结局
Number of patients with infection
时间窗: 6 months
Infection according to Surgical site infection by CDC
次要结局
- Number of patients with infection(12 weeks)
- Number of days between trauma and first antibiotic administration(at dismissal from hospital, expected to be after 5 days)
- Number of days between trauma and operation(At dismissal from hospital, expected to be after 5 days)
- Location of fracture(At the end of surgery, expected to be after 90 minutes)
- Duration of surgery(At the end of surgery, expected to be after 90 minutes)
- Number of patients with concomitant injuries(At the end of surgery, expected to be after 90 minutes)