The Role of Antibiotics in the Reduction of Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax: A Prospective, Double-Blinded Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- efficacy of prophylactic antibiotics in reduction of empyema
研究概览
简要总结
The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.
详细描述
In this study, the medication (an antibiotic which is used to treat or prevent infections) will be compared with a placebo. A placebo is something that looks like a "real" medication, but it doesn't contain any active medication. As a participant in this study, you may receive the active medication (Cefazolin Sodium Injection or Clindamycin) or you may receive a placebo.
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
- 是
入选标准
- •Age ≥ 16 years of age.
- •Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
- •Traumatic pneumothorax, hemothorax or hemopneumothorax
排除标准
- •Open fracture
- •Immunocompromised
- •Require antibiotics for treatment of other injuries
- •Chest tube placement greater than 72hrs after admission
研究组 & 干预措施
Ancef 1 gm or Clindamycin 300 mg
Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists
干预措施: Ancef or Clindamycin (Drug)
Placebo
Group B will receive .9% Normal Saline as a placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
efficacy of prophylactic antibiotics in reduction of empyema
时间窗: 30 days
The primary objective of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.
次要结局
- Incidence of Pneumonia and/or development of resistant microorganisms(30 days)