Antibiotic Prophylaxis in Pediatric Open Fractures
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Number of participants with an infection at the fracture site.
研究概览
简要总结
This research will involve a prospective study on infection rates after grade 1 or 2 open fractures in the skeletally immature pediatric population. There will be 3 arms: one dose intravenous cefazolin, 24 hours intravenous cefazolin, and 24 hours intravenous cefazolin plus 5 days of oral cephalexin.
详细描述
Pediatric patients presenting with open fractures will be screened for eligibility at the time of presentation. Informed consent form discussion will take place within 8 hours of the patient's presentation, or before their second dose of antibiotics would be due (if randomized to group 2 or 3).
Upon arrival to the ED with an open fracture (grade I or II), the patient is assessed and care is initiated based on patient presentation. Patients are given an IV for medication administration and receive the first dose of antibiotics (cefazolin) as soon as possible. This is standard of care.
Treatment of the fracture includes irrigation with saline (at least 1 liter depending on wound size). The fracture then needs to be stabilized and wound closed. Patients are taken to the trauma room typically within 8 hours of presentation for sedation and closed reduction of the fracture. These practices are standard of care.
If the patient and guardian consent to the study, the patient will be randomized to one of three study arms:
A) one dose of IV cefazolin B) 24 hours IV cefazolin (3 doses Q8hrs) C) 24 hours IV cefazolin (3 doses Q8hrs) plus 5 days oral cephalexin.
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
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients ages 0-17 years old
- •Skeletally immature patients, as confirmed by xray imaging evaluated by an orthopaedic surgeon
- •Patient as sustained a grade 1 or 2 open fracture within 24 hours of presentation
- •Physician plans to manage the fracture non-operatively
排除标准
- •Patients 18 years or older
- •Skeletally mature patients, as as confirmed by xray imaging evaluated by an orthopaedic surgeon
- •Patients with grade 3 open fractures
- •Gross contamination of the fracture
- •Fracture requires surgery
- •Immunocompromised patients
- •Allergies to cephalosporins
- •Severe penicillin allergy
- •non-English speaking patients &/or guardian
研究组 & 干预措施
One dose of IV cefazolin
Patients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration.
干预措施: Cefazolin (Drug)
24 hours IV cefazolin
Patients in group B will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses).
干预措施: Cefazolin (Drug)
24 hours IV cefazolin plus 5 days oral cephalexin
Patients in group C will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses). Additionally, they will be instructed to take 5 days of oral cephalexin.
干预措施: Cefazolin (Drug)
24 hours IV cefazolin plus 5 days oral cephalexin
Patients in group C will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses). Additionally, they will be instructed to take 5 days of oral cephalexin.
干预措施: Cephalexin (Drug)
结局指标
主要结局
Number of participants with an infection at the fracture site.
时间窗: Up to 3 months following injury.
Participants will be monitored for infection at follow-up appointments and/or through follow-up phone contact.
次要结局
- Drug adverse events(Up to 3 months following injury.)
研究者
Raju Sivashanmugam
Associate Professor
St. Louis University