Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- deep post operative infection
研究概览
简要总结
Prospective, multi-center, randomized controlled trial studying infection rate with or without prophylactic antibiotics at the time of closed reduction and percutaneous pinning of pediatric supracondylar humerus fractures.
详细描述
The goal of the SPAS trial will be to determine the role of prophylactic antibiotics in closed reduction and percutaneous fixation of pediatric supracondylar humerus fractures. The study will be designed as a prospective, double-blinded, two-arm, non-inferiority trial. The control arm will receive standard of care preoperative prophylactic antibiotics. The intervention group will receive a preoperative saline placebo. The primary outcome of the study will be the development of a surgical site infection, including all infections both superficial and deep. Secondary outcomes will include rate and type of post-operative complications in either group, to account for any drug-related adverse outcomes. The hypothesis is that this surgery is safe to perform without prophylactic antibiotics, and the investigators anticipate finding no difference in infection rates between the two groups. Inclusion criteria will consist of an isolated, closed, displaced supracondylar humerus fracture treated with closed reduction and temporary percutaneous pinning. Immunocompromised patients, pathological fractures, open fractures, polytrauma, skeletally mature patients, and those treated primarily with open reduction or those converted to open reduction will be excluded. Because of the low infection rate observed in this type of surgery, the sample size for the study is estimated at 600 patients per arm for adequate power. With a multicenter design, the expectation will be enrollment over the course of 1-2 years with a follow up of approximately 3 months post-surgical intervention per participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
'study drug' will be prepared by a participating pharmacist and labeled with a study identification number. The drug will be otherwise not labeled with regard to the arm of the study. This will be delivered to the operating room and administered to the patient. The patient will be entered into a spreadsheet with the study identification number to be used later to evaluate the data. The enrolling/consenting surgeon, and the patient and consenting family member, will be masked to the arm of the study throughout.
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Closed, isolated extension type supracondylar humerus fracture, Gartland type 2, 3, or 4
排除标准
- •Inability to secure consent
- •Open fractures
- •Polytrauma
- •Pathologic fractures
- •Flexion type fracture
- •Associated compartment syndrome
- •Allergy to cefazolin which precludes its use
- •Skeletally mature patients or patients greater than 18 years of age
- •Medical comorbidities including immunocompromised state, active infection, and any associated bone, endocrine, or neoplastic conditions contributing to local or generalized abnormal bone mineralization.
- •Inability to attain satisfactory reduction and fixation via closed manipulation, resulting in conversion to open reduction
研究组 & 干预措施
Placebo control
Patient will receive 'study drug' which is comprised of 300 mL of normal saline without any medication/antibiotic, which will be delivered by intravenous means at the time of surgery.
干预措施: normal saline (Drug)
Cefazolin prophylaxis
Patient will receive 'study drug' which is comprised of weight-based dose of cefazolin mixed in 300 mL of normal saline, which will be delivered by intravenous means at the time of surgery.
干预措施: Cefazolin (Drug)
结局指标
主要结局
deep post operative infection
时间窗: 3 months post intervention/surgery
rate of deep post operative infections at the surgical site, requiring treatment including possible hospital admission, intravenous antibiotics, or surgical intervention
superficial post operative infection
时间窗: 3 months post intervention/surgery
rate of superficial post operative infections at the surgical site, requiring treatment limited to oral antibiotics, local wound care, pin removal, or cast change/removal
次要结局
未报告次要终点
研究者
Justin Brohard
Co-Investigator
Legacy Health System