Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sumit Gupta
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Number of Participants With the Presence of Post-Operative Infection
研究概览
简要总结
The aim of this study is to determine if antibiotics affect the outcome after percutaneous surgery for pediatric supracondylar humerus fractures. The patient population will be recruited from the cohort presenting to Women and Children's Hospital for percutaneous fixation of pediatric supracondylar humerus fractures who meet the eligibility criteria and consent to taking part in the study. Patients will be followed up for 3-6 weeks depending on age, and will be evaluated on the presence or absence superficial or deep infection, Visual Analog Scale pain scores, time to healing, need for repeat casting, and loss of fixation.
详细描述
This patient population will be recruited from the cohort presenting to Women and Children's Hospital for percutaneous fixation of pediatric supracondylar humerus fractures. Participants will be asked to assent to take part in the study and their parents or guardian will be asked to sign an informed consent. Patients will be randomized to a treatment group that receives one dose of pre-operative antibiotics or one that does not. Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin. Patients randomized to the no-antibiotic group will receive a saline placebo. The resident, anesthesiologist, circulating nurse and other operating room staff will be instructed to not reveal the patient's randomization to the attending physician so as not to interfere with blinding.
The patient will then undergo closed reduction percutaneous pinning of supracondylar humerus fracture. Final AP and lateral fluoroscopic images in the case will be taken. The patient will be discharged from the hospital when pain is controlled with standard oral pain medications and all goals of inpatient management have been achieved. No patients will receive post-operative antibiotics regardless of randomization group as is the existing standard of care. Patients will be scheduled to follow up in 3-6 weeks depending on age. At that time the cast will be removed and AP and lateral radiographs will be used to assess healing. The pins will be removed in clinic and a soft dressing applied to the elbow region.
In cases of excessive pain or cast loosening the patient may be seen in clinic earlier with radiographs and physical exam as indicated. If the attending physician determines that a deep or superficial infection is present at any time during the treatment period the patient will be categorized as infected. If no infection is detected at an earlier-scheduled appointment the patient will be recasted and instructed to follow up as previously scheduled.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization envelops will be created. Attending surgeons/Investigators will be blinded. Participant will be blinded.
入排标准
- 年龄范围
- — 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age<14 years
- •Open growth plates
- •Gartland type II or III extension type fracture of the distal humerus OR Flexion type fracture of the distal humerus
排除标准
- •Need for open reduction
- •Need for antibiotics due to other injuries or conditions during the entire study period
- •Immunosuppression
- •History of malignancy or metabolic bone disease
- •Open fractures
- •Pre-existing Infection
- •Intra-operative breech of sterile technique
研究组 & 干预措施
Pre-operative Antibiotics
Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin.
干预措施: Cefazolin (Drug)
Pre-operative Antibiotics
Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin.
干预措施: Clindamycin (Drug)
Saline Placebo
Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline.
干预措施: Saline (Drug)
结局指标
主要结局
Number of Participants With the Presence of Post-Operative Infection
时间窗: Six weeks
The primary outcome measure will be the presence of infection as judged by the blinded attending surgeon at the time of cast removal. A superficial infection is defined as a clinical diagnosis based on increased erythema, granulation tissue or purulence at the pin sites that resolves with a short course of oral antibiotics. A deep infection is defined as the presence of septic arthritis or osteomyelitis requiring return to the operating room for debridement or a prolonged course of IV antibiotics. If the attending physician determines that a deep or superficial infection is present at any time during the treatment period the patient will be categorized as infected.
次要结局
- Visual Analog Pain Scale(Three to Six Week Follow Up)
- Number of Participants With a Need for Repeat Casting(Three to Six Weeks Follow Up)
- Fractures Fully Healed(Three to Six Week Follow Up)
- Number of Participants Experiencing Loss of Fixation(Three to Six Weeks Follow Up)
研究者
Sumit Gupta
Professor, Assistant Clinical - Department of Orthopaedic Surgery
University of Missouri-Columbia