跳至主要内容
临床试验/NCT02433704
NCT02433704撤回4 期

Preoperative Antibiotic Dosing for Total Knee Arthroplasty: Intraosseous Versus Systemic Infusion

Duke University1 个研究点 分布在 1 个国家开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
rate of acute surgical site infection

研究概览

简要总结

To directly compare acute infection rates in patients undergoing total knee replacement with intraosseous regional administration or systemic intravenous administration of prophylactic antibiotics.

详细描述

Subjects will be prospectively enrolled into the Intraosseous Regional Administration (IORA) group, and the investigators will use historical controls for the Systemic Intravenous Administration (SIA) group, to include a matched group of patients from 6 months prior to enrollment. SIA group will receive systemic dosing of cefazolin within one hour of the incision, which is the current standard of care. IORA group will receive intraosseous dosing after the tourniquet is inflated to 300-350mm/Hg. Cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. The cefazolin will be administered as a bolus in 200 mL of normal saline. Incision will be made immediately after infusion. Subjects in both groups will receive routine care following the procedure. Primary outcome will be acute surgical site infection, which is defined as within 3 weeks after the surgical procedure. Secondary outcomes will include correlation of clinical comorbidities to the primary outcome, report complications, and compare surgery specific information (tourniquet time, blood loss).

Subjects with a penicillin allergy will receive a 200mg cefazolin test dose via a systemic intravenous route, which is the current standard of care. If no adverse reaction is observed, then the investigators will proceed with administration of 1g cefazolin via the intraosseus route.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary diagnoses of osteoarthritis

排除标准

  • history of compartment syndrome
  • allergy to an antibiotic in the study
  • venous stasis
  • peripheral vascular disease

研究组 & 干预措施

Intraosseous Administration

Active Comparator

Cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. The cefazolin will be administered as a bolus in 200 mL of normal saline.

干预措施: New Intraosseous (Device)

Intraosseous Administration

Active Comparator

Cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. The cefazolin will be administered as a bolus in 200 mL of normal saline.

干预措施: Cefazolin (Drug)

结局指标

主要结局

rate of acute surgical site infection

时间窗: defined as within 3 weeks after the surgical procedure

次要结局

  • correlation of clinical comorbidities to acute infection rates(1 year post surgical intervention)
  • blood loss(during procedure, up to approximately 2.5 hours)
  • number of complications(1 year post surgical intervention)
  • tourniquet time(during procedure, up to approximately 2.5 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Preoperative Antibiotic Dosing for Total Knee... | 临床试验