NCT02027532终止不适用
Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- incidence of infection
研究概览
简要总结
The purpose of this study is to compare the incidence rate of infection in surgical patients with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the peri-operative period.
The hypothesis of this study is that patients undergoing surgical treatment for closed fractures who are treated prophylactically with Vancomycin will have a lower incidence rate of infection than patients who are treated prophylactically with Cefazolin.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 years old and 85 years old
- •Closed fracture
- •Fracture treatment plan is for one operation on one day (one surgical setting)
- •Likely to follow-up with surgeon until fracture is healed
- •Ability to understand and agree to Informed Consent
排除标准
- •Under 18 years old or over 85 years old
- •Open fracture(s)
- •Fracture requires multiple operations
- •Other injuries requiring operations
- •Documented allergy to Cefazolin or Vancomycin
- •Previous history of Methicillin-resistant Staphylococcus aureus infection
- •Previous surgery on the injured extremity within 1 year
- •Use of antibiotics within 2 weeks before or after injury
- •Use of antibiotics within 2 weeks before surgery
- •Unlikely to follow-up until fracture is healed
- •Unable to understand and agree to Informed Consent
研究组 & 干预措施
Cefazolin
Active Comparator
intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
干预措施: Cefazolin (Drug)
Vancomycin
Active Comparator
intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively
干预措施: Vancomycin (Drug)
结局指标
主要结局
incidence of infection
时间窗: one year
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)Ventral Hernia RepairNCT03945357Prisma Health-Upstate250
已完成
不适用
The Effect of Bundle Application on Surgical Site InfectionCraniotomy SurgeryPreventive Health CareNCT06724354Cukurova University102
招募中
不适用
Prophylaxis of Surgical Wound Infection With Topical AntibioticsSurgical Site InfectionSurgery--ComplicationsColorectal SurgeryHernia, AbdominalCesarean Section InfectionNCT04476212Hospital de Granollers560
已完成
不适用
DACC in the REduction of Surgical Site INfectionInfection, BacterialWound Infection, SurgicalSurgical IncisionSurgical WoundWound InfectionNCT02992951Hull University Teaching Hospitals NHS Trust722
撤回
4 期
Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSISurgical Wound InfectionSurgical Site InfectionNCT04975945The Grant Medical College & Sir J.J. Group of Hospitals250