AO Multicenter Intervention Trial to Evaluate the Impact of a Bundle of Measures for the Prevention of Surgical Site Infection in Fracture Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 222
- 试验地点
- 22
- 主要终点
- Infection Rate
研究概览
简要总结
This study is designed to collect data from 8,476 fracture patients during a pre-and post-intervention phases of two years length each. The intervention consists on the implementation of the AOT SSI Prevention Bundle.
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详细描述
During the first phase of the study, 4,238 patients will be recruited and the baseline incidence of surgical site infection at each participating site will be determined. At the beginning of the third year, the bundle will be implemented and data on 4,238 additional patients will be collected. The incidence rate on surgical site infection before and after the intervention will be compared. We hypothesize that this intervention will reduce the infection rate within the first 3 months after surgery from 6% to 4.5% (5% to 3.75% in closed fractures and from 10% to 7.5% in open fractures).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
It is that preventino measures are enforced in the hospital. This will apply to all patients and no masking is required.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age > 18 years
- •Recent fracture (< 10 days) located in femur, tibia or humerus
- •Any type of open or closed fracture
- •Produced by high or low energy trauma
- •Primary fracture treatment with surgery and use of any of the following:
- •Intramedullary or extramedullary devices including cases in which a temporary external fixator is used
- •Joint replacement
- •Informed consent obtained (if required by local EC/IRB), i.e.:
- •Ability to understand the content of the patient information/ICF
- •Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- •Signed and dated EC/IRB approved written informed consent
排除标准
- •Pathologic fracture secondary to tumors, infection or cysts
- •Patients with an underlying chronic, bone and joint infection or prior history of a bone and joint infection
- •Refracture and non-union
- •Peri-implant fractures
- •Patients with terminal illness
- •Pregnancy or women planning to conceive within the study period
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
结局指标
主要结局
Infection Rate
时间窗: within 3 months after surgery
Surgical site infection rate as defined by CDC or FRI definition
次要结局
- Evaluation of attitudes, perception and knowledge concerning SSI(up to 48 months)
- Implementation success of the AOT SSI Prevention Bundle(up to 48 months)
- Health-economic analysis(up to 48 months)
- Surgeon satisfaction(up to 48 months)