Early Determination of Biofilm Formation on Orthopaedic Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)
研究概览
简要总结
A prospective trial conducted at Shock Trauma of patients between 18 years of age and older who have sustained a fracture with metal implanted. The investigators will be collecting between 1-3 routine blood draws for the purpose of laboratory analysis to assess biofilm growth. Patients may be infected or non-infected at the time of blood draw; they will be selected at random for purposes of this study. All patients will be followed as standard of care by their treating physician for all their follow up visits.
详细描述
Surgical site infection in the orthopaedic surgery population is a significant public health issue. Wound infections result in both increased length of hospital stay and total cost of care.
Surgical site infection (SSI) is the most common preventable adverse outcome after a major operation. The economic costs to the US healthcare system are enormous estimated to be in excess of $1.8 billion per year. For patients who develop an SSI, the cost may be even higher with length of stay and risk of death doubled. Thus the benefits of any intervention decreasing the risk of SSI are very tangible.
A biofilm is a layer of bacteria that adheres to a surface; in Orthopaedics, this often means adherence to implanted metal after fracture surgery. The test that has been designed by one of the investigators on the study has been shown in an animal model to detect the formation of a biofilm up to 1 month prior to clinical detection. Having a blood assay such as this would allow earlier antibiotics and potentially prevent the need for further surgeries to remove metal implants and clean out the biofilm.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous fracture fixation with an implant (intramedullary nail, plate, screws), or joint revisions, or periprosthetic fracture, or admitted from orthopaedic trauma clinic due to infection, or inpatient with a known infection.
- •English speaking
排除标准
- •Patients with planned follow-up at another medical center
- •Patient lives outside of the hospital catchment area
结局指标
主要结局
Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)
时间窗: 1 year of clinical follow-up
A high level of absorbance via ELISA (greater than 1.5 ratio compared to control human serum) is a positive test result. The rate of not infected patient samples that return positive will demonstrate the false positive rate of the test.
次要结局
- Number of Blood Samples With Low Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)(1 year of clinical follow-up)
研究者
Robert O'Toole
Head of the UM SOM's Division of Orthopaedic Traumatology and Chief of Orthopaedic Traumatology and CHief of Orthopaedics for the University of Maryland Medical Center's (UMMS) R Adams Cowley Shock Trauma Center
University of Maryland, Baltimore