Evaluation of the microDTTect Device (Heraeus) in the Diagnosis of Low-grade Chronic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of bacteria isolated isolated
研究概览
简要总结
Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.
In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.
详细描述
Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.
In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Adult patients with painful prosthesis or prosthesis loosening <10 years
- •without mechanical explanation,
- •without clinical evidence of infection (no fistula, no abscess, no discharge, no local inflammation),
- •without microbiological diagnosis (absence of preoperative joint puncture (not performed or not feasible) or with a culture-negative preoperative joint puncture).
排除标准
- •Patients with painful prosthesis or prosthesis loosening
- •with mechanical explanation,
- •or with clinical evidence of infection (fistula, abscess, discharge, local inflammation),
- •with a previous microbiological diagnosis
结局指标
主要结局
Rate of bacteria isolated isolated
时间窗: every day until 15 days of culture
type of bacteria isolated
次要结局
- time to positivity of cultures(every day until 15 days of culture)
研究者
Eugénie MABRUT
clinical research assistant
Hospices Civils de Lyon