Comparative Evaluation of Two Techniques for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis: Grinding (Ultra Turrax) Versus Standard Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Presence/absence of an osteo-articular infection according to sample that underwent standard treatment
研究概览
简要总结
The main objective of this study was to compare the diagnostic capability (sensitivity and specificity) of standard bacteriological analysis made from one or other of the two sampling processing techniques and perioperative management of samples : the Ultra Turrax method that uses grinding versus the standard method.
详细描述
The secondary objectives of this study are to:
A. Compare the two techniques in terms of bacterial species identified.
B. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of analyzed samples (soft tissue, bone tissue) (subgroup analysis).
C. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of joint (subgroup analysis).
D. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of implanted materials (prosthesis versus other equipment) (subgroup analysis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is cared for in the operating theater because of a suspicion of an osteo-articular infection involving any type of material (protheses, screws, plates) and requiring bacteriological sampling
- •The patient has not taken any antibiotics within the past 15 days
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The subject presents with an osteo-articulaire infection without material
- •Systematic samplings from reversals of aseptic prostheses
- •Second intervention for the same patient
研究组 & 干预措施
Per-op biopsy around material
Patients included in this study require biopsies for suspicion of infected osteo-articular materials (implants, protheses, nails, screw, plates).
Interventions:
- Biological sampling grinding
- Biological sampling with standard procedures
干预措施: Biological sampling grinding (Biological)
Per-op biopsy around material
Patients included in this study require biopsies for suspicion of infected osteo-articular materials (implants, protheses, nails, screw, plates).
Interventions:
- Biological sampling grinding
- Biological sampling with standard procedures
干预措施: Biological sampling with standard procedures (Biological)
结局指标
主要结局
Presence/absence of an osteo-articular infection according to sample that underwent standard treatment
时间窗: Baseline
Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding
时间窗: Baseline
次要结局
- Identification of bacterial species(Baseline)