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临床试验/NCT02602548
NCT02602548已完成不适用

The Incidence and Incubation Period of False Positive Cultures in Shoulder Surgery Study Protocol: A Pilot Study

Forte Sports Medicine and Orthopedics0 个研究点目标入组 100 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
Incidence of positive cultures

研究概览

简要总结

This study will describe the time point at which a positive culture from a patient who has undergone shoulder surgery should be treated as an infection versus a false positive result that should be disregarded. Intraoperative biopsies will be taken and cultured from 50 subjects who have undergone an "open" surgical procedure and 50 from subjects undergoing an arthroscopic procedure.

详细描述

Postoperative infection is a significant complication that requires timely identification and treatment. Indolent infections, such as those involving Propionibacterium acnes (P. acnes), pose a diagnostic dilemma as they present differently than the acute symptoms typically associated with most postoperative bone and joint infections. The workup of these suspected infections is also somewhat difficult, as these colonies are slow growing, necessitating that cultures be kept for an extended period of time. Previous studies have shown that positive cultures are typically identified between 7 and 13 days. In a recent study of patients undergoing primary shoulder arthroplasty, 41.8% of patients were found to have P. acnes growth from their joint fluid at a mean of 7 days (range 5-9 days). All of these patients were then treated immediately with 4 weeks of dual oral antibiotic therapy1.

As the incubation of laboratory cultures increases, there is the potential concern of false positive growth. Timely identification is critical in order to avoid performing unnecessary treatments on patients in whom no infection is actually present.

The investigators will enroll patients undergoing primary shoulder surgery for a clearly identified mechanical dysfunction, in which there is no clinical suspicion for infection. Infection should not exist in this population, making it an appropriate clinical sample in which to study results that the investigators would consider to be false positives.

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

入选标准

  • Patients undergoing primary open and arthroscopic shoulder surgery in which there is a clear diagnosis of a mechanical problem that is felt to be amenable to surgical intervention and there is no suspicion of infection. Examples include, but are not limited to: rotator cuff tear, labral tear, instability, impingement, and osteoarthritis.

排除标准

  • Prior shoulder surgery
  • Prior glenohumeral injection within the last 6 months
  • Systemic or shoulder inflammatory disorder
  • Any clinical, imaging, or laboratory findings that raise suspicion of infection
  • Erythrocyte sedimentation rate (ESR) >15 mm/hr for males less than 50 years old, >20 mm/hr for males greater than 50 years old and females less than 50 years old, and >30 mm/hr for females greater than 50 years old
  • C reactive protein (CRP) >1 mg/d,
  • Procalcitonin (PCT) >0.05 ng/ml.

结局指标

主要结局

Incidence of positive cultures

时间窗: 28 days

次要结局

  • Incubation time clarification for culture growth if it occurs(Less than or equal to 28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gary Misamore

Orthopedic Surgeon

Forte Sports Medicine and Orthopedics

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