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NCT Number: NCT02602548

The Incidence and Incubation Period of False Positive Cultures in Shoulder Surgery

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Minors
  • 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.

Treatment and study plan

Culture

Other

Specimens will be obtained and sent to the lab for cultures.

Primary outcomes

  1. Incidence of positive cultures

    Time frame: 28 days

Secondary outcomes

  1. Incubation time clarification for culture growth if it occurs

    Time frame: Less than or equal to 28 days

Sponsors and collaborators

Lead sponsor

Forte Sports Medicine and Orthopedics

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 11, 2015
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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