NCT02602548

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Forte Sports Medicine and Orthopedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Infection

Interventions

Type	Name	Description
OTHER	Culture	Specimens will be obtained and sent to the lab for cultures.

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-11-11
• Last updated: 2018-08-16