NCT03132246

MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants

Early Determination of Biofilm Formation on Orthopaedic Devices

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 260 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective trial conducted at Shock Trauma of patients between 18 years of age and older who have sustained a fracture with metal implanted. The investigators will be collecting between 1-3 routine blood draws for the purpose of laboratory analysis to assess biofilm growth. Patients may be infected or non-infected at the time of blood draw; they will be selected at random for purposes of this study. All patients will be followed as standard of care by their treating physician for all their follow up visits.

Detailed description

Surgical site infection in the orthopaedic surgery population is a significant public health issue. Wound infections result in both increased length of hospital stay and total cost of care. Surgical site infection (SSI) is the most common preventable adverse outcome after a major operation. The economic costs to the US healthcare system are enormous estimated to be in excess of $1.8 billion per year. For patients who develop an SSI, the cost may be even higher with length of stay and risk of death doubled. Thus the benefits of any intervention decreasing the risk of SSI are very tangible. A biofilm is a layer of bacteria that adheres to a surface; in Orthopaedics, this often means adherence to implanted metal after fracture surgery. The test that has been designed by one of the investigators on the study has been shown in an animal model to detect the formation of a biofilm up to 1 month prior to clinical detection. Having a blood assay such as this would allow earlier antibiotics and potentially prevent the need for further surgeries to remove metal implants and clean out the biofilm.

Conditions

• Open Reduction and Internal Fixation of Extremity Fractures

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood draws	The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-06-30
• Completion: 2018-07-31
• First posted: 2017-04-27
• Last updated: 2020-05-15
• Results posted: 2020-05-15

Locations

1 site across 1 country: United States