Clinical trial NCT03132246: MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants
Official title: Early Determination of Biofilm Formation on Orthopaedic Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Reduction and Internal Fixation of Extremity Fractures
Keywords: Methicillin-resistant Staphylococcus aureus (MRSA)
Infection
Biofilm Assay
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Trauma patients that were considered at risk for infection after fracture fixation. Inclusion criteria included open fractures, proximal tibia fractures, pilon fractures, and calcaneus fractures treated with surgical fixation.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Previous fracture fixation with an implant (intramedullary nail, plate, screws), or joint revisions, or periprosthetic fracture, or admitted from orthopaedic trauma clinic due to infection, or inpatient with a known infection.
* English speaking

Exclusion Criteria:

* Patients with planned follow-up at another medical center
* Patient lives outside of the hospital catchment area

Primary outcomes:
measure: Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)
timeFrame: 1 year of clinical follow-up
Secondary outcomes:
measure: Number of Blood Samples With Low Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)
timeFrame: 1 year of clinical follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Shock Trauma Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Robert V O'Toole, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, College Park
name: Mark Shirtliff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prabhakara R, Harro JM, Leid JG, Harris M, Shirtliff ME. Murine immune response to a chronic Staphylococcus aureus biofilm infection. Infect Immun. 2011 Apr;79(4):1789-96. doi: 10.1128/IAI.01386-10. Epub 2011 Jan 31.