Open Reduction and Internal Fixation of Extremity Fractures Clinical Trial
Official title:
Early Determination of Biofilm Formation on Orthopaedic Devices
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.
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.
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