MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants

Completed

• Conditions: Open Reduction and Internal Fixation of Extremity Fractures
• Interventions: Diagnostic Test: Blood draws

• Registration Number: NCT03132246
• Lead Sponsor: University of Maryland, Baltimore

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-04-27
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-31
• Results First Submitted: 2020-03-17
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-13
• Last Update Submitted: 2020-05-13
• Results First Posted: 2020-05-15
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infected	Blood draws	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. Each patient enrolled in the study provided 1-3 blood samples. These blood samples were tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time. The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory. Patients were enrolled if presented as high risk but later separated into the Infected Group or the Not Infected Group based on whether or not they went on to develop an infection post surgery. All patients in this group went on to develop an infection.
Not Infected	Blood draws	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. Each patient enrolled in the study provided 1-3 blood samples. These blood samples were tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time. The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory. Patients were enrolled if presented as high risk but later separated into the Infected Group or the Not Infected Group based on whether or not they went on to develop an infection post surgery. All patients in this group did not go on to develop an infection.

Primary Outcome Measures

Name	Time	Method
Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)	1 year of clinical follow-up	A high level of absorbance via ELISA (greater than 1.5 ratio compared to control human serum) is a positive test result. The rate of not infected patient samples that return positive will demonstrate the false positive rate of the test.

Secondary Outcome Measures

Name	Time	Method
Number of Blood Samples With Low Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)	1 year of clinical follow-up	A low level of absorbance via ELISA (greater than 1.5 ratio compared to control human serum) is a negative test result. The rate of infected patient samples that return negative will demonstrate the false negative rate of the test.

Trial Locations

Locations (1)

University of Maryland, Shock Trauma Center; 🇺🇸 Baltimore, Maryland, United States