Open Reduction and Internal Fixation of Extremity Fractures
Conditions
Keywords
Methicillin-resistant Staphylococcus aureus (MRSA), Infection, Biofilm Assay
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.
Interventions
DIAGNOSTIC_TESTBlood draws
The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.
Sponsors
University of Maryland, Baltimore
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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. Group assignment is unknown for patients that did not complete the study and therefore groups are combined for reporting overall study numbers.
Participants by arm
| Arm | Count |
|---|---|
| Infected 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. All patients in this arm went on to develop an infection. Each patient enrolled in the study provides blood samples up to 10 times. These blood samples are to be tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time.
Blood draw: The only intervention patients experience is a non-standard of care blood draw. The blood is then tested in a basic science laboratory. | 20 |
| Not Infected 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. All patients in this arm did not go on to develop an infection. Each patient enrolled in the study provides blood samples up to 10 times. These blood samples are to be tested using basic science techniques to determine the level of exposure to a staphylococcal biofilm each patient has experienced over a period of time.
Blood draw: The only intervention patients experience is a non-standard of care blood draw. The blood is then tested in a basic science laboratory. | 136 |
| Total | 156 |
Baseline characteristics
| Characteristic | Total | Infected | Not Infected |
|---|---|---|---|
| Age, Continuous | 44 years | 45 years | 44 years |
| Body Mass Index | 28 kg/m2 | 27 kg/m2 | 28 kg/m2 |
| Closed Fractures | 97 Participants | 12 Participants | 85 Participants |
| Follow up | 43 months | 58 months | 28 months |
| Open Fracture | 59 Participants | 8 Participants | 51 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 56 Participants | 5 Participants | 51 Participants |
| Sex: Female, Male Male | 100 Participants | 15 Participants | 85 Participants |
| Smoker | 67 Participants | 12 Participants | 55 Participants |
| Time to Infection | 11 months | 11 months | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 1 / 20 | 3 / 136 |
| other Total, other adverse events | 0 / 104 | 0 / 20 | 0 / 136 |
| serious Total, serious adverse events | 0 / 104 | 0 / 20 | 0 / 136 |
Outcome results
Primary
Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)
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.
Time frame: 1 year of clinical follow-up
Population: One to three blood sample tests were taken for each participant prior to the one-year post-operative clinical follow-up. Clinical cultures will also be monitored for the one-year post-operative period and compared to the blood sample test results to determine if the test is able to identify patients with positive staphylococcal infection cultures.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Infected | Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum) | 48 blood draw samples |
| Not Infected | Number of Blood Samples With High Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum) | 53 blood draw samples |
Secondary
Number of Blood Samples With Low Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum)
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.
Time frame: 1 year of clinical follow-up
Population: One to three blood sample tests were taken for each participant prior to the one-year post-operative clinical follow-up. Clinical cultures will also be monitored for the one-year post-operative period and compared to the blood sample test results to determine if the test is able to identify patients with positive staphylococcal infection cultures.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Infected | Number of Blood Samples With Low Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum) | 4 blood draw samples |
| Not Infected | Number of Blood Samples With Low Levels of Absorbance Via ELISA for Patients (Greater Than 1.5 Ratio Compared to Control Human Serum) | 92 blood draw samples |