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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. 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. |
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| 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. 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draws | Diagnostic Test | The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year of clinical follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year of clinical follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Robert V O'Toole, MD | University of Maryland, College Park | Principal Investigator |
| Mark Shirtliff, PhD | University of Maryland, College Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21282411 | Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled | 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. Group assignment is unknown for patients that did not complete the study and therefore groups are combined for reporting overall study numbers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Units | blood draw samples | 1 year of clinical follow-up | blood draw samples | blood draw samples |
|
3 months - 1 year depending on if the patient experienced a clinical culture return of staphylococcal-positive
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unmasked Non-completers | 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. Group assignment is unknown for patients that did not complete the study and therefore this group is representative of those patients that were enrolled but did not complete the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aaron Johnson | University of Maryland School of Medicine | 410-328-1868 | ajohnson1@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2018 | Apr 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Mean | Full Range | kg/m2 |
|
| Smoker | Count of Participants | Participants |
|
| Follow up | Mean | Full Range | months |
|
| Time to Infection | This measure is only valid for infection patients. | Mean | Full Range | months |
|
| Open Fracture | Count of Participants | Participants |
|
| Closed Fractures | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | 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. | Posted | Count of Units | blood draw samples | 1 year of clinical follow-up | blood draw samples | blood draw samples |
|
|
|
| 0 |
| 104 |
| 0 |
| 104 |
| 0 |
| 104 |
| EG001 | 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. 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. | 1 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 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. 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. | 3 | 136 | 0 | 136 | 0 | 136 |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |