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The purpose of the study is to determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty and determine the serum concentrations of these antibiotics postoperatively.
Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria. Patients that qualify and sign consent will have tobramycin and vancomycin antibiotic powder placed into the knee during surgery. Postoperative drain fluid from the knee will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin Powder | Experimental | All patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels. |
|
| Tobramycin Powder | Experimental | All patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobramycin Powder | Drug | Everyone gets tobramycin powder. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Antibiotics in Cementless Knees Post op | 1. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty. | 1 hour, 4 hours, and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. | 2. Determine the serum concentrations of these antibiotics postoperatively | 1 hour, 4 hours, and 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vancomycin | All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vancomycin | All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Concentration of Antibiotics in Cementless Knees Post op | 1. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty. | All primary cementless TKA two surgeons at a single institution over a 4-week period were assessed preoperatively for study inclusion. | Posted | Median | Full Range | micrograms per milliliter | 1 hour, 4 hours, and 24 hours |
|
Adverse events were captured while patient was in hospital which was about 24 hours.
study involved collecting fluid and blood from patients at post-op timepoints.
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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 | Intraarticular Concentrations of Tobramycin and Vancomycin | All patients getting vancomycin and tobramycin to see serum concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Venessa Riegler | Washington University | 3143621721 | rieglerv@wustl.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 | Feb 10, 2020 | Aug 3, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 13, 2020 | Aug 3, 2021 | ICF_001.pdf |
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| Vancomyscin |
| Device |
Everyone gets the vancomyscin powder. |
|
| Participants |
|
| 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 |
|
| Vancomycin | All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. | 2. Determine the serum concentrations of these antibiotics postoperatively | Posted | Median | Full Range | micrograms per milliliter | 1 hour, 4 hours, and 24 hours |
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| 20 |
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| 20 |
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| Title | Measurements |
|---|---|
|
| 1 hour tobramycin serum concentration |
|
| 4 tobramycin |
|
| 24 hour tobramycin |
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