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| Name | Class |
|---|---|
| Vidacare Corporation | INDUSTRY |
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The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.
Patients were assigned to one of two groups by chance (like a coin toss):
For both groups, the revision knee replacement will then be carried out as normal.
OTHER ANTIBIOTICS All patients received cefazolin IV (an antibiotic used to prevent infection) prior to the beginning of surgery to ensure effective preventive antibiotics. The patient will also received 3 postoperative doses of cefazolin over a 24-hour period (4 doses in total). This is standard of care for all total knee replacement surgeries.
TISSUE SAMPLES
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin 500mg intraosseous | Experimental | Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision. |
|
| Vancomycin 1g IV | Active Comparator | Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Concentration of Vancomycin in Subcutaneous Fat | During the procedure, subcutaneous fat samples (approximately 0.5 cm^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision. | Baseline to 24 hours |
| Mean Concentration of Vancomycin in Bone Samples | During the procedure, bone samples (approximately 0.5 cm^3) were taken at regular intervals were taken at regular intervals until skin closure. All bone samples were taken from the femur, distant from the tibial intraosseous injection site. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision. | baseline to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Spangehl, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
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Subjects were enrolled between January 2014 and April 2015 at Mayo Clinic in Arizona.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vancomycin 500mg Intraosseous | Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision. |
| FG001 | Vancomycin 1g IV | Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Although 22 subjects were enrolled, 2 subjects were withdrawn from the study following an intra-operative decision not to proceed with a full revision. Baseline demographics are provided for the subjects who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vancomycin 500mg Intraosseous | Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision. |
| BG001 | Vancomycin 1g IV |
| 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 | Mean Concentration of Vancomycin in Subcutaneous Fat | During the procedure, subcutaneous fat samples (approximately 0.5 cm^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision. | Posted | Mean | Standard Deviation | µg/g | Baseline to 24 hours |
|
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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 | Vancomycin 500mg Intraosseous | Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute renal failure with olgiurea | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered mental state | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark J. Spanghel | Mayo Clinic | 480-301-5685 | Spangehl.Mark@mayo.edu |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
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| Primary | Mean Concentration of Vancomycin in Bone Samples | During the procedure, bone samples (approximately 0.5 cm^3) were taken at regular intervals were taken at regular intervals until skin closure. All bone samples were taken from the femur, distant from the tibial intraosseous injection site. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision. | Posted | Mean | Standard Deviation | µg/g | baseline to 24 hours |
|
|
|
| 4 |
| 10 |
| 5 |
| 10 |
| EG001 | Vancomycin 1g IV | Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation. | 0 | 10 | 3 | 10 |
| Acute blood loss anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Intraoperative opiate overdose | Surgical and medical procedures | Systematic Assessment | Required postoperative infusion of Narcan |
|
| Postoperative hypoxemia | Blood and lymphatic system disorders | Systematic Assessment | Secondary to acute asthma exacerbation; pulmonary embolism ruled out. |
|
| Foot drop of left leg | Nervous system disorders | Systematic Assessment |
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| Left peroneal neuropathy | Nervous system disorders | Systematic Assessment |
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| Hypotension | Blood and lymphatic system disorders | Systematic Assessment |
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| Intermittent atrial tachycardia | Cardiac disorders | Systematic Assessment |
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| Hyponatremia | Blood and lymphatic system disorders | Systematic Assessment |
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| Procedure turned into a brief operation and not full revision | Surgical and medical procedures | Systematic Assessment | Patient withdrawn and study collection terminated |
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| Pulmonary bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | With oxygen desaturation with leg swelling |
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| Hypovolemic hyponatremia | Blood and lymphatic system disorders | Systematic Assessment |
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| Acute urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Premature ventricular complexes | Cardiac disorders | Systematic Assessment |
|
| Elevated temperature post surgery | General disorders | Systematic Assessment |
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| Swelling below eyes | General disorders | Systematic Assessment | Possibly due to intraoperative fluid volume and positioning |
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| Replacement of thoracic pulse generator | Surgical and medical procedures | Systematic Assessment | Device could not be started up after patient's knee surgery. Patient has history of cervical enteropathic syndrome. |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| At approximately 115 minutes |
|
| At approximately 145 minutes |
|