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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 (upper extremity) is more effective at preventing infection than the current standard dose which is given intravenously (IV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bier Block Group | Experimental | Subjects will receive antibiotic Vancomycin from a Bier Block (injected into an arm vein with a tourniquet up to keep antibiotics in the arm). Samples will be collected from bone and tissue that is normally removed during surgery. |
|
| Systemic Intravenous IV Group | Active Comparator | Subjects will receive antibiotic Vancomycin through intravenous administration. Samples will be collected from bone and tissue that is normally removed during during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systemic IV Vancomycin | Drug | 1 g of vancomycin will be delivered intravenously over a period of one hour prior to tourniquet inflation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tissue concentrations of vancomycin | Tissue concentrations of vancomycin in the hand and wrist following Bier Block administration versus systemic IV administration | Approximately 45-60 minutes after skin incision |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of adverse events reported for Bier Block administered vancomycin | 1 year |
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Inclusion Criteria:
Patients undergoing upper extremity reconstruction by a single surgeon.
Surgical cases will include:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Renfree, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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 | Aug 23, 2020 | Oct 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D006230 | Hand Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| Bier Block | Procedure | After exsanguination of the limb and elevation of the tourniquet in the prepped and draped patient, Vancomycin will be injected into a superficial vein in the hand, wrist or forearm. |
|
| Vancomycin | Drug | 500 mg diluted in 50 cc normal saline of injection into superficial vein in the hand, wrist or forearm |
|
| D000602 |
| Amino Acids, Peptides, and Proteins |