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NCT04673877 Clinical Trial

Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

Infection Clinical Trial

Official title:
Tissue Concentrations of Vancomycin Achieved With Bier Block Administration Versus Intravenous Prophylaxis in Upper Extremity Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04673877
Other study ID # 20-007132
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 26, 2021
Est. completion date August 17, 2022

Study information
Verified date October 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 17, 2022
Est. primary completion date August 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing upper extremity reconstruction by a single surgeon. - Surgical cases will include: - Trapeziectomy/suspensionplasty. - PIPJ/MPJ arthroplasty. - Proximal row carpectomy. - Distal ulnar resection. - Distal radius fracture fixation. Exclusion Criteria: - Inability to adequately cannulate a superficial vein in the upper extremity within 5 minutes of tourniquet inflation. - Evidence of subcutaneous extravasation in Bier block group. - History of renal dysfunction. - Vancomycin allergy. - ASA>/= 3. - History of lung cancer. - Known HIV infection. - History of organ transplantation.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Systemic IV Vancomycin
1 g of vancomycin will be delivered intravenously over a period of one hour prior to tourniquet inflation.
Procedure:
• Bier Block
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.
Drug:
• Vancomycin
500 mg diluted in 50 cc normal saline of injection into superficial vein in the hand, wrist or forearm

Locations
Country Name City State
United States Mayo Clinic in Arizona Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary Adverse Events Number of adverse events reported for Bier Block administered vancomycin 1 year
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