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
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Hand Arthritis
• Hand Injuries
• Hand Injuries and Disorders
• Hand Injury Wrist
• Infection
• Wounds and Injuries

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

External Links

•   Mayo Clinic Clinical Trials