Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Infection; Hand Injuries; Hand Injury Wrist; Hand Injuries and Disorders; Hand Arthritis

Treatments: Drug: Systemic IV Vancomycin; Procedure: Bier Block; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT04673877

20-007132

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Bier Block Group

Experimental group

Description:

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.

Treatment:

Drug: Vancomycin

Procedure: Bier Block

Systemic Intravenous IV Group

Active Comparator group

Description:

Subjects will receive antibiotic Vancomycin through intravenous administration. Samples will be collected from bone and tissue that is normally removed during during surgery.

Treatment:

Drug: Systemic IV Vancomycin