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OpenTrials
Completed

NCT Number: NCT04673877

Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

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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Key information

Conditions

Infection Disease Hand Arthritis Hand Injuries Hand Injuries and Disorders Hand Injury Wrist Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systemic IV Vancomycin

Drug

1 g of vancomycin will be delivered intravenously over a period of one hour prior to tourniquet inflation.

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

Primary outcomes

  1. Tissue concentrations of vancomycin

    Time frame: Approximately 45-60 minutes after skin incision

    Tissue concentrations of vancomycin in the hand and wrist following Bier Block administration versus systemic IV administration

Secondary outcomes

  1. Adverse Events

    Time frame: 1 year

    Number of adverse events reported for Bier Block administered vancomycin

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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