Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

NCT04673877 | Completed Phase 1 FDA Drug

• 1 other identifier: 20-007132
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events

  1 year

Study Arms (2)

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.

Procedure: Bier Block; Drug: Vancomycin

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.

Drug: Systemic IV Vancomycin

Interventions

Systemic IV Vancomycin DRUG

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

Systemic Intravenous IV Group

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.

Bier Block Group

Vancomycin DRUG

500 mg diluted in 50 cc normal saline of injection into superficial vein in the hand, wrist or forearm

Bier Block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Infections; Hand Injuries; Disease

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Kevin Renfree, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: December 17, 2020
• Study Start: August 26, 2021
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)