Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

October 5, 2022 updated by: Kevin J. Renfree, Mayo Clinic

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bier Block Group
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
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
Active Comparator: Systemic Intravenous IV Group
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
1 g of vancomycin will be delivered intravenously over a period of one hour prior to tourniquet inflation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 45-60 minutes after skin incision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 1 year
Number of adverse events reported for Bier Block administered vancomycin
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Kevin Renfree, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2021

Primary Completion (Actual)

August 17, 2022

Study Completion (Actual)

August 17, 2022

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-007132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection

Clinical Trials on Bier Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe