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Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

Primary Purpose

Infection, Hand Injury Wrist, Hand Injuries

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Systemic IV Vancomycin
Bier Block
Vancomycin
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bier Block Group

Systemic Intravenous IV Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Events
Number of adverse events reported for Bier Block administered vancomycin

Full Information

First Posted
October 26, 2020
Last Updated
October 5, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04673877
Brief Title
Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration
Official Title
Tissue Concentrations of Vancomycin Achieved With Bier Block Administration Versus Intravenous Prophylaxis in Upper Extremity Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Hand Injury Wrist, Hand Injuries, Hand Injuries and Disorders, Hand Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bier Block Group
Arm Type
Experimental
Arm 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.
Arm Title
Systemic Intravenous IV Group
Arm Type
Active Comparator
Arm Description
Subjects will receive antibiotic Vancomycin through intravenous administration. Samples will be collected from bone and tissue that is normally removed during during surgery.
Intervention Type
Drug
Intervention Name(s)
Systemic IV Vancomycin
Intervention Description
1 g of vancomycin will be delivered intravenously over a period of one hour prior to tourniquet inflation.
Intervention Type
Procedure
Intervention Name(s)
Bier Block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
500 mg diluted in 50 cc normal saline of injection into superficial vein in the hand, wrist or forearm
Primary Outcome Measure Information:
Title
Tissue concentrations of vancomycin
Description
Tissue concentrations of vancomycin in the hand and wrist following Bier Block administration versus systemic IV administration
Time Frame
Approximately 45-60 minutes after skin incision
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number of adverse events reported for Bier Block administered vancomycin
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Renfree, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

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