Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

Phase 1

Completed

• Conditions: Hand Injuries; Hand Injuries and Disorders; Infection; Hand Injury Wrist; Hand Arthritis
• Interventions: Procedure: Bier Block; Drug: Systemic IV Vancomycin; Drug: Vancomycin

• Registration Number: NCT04673877
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Study Start: 2021-08-26
• Primary Completion: 2022-08-17
• Study Completion: 2022-08-17
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bier Block Group	Bier Block	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.
Systemic Intravenous IV Group	Systemic IV Vancomycin	Subjects will receive antibiotic Vancomycin through intravenous administration. Samples will be collected from bone and tissue that is normally removed during during surgery.
Bier Block Group	Vancomycin	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.

Primary Outcome Measures

Name	Time	Method
Tissue concentrations of vancomycin	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 Outcome Measures

Name	Time	Method
Adverse Events	1 year	Number of adverse events reported for Bier Block administered vancomycin

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States