Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-26

Study Completion Date

2022-08-17

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Bier Block

Intervention Type 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

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Systemic IV Vancomycin

Intervention Type DRUG

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

Interventions

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Systemic IV Vancomycin

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

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Vancomycin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No