Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04673877
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kevin Renfree, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Infection, Hand Injury Wrist, Hand Injuries, Hand Injuries and Disorders, Hand Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

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.

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.

Interventions

Drug: - Systemic IV Vancomycin

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Arizona, Phoenix, Arizona

Status

Address

Mayo Clinic in Arizona

Phoenix, Arizona, 85054