Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04673877

Collaborator

(none)

Enrollment

Location

Arms

15.2

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Infection Hand Injury Wrist Hand Injuries Hand Injuries and Disorders Hand Arthritis	Drug: Systemic IV Vancomycin Procedure: Bier Block Drug: Vancomycin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 26, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Adverse Events [1 year]
Number of adverse events reported for Bier Block administered vancomycin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Phoenix	Arizona	United States	85054

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Kevin Renfree, MD, Mayo Clinic

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Aug 23, 2020

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Kevin J. Renfree, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04673877

Other Study ID Numbers:

20-007132

First Posted:

Dec 17, 2020

Last Update Posted:

Sep 8, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wounds and Injuries

Hand Injuries

Vancomycin

Study Results

No Results Posted as of Sep 8, 2021