InfectionPhase 1NCT04673877
Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration
A Phase 1 study testing Systemic IV Vancomycin, Bier Block and Vancomycin in people with Infection and Hand Injury Wrist, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Hand Injury Wrist, Hand Injuries
- What is being tested?
- Systemic IV Vancomycin, Bier Block and Vancomycin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2021to 17 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Tissue Concentrations of Vancomycin Achieved With Bier Block Administration Versus Intravenous Prophylaxis in Upper Extremity Surgery: A Randomized Controlled Trial
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).
- Being tested
- Systemic IV Vancomycin, Bier Block, Vancomycin
- Medical subject headings
- Infections, Hand Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic IV VancomycinDrug
1 g of vancomycin will be delivered intravenously over a period of one hour prior to tourniquet inflation.
Bier BlockProcedure or surgery
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.
VancomycinDrug
500 mg diluted in 50 cc normal saline of injection into superficial vein in the hand, wrist or forearm
| Study group | Role | What they receive |
|---|---|---|
| Bier Block Group | Experimental | 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. Receives: Procedure: Bier Block; Drug: Vancomycin |
| Systemic Intravenous IV Group | Active comparator | Subjects will receive antibiotic Vancomycin through intravenous administration. Samples will be collected from bone and tissue that is normally removed during during surgery. Receives: Drug: Systemic IV Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue concentrations of vancomycin
Tissue concentrations of vancomycin in the hand and wrist following Bier Block administration versus systemic IV administration
Measured: Approximately 45-60 minutes after skin incision
Secondary outcomes (1)
Adverse Events
Number of adverse events reported for Bier Block administered vancomycin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start26 Aug 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin J. Renfree, Mayo Clinic
- Investigators
- Kevin Renfree, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673877
- Sponsor's protocol ID
- 20-007132
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2020
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Concentrations of Vancomycin Achieved With Bier Block Administration Versus Intravenous Prophylaxis in Upper Extremity Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04673877
- Acronym / sponsor ID
- 20-007132
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bier Block Group | Experimental | Procedure: Bier Block, Drug: VancomycinSubjects 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 | Active comparator | Drug: Systemic IV VancomycinSubjects will receive antibiotic Vancomycin through intravenous administration. Samples will be collected from bone and tissue that is normally removed during during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients undergoing upper extremity reconstruction by a single surgeon.
- Surgical cases will include:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic IV Vancomycin1 g of vancomycin will be delivered intravenously over a period of one hour prior to tourniquet inflation. | Drug | Systemic Intravenous IV Group |
| Bier BlockAfter 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. | Procedure or surgery | Bier Block Group |
| Vancomycin500 mg diluted in 50 cc normal saline of injection into superficial vein in the hand, wrist or forearm | Drug | Bier Block Group |
Primary outcome
Tissue concentrations of vancomycin
Time frame: Approximately 45-60 minutes after skin incision
Tissue concentrations of vancomycin in the hand and wrist following Bier Block administration versus systemic IV administration
1 secondary outcome
Adverse Events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Renfree, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Systemic IV Vancomycin, Bier Block and Vancomycin in people with Infection and Hand Injury Wrist, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue concentrations of vancomycin (time frame: Approximately 45-60 minutes after skin incision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.