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Anti-infective

Vancomycin Delivery Methods for Ankle Surgery (IOTAA Trial)

Phase 4

Recruiting

Led By Jason S Ahuero, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is undergoing total ankle arthroplasty

Age Range >18

Must not have

Patient refusal to participate

Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C >7.5

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to compare two different ways of giving antibiotics during ankle surgery. The main goal is to see if the levels of antibiotics in the bone, tissue, and blood are similar between the two groups

Who is the study for?

This trial is for individuals undergoing total ankle arthroplasty who can safely receive vancomycin. It's not suitable for those with allergies to this antibiotic, other specific medical conditions that could interfere with the study, or those unable to follow the protocol.

What is being tested?

The study compares two ways of giving vancomycin during ankle surgery: directly into the bone (intraosseous) versus into a vein (intravenous). The goal is to see if both methods result in similar drug levels in bone and tissue and have comparable infection rates after surgery.

What are the potential side effects?

Vancomycin may cause side effects like kidney problems, hearing issues, allergic reactions, and infusion-related discomfort. These risks are generally similar whether the drug is given intraosseously or intravenously.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for total ankle replacement surgery.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not want to participate in the clinical trial.

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My diabetes is not under control, with an A1C level over 7.5.

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My BMI is over 40.

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I cannot take certain antibiotics like vancomycin or cefepime due to allergies or other issues.

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I have a weakened immune system due to a condition or treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intraosseous VancomycinExperimental Treatment1 Intervention

IV antibiotics per physician's standard of care: Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be given preoperatively in this group. IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). IO Injection will take place into the medial malleolus.

Group II: Intravenous VancomycinActive Control1 Intervention

Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL normal saline (NS))

0 / 7Eligibility criteria met