What side effects are associated with this type of intervention?

The most common treatments for Surgical Site Infections (SSIs) using intravenous (IV) and intraosseous (IO) antibiotic administration can have several side effects. These include allergic reactions, gastrointestinal disturbances, nephrotoxicity, and ototoxicity. IV administration may also cause phlebitis, while IO administration can lead to local pain and, in rare cases, osteomyelitis.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment and prevention of Surgical Site Infections (SSI), particularly those administered intravenously. Vancomycin is commonly used for its efficacy against gram-positive bacteria, including MRSA, and can be administered intravenously or as a local prophylactic measure using vancomycin-impregnated cement or powder. Other FDA-approved antibiotics for SSI include cephalosporins like cefazolin, which is often used for its broad-spectrum activity against gram-positive and some gram-negative bacteria. These antibiotics are typically administered within one hour before surgical incision to maximize their prophylactic effect.

What other types of research exist?

Promising novel alternatives to IV and IO antibiotic administration for SSI patients include: 1) Antibiotic-loaded bone cement, 2) Antibiotic-impregnated collagen sponges, 3) Polymethylmethacrylate beads, 4) Antibiotic-loaded bone grafts, 5) Antibiotic-loaded synthetic bone substitutes, 6) Antibiotic-coated implants, and 7) Bioactive ceramic carriers for sustained antibiotic release. These methods focus on localized delivery to enhance treatment efficacy and minimize systemic side effects.

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Antibiotic

IO vs IV Vancomycin for Preventing Infection in Knee Surgery

Phase 4

Recruiting

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post-op, 90 days post-op

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing two methods of giving an antibiotic during knee replacement surgery: through a vein and directly into the bone. It aims to see which method helps the antibiotic reach the knee area better and if it affects infection rates after surgery. Delivering antibiotics directly into the bone achieves higher local concentrations with fewer side effects and has been shown to be more effective for preventing infection following surgery.

Who is the study for?

This trial is for adults over 18 who are having their first knee replacement surgery without a tourniquet. They must understand the study and agree to participate. It's not for people with weak immune systems, uncontrolled diabetes (Hemoglobin A1C >7.5), allergies to vancomycin or similar antibiotics, BMI over 35, or those who've had previous knee surgeries.

What is being tested?

The study compares two ways of giving antibiotics during knee replacement surgery: directly into the bone (intraosseous) vs. into a vein (intravenous). The goal is to see which method better prevents infections after surgery without using a tourniquet.

What are the potential side effects?

Possible side effects include allergic reactions to vancomycin, such as rash, itching, or more severe responses like trouble breathing if there's an allergy present. There may also be site-specific issues where the drug is administered.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediate post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Systemic Vancomycin Concentrations

Vancomycin Bone/Tissue Concentrations

Secondary study objectives

30 day & 90 day post-operative complication rates

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 Vancomycin AdministrationExperimental 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 administered preoperatively in this group. * IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS). * Injection will take place into the tibial tubercle (within a pre-specified region) immediately prior to incision.

Group II: Intravenous Vancomycin AdministrationActive Control1 Intervention

Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty 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 \[12,13\] generally 1000-1750mg in 500mL NS).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intravenous (IV) and intraosseous (IO) antibiotic administration are common treatments for Surgical Site Infections (SSIs) due to their ability to deliver antibiotics directly into the bloodstream, ensuring rapid and effective distribution to the infection site. These antibiotics work by inhibiting bacterial cell wall synthesis, protein synthesis, or DNA replication, leading to bacterial cell death or growth inhibition. This rapid action is crucial for SSI patients as it helps to quickly reduce the bacterial load, prevent the spread of infection, and promote faster recovery.

Prophylactic antibiotics in elective orthopedic surgery: a prospective study of 1,591 cases.Is oral antibiotic therapy as effective as intravenous treatment in bacterial osteomyelitis? A real-life experience.Regional antibiotic prophylaxis in elbow surgery.