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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

Study Summary

This trial compares how well antibiotics work when given through a vein or a bone during knee 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Systemic Vancomycin Concentrations

Vancomycin Bone/Tissue Concentrations

Secondary outcome measures

30 day & 90 day post-operative complication rates

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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

271 Previous Clinical Trials

80,335 Total Patients Enrolled

Media Library

Vancomycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05705843 — Phase 4

Surgical Site Infection Research Study Groups: Intravenous Vancomycin Administration, Intraosseous Vancomycin Administration

Surgical Site Infection Clinical Trial 2023: Vancomycin Highlights & Side Effects. Trial Name: NCT05705843 — Phase 4

Vancomycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05705843 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in the trial open to individuals above twenty years of age?

"This clinical trial mandates that potential participants be between 19 and 80 years of age. There are 7 additional trials for persons younger than 18 and 70 studies available to those 65 or older."

Answered by AI

Are there still openings available to participate in this experiment?

"Affirmative. Clinicaltrials.gov reveals that enrollment for this experiment is currently open and was initially posted on the 25th of January 2023 with a recent edit occurring two days later. 40 individuals need to be recruited from one medical site."

Answered by AI

Does the FDA accept Intraosseous Vancomycin Administration as a valid medical procedure?

"Due to this being a Phase 4 trial, the safety of Intraosseous Vancomycin Administration was rated 3 out of 3 by Power's team as it is approved for clinical use."

Answered by AI

How many individuals are currently partaking in this research endeavor?

"Affirmative. The details posted on clinicaltrials.gov demonstrate that this medical trial is actively enrolling individuals, with the first post being made on January 25th 2023 and edited as recently as January 27th 2023. This investigation requires 40 participants to be recruited from 1 center of care."

Answered by AI

Are my credentials sufficient to qualify me for participating in this clinical research?

"This medical investigation is seeking 40 adults, aged 19 to 80, with surgical site infections. All applicants must have an aptitude for comprehending the experiment's structure and its associated therapies in order to give informed consent; no LAR consents will be used. Furthermore, all patients should have experienced a primary total knee arthroplasty without tourniquet use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IO vs IV Vancomycin in Tourniquetless TKA

Timothy S. Brown 2023. "IO vs IV Vancomycin in Tourniquetless TKA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05705843.