Recruiting

Vancomycin vs. Vancomycin

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06384651

Conditions

Infections

Ankle Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intraosseous Vancomycin Injection

Intravenous Vancomycin

Study Details

Brief summary:

The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).

Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.

Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.

Conditions

Infections

Ankle Arthritis

Study ID

NCT06384651

Start date

Dec 3, 2024

Status verified date

Jan, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Patient is undergoing total ankle arthroplasty.
  • Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study
  • Age Range >18

Exclusion Criteria

  • Previous lower extremity surgery that in the opinion of the principal investigator or qualified research personnel precludes the participant from safely participating on the study.
  • BMI > 40.
  • Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
  • Inability to administer the IO infusion.
  • Patient refusal to participate.
  • Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C >7.5.
  • Immunocompromised or immunosuppressed patients (HIV, Hep C, end stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).
  • Vulnerable populations

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intravenous Vancomycin

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))

experimental: Intraosseous Vancomycin

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.

Interventions

Intraosseous Vancomycin Injection

  • 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.

Intravenous Vancomycin

• 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))

Primary outcome measure

  • Systemic Sample Vancomycin Tissue Concentration - Start of Case [ Time Frame: perioperatively ]
  • Systemic Sample Vancomycin Tissue Concentration - End of Case [ Time Frame: perioperatively ]
  • Capsule or Synovium Sample Vancomycin Tissue Concentration [ Time Frame: immediately after the procedure ]
  • Distal Tibia Sample Vancomycin Tissue Concentration [ Time Frame: immediately after the procedure ]
  • Talar Bone Sample Vancomycin Tissue Concentration [ Time Frame: immediately after the procedure ]

Central Contacts and Locations

Central contacts

Thomas C Sullivan, BS

346-238-1603tsullivan@houstonmethodist.org

Blesson Varghese, BS

713-441-3814bvarghese6@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Thomas C Sullivan, BS

346-238-1603tsullivan@houstonmethodist.org

Principal Investigator:

Jason S Ahuero, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Jan 24, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2025-01-24.