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OpenTrials
Completed

NCT Number: NCT02020031

Regional Prophylactic Vancomycin in Revision Total Knee Replacement

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 (the knee joint) is more effective at preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic

Phoenix, Arizona, 85054, United States

About this study

Patients were assigned to one of two groups by chance (like a coin toss):

  • GROUP 1 - Received 500mg of vancomycin into the tibia (shin) bone of the leg being operated on.
  • GROUP 2 - Received 1g of vancomycin, which is the amount normally given to patients.

For both groups, the revision knee replacement will then be carried out as normal.

OTHER ANTIBIOTICS All patients received cefazolin IV (an antibiotic used to prevent infection) prior to the beginning of surgery to ensure effective preventive antibiotics. The patient will also received 3 postoperative doses of cefazolin over a 24-hour period (4 doses in total). This is standard of care for all total knee replacement surgeries.

TISSUE SAMPLES

  • Ten (10) tissue samples were taken during the surgery, consisting of both bone and fat beneath the skin. Each sample were very small, around the size of a pinhead.
  • In addition, a drain sample was taken from the knee joint drain fluid to measure vancomycin concentration the morning following surgery.
  • These samples were frozen and sent to a lab for analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Revision total knee arthroplasty
  • Informed consent given

Exclusion criteria

  • Current treatment with IV Vancomycin within the preceding 7 days
  • Previous hypersensitivity to vancomycin
  • Significant cardiac or respiratory abnormality
  • Contraindications to using the intraosseous vascular access system (EZ-IO)
  • Sepsis

Treatment and study plan

Vancomycin

Drug

Other names: Vancocin

Primary outcomes

  1. Mean Concentration of Vancomycin in Subcutaneous Fat

    Time frame: Baseline to 24 hours

    During the procedure, subcutaneous fat samples (approximately 0.5 cm^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.

  2. Mean Concentration of Vancomycin in Bone Samples

    Time frame: baseline to 24 hours

    During the procedure, bone samples (approximately 0.5 cm^3) were taken at regular intervals were taken at regular intervals until skin closure. All bone samples were taken from the femur, distant from the tibial intraosseous injection site. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Vidacare Corporation

Registry information

Acronym: VIDACARE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2013
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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