Regional Prophylactic Vancomycin in Revision Total Knee Replacement (VIDACARE)

Mayo Clinic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Arthropathy of Knee Joint

Treatments: Drug: Vancomycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02020031

13-004988

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Vancomycin 500mg intraosseous

Experimental group

Description:

Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.

Treatment:

Drug: Vancomycin

Vancomycin 1g IV

Active Comparator group

Description:

Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.

Treatment:

Drug: Vancomycin