Regional Prophylactic Vancomycin in Revision Total Knee Replacement (VIDACARE)
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|ClinicalTrials.gov Identifier: NCT02020031|
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : November 25, 2016
Last Update Posted : November 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Arthropathy of Knee Joint||Drug: Vancomycin||Phase 2 Phase 3|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Regional Prophylactic Vancomycin in Revision Total Knee Replacement|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Vancomycin 500mg intraosseous
Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
Other Name: Vancocin
Active Comparator: Vancomycin 1g IV
Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
Other Name: Vancocin
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020031
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|Principal Investigator:||Mark Spangehl, MD||Mayo Clinic|