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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic
Phoenix, Arizona, United States
Start Date
December 1, 2013
Primary Completion Date
June 1, 2015
Completion Date
June 1, 2015
Last Updated
November 25, 2016
22
ACTUAL participants
Vancomycin
DRUG
Lead Sponsor
Mayo Clinic
Collaborators
NCT05266027
NCT05504577
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01333189