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Trial record 5 of 540 for:    VANCOMYCIN

Regional Prophylactic Vancomycin With Restricted Tourniquet Time in Primary Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03506347
Recruitment Status : Completed
First Posted : April 24, 2018
Results First Posted : December 17, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Mark J. Spangehl, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE April 24, 2018
Results First Submitted Date  ICMJE December 2, 2019
Results First Posted Date  ICMJE December 17, 2019
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE September 24, 2018
Actual Primary Completion Date January 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • Vancomycin Concentration in Fat [ Time Frame: Approximately 60 minutes post surgical incision ]
    Mean vancomycin concentration in fat measured in ug/g at surgical closure
  • Vancomycin Concentration in Bone [ Time Frame: Approximately 60 minutes post surgical incision ]
    Mean vancomycin concentration in bone measured in ug/g at surgical closure
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
Effective Tissue Concentration [ Time Frame: Duration of Study ]
Evaluate whether IORA vancomycin can achieve effective tissue concentrations with tourniquet use minimized in primary TKA.
Change History Complete list of historical versions of study NCT03506347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regional Prophylactic Vancomycin With Restricted Tourniquet Time in Primary Total Knee Replacement
Official Title  ICMJE Regional Prophylactic Vancomycin With Restricted Tourniquet Time in Primary Total Knee Replacement
Brief Summary 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 obtaining adequate tissue levels of the antibiotic than the current standard dose which is given intravenously (IV) through a wrist vein. The use of intraosseous regional administration (IORA) of vancomycin requires the use of a tourniquet for the duration of the procedure. Many surgeons prefer to perform the surgery with tourniquet use minimised or without a tourniquet at all. The aim of this study is to evaluate whether IORA vancomycin can achieve effective tissue concentrations with tourniquet use minimised.
Detailed Description

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

GROUP A - Will receive 15mg/kg based on actual body weight (maximum of 2g) of vancomycin via the systemic route at a rate of 15mg/kg as per hospital guidelines. Systemic IV vancomycin is given via a forearm vein, given over an infusion timed to finish immediately prior to surgery.

GROUP B - Will have the limb exsanguinated and an above knee tourniquet inflated to 300 mmHg. Immediately following tourniquet inflation, Group B will receive 500mg of vancomycin, via an EZ-IO intraosseous cannula. The vancomycin would be administered in 150ml of saline solution. The intraosseous cannula would be placed into the epiphysis of the proximal tibia. The tourniquet will be left inflated for 10 minutes following completion of the IORA injection then deflated.

Both Groups will receive weight-based dose of systemic cefazolin ( or alternative antibiotic if allergic to cefazolin 15 minutes prior to inflation of tourniquet. This ensures all patients in the study receive effective antibiotic prophylaxis regardless of randomization. Both groups of patients would then undergo routine prep and draping For both groups, Total knee replacement would then be carried out as normal and the tourniquet will be inflated for cementation of the implants.

TISSUE SAMPLES Ten (10) tissue samples will be taken from each patient, 6 'fat' samples and 4 'bone' samples. Each sample is very small, around the size of a pinhead. Bone samples will be taken from the femur only to ensure no direct contamination from the site of injection (tibia) In addition, drain samples will be taken from the intra-articular drain site to measure vancomycin concentration the morning following surgery.

Three blood samples will be taken in both groups, intraoperatively, in recovery, and the following morning.

These samples are frozen and sent to a lab for analysis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Arthropathy of Knee Joint
Intervention  ICMJE Drug: Vancomycin
Antibiotic
Other Name: Vancocin
Study Arms  ICMJE
  • Active Comparator: Vancomycin 15mg/kg IV
    Will receive 15mg/kg based on actual body weight (maximum of 2g) of vancomycin via the systemic route at a rate of 15mg/kg as per hospital guidelines. Systemic IV vancomycin is given via a forearm vein, given over an infusion timed to finish immediately prior to surgery.
    Intervention: Drug: Vancomycin
  • Experimental: Vancomycin 500mg Intraosseous
    Will have the limb exsanguinated and an above knee tourniquet inflated to 300 mmHg. Immediately following tourniquet inflation, Group B will receive 500mg of vancomycin, via an EZ-IO intraosseous cannula. The vancomycin would be administered in 150ml of saline solution. The intraosseous cannula would be placed into the epiphysis of the proximal tibia. The tourniquet will be left inflated for 10 minutes following completion of the IORA injection then deflated.
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 17, 2019
Actual Primary Completion Date January 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Primary Total Knee Arthroplasty for osteoarthritis Informed consent given

Exclusion Criteria

Current or treatment with IV Vancomycin within preceding 7 days Previous hypersensitivity to vancomycin Significant cardiac or respiratory abnormality Patient has contraindications to IO vascular access using the EZ-IO

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03506347
Other Study ID Numbers  ICMJE 17-007853
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mark J. Spangehl, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark J Spangehl Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP