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Regional Prophylactic Vancomycin in Revision Total Knee Replacement (VIDACARE)

Primary Purpose

Arthropathy of Knee Joint

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Knee Joint focused on measuring Revision knee joint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vancomycin 500mg intraosseous

Vancomycin 1g IV

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Concentration of Vancomycin in Subcutaneous Fat
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
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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2013
Last Updated
October 4, 2016
Sponsor
Mayo Clinic
Collaborators
Vidacare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02020031
Brief Title
Regional Prophylactic Vancomycin in Revision Total Knee Replacement
Acronym
VIDACARE
Official Title
Regional Prophylactic Vancomycin in Revision Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Vidacare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee Joint
Keywords
Revision knee joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin 500mg intraosseous
Arm Type
Experimental
Arm Description
Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
Arm Title
Vancomycin 1g IV
Arm Type
Active Comparator
Arm Description
Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancocin
Primary Outcome Measure Information:
Title
Mean Concentration of Vancomycin in Subcutaneous Fat
Description
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.
Time Frame
Baseline to 24 hours
Title
Mean Concentration of Vancomycin in Bone Samples
Description
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.
Time Frame
baseline to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Spangehl, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Regional Prophylactic Vancomycin in Revision Total Knee Replacement

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