Trial Outcomes & Findings for Regional Prophylactic Vancomycin With Restricted Tourniquet Time in Primary Total Knee Replacement (NCT NCT03506347)

Results Overview

Mean vancomycin concentration in fat measured in ug/g at surgical closure

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

24 participants

Primary outcome timeframe

Approximately 60 minutes post surgical incision

Results posted on

2020-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	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. Vancomycin: Antibiotic	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 intraosseous regional administration (IORA) injection then deflated. Vancomycin: Antibiotic
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vancomycin 15mg/kg IV n=12 Participants 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. Vancomycin: Antibiotic	Vancomycin 500mg Intraosseous n=12 Participants 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. Vancomycin: Antibiotic	Total n=24 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 8.29 • n=12 Participants	69.1 years STANDARD_DEVIATION 8.15 • n=12 Participants	68 years STANDARD_DEVIATION 8.07 • n=24 Participants
Sex: Female, Male Female	7 Participants n=12 Participants	5 Participants n=12 Participants	12 Participants n=24 Participants
Sex: Female, Male Male	5 Participants n=12 Participants	7 Participants n=12 Participants	12 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	12 participants n=12 Participants	24 participants n=24 Participants

PRIMARY outcome

Timeframe: Approximately 60 minutes post surgical incision

Mean vancomycin concentration in fat measured in ug/g at surgical closure

Outcome measures

Outcome measures
Measure	Vancomycin 15mg/kg IV n=72 fat 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. Vancomycin: Antibiotic	Vancomycin 500mg Intraosseous n=72 fat 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. Vancomycin: Antibiotic
Vancomycin Concentration in Fat	6.0 ug/g Standard Deviation 0.85	40.5 ug/g Standard Deviation 8.08

PRIMARY outcome

Timeframe: Approximately 60 minutes post surgical incision

Mean vancomycin concentration in bone measured in ug/g at surgical closure

Outcome measures

Outcome measures
Measure	Vancomycin 15mg/kg IV n=48 bone 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. Vancomycin: Antibiotic	Vancomycin 500mg Intraosseous n=48 bone 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. Vancomycin: Antibiotic
Vancomycin Concentration in Bone	8.3 ug/g Standard Deviation 0.77	26.9 ug/g Standard Deviation 1.31

Adverse Events

Vancomycin 15mg/kg IV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vancomycin 500mg Intraosseous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark Spangehl

Mayo Clinic

Phone: 480-342-2948

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place