Houston Methodist Hospital
Houston, Texas, 77030, United States
NCT Number: NCT04042233
The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.
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Notify Me19 year and older
All sexes
Interventional
Phase 4
Houston, Texas, 77030, United States
Patients are randomized to one of two groups.
GROUP A - Will receive IV antibiotics (cefepime & vancomycin) are started in pre-op approximately 1 hour prior to incision vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 milliliters (mL) normal saline (NS).
GROUP B - Will have IV cefepime started in pre-op within 1 hour of incision. Intraosseous (IO) administration of vancomycin (500mg in 250 milliliters NS) will be administered in the OR after sterile prep and draping has occurred. Injection will take place into the greater trochanter (within a pre-specified region).
Both Groups will be monitored during surgery and immediately post-operatively for adverse injection reactions (i.e. Red Man Syndrome). Both groups will otherwise follow identical post-operative protocols (including post-operative antibiotic administration).
TISSUE SAMPLES Five (5) tissue samples will be taken from each patient, 2 soft tissue samples and 3 bone samples will be taken throughout the course of the procedure.
One blood sample will be taken in both groups intraoperatively at the time of initiation of closure.
These samples will immediately be sent to a lab for analysis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.
IV antibiotics (cefepime & vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).
Time frame: approximately 10 minutes before incision
vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.
Time frame: end of surgical case
Time frame: intraoperative
vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.
Time frame: intraoperative
Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.
Time frame: at start of case within 15 minutes after incision
at start , soft tissue. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.
Time frame: intraoperative
Intraoperative femur bone sample measured for vancomycin concentration (ug/mL). Vancomycin tissue concentration measured by high performance liquid chromatography.
Time frame: intraoperative
Intra-operative Acetabulum bone vancomycin concentrations (ug/mL) measured by high performance liquid chromatography.
Time frame: From the administration of antibiotics perioperatively to 30 days post op.
Complications 30 days post surgery eg. infection.
Time frame: From the administration of antibiotics perioperatively to 90 days post op.
Complications 90 days post surgery eg. infection
Time frame: right before wound closure is initiated at the end of the case
soft tissue taken at end of case, right before wound closure is initiated. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.
The Methodist Hospital Research Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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