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Clinical trial

Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

ID
Name
Pro00022651
Description
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.
Trial arms
Trial start
2019-12-31
Estimated PCD
2022-05-25
Trial end
2022-09-01
Status
Completed
Phase
Early phase I
Treatment
Experimental Intraosseous vancomycin 500mg in 250 mL NS
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.
Arms:
IO Vancomycin 500mg in 250 mL NS
Standard IV administration of vancomycin
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).
Arms:
IV administration of vancomycin
Size
23
Primary endpoint
Systemic Vancomycin level
1 year
Eligibility criteria
Inclusion Criteria: * Patient is undergoing a primary total hip arthroplasty * Patient gives informed consent to participate in the study. * Age Range \>18 Exclusion Criteria: * Previous surgery on the hip (including hip scopes) * BMI above 35 * Contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc) * Inability to locate the greater trochanter or administer the IO infusion * Refusal to participate * Diabetes * Immunocompromised or immunosuppressed patients (HIV, Hep C, End stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}
Updated at
2023-03-15

1 organization

2 products

3 indications

Organization
Methodist Hospital Research Institute
Product
Intraosseous vancomycin
Indication
Periprosthetic Joint Infection
Indication
Vancomycin
Indication
Arthritis
Product
Vancomycin