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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04042233
Other study ID # Pro00022651
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 31, 2019
Est. completion date September 1, 2022

Study information

Verified date March 2023
Source The Methodist Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date September 1, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
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).

Locations

Country Name City State
United States Houston Methodist Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Systemic Vancomycin level vancomycin blood level at time of initiation of closure. 1 year
Secondary Tissue vancomycin level at start and end of case. 1 year
Secondary Femur vancomycin level at start and end of case. 1 year
Secondary Acetabulum vancomycin level at start and end of case. 1 year
Secondary 30-Day Complications Complications 30 days post surgery i.e. infection. From the administration of antibiotics perioperatively to 30 days post op.
Secondary 90-Day Complications Complications 90 days post surgery i.e. infection From the administration of antibiotics perioperatively to 90 days post op.
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