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Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

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ClinicalTrials.gov Identifier: NCT04042233
Recruitment Status : Not yet recruiting
First Posted : August 1, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Stephen Incavo MD, The Methodist Hospital System

Brief 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.

Condition or disease Intervention/treatment Phase
Prosthetic Joint Infection Vancomycin Joint Diseases Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS Drug: Standard IV administration of vancomycin Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Active Comparator: IV administration of vancomycin
Standard IV vancomycin administration protocol.
Drug: 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).

Experimental: IO Vancomycin 500mg in 250 mL NS
Experimental Intraosseous administration protocol.
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.




Primary Outcome Measures :
  1. Systemic Vancomycin level [ Time Frame: 1 year ]
    vancomycin blood level at time of initiation of closure.


Secondary Outcome Measures :
  1. Tissue vancomycin level [ Time Frame: 1 year ]
    at start and end of case.

  2. Femur vancomycin level [ Time Frame: 1 year ]
    at start and end of case.

  3. Acetabulum vancomycin level [ Time Frame: 1 year ]
    at start and end of case.

  4. 30-Day Complications [ Time Frame: From the administration of antibiotics perioperatively to 30 days post op. ]
    Complications 30 days post surgery i.e. infection.

  5. 90-Day Complications [ Time Frame: From the administration of antibiotics perioperatively to 90 days post op. ]
    Complications 90 days post surgery i.e. infection



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042233


Contacts
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Contact: Thomas C Sullivan, B.S. 346-238-1603 tsullivan@houstonmethodist.org
Contact: David Dong, B.S. 713-363-7390 ddong@houstonmethodist.org

Locations
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United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Investigators
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Principal Investigator: Stephen J Incavo, MD The Methodist Hospital System

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Responsible Party: Stephen Incavo MD, Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT04042233     History of Changes
Other Study ID Numbers: Pro00022651
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Stephen Incavo MD, The Methodist Hospital System:
total hip arthroplasty
vancomycin
intraosseous vancomycin
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents