Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04042233|
Recruitment Status : Not yet recruiting
First Posted : August 1, 2019
Last Update Posted : August 22, 2019
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Systemic Vancomycin level [ Time Frame: 1 year ]vancomycin blood level at time of initiation of closure.
- Tissue vancomycin level [ Time Frame: 1 year ]at start and end of case.
- Femur vancomycin level [ Time Frame: 1 year ]at start and end of case.
- Acetabulum vancomycin level [ Time Frame: 1 year ]at start and end of case.
- 30-Day Complications [ Time Frame: From the administration of antibiotics perioperatively to 30 days post op. ]Complications 30 days post surgery i.e. infection.
- 90-Day Complications [ Time Frame: From the administration of antibiotics perioperatively to 90 days post op. ]Complications 90 days post surgery i.e. infection
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
|Contact: Thomas C Sullivan, B.S.||email@example.com|
|Contact: David Dong, B.S.||firstname.lastname@example.org|
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Stephen J Incavo, MD||The Methodist Hospital System|