Antibiotic Prophylaxis Surgery
Conditions
Keywords
Antibiotic prophylaxis, intraosseous antibiotics, intraosseous ancef
Brief summary
The goal of this clinical trial is to learn if intraosseous antibiotic (cefazolin) administration can improve antibiotic levels in adults undergoing primary total hip replacement. The main question it aims to answer is: • Does intraosseous cefazolin increase antibiotic concentrations in blood and tissue compared with standard intravenous cefazolin alone? Researchers will compare patients receiving intraosseous cefazolin plus standard intravenous cefazolin to those receiving placebo injection plus standard intravenous cefazolin to see if local antibiotic delivery improves outcomes. Participants will: * Receive standard intravenous cefazolin before surgery and either intraosseous cefazolin or placebo * Provide blood samples before and after antibiotic administration * Have small tissue samples collected during surgery * Complete routine postoperative follow-up and outcome assessment for 90 days
Interventions
1 gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter
normal saline
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized control trial with intraosseous ancef group and placebo (saline) group with goal of determining antibiotic concentrations in local tissues and serum
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Scheduled to undergo primary total hip arthroplasty * Receiving standard institutional antibiotic prophylaxis with IV bolus cefazolin prior to surgery
Exclusion criteria
* Reduced renal function (GFR \< 30) * Reduced liver function (AST/ALT \> 3× upper limit of normal) * Weight \> 120 kg * Undergoing bilateral total hip arthroplasty * Documented cefazolin anaphylaxis * Active joint infection * History of diabetes * Inflammatory arthropathies * Inability to understand written and/or spoken English * Undergoing revision total hip arthroplasty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cefazolin Concentration | From administration of intra-osseous ancef to 4 hours post-operatively | Cefazolin concentration in local tissues and serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative complications | time of surgery to 90 days from surgery | Any post-operative complications, potentially related to the intra-osseous ancef or otherwise |
Countries
United States
Outcome results
None listed