Phase 4
N=12
Skeletal Muscle and Adipose Tissue Study
Idiopathic Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT03190668 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Unbound Cefazolin Concentration in Skeletal Muscle — 3.22; 5.84 µg/ml/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bolus dose of Cefazolin (Drug); Continuous Cefazolin drip (Drug); Paraspinal muscle microdialysis catheters (Device); Subcutaneous microdialysis catheters (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unbound Cefazolin Concentration in Skeletal Muscle |
3.22; 5.84 | — |
| PRIMARY Unbound Cefazolin in Adipose Tissue |
3.21; 6.13 | — |
Summary
The purpose of this research study is to compare the current standard of care for prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of Cefazolin during pediatric spinal surgery.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of idiopathic scoliosis
- Planned posterior spinal fusion surgery (PSFS)
- Age: 12-20 years old
- American Society of Anesthesiology status I or II undergoing posterior spinal fusion for at least 6 levels
- No known allergy to cefazolin
Exclusion Criteria
- Known allergy to cefazolin
- Anatomical or other abnormalities that precluded insertion of a microdialysis catheter into the selected paraspinal muscle
- Known renal or hepatic insufficiency or failure
Data sourced from ClinicalTrials.gov (NCT03190668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.