Phase 4
Completed N=12
Skeletal Muscle and Adipose Tissue Study
Source: ClinicalTrials.gov NCT03190668 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Unbound Cefazolin Concentration in Skeletal Muscle — 3.22; 5.84 µg/ml/kg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.