NCT03190668

Skeletal Muscle and Adipose Tissue Study

Skeletal Muscle and Adipose Tissue Concentrations of Cefazolin Comparing Two Different Dosing Regimens During Pediatric Posterior Spinal Fusion Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 12 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Determine the skeletal muscle and adipose tissue disposition of prophylactic Cefazolin using microdialysis sampling in a cohort of patients diagnosed with idiopathic scoliosis undergoing posterior spinal fusion (PSF) for administration of Cefazolin by either continuous infusion or intermittent bolus.

Conditions

• Idiopathic Scoliosis

Interventions

Type	Name	Description
DRUG	Bolus dose of Cefazolin	Mode of Cefazolin administration will be a intermittent bolus
DRUG	Continuous Cefazolin drip	Mode of Cefazolin administration will be a continuous drip
DEVICE	Paraspinal muscle microdialysis catheters	Two dialysis probes will be inserted into a paraspinal muscle
DEVICE	Subcutaneous microdialysis catheters	Two dialysis probes will be inserted into a paraspinal subcutaneous region

Timeline

• Start date: 2018-05-29
• Primary completion: 2022-06-23
• Completion: 2022-06-23
• First posted: 2017-06-19
• Last updated: 2023-07-11
• Results posted: 2023-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study