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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Scoliosis
• Intervention / Treatment: Drug: Bolus dose of Cefazolin; Device: Paraspinal muscle microdialysis catheters; Device: Subcutaneous microdialysis catheters; Drug: Continuous Cefazolin drip

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: First Regimen Group; The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.	Drug: Bolus dose of Cefazolin; Mode of Cefazolin administration will be a intermittent bolus; Other Names: Standard mode of prophylactic cefazolin administration; Device: Paraspinal muscle microdialysis catheters; Two dialysis probes will be inserted into a paraspinal muscle; Other Names: Paraspinal muscle dialysate sample; Device: Subcutaneous microdialysis catheters; Two dialysis probes will be inserted into a paraspinal subcutaneous region; Other Names: Subcutaneous dialysate sample
Active Comparator: Second Regimen Group; The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.	Device: Paraspinal muscle microdialysis catheters; Two dialysis probes will be inserted into a paraspinal muscle; Other Names: Paraspinal muscle dialysate sample; Device: Subcutaneous microdialysis catheters; Two dialysis probes will be inserted into a paraspinal subcutaneous region; Other Names: Subcutaneous dialysate sample; Drug: Continuous Cefazolin drip; Mode of Cefazolin administration will be a continuous drip; Other Names: Continuous infusion of prophylactic cefazolin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unbound Cefazolin Concentration in Skeletal Muscle	First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle	Changes from baseline (pre-op) up to end of surgical procedure
Unbound Cefazolin in Adipose Tissue	First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue	Changes from baseline (pre-op) up to end of surgical procedure

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Christoph Seubert, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: surgical site infection; spinal fusion; tissue microdialysis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Anti-Infective Agents; Anti-Bacterial Agents; Pharmaceutical Solutions; Cefazolin; Dialysis Solutions
• Other Study ID Numbers: IRB201701129 -A; OCR18899 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No