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Completed

NCT Number: NCT03190668

Skeletal Muscle and Adipose Tissue Study

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.

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Key information

Conditions

Idiopathic Scoliosis Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bolus dose of Cefazolin

Drug

Mode of Cefazolin administration will be a intermittent bolus

Other names: Standard mode of prophylactic cefazolin administration

Continuous Cefazolin drip

Drug

Mode of Cefazolin administration will be a continuous drip

Other names: Continuous infusion of prophylactic cefazolin

Paraspinal muscle microdialysis catheters

Device

Two dialysis probes will be inserted into a paraspinal muscle

Other names: Paraspinal muscle dialysate sample

Subcutaneous microdialysis catheters

Device

Two dialysis probes will be inserted into a paraspinal subcutaneous region

Other names: Subcutaneous dialysate sample

Primary outcomes

  1. Unbound Cefazolin Concentration in Skeletal Muscle

    Time frame: Changes from baseline (pre-op) up to end of surgical procedure

    First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle

  2. Unbound Cefazolin in Adipose Tissue

    Time frame: Changes from baseline (pre-op) up to end of surgical procedure

    First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 19, 2017
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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