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Skeletal Muscle and Adipose Tissue Study

NCT03190668 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-07-11

Study results available
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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.

Conditions

  • Idiopathic Scoliosis

Interventions

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

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Christoph Seubert, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2022-06-23
Completion
2022-06-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03190668 on ClinicalTrials.gov