Skeletal Muscle and Adipose Tissue Study

NCT03190668 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB201701129 -AOCR18899
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tissue microdialysis; spinal fusion; surgical site infection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

First Regimen Group

ACTIVE COMPARATOR

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; Device: Paraspinal muscle microdialysis catheters; Device: Subcutaneous microdialysis catheters

Second Regimen Group

ACTIVE COMPARATOR

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.

Drug: Continuous Cefazolin drip; Device: Paraspinal muscle microdialysis catheters; Device: Subcutaneous microdialysis catheters

Interventions

Bolus dose of Cefazolin DRUG

Mode of Cefazolin administration will be a intermittent bolus

Also known as: Standard mode of prophylactic cefazolin administration

First Regimen Group

Continuous Cefazolin drip DRUG

Mode of Cefazolin administration will be a continuous drip

Also known as: Continuous infusion of prophylactic cefazolin

Second Regimen Group

Paraspinal muscle microdialysis catheters DEVICE

Two dialysis probes will be inserted into a paraspinal muscle

Also known as: Paraspinal muscle dialysate sample

First Regimen Group; Second Regimen Group

Subcutaneous microdialysis catheters DEVICE

Two dialysis probes will be inserted into a paraspinal subcutaneous region

Also known as: Subcutaneous dialysate sample

First Regimen Group; Second Regimen Group

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christoph Seubert, MD
• Organization: University of Florida

cseubert@anest.ufl.edu

352-273-8960

Study Officials

• Christoph Seubert, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simple randomization will be used with each patient has probability 0.5 to be assigned in Group I or Group II. Computer program will generate a uniform random variable between 0 to 1, with subject assigned to Group I if the value is less than 0.5 and assigned to Group II if the value is greater than 0.5.

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: May 29, 2018
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: July 11, 2023
• Results First Posted: July 11, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)