Prospective Analysis of Spinal Epidural Abscess (SEA)

Prospective Analysis of Spinal Epidural Abscess Associated Outcomes at the University of Kentucky

This is a prospective study involving all patients treated at the University of Kentucky for spinal epidural abscess over a 2-year period. Based on ongoing referrals of patients with SEA, we expect that 200 patients will be enrolled during this time window. We propose to study all available clinical, pathological, radiological, and socioeconomic data of patients diagnosed with a spinal infection with or without a history of drug abuse over this study period. All patients' charts will be prospectively reviewed starting at the time of presentation for a period of 1 year.

Study Overview

• Status: Recruiting
• Conditions: Spinal Epidural Abscess
• Intervention / Treatment: Other: Prospective chart review of subjects diagnosed with spinal epidural abscess

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Francis Farhadi, MD, PhD; Phone Number: 859-562-0247; Email: francis.farhadi@uky.edu
• Study Contact Backup: Name: Jaimie Hixson; Phone Number: 8593231908; Email: henderson.jaimie@gmail.com

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky
      • Contact: Francis Farhadi, MD, PhD; Phone Number: 859-562-0247; Email: francis.farhadi@uky.edu
      • Contact: Jaimie Hixson, BS; Phone Number: 859-323-1908; Email: jlhend3@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include all patients, over the age of 18, who will undergo treatment for spinal epidural abscess infections at the University of Kentucky during the study period.

Description

Inclusion Criteria:

• All patient with ICD codes for pyogenic vertebral osteomyelitis, discitis, and spinal epidural abscess will be reviewed for inclusion.

Exclusion Criteria:

• Patients unwilling or unable to attend follow up appointments.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with spinal epidural abscess with a history of drug abuse	Other: Prospective chart review of subjects diagnosed with spinal epidural abscess; Collection and assessment of available clinical, pathological, radiological, and socioeconomic data on subjects presenting with spinal epidural abscess. Standard of care treatment and outcomes for each group will be analyzed.
Subjects with spinal epidural abscess with no history of drug abuse	Other: Prospective chart review of subjects diagnosed with spinal epidural abscess; Collection and assessment of available clinical, pathological, radiological, and socioeconomic data on subjects presenting with spinal epidural abscess. Standard of care treatment and outcomes for each group will be analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between employment status and infection reoccurrence.	Determine the statistical correlation between employment status and infection reoccurrence within 1 year of diagnosis.	1 year
Correlation between income and infection reoccurrence.	Determine the statistical correlation between income and infection reoccurrence within 1 year of diagnosis.	1 year
Correlation between insurer and infection reoccurrence.	Determine the statistical correlation between insurer (private, Medicare/Medicade and uninsured) and infection reoccurrence within 1 year of diagnosis.	1 year
Correlation between living situation and infection reoccurrence.	Determine the statistical correlation between living situation (owns, rents, or homeless) and infection reoccurrence within 1 year of diagnosis.	1 year

Collaborators and Investigators

• Sponsor: University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Infections; Inflammation; Central Nervous System Infections; Suppuration; Perimeningeal Infections; Abscess; Epidural Abscess
• Other Study ID Numbers: 78749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No