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Device

3D printed EAF management device for Fistula

N/A
Waitlist Available
Led By Andrew Bernard, MD, FACS
Research Sponsored by Andrew Bernard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through duration of study, up to 1 year
Awards & highlights

Study Summary

This trialevaluates a custom-fitted device to isolate fistula effluent and determine effects on dressings, time, cost, and ease of use.

Eligible Conditions
  • Fistula
  • Abdominal Injury
  • Negative Pressure Wound Therapy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through duration of study, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through duration of study, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient
Change in Inpatient Participant Mobility Assessment
Change in Inpatient Participant Pain Rating
+8 more
Secondary outcome measures
Complication Occurrences
Fistula Resolution Time
Infection Rates
+2 more
Other outcome measures
Cost Analysis of the 3D Printed Device

Trial Design

1Treatment groups
Experimental Treatment
Group I: Enteroatmospheric fistula (EAF) management solutionExperimental Treatment1 Intervention
Participants will receive a custom fitted device designed to isolate EAF effluent independent of negative pressure wound therapy (NPWT) utilizing 3D printing technology to design a participant-matched device that more easily and effectively separates the participant's fistula and any emanated intestinal contents surrounding the wound.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3D printed EAF management device
2021
N/A
~10

Find a Location

Who is running the clinical trial?

Andrew BernardLead Sponsor
Andrew Bernard, MD, FACSPrincipal Investigator - University of Kentucky
University of Kentucky
University Of Kentucky College Of Medicine (Medical School)
University Of Ky A B Chandler (Residency)
~1 spots leftby Jun 2025
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