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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through duration of study, up to 1 year

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

Do I qualify?Apply below to find out

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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the sample size of this research project populated?

"Correct. The clinicaltrials.gov database confirms that this research has opened recruitment and is presently in search of 2 individuals from a single medical site. This trial was first posted on July 1st 2021, with its latest modification made November 6th 2022."

Answered by AI

Are any further participants being recruited for this experiment?

"Affirmative. The clinical trial is actively taking applications and can be seen in the records hosted on clinicaltrials.gov, which note that it was first published on July 1st 2021 with a subsequent update made to November 6th 2022. 2 participants are necessary for this single-site study."

Answered by AI

What are the desired outcomes of this clinical experiment?

"The principal objective of this trial is to track the alteration in wound dressing needs for hospitalised patients over a period lasting up to one year. Ancillary objectives encompass counting observed leaks related to the device, tabulating length of stay and measuring fistula resolution time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy

Andrew Bernard 2021. "Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04978090.