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

This study aims to assess the efficacy of a custom fitted device designed to isolate enteroatmospheric fistulas effluent independent of negative pressure wound therapy and to evaluate the effects on the device related to dressing changes, time required for dressing changes, management costs, and the ease of use.

Study Overview

• Status: Completed
• Conditions: Fistula; Abdominal Injury; Negative Pressure Wound Therapy
• Intervention / Treatment: Device: 3D printed EAF management device

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Bernard, MD, FACS; Phone Number: 859-257-3253; Email: andrew.bernard@uky.edu
• Study Contact Backup: Name: Anna Rockich, PharmD, MS; Phone Number: 859-323-6346; Email: arockich@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Stable condition, as determined by attending physician
• Has enteroatmospheric fistula (EAF) in the setting of open abdomen
• EAF is determined to require surgical resolution

Exclusion Criteria:

• Unstable condition, as determined by attending physician
• Significant risk of complication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Enteroatmospheric fistula (EAF) management solution; 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.

Device: 3D printed EAF management device; Participants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inpatient Participant Pain Rating	Participants will be asked to rate their pain on a scale of 1-10, where 10 indicates more pain.	Daily from admission to discharge, up to 1 year
Change in Outpatient Participant Pain Rating	Participants will be asked to rate their pain on a scale of 1-10, where 10 indicates more pain.	Weekly from discharge until fistula resolves or study ends, up to 1 year
Change in Inpatient Participant Mobility Assessment	Mobility will be assessed by asking the participant to select the following statement that most accurately describes their mobility: a. completely immobile; b. unable to sit up supported for less than 10 minutes; c. able to sit supported for more than 10 minutes; d. able to sit unsupported, can lift arms; e. can stand up and pivot torso; or f. can walk and move with minimal assistance required.	Daily from admission to discharge, up to 1 year
Change in Outpatient Participant Mobility Assessment	Mobility will be assessed by asking the participant to select the following statement that most accurately describes their mobility: a. completely immobile; b. unable to sit up supported for less than 10 minutes; c. able to sit supported for more than 10 minutes; d. able to sit unsupported, can lift arms; e. can stand up and pivot torso; or f. Can walk and move with minimal assistance required.	Weekly from until fistula resolves or study ends, up to 1 year
Change in Number of Required Wound Dressing Changes - Inpatient	The number of dressing changes will be tracked for inpatients on a daily bases.	Daily from admission to discharge, up to 1 year
Change in Number of Required Wound Dressing Changes - Outpatient	The number of dressing changes will be tracked for outpatients on a daily bases.	Daily from discharge until fistula resolves or study ends, up to 1 year
Change in Perceived Usefulness - Inpatient	Inpatient participants will be asked three questions about the perceived usefulness of the device. The questions use a 5-point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived usefulness.	Daily from admission to discharge, up to 1 year
Change in Perceived Usefulness - Outpatient	Outpatient participants will be asked two questions about the perceived usefulness of the device. The questions use a 5-point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived usefulness.	Weekly from discharge until fistula resolves or study ends, up to 1 year
Change in Perceived Ease of Use - Inpatient	Inpatient participants will be asked four questions about the perceived ease of use of the device. The question uses a 5 point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived ease of use.	Daily from admission to discharge, up to 1 year
Change in Perceived Ease of Use - Outpatient	Inpatient participants will be asked four questions about the perceived ease of use of the device. The question uses a 5 point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived ease of use.	Weekly from discharge until fistula resolves or study ends, up to 1 year
Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient	The time required to change the wound dressings will be recorded.	Daily from admission to discharge, up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection Rates	The number of infections in participants that are related to the device will be recorded.	Through duration of study, up to 1 year
Number of Observed Leakages	The number of observed leakages in participants that are related to the device will be recorded.	Through duration of study, up to 1 year
Length of Stay	Length of stay in hospital	Through duration of study, up to 1 year
Fistula Resolution Time	Fistula resolution time for participants	Through duration of study, up to 1 year
Complication Occurrences	The number of complication occurrences related to the device will be recorded.	Through duration of study, up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Analysis of the 3D Printed Device	The cost of the patient management with the device will be estimated	Weekly from beginning of study until the end of the study, up to 1 year

Collaborators and Investigators

• Sponsor: Andrew Bernard
• Investigators: Principal Investigator: Andrew Bernard, MD, FACS, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 16, 2022
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Wound care; Open abdominal
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Wounds and Injuries; Fistula; Abdominal Injuries
• Other Study ID Numbers: 46641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No