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

Not Applicable

Completed

• Conditions: Abdominal Injury; Fistula; Negative Pressure Wound Therapy
• Interventions: Device: 3D printed EAF management device

• Registration Number: NCT04978090
• Lead Sponsor: Andrew Bernard

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-27
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Status Verified: 2023-09
• Results First Submitted: 2023-09-15
• Results First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Results First Posted: 2023-10-10
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enteroatmospheric fistula (EAF) management solution	3D printed EAF management device	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.

Primary Outcome Measures

Name	Time	Method
Change in Inpatient Participant Pain Rating	Daily from admission to discharge, up to 1 year	Participants will be asked to rate their pain on a scale of 1-10, where 10 indicates more pain.
Change in Inpatient Participant Mobility Assessment	Daily from admission to discharge, up to 1 year	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.
Change in Number of Required Wound Dressing Changes - Outpatient	Daily from discharge until fistula resolves or study ends, up to 1 year	The number of dressing changes will be tracked for outpatients on a daily bases.
Change in Outpatient Participant Pain Rating	Weekly from discharge until fistula resolves or study ends, up to 1 year	Participants will be asked to rate their pain on a scale of 1-10, where 10 indicates more pain.
Change in Number of Required Wound Dressing Changes - Inpatient	Daily from admission to discharge, up to 1 year	The number of dressing changes will be tracked for inpatients on a daily bases.
Change in Perceived Ease of Use - Outpatient	Weekly from discharge until fistula resolves or study ends, up to 1 year	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.
Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient	Daily from admission to discharge, up to 1 year	The time required to change the wound dressings will be recorded.
Change in Outpatient Participant Mobility Assessment	Weekly from until fistula resolves or study ends, up to 1 year	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.
Change in Perceived Usefulness - Outpatient	Weekly from discharge until fistula resolves or study ends, up to 1 year	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.
Change in Perceived Usefulness - Inpatient	Daily from admission to discharge, up to 1 year	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.
Change in Perceived Ease of Use - Inpatient	Daily from admission to discharge, up to 1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States