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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fistula, Abdominal Injury, Negative Pressure Wound Therapy

Intervention / Treatment
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* Device: 3D printed EAF management device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteroatmospheric fistula (EAF) management solution<br>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<br>* Participants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open abdominal, Wound care