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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteroatmospheric fistula (EAF) management solution | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printed EAF management device | 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. |
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Bernard, MD, FACS | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jan 22, 2021 |
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| 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 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Daily from admission to discharge, up to 1 year |
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| Primary | 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. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Weekly from discharge until fistula resolves or study ends, up to 1 year |
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| Primary | 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. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Daily from admission to discharge, up to 1 year |
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| Primary | 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. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Weekly from until fistula resolves or study ends, up to 1 year |
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| Primary | Change in Number of Required Wound Dressing Changes - Inpatient | The number of dressing changes will be tracked for inpatients on a daily bases. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Daily from admission to discharge, up to 1 year |
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| Primary | Change in Number of Required Wound Dressing Changes - Outpatient | The number of dressing changes will be tracked for outpatients on a daily bases. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Daily from discharge until fistula resolves or study ends, up to 1 year |
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| Primary | 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. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Daily from admission to discharge, up to 1 year |
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| Primary | 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. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Weekly from discharge until fistula resolves or study ends, up to 1 year |
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| Primary | 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. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Daily from admission to discharge, up to 1 year |
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| Primary | 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. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Weekly from discharge until fistula resolves or study ends, up to 1 year |
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| Primary | Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient | The time required to change the wound dressings will be recorded. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Daily from admission to discharge, up to 1 year |
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| Secondary | Infection Rates | The number of infections in participants that are related to the device will be recorded. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Through duration of study, up to 1 year |
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| Secondary | Number of Observed Leakages | The number of observed leakages in participants that are related to the device will be recorded. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Through duration of study, up to 1 year |
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| Secondary | Length of Stay | Length of stay in hospital | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Through duration of study, up to 1 year |
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| Secondary | Fistula Resolution Time | Fistula resolution time for participants | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Through duration of study, up to 1 year |
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| Secondary | Complication Occurrences | The number of complication occurrences related to the device will be recorded. | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Through duration of study, up to 1 year |
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| Other Pre-specified | Cost Analysis of the 3D Printed Device | The cost of the patient management with the device will be estimated | Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented. | Posted | Weekly from beginning of study until the end of the study, up to 1 year |
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Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Bernard | University of Kentucky | 859-257-3253 | andrew.bernard@uky.edu |
| Sep 15, 2023 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D005402 | Fistula |
| D000007 | Abdominal Injuries |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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