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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
2
Participants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed.
University of Kentucky
Lexington, Kentucky, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Daily from admission to discharge, up to 1 year
Change in Number of Required Wound Dressing Changes - Outpatient
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The number of dressing changes will be tracked for outpatients on a daily bases.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Daily from admission to discharge, up to 1 year
Infection Rates
The number of infections in participants that are related to the device will be recorded.
Time frame: 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.
Time frame: Through duration of study, up to 1 year
Length of Stay
Length of stay in hospital
Time frame: Through duration of study, up to 1 year
Fistula Resolution Time
Fistula resolution time for participants
Time frame: Through duration of study, up to 1 year
Complication Occurrences
The number of complication occurrences related to the device will be recorded.
Time frame: Through duration of study, up to 1 year