Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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 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 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 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 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 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 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 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 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.
- 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.
Secondary Outcome Measures
- 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.
Other Outcome Measures
- Cost analysis of the 3D printed device [Weekly from beginning of study until the end of the study, up to 1 year]
The cost of the patient management with the device will be estimated
Eligibility Criteria
Criteria
Inclusion Criteria:
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Stable condition, as determined by attending physician
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Has enteroatmospheric fistula (EAF) in the setting of open abdomen
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EAF is determined to require surgical resolution
Exclusion Criteria:
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Unstable condition, as determined by attending physician
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Significant risk of complication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
Sponsors and Collaborators
- Andrew Bernard
Investigators
- Principal Investigator: Andrew Bernard, MD, FACS, University of Kentucky
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 46641