Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Change in Inpatient Participant Pain Rating
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in Inpatient Participant Pain Rating
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Infection Rates(Through duration of study, up to 1 year)
- Number of Observed Leakages(Through duration of study, up to 1 year)
- Length of Stay(Through duration of study, up to 1 year)
- Fistula Resolution Time(Through duration of study, up to 1 year)
- Complication Occurrences(Through duration of study, up to 1 year)
Investigators
Andrew Bernard
Professor
University of Kentucky