Back to resultsPilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
Primary Purpose
Fistula, Abdominal Injury, Negative Pressure Wound Therapy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D printed EAF management device
Sponsored by
About this trial
This is an interventional prevention trial for Fistula focused on measuring Open abdominal, Wound care
Eligibility Criteria
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
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enteroatmospheric fistula (EAF) management solution
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Change in Number of Required Wound Dressing Changes - Inpatient
The number of dressing changes will be tracked for inpatients on a daily bases.
Change in Number of Required Wound Dressing Changes - Outpatient
The number of dressing changes will be tracked for outpatients on a daily bases.
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.
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.
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.
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.
Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient
The time required to change the wound dressings will be recorded.
Secondary Outcome Measures
Infection Rates
The number of infections in participants that are related to the device will be recorded.
Number of Observed Leakages
The number of observed leakages in participants that are related to the device will be recorded.
Length of Stay
Length of stay in hospital
Fistula Resolution Time
Fistula resolution time for participants
Complication Occurrences
The number of complication occurrences related to the device will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04978090
Brief Title
Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
Official Title
Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Bernard
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fistula, Abdominal Injury, Negative Pressure Wound Therapy
Keywords
Open abdominal, Wound care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enteroatmospheric fistula (EAF) management solution
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
3D printed EAF management device
Intervention Description
Participants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed.
Primary Outcome Measure Information:
Title
Change in Inpatient Participant Pain Rating
Description
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
Title
Change in Outpatient Participant Pain Rating
Description
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
Title
Change in Inpatient Participant Mobility Assessment
Description
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
Title
Change in Outpatient Participant Mobility Assessment
Description
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
Title
Change in Number of Required Wound Dressing Changes - Inpatient
Description
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
Title
Change in Number of Required Wound Dressing Changes - Outpatient
Description
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
Title
Change in Perceived Usefulness - Inpatient
Description
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
Title
Change in Perceived Usefulness - Outpatient
Description
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
Title
Change in Perceived Ease of Use - Inpatient
Description
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
Title
Change in Perceived Ease of Use - Outpatient
Description
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
Title
Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient
Description
The time required to change the wound dressings will be recorded.
Time Frame
Daily from admission to discharge, up to 1 year
Secondary Outcome Measure Information:
Title
Infection Rates
Description
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
Title
Number of Observed Leakages
Description
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
Title
Length of Stay
Description
Length of stay in hospital
Time Frame
Through duration of study, up to 1 year
Title
Fistula Resolution Time
Description
Fistula resolution time for participants
Time Frame
Through duration of study, up to 1 year
Title
Complication Occurrences
Description
The number of complication occurrences related to the device will be recorded.
Time Frame
Through duration of study, up to 1 year
Other Pre-specified Outcome Measures:
Title
Cost Analysis of the 3D Printed Device
Description
The cost of the patient management with the device will be estimated
Time Frame
Weekly from beginning of study until the end of the study, up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Bernard, MD, FACS
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
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