FistulaNCT04978090
Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
A study testing 3D printed EAF management device in people with Fistula and Abdominal Injury, run by Andrew Bernard at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fistula, Abdominal Injury, Negative Pressure Wound Therapy
- What is being tested?
- 3D printed EAF management device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 16 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable condition, as determined by attending physician
- Has enteroatmospheric fistula (EAF) in the setting of open abdomen
- EAF is determined to require surgical resolution
Who cannot join
- Unstable condition, as determined by attending physician
- Significant risk of complication
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fistula, Abdominal Injury, Negative Pressure Wound Therapy
- Being tested
- 3D printed EAF management device
- Keywords
- Open abdominal, Wound care
- Medical subject headings
- Fistula, Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed EAF management deviceDevice
Participants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 3D printed EAF management device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily from admission to discharge, up to 1 year
Change in Number of Required Wound Dressing Changes - Outpatient
The number of dressing changes will be tracked for outpatients on a daily bases.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily from admission to discharge, up to 1 year
Secondary outcomes (5)
Infection Rates
The number of infections in participants that are related to the device will be recorded.
Measured: 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.
Measured: Through duration of study, up to 1 year
Length of Stay
Length of stay in hospital
Measured: Through duration of study, up to 1 year
Fistula Resolution Time
Fistula resolution time for participants
Measured: Through duration of study, up to 1 year
Complication Occurrences
The number of complication occurrences related to the device will be recorded.
Measured: Through duration of study, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Jul 2021
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Bernard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Bernard, University of Kentucky
- Investigators
- Andrew Bernard, MD, FACS, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978090
- Sponsor's protocol ID
- 46641
- Status last verified
- Sep 2023
- First submitted
- 1 Jul 2021
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04978090
- Acronym / sponsor ID
- 46641
- Conditions
- Fistula, Abdominal Injury, Negative Pressure Wound Therapy
- Keywords
- Open abdominal, Wound care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Andrew BernardUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Posted 10 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteroatmospheric fistula (EAF) management solution | Experimental | Device: 3D printed EAF management deviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable condition, as determined by attending physician
- Has enteroatmospheric fistula (EAF) in the setting of open abdomen
- EAF is determined to require surgical resolution
Key exclusion criteria (2 listed)
- Unstable condition, as determined by attending physician
- Significant risk of complication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed EAF management deviceParticipants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed. | Device | Enteroatmospheric fistula (EAF) management solution |
Primary outcome
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 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 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 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 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 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 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 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 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.
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.
5 secondary outcomes
Infection Rates
Time frame: Through duration of study, up to 1 year
Number of Observed Leakages
Time frame: Through duration of study, up to 1 year
Length of Stay
Time frame: Through duration of study, up to 1 year
Fistula Resolution Time
Time frame: Through duration of study, up to 1 year
Complication Occurrences
Time frame: Through duration of study, up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Bernard, MD, FACS principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed EAF management device in people with Fistula and Abdominal Injury, run by Andrew Bernard at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inpatient Participant Pain Rating (time frame: Daily from admission to discharge, up to 1 year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.