Abdominal Injury, Fistula, Negative Pressure Wound Therapy
Conditions
Keywords
Open abdominal, Wound care
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.
Interventions
DEVICE3D 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.
Sponsors
Andrew Bernard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | unable to adequately fit device | 2 |
Baseline characteristics
| Characteristic | Enteroatmospheric Fistula (EAF) Management Solution |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Primary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Primary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Primary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Primary
Change in Number of Required Wound Dressing Changes - Outpatient
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Primary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Primary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Primary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Primary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Primary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Primary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Secondary
Complication Occurrences
The number of complication occurrences related to the device will be recorded.
Time frame: Through duration of study, up to 1 year
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Secondary
Fistula Resolution Time
Fistula resolution time for participants
Time frame: Through duration of study, up to 1 year
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Secondary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Secondary
Length of Stay
Length of stay in hospital
Time frame: Through duration of study, up to 1 year
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Secondary
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.
Other Pre-specified
Cost Analysis of the 3D Printed Device
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
Population: Two participants were enrolled in this study. Due to the possibility that the participants could reasonably be identified due to low enrollment, data cannot be presented.