Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy

Fistula Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04978090
• Other study ID #: 46641
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: September 16, 2022

Study information

• Verified date: September 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Injuries
• Abdominal Injury
• Fistula
• Negative Pressure Wound Therapy
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Andrew Bernard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost Analysis of the 3D Printed Device	The cost of the patient management with the device will be estimated	Weekly from beginning of study until the end of the study, up to 1 year
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.	Daily from admission to discharge, up to 1 year
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.	Weekly from discharge until fistula resolves or study ends, up to 1 year
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.	Daily from admission to discharge, up to 1 year
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.	Weekly from until fistula resolves or study ends, up to 1 year
Primary	Change in Number of Required Wound Dressing Changes - Inpatient	The number of dressing changes will be tracked for inpatients on a daily bases.	Daily from admission to discharge, up to 1 year
Primary	Change in Number of Required Wound Dressing Changes - Outpatient	The number of dressing changes will be tracked for outpatients on a daily bases.	Daily from discharge until fistula resolves or study ends, up to 1 year
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.	Daily from admission to discharge, up to 1 year
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.	Weekly from discharge until fistula resolves or study ends, up to 1 year
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.	Daily from admission to discharge, up to 1 year
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.	Weekly from discharge until fistula resolves or study ends, up to 1 year
Primary	Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient	The time required to change the wound dressings will be recorded.	Daily from admission to discharge, up to 1 year
Secondary	Infection Rates	The number of infections in participants that are related to the device will be recorded.	Through duration of study, up to 1 year
Secondary	Number of Observed Leakages	The number of observed leakages in participants that are related to the device will be recorded.	Through duration of study, up to 1 year
Secondary	Length of Stay	Length of stay in hospital	Through duration of study, up to 1 year
Secondary	Fistula Resolution Time	Fistula resolution time for participants	Through duration of study, up to 1 year
Secondary	Complication Occurrences	The number of complication occurrences related to the device will be recorded.	Through duration of study, up to 1 year