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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04978090
Other study ID # 46641
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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