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

NCT04978090 | Completed Results DMC FDA Device

• 1 other identifier: 46641
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Fistula; Abdominal Injury; Negative Pressure Wound Therapy

Keywords

Open abdominal; Wound care

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Infection Rates

  Through duration of study, up to 1 year

• Number of Observed Leakages

  Through duration of study, up to 1 year

• Length of Stay

  Through duration of study, up to 1 year

• Fistula Resolution Time

  Through duration of study, up to 1 year

• Complication Occurrences

  Through duration of study, up to 1 year

Other Outcomes (1)

• Cost Analysis of the 3D Printed Device

  Weekly from beginning of study until the end of the study, up to 1 year

Study Arms (1)

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.

Device: 3D printed EAF management device

Interventions

3D printed EAF management device 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.

Enteroatmospheric fistula (EAF) management solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable condition, as determined by attending physician
• Has enteroatmospheric fistula (EAF) in the setting of open abdomen
• EAF is determined to require surgical resolution

You may not qualify if:

• Unstable condition, as determined by attending physician
• Significant risk of complication

Sponsors & Collaborators

• Andrew Bernard: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Fistula; Abdominal Injuries

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Results Point of Contact

• Title: Dr. Andrew Bernard
• Organization: University of Kentucky

andrew.bernard@uky.edu

859-257-3253

Study Officials

• Andrew Bernard, MD, FACS

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 27, 2021
• Study Start: July 1, 2021
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)