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Completed

NCT Number: NCT04978090

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

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.

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Key information

Conditions

Fistula Abdominal Injuries Abdominal Injury Negative Pressure Wound Therapy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Secondary outcomes

  1. Infection Rates

    Time frame: Through duration of study, up to 1 year

    The number of infections in participants that are related to the device will be recorded.

  2. Number of Observed Leakages

    Time frame: Through duration of study, up to 1 year

    The number of observed leakages in participants that are related to the device will be recorded.

  3. Length of Stay

    Time frame: Through duration of study, up to 1 year

    Length of stay in hospital

  4. Fistula Resolution Time

    Time frame: Through duration of study, up to 1 year

    Fistula resolution time for participants

  5. Complication Occurrences

    Time frame: Through duration of study, up to 1 year

    The number of complication occurrences related to the device will be recorded.

Other outcomes

  1. Cost Analysis of the 3D Printed Device

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Andrew Bernard

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 27, 2021
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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