Clinical trial NCT04978090: Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fistula
Abdominal Injury
Negative Pressure Wound Therapy
Keywords: Open abdominal
Wound care
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Inpatient Participant Pain Rating
timeFrame: Daily from admission to discharge, up to 1 year
measure: Change in Outpatient Participant Pain Rating
timeFrame: Weekly from discharge until fistula resolves or study ends, up to 1 year
measure: Change in Inpatient Participant Mobility Assessment
timeFrame: Daily from admission to discharge, up to 1 year
measure: Change in Outpatient Participant Mobility Assessment
timeFrame: Weekly from until fistula resolves or study ends, up to 1 year
measure: Change in Number of Required Wound Dressing Changes - Inpatient
timeFrame: Daily from admission to discharge, up to 1 year
measure: Change in Number of Required Wound Dressing Changes - Outpatient
timeFrame: Daily from discharge until fistula resolves or study ends, up to 1 year
measure: Change in Perceived Usefulness - Inpatient
timeFrame: Daily from admission to discharge, up to 1 year
measure: Change in Perceived Usefulness - Outpatient
timeFrame: Weekly from discharge until fistula resolves or study ends, up to 1 year
measure: Change in Perceived Ease of Use - Inpatient
timeFrame: Daily from admission to discharge, up to 1 year
measure: Change in Perceived Ease of Use - Outpatient
timeFrame: Weekly from discharge until fistula resolves or study ends, up to 1 year
measure: Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient
timeFrame: Daily from admission to discharge, up to 1 year
Secondary outcomes:
measure: Infection Rates
timeFrame: Through duration of study, up to 1 year
measure: Number of Observed Leakages
timeFrame: Through duration of study, up to 1 year
measure: Length of Stay
timeFrame: Through duration of study, up to 1 year
measure: Fistula Resolution Time
timeFrame: Through duration of study, up to 1 year
measure: Complication Occurrences
timeFrame: Through duration of study, up to 1 year
Other outcomes:
measure: Cost Analysis of the 3D Printed Device
timeFrame: Weekly from beginning of study until the end of the study, up to 1 year
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Andrew Bernard, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: