At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2 enrolled
Drug / intervention
3D printed EAF management devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
In Brief
A clinical study evaluating 3D printed EAF management device for Fistula and 2 related conditions. Completed, enrolled 2 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFistula, Abdominal Injury, Negative Pressure Wound Therapy
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartJul 2021
First PostedJul 2021
Primary CompletionSep 2022
TodayJul 2026
First PostedJul 27, 2021
Enrollment StartJul 1, 2021
Primary CompletionSep 16, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.9 years ago
Interventions
3D printed EAF management devicedevice
Participants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed.