NCT04978090

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Andrew Bernard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-09-16
• Completion: 2022-09-16
• First posted: 2021-07-27
• Last updated: 2023-10-10
• Results posted: 2023-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study