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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-09-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries

NCT00582998

Fracture of Calcaneus, Pilon or Tibial Plateau

COMPLETED NA

Study on Fistuloplasty Using Flow Measurement Guidance

NCT01643733

End Stage Renal Failure on Dialysis Renal Failure

TERMINATED NA

Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF

NCT04418726

Vascular Access Malfunction Vascular Access Complication Vascular Access Site Occlusion

UNKNOWN NA

Vacuum Assisted Closure as a Treatment for Open Fractures

NCT00582361

Orthopaedic Traumatic Open Fractures

COMPLETED NA

Intraoperative Fluorescence Angiography in Debridement of Open Fractures

NCT05006313

Intraoperative Fluorescence Angiography

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fistula Abdominal Injury Negative Pressure Wound Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Enteroatmospheric fistula (EAF) management solution

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.

Group Type EXPERIMENTAL

3D printed EAF management device

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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