N/A N=2 Prevention

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

Fistula · Abdominal Injury · Negative Pressure Wound Therapy

Bottom Line

View on ClinicalTrials.gov: NCT04978090 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Oct 2023

Primary outcome: Primary: Change in Inpatient Participant Pain Rating

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 3D printed EAF management device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Andrew Bernard
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Inpatient Participant Pain Rating	—	—
PRIMARY Change in Outpatient Participant Pain Rating	—	—
PRIMARY Change in Inpatient Participant Mobility Assessment	—	—
PRIMARY Change in Outpatient Participant Mobility Assessment	—	—
PRIMARY Change in Number of Required Wound Dressing Changes - Inpatient	—	—
PRIMARY Change in Number of Required Wound Dressing Changes - Outpatient	—	—
PRIMARY Change in Perceived Usefulness - Inpatient	—	—
PRIMARY Change in Perceived Usefulness - Outpatient	—	—
PRIMARY Change in Perceived Ease of Use - Inpatient	—	—
PRIMARY Change in Perceived Ease of Use - Outpatient	—	—
PRIMARY Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient	—	—
SECONDARY Infection Rates	—	—
SECONDARY Number of Observed Leakages	—	—
SECONDARY Length of Stay	—	—
SECONDARY Fistula Resolution Time	—	—
SECONDARY Complication Occurrences	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04978090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.