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Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers

NCT03522714 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-28

Study results available
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Summary

The primary objective is to compare the efficacy of the FIS on closure rate to the AFB after 2 weeks of operative debridement and closure.

Conditions

  • Pressure Ulcer

Interventions

DEVICE

Fluid Immersion Simulation System

Dolphin Fluid Immersion Simulation® System Mattress will be used

DEVICE

Air Fluidized Bed System

Air Fluidized Bed (Clinitron) will be used.

Sponsors & Collaborators

Principal Investigators

  • Robert D Galiano, MD · Northwestern Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-08
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03522714 on ClinicalTrials.gov