At a glance
ClinicalIndex Comparison RecordN/ACompleted· 80 enrolled
Drug / intervention
Fluid Immersion Simulation System +1 moredevice
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.
A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of the Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System in the Acute Post-Operative Management of Surgically Closed Pressure Ulcers
In Brief
A clinical study evaluating Fluid Immersion Simulation System and Air Fluidized Bed System for Pressure Ulcer. Completed, enrolled 80 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPressure Ulcer
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedMay 2018
Primary CompletionDec 2020
TodayJul 2026
First PostedMay 11, 2018
Enrollment StartAug 8, 2015
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.1 years ago
Interventions
Fluid Immersion Simulation Systemdevice
Dolphin Fluid Immersion Simulation® System Mattress will be used
Air Fluidized Bed Systemdevice
Air Fluidized Bed (Clinitron) will be used.