NCT03522714

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Secondary Objectives: 1. Compare the complication rate in each treatment group during the acute postoperative period (2 weeks). 2. Comparisons of the inflammatory and bacterial microbiomes of pressure ulcers following surgical therapy. 3. Comparisons of baseline patient characteristics and their relationship to both early and late pressure ulcer recurrence, and complication rates. 4. Assessment of outcomes and complications associated with flap technique and surgeon guided descriptions of the operative closure. 5. Compare the absolute costs associated with the FIS System against AFB system. 6. Compare the acceptance of each system by subjects and nursing staff, including the parameter of patient comfort at 7 and 14 days postoperative. 7. Assessing the incidence of complications and additional treatments needed following the two week study period.

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-08-08
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-05-11
• Last updated: 2023-05-03
• Results posted: 2023-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study