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

Pressure Ulcer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03522714
Study type Interventional
Source Northwestern University
Contact
Status Completed
Phase N/A
Start date August 8, 2015
Completion date December 2020
View Details
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