Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pressure Ulcer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 1:1 allocation ratioMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
Secondary Objectives: Compare the complication rate in each treatment group during the acute postoperative period (2 weeks). Comparisons of the inflammatory and bacterial microbiomes of pressure ulcers following surgical therapy. Comparisons of baseline patient characteristics and their relationship...
Secondary Objectives: Compare the complication rate in each treatment group during the acute postoperative period (2 weeks). Comparisons of the inflammatory and bacterial microbiomes of pressure ulcers following surgical therapy. Comparisons of baseline patient characteristics and their relationship to both early and late pressure ulcer recurrence, and complication rates. Assessment of outcomes and complications associated with flap technique and surgeon guided descriptions of the operative closure. Compare the absolute costs associated with the FIS System against AFB system. Compare the acceptance of each system by subjects and nursing staff, including the parameter of patient comfort at 7 and 14 days postoperative. Assessing the incidence of complications and additional treatments needed following the two week study period.
Tracking Information
- NCT #
- NCT03522714
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Robert D Galiano, MD Northwestern Medicine
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