Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers
Completed · Not applicable
Conditions studied: Pressure Ulcer
In brief
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.
Key facts
- Study ID
- NCT03522714
- Run by
- Northwestern University
- People needed
- 80
- Starts
- 2015-08-08
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2026-04-28
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- will be admitted as an inpatient
- is ≥ 18 years of age and ≤ 85 years of age at time of consent
- is able to provide his/her own informed consent
- is deemed by the investigators to be reasonably compliant
- has a pressure ulcer meeting criteria for stage III or IV
- has not participated in a clinical trial within the past 30 days
- has a 30-day wound history available if the wound has been previously treated
You may not qualify if…
- has a life expectancy of < 12 months
- is not healthy enough to undergo surgery for any reason
- has a history of radiation therapy
- is, in the opinion of the investigator, noncompliant
- has a history of > 3 closures of pressure ulcers in the same site
- has a history of a bleeding disorder
- has severe fecal incontinence
Where it is running
- Northwestern Memorial Hospital Plastic Surgery — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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