N/A
N=80
Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers
Pressure Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03522714 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
May 2023
Primary outcome: Primary: Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery — 85.7142857; 87.5 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fluid Immersion Simulation System (Device); Air Fluidized Bed System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery |
85.7142857; 87.5 | — |
| SECONDARY Number of Participants With Complications |
8; 15; 17; 20 | — |
| SECONDARY Differences in Quantitative Patient Survey Responses: Acceptability |
2.08; 2.06 | — |
| SECONDARY Differences in Quantitative Nurse Survey Responses |
1.49; 1.72 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- has a life expectancy of 3 closures of pressure ulcers in the same site
- has a history of a bleeding disorder
- has severe fecal incontinence
Data sourced from ClinicalTrials.gov (NCT03522714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.