Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers
NCT ID: NCT03522714
Last Updated: 2023-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2015-08-08
2020-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluid Immersion Simulation System (FIS)
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Fluid Immersion Simulation System
Dolphin Fluid Immersion Simulation® System Mattress will be used
Air Fluidized Bed System (AFB)
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Air Fluidized Bed System
Air Fluidized Bed (Clinitron) will be used.
Interventions
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Fluid Immersion Simulation System
Dolphin Fluid Immersion Simulation® System Mattress will be used
Air Fluidized Bed System
Air Fluidized Bed (Clinitron) will be used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. is ≥ 18 years of age and ≤ 85 years of age at time of consent
3. is able to provide his/her own informed consent
4. is deemed by the investigators to be reasonably compliant
5. has a pressure ulcer meeting criteria for stage III or IV
6. has not participated in a clinical trial within the past 30 days
7. has a 30-day wound history available if the wound has been previously treated
Exclusion Criteria
2. is not healthy enough to undergo surgery for any reason
3. has a history of radiation therapy
4. is, in the opinion of the investigator, noncompliant
5. has a history of \> 3 closures of pressure ulcers in the same site
6. has a history of a bleeding disorder
7. has severe fecal incontinence
18 Years
85 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Robert Galiano
Associate Professor of Surgery (Plastic Surgery) and Dermatology
Principal Investigators
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Robert D Galiano, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Medicine
Locations
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Northwestern Memorial Hospital Plastic Surgery
Chicago, Illinois, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STU00200584
Identifier Type: -
Identifier Source: org_study_id
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