Pressure UlcerNCT03522714
Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers
A study testing Fluid Immersion Simulation System and Air Fluidized Bed System in people with Pressure Ulcer, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Fluid Immersion Simulation System and Air Fluidized Bed System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital Plastic Surgery
Chicago, Illinois, 60611
About this study
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
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.
Read the detailed 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 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.
- Conditions
- Pressure Ulcer
- Being tested
- Fluid Immersion Simulation System, Air Fluidized Bed System
- Keywords
- support, flap, pressure, surface, closure, ulcer
- Medical subject headings
- Pressure Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid Immersion Simulation SystemDevice
Also called FIS, Dolphin
Dolphin Fluid Immersion Simulation® System Mattress will be used
Air Fluidized Bed SystemDevice
Also called AFB, Clinitron
Air Fluidized Bed (Clinitron) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Fluid Immersion Simulation System (FIS) | Active comparator | Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure. Receives: Device: Fluid Immersion Simulation System |
| Air Fluidized Bed System (AFB) | Active comparator | Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure Receives: Device: Air Fluidized Bed System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
Comparison of successful closure of wound at 2 weeks after surgery between treatment groups.
Measured: 2 weeks
Secondary outcomes (3)
Number of Participants With Complications
Comparison of complication rate, including dehiscence, necrosis, maceration, and seromas between treatment groups. These are gathered via the patient's medical chart and interaction with the Principle Investigator (their physician).
Measured: 2 weeks
Differences in Quantitative Patient Survey Responses: Acceptability
Differences in quantitative patient survey responses regarding acceptability. This scale includes three subscales: 1) comfort, 2) difficulty with mobilization, and 3) pain at surgical site. Each subscale is graded on a scale of 1-5 with 1 being "better" (i.e. very comfortable, no difficulty, or no pain) and 5 being "worse" (i.e. very uncomfortable, extreme difficulty, or extreme pain). Subscales will be combined to compute a total score by averaging the sum of each of the three subscales. The total score indicates patient acceptability on a scale of 1-5 with 1 being "better" (very acceptable) and 5 being "worse" (not acceptable).
Measured: 2 weeks
Differences in Quantitative Nurse Survey Responses
Differences in quantitative nurse survey responses regarding acceptability and tolerance of each therapeutic modality, including patient comfort. This survey includes three subscales: 1) ease of use, 2) amount of training required, and 3) Time Required for Troubleshooting or Otherwise Occupied by Device. Each subscale is graded on a scale of 1-5 with 1 being "better" (i.e. no difficulty, no training, or no time) and 5 being "worse" (i.e. extreme difficulty, very high amount of training, or >30 minutes a day). Subscales will be combined to compute a total score by averaging the sum of each of the three subscales. The total score indicates nurse acceptability on a scale of 1-5 with 1 being "better" (very acceptable) and 5 being "worse" (not acceptable).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start8 Aug 2015
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Galiano, Northwestern University
- Investigators
- Robert D Galiano, MD, Principal investigator, Northwestern Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522714
- Sponsor's protocol ID
- STU00200584
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2018
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03522714
- Acronym / sponsor ID
- STU00200584
- Conditions
- Pressure Ulcer
- Keywords
- support, flap, pressure, surface, closure, ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 8 Aug 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Fluid Immersion Simulation System (FIS) | Active comparator | Device: Fluid Immersion Simulation SystemPressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure. |
| Air Fluidized Bed System (AFB) | Active comparator | Device: Air Fluidized Bed SystemPressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid Immersion Simulation SystemAlso: FIS, DolphinDolphin Fluid Immersion Simulation® System Mattress will be used | Device | Fluid Immersion Simulation System (FIS) |
| Air Fluidized Bed SystemAlso: AFB, ClinitronAir Fluidized Bed (Clinitron) will be used. | Device | Air Fluidized Bed System (AFB) |
Primary outcome
Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
Time frame: 2 weeks
Comparison of successful closure of wound at 2 weeks after surgery between treatment groups.
3 secondary outcomes
Number of Participants With Complications
Time frame: 2 weeks
Differences in Quantitative Patient Survey Responses: Acceptability
Time frame: 2 weeks
Differences in Quantitative Nurse Survey Responses
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Galiano, MD principal investigator
Northwestern Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid Immersion Simulation System and Air Fluidized Bed System in people with Pressure Ulcer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.