Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers

NCT03522714 | Completed Results FDA Device

• 1 other identifier: STU00200584
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Ulcer

Keywords

support; flap; pressure; surface; closure; ulcer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (3)

• Number of Participants With Complications

  2 weeks

• Differences in Quantitative Patient Survey Responses: Acceptability

  2 weeks

• Differences in Quantitative Nurse Survey Responses

  2 weeks

Study Arms (2)

Fluid Immersion Simulation System (FIS)

ACTIVE COMPARATOR

Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.

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

Device: Air Fluidized Bed System

Interventions

Fluid Immersion Simulation System DEVICE

Dolphin Fluid Immersion Simulation® System Mattress will be used

Also known as: FIS, Dolphin

Fluid Immersion Simulation System (FIS)

Air Fluidized Bed System DEVICE

Air Fluidized Bed (Clinitron) will be used.

Also known as: AFB, Clinitron

Air Fluidized Bed System (AFB)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital Plastic Surgery

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Peter Ullrich, Clinical Research Coordinator
• Organization: Northwestern University

peter.ullrich@nm.org

3129267037

Study Officials

• Robert D Galiano, MD

  Northwestern Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery (Plastic Surgery) and Dermatology

Model Details: 1:1 allocation ratio

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: May 11, 2018
• Study Start: August 8, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 28, 2026
• Results First Posted: May 3, 2023

Record last verified: 2026-04

Locations

US (1)