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

April 10, 2023 updated by: Robert Galiano, Northwestern University

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.

Study Overview

Detailed Description

Secondary Objectives:

  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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. will be admitted as an inpatient
  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:

  1. has a life expectancy of < 12 months
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluid Immersion Simulation System (FIS)
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Dolphin Fluid Immersion Simulation® System Mattress will be used
Other Names:
  • FIS, Dolphin
Active Comparator: Air Fluidized Bed System (AFB)
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Air Fluidized Bed (Clinitron) will be used.
Other Names:
  • AFB, Clinitron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
Time Frame: 2 weeks
Comparison of success of closure between treatment groups.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Complications
Time Frame: 2 weeks
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).
2 weeks
Differences in Quantitative Patient Survey Responses: Acceptability
Time Frame: 2 weeks
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).
2 weeks
Differences in Quantitative Nurse Survey Responses
Time Frame: 2 weeks
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).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert D Galiano, MD, Northwestern Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2015

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

February 13, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STU00200584

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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