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

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluid Immersion Simulation System
Air Fluidized Bed System
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcer focused on measuring support, flap, pressure, surface, closure, ulcer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Memorial Hospital Plastic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fluid Immersion Simulation System (FIS)

Air Fluidized Bed System (AFB)

Arm Description

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

Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure

Outcomes

Primary Outcome Measures

Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
Comparison of success of closure between treatment groups.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
February 13, 2018
Last Updated
April 10, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03522714
Brief Title
Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2015 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
support, flap, pressure, surface, closure, ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 allocation ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluid Immersion Simulation System (FIS)
Arm Type
Active Comparator
Arm Description
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Arm Title
Air Fluidized Bed System (AFB)
Arm Type
Active Comparator
Arm Description
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Intervention Type
Device
Intervention Name(s)
Fluid Immersion Simulation System
Other Intervention Name(s)
FIS, Dolphin
Intervention Description
Dolphin Fluid Immersion Simulation® System Mattress will be used
Intervention Type
Device
Intervention Name(s)
Air Fluidized Bed System
Other Intervention Name(s)
AFB, Clinitron
Intervention Description
Air Fluidized Bed (Clinitron) will be used.
Primary Outcome Measure Information:
Title
Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
Description
Comparison of success of closure between treatment groups.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Complications
Description
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).
Time Frame
2 weeks
Title
Differences in Quantitative Patient Survey Responses: Acceptability
Description
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).
Time Frame
2 weeks
Title
Differences in Quantitative Nurse Survey Responses
Description
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).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 < 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D Galiano, MD
Organizational Affiliation
Northwestern Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital Plastic Surgery
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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

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