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

Not Applicable

Completed

• Conditions: Pressure Ulcer
• Interventions: Device: Fluid Immersion Simulation System; Device: Air Fluidized Bed System

• Registration Number: NCT03522714
• Lead Sponsor: Northwestern University

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:

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 Timeline

• Study Start: 2015-08-08
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-11
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Results First Submitted: 2021-12-14
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-10
• Last Update Submitted: 2023-04-10
• Results First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid Immersion Simulation System (FIS)	Fluid Immersion Simulation System	Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Air Fluidized Bed System (AFB)	Air Fluidized Bed System	Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Differences in Quantitative Patient Survey Responses: Acceptability	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).
Differences in Quantitative Nurse Survey Responses	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).
Number of Participants With Complications	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).

Trial Locations

Locations (1)

Northwestern Memorial Hospital Plastic Surgery; 🇺🇸 Chicago, Illinois, United States