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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Device: Fluid Immersion Simulation System
* Device: Air Fluidized Bed System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 allocation ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluid Immersion Simulation System (FIS)<br>Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure. | Device: Fluid Immersion Simulation System<br>* Dolphin Fluid Immersion Simulation® System Mattress will be used<br>* Other names: FIS, Dolphin;|
| Active Comparator: Air Fluidized Bed System (AFB)<br>Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure | Device: Air Fluidized Bed System<br>* Air Fluidized Bed (Clinitron) will be used.<br>* Other names: AFB, Clinitron;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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support, flap, pressure, surface, closure, ulcer