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

Northwestern University

Status: Completed

Conditions: Pressure Ulcer

Treatments: Device: Air Fluidized Bed System; Device: Fluid Immersion Simulation System

Study type: Interventional

Funder types: Other

Identifiers

NCT03522714

STU00200584

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Fluid Immersion Simulation System (FIS)

Active Comparator group

Description:

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

Treatment:

Device: Fluid Immersion Simulation System

Air Fluidized Bed System (AFB)

Active Comparator group

Description:

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

Treatment:

Device: Air Fluidized Bed System