Clinical trial NCT03522714: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: support
flap
pressure
surface
closure
ulcer
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 allocation ratio
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Participants With Complications
timeFrame: 2 weeks
measure: Differences in Quantitative Patient Survey Responses: Acceptability
timeFrame: 2 weeks
measure: Differences in Quantitative Nurse Survey Responses
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital Plastic Surgery
state: Illinois
Study officials:
affiliation: Northwestern Medicine
name: Robert D Galiano, MD
role: PRINCIPAL_INVESTIGATOR
References: