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Completed

NCT Number: NCT03522714

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

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.

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Key information

Conditions

Pressure Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Ulcer

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital Plastic Surgery

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid Immersion Simulation System

Device

Dolphin Fluid Immersion Simulation® System Mattress will be used

Other names: FIS, Dolphin

Air Fluidized Bed System

Device

Air Fluidized Bed (Clinitron) will be used.

Other names: AFB, Clinitron

Primary outcomes

  1. Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery

    Time frame: 2 weeks

    Comparison of successful closure of wound at 2 weeks after surgery between treatment groups.

Secondary outcomes

  1. Number of Participants With Complications

    Time frame: 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).

  2. Differences in Quantitative Patient Survey Responses: Acceptability

    Time frame: 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).

  3. Differences in Quantitative Nurse Survey Responses

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 11, 2018
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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