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

Pressure Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522714
• Other study ID #: STU00200584
• Status: Completed
• Phase: N/A
• Start date: August 8, 2015
• Est. completion date: December 2020

Study information

• Verified date: April 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• Fluid Immersion Simulation System
Dolphin Fluid Immersion Simulation® System Mattress will be used
• Air Fluidized Bed System
Air Fluidized Bed (Clinitron) will be used.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital Plastic Surgery	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery	Comparison of success of closure between treatment groups.	2 weeks
Secondary	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
Secondary	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
Secondary	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