Trial Outcomes & Findings for Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers (NCT NCT03522714)
NCT ID: NCT03522714
Last Updated: 2023-05-03
Results Overview
Comparison of success of closure between treatment groups.
COMPLETED
NA
80 participants
2 weeks
2023-05-03
Participant Flow
Participant milestones
| Measure |
Fluid Immersion Simulation System (FIS)
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Fluid Immersion Simulation System: Dolphin Fluid Immersion Simulation® System Mattress will be used
|
Air Fluidized Bed System (AFB)
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Air Fluidized Bed System: Air Fluidized Bed (Clinitron) will be used.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
42
|
|
Overall Study
COMPLETED
|
28
|
40
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers
Baseline characteristics by cohort
| Measure |
Fluid Immersion Simulation System (FIS)
n=38 Participants
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Fluid Immersion Simulation System: Dolphin Fluid Immersion Simulation® System Mattress will be used
|
Air Fluidized Bed System (AFB)
n=42 Participants
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Air Fluidized Bed System: Air Fluidized Bed (Clinitron) will be used.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.61 years
STANDARD_DEVIATION 13.75 • n=5 Participants
|
47.45 years
STANDARD_DEVIATION 42 • n=7 Participants
|
48.48 years
STANDARD_DEVIATION 13.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
27 participants
n=5 Participants
|
20 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
42 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksComparison of success of closure between treatment groups.
Outcome measures
| Measure |
Fluid Immersion Simulation System (FIS)
n=28 Participants
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Fluid Immersion Simulation System: Dolphin Fluid Immersion Simulation® System Mattress will be used
|
Air Fluidized Bed System (AFB)
n=40 Participants
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Air Fluidized Bed System: Air Fluidized Bed (Clinitron) will be used.
|
|---|---|---|
|
Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
|
85.7142857 percent of participants
|
87.5 percent of participants
|
SECONDARY outcome
Timeframe: 2 weeksComparison 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).
Outcome measures
| Measure |
Fluid Immersion Simulation System (FIS)
n=28 Participants
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Fluid Immersion Simulation System: Dolphin Fluid Immersion Simulation® System Mattress will be used
|
Air Fluidized Bed System (AFB)
n=40 Participants
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Air Fluidized Bed System: Air Fluidized Bed (Clinitron) will be used.
|
|---|---|---|
|
Number of Participants With Complications
Complications Prior to ClimateCare introduction
|
8 Participants
|
15 Participants
|
|
Number of Participants With Complications
Complications Following ClimateCare introduction
|
17 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 2 weeksDifferences 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).
Outcome measures
| Measure |
Fluid Immersion Simulation System (FIS)
n=28 Participants
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Fluid Immersion Simulation System: Dolphin Fluid Immersion Simulation® System Mattress will be used
|
Air Fluidized Bed System (AFB)
n=40 Participants
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Air Fluidized Bed System: Air Fluidized Bed (Clinitron) will be used.
|
|---|---|---|
|
Differences in Quantitative Patient Survey Responses: Acceptability
|
2.08 Scores on a scale
Interval 1.0 to 5.0
|
2.06 Scores on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 2 weeksDifferences 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).
Outcome measures
| Measure |
Fluid Immersion Simulation System (FIS)
n=28 Participants
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Fluid Immersion Simulation System: Dolphin Fluid Immersion Simulation® System Mattress will be used
|
Air Fluidized Bed System (AFB)
n=40 Participants
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Air Fluidized Bed System: Air Fluidized Bed (Clinitron) will be used.
|
|---|---|---|
|
Differences in Quantitative Nurse Survey Responses
|
1.49 Scores on a scale
Interval 1.0 to 5.0
|
1.72 Scores on a scale
Interval 1.0 to 5.0
|
Adverse Events
Fluid Immersion Simulation System (FIS)
Air Fluidized Bed System (AFB)
Serious adverse events
| Measure |
Fluid Immersion Simulation System (FIS)
n=38 participants at risk
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Fluid Immersion Simulation System: Dolphin Fluid Immersion Simulation® System Mattress will be used
|
Air Fluidized Bed System (AFB)
n=42 participants at risk
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Air Fluidized Bed System: Air Fluidized Bed (Clinitron) will be used.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Severe Dehiscence
|
0.00%
0/38 • Baseline to 1 year.
|
2.4%
1/42 • Baseline to 1 year.
|
Other adverse events
| Measure |
Fluid Immersion Simulation System (FIS)
n=38 participants at risk
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
Fluid Immersion Simulation System: Dolphin Fluid Immersion Simulation® System Mattress will be used
|
Air Fluidized Bed System (AFB)
n=42 participants at risk
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
Air Fluidized Bed System: Air Fluidized Bed (Clinitron) will be used.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Minor Complications
|
57.9%
22/38 • Baseline to 1 year.
|
23.8%
10/42 • Baseline to 1 year.
|
Additional Information
Peter Ullrich, Clinical Research Coordinator
Northwestern University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place