Pressure Ulcer
Conditions
Keywords
support, flap, pressure, surface, closure, ulcer
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.
Interventions
DEVICEFluid Immersion Simulation System
Dolphin Fluid Immersion Simulation® System Mattress will be used
DEVICEAir Fluidized Bed System
Air Fluidized Bed (Clinitron) will be used.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 allocation ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery | 2 weeks | Comparison of successful closure of wound at 2 weeks after surgery between treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complications | 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). |
| Differences in Quantitative Patient Survey Responses: Acceptability | 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). |
| Differences in Quantitative Nurse Survey Responses | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert D Galiano, MD
Northwestern Medicine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 38 |
| 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. | 42 |
| Total | 80 |
Baseline characteristics
| Characteristic | Total | Air Fluidized Bed System (AFB) | Fluid Immersion Simulation System (FIS) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 42 Participants | 38 Participants |
| Age, Continuous | 48.48 years STANDARD_DEVIATION 13.37 | 47.45 years STANDARD_DEVIATION 42 | 49.61 years STANDARD_DEVIATION 13.75 |
| Race/Ethnicity, Customized African American | 25 participants | 15 participants | 10 participants |
| Race/Ethnicity, Customized Hispanic | 7 participants | 6 participants | 1 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 47 participants | 20 participants | 27 participants |
| Region of Enrollment United States | 80 participants | 42 participants | 38 participants |
| Sex: Female, Male Female | 27 Participants | 12 Participants | 15 Participants |
| Sex: Female, Male Male | 53 Participants | 30 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 38 | 2 / 42 |
| other Total, other adverse events | 22 / 38 | 10 / 42 |
| serious Total, serious adverse events | 0 / 38 | 1 / 42 |
Outcome results
Primary
Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
Comparison of success of closure between treatment groups.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluid Immersion Simulation System (FIS) | Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery | 85.7142857 percent of participants |
| Air Fluidized Bed System (AFB) | Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery | 87.5 percent of participants |
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).
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fluid Immersion Simulation System (FIS) | Differences in Quantitative Nurse Survey Responses | 1.49 Scores on a scale |
| Air Fluidized Bed System (AFB) | Differences in Quantitative Nurse Survey Responses | 1.72 Scores on a scale |
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).
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fluid Immersion Simulation System (FIS) | Differences in Quantitative Patient Survey Responses: Acceptability | 2.08 Scores on a scale |
| Air Fluidized Bed System (AFB) | Differences in Quantitative Patient Survey Responses: Acceptability | 2.06 Scores on a scale |
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).
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluid Immersion Simulation System (FIS) | Number of Participants With Complications | Complications Prior to ClimateCare introduction | 8 Participants |
| Fluid Immersion Simulation System (FIS) | Number of Participants With Complications | Complications Following ClimateCare introduction | 17 Participants |
| Air Fluidized Bed System (AFB) | Number of Participants With Complications | Complications Prior to ClimateCare introduction | 15 Participants |
| Air Fluidized Bed System (AFB) | Number of Participants With Complications | Complications Following ClimateCare introduction | 20 Participants |