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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.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluid Immersion Simulation System (FIS) | Active Comparator | Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure. |
|
| Air Fluidized Bed System (AFB) | Active Comparator | Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid Immersion Simulation System | Device | Dolphin Fluid Immersion Simulation® System Mattress will be used |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery | Comparison of successful closure of wound at 2 weeks after surgery between treatment groups. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Differences in Quantitative Patient Survey Responses: Acceptability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D Galiano, MD | Northwestern Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital Plastic Surgery | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Air Fluidized Bed System (AFB) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery | Comparison of successful closure of wound at 2 weeks after surgery between treatment groups. | Posted | Number | percent of participants | 2 weeks |
|
Baseline to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor Complications | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Ullrich, Clinical Research Coordinator | Northwestern University | 3129267037 | peter.ullrich@nm.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 | Dec 14, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2019 | Dec 14, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
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1:1 allocation ratio
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| Air Fluidized Bed System | Device | Air Fluidized Bed (Clinitron) will be used. |
|
|
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 |
| 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 |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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). | Posted | Number | Participants | 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). | Posted | Mean | Full Range | Scores on a scale | 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). | Posted | Mean | Full Range | Scores on a scale | 2 weeks |
|
|
|
| 4 |
| 38 |
| 0 |
| 38 |
| 22 |
| 38 |
| EG001 | 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. | 2 | 42 | 1 | 42 | 10 | 42 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |