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This pilot study will compare the incidence of pressure ulcers and the change in existing pressure ulcers for patients who are either placed on the new TC500 bed against those placed on the standard ICU bed in the Cardiovascular unit of University of Nebraska Medical Center. Additionally, the cost associated with rental beds will be calculated as well as skin care compliance. Sixty patients will be enrolled (30 per study arm).
This single center convenience sample controlled study will admit all subjects admitted to the Cardiovascular Surgical ICU unit. Subjects can have up to a Stage III pressure ulcer (full thickness ulcer) if they are assessed by the clinical wound team not to require a specialty mattress. This 12 bed ICU will have 6 TC500 beds, and 6 existing Total Care beds. A waiver of consent is requested for initial bed placement, to accommodate normal bed assignments within the facility, however, informed consent will be obtained prior to the collection of data for study purposes. Consented subjects will have primary and secondary diagnoses recorded, as well as pressure ulcer risk assessments, assessment of ventilation / oxygenation support measures, and estimated cardiac condition. They will be followed by daily skin assessments until they reach one of the following study endpoints: 1) discharge from the 850 Cardiovascular SICU unit, 2) have skin breakdown, which in the clinical assessment of the wound team staff would require a specialty bed, 3) expire, 4) withdraw informed consent, or 5) complete the 21 day study period.
Subjects who experience either development of pressure ulcers, or worsening of their skin and/or existing pressure ulcers to the point where a specialty bed is deemed required by the wound team staff will be considered treatment failures, and will be placed on the appropriate mattress identified by the treating staff of the hospital for their admitted condition. If the mattress is a rental therapy mattress, an estimate of the costs to rent this product will be calculated for each patient moving onto a rental mattress.
An assessment of skin care protocol adherence will be performed by the Wound Care team on a daily basis where subjects will be audited as to the percent of prescribed measures implemented.
If subjects require rental therapy beds for pressure ulcer development, the costs associated with this rental will be estimated (# days x average dollar value). These costs will be compared between the rental groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P500 Mattress | Experimental | The new P500 Low Air Loss mattress will be used to replace the standard mattress for this study arm. |
|
| Standard of Care Mattress | No Intervention | Cardiovascular ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care. All patients had daily skin assessments, as per normal care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P500 Mattress | Device | Study mattress |
|
| Measure | Description | Time Frame |
|---|---|---|
| Indicence of Pressure Ulcers | New pressure ulcers were assessed | at the end of study period (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of Rental Beds | Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only | End of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joyce Black, PhD, RN | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-5330 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | P500 Mattress | ICU patients placed on a TC500 bed with standard pressure ulcer prevention care Total Care P500 Mattress: Study mattress |
| FG001 | Standard Care Arm | ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ICU patients in a high acuity Medical / Surgical ICU.
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| ID | Title | Description |
|---|---|---|
| BG000 | P500 Mattress | ICU patients placed on a TC500 bed with standard pressure ulcer prevention care Total Care P500 Mattress: Study mattress |
| BG001 | Standard Care Arm | ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Indicence of Pressure Ulcers | New pressure ulcers were assessed | Tertiary Care ICU patients | Posted | Number | participants | at the end of study period (21 days) |
|
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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 | P500 Mattress | ICU patients placed on a TC500 bed with standard pressure ulcer prevention care Total Care P500 Mattress: Study mattress |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient fall out of bed | Skin and subcutaneous tissue disorders | Systematic Assessment | Patient was not harmed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Black, PhD, RN | Nebraska Medical Center | 402-559-6573 | JBlack@unmc.edu |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
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|
| Secondary | Cost of Rental Beds | Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only | Tertiary Care ICU patients | Posted | Number | US Dollars | End of study |
|
|
|
| 0 |
| 31 |
| 1 |
| 31 |
| EG001 | Standard Care Arm | ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care. | 0 | 21 | 0 | 21 |
|
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