Pressure Ulcers
Conditions
Keywords
pressure ulcers, Therapy mattresses, Incidence of pressure ulcers
Brief summary
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).
Detailed description
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.
Interventions
DEVICEP500 Mattress
Study mattress
Sponsors
Hill-Rom
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects admitted to the 850 Surgical ICU 2. Subjects or their legal reprehensive able to provide written consent for study 3. Subjects must be within the weight limits of the beds (70-500 lbs) 4. Subjects who do not require a specialty bed (subjective assessment by wound team) 5. Subjects are 19 years or older
Exclusion criteria
1. Subjects that do not wish to participate 2. Subjects thought to require a different mattress by current clinical bed protocols. 3. Subjects who require pulmonary clearance therapy delivered by a pulmonary mattress. 4. Subjects whose weight is outside of the limits of the bed system. 5. Subjects who have already completed 3 days of this study protocol and are considered completed Subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Indicence of Pressure Ulcers | at the end of study period (21 days) | New pressure ulcers were assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost of Rental Beds | End of study | Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| P500 Mattress ICU patients placed on a TC500 bed with standard pressure ulcer prevention care
Total Care P500 Mattress: Study mattress | 31 |
| Standard Care Arm ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care. | 21 |
| Total | 52 |
Baseline characteristics
| Characteristic | P500 Mattress | Standard Care Arm | Total |
|---|---|---|---|
| Age, Continuous | 62.1 Years STANDARD_DEVIATION 11.4 | 54.8 Years STANDARD_DEVIATION 19.1 | 59.1 Years STANDARD_DEVIATION 15.3 |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 20 Participants | 9 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 31 | 0 / 21 |
| serious Total, serious adverse events | 0 / 31 | 0 / 21 |
Outcome results
Primary
Indicence of Pressure Ulcers
New pressure ulcers were assessed
Time frame: at the end of study period (21 days)
Population: Tertiary Care ICU patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| P500 Mattress | Indicence of Pressure Ulcers | 0 participants |
| Standard Care Arm | Indicence of Pressure Ulcers | 4 participants |
Secondary
Cost of Rental Beds
Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only
Time frame: End of study
Population: Tertiary Care ICU patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| P500 Mattress | Cost of Rental Beds | 0 US Dollars |
| Standard Care Arm | Cost of Rental Beds | 4116 US Dollars |