Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds
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|ClinicalTrials.gov Identifier: NCT00771238|
Recruitment Status : Completed
First Posted : October 13, 2008
Results First Posted : September 28, 2015
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcers||Device: P500 Mattress||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Pressure Ulcer Incidence and Change in Existing Pressure Ulcers Comparing Subjects Placed on the TC500 Bed With Standard Beds in the 850-SICU Unit|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Experimental: P500 Mattress
The new P500 Low Air Loss mattress will be used to replace the standard mattress for this study arm.
Device: P500 Mattress
No Intervention: Standard of Care Mattress
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.
- Indicence of Pressure Ulcers [ Time Frame: at the end of study period (21 days) ]New pressure ulcers were assessed
- Cost of Rental Beds [ Time Frame: End of study ]Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771238
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-5330|
|Principal Investigator:||Joyce Black, PhD, RN||University of Nebraska|