Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds

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.

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.