Pressure Redistributing Overlay With Targeted Cooling Technology (PRO-TECT) for Pressure Ulcer Prevention

To demonstrate the efficacy of the pressure redistributing cooling mattress overlay for
prevention of pressure ulcers in critical care units, a prospective randomized human clinical
trial will be performed. The trial will use functionally equivalent test overlays. The
initial pilot clinical trial will evaluate the efficacy and safety of the PRO-TECT ™ mattress
overlay in ICU patients who have already developed early pressure ulcers (Stage 1 and 2) and
preventing further progression.

The trial will be performed in UPMC ICUs by enrolling patients age 18 or older with Stage 1
and Stage 2 sacral/coccyx pressure ulcers. The trial will consist of 2 arms: 1) current usual
care (UC) vs. 2) UC + targeted cooling overlay mattress (TCOM). Exclusion criteria will
include anticipated ICU length of stay < 3 days, patients initially designated for specialty
overlay/bed for pulmonary or bariatric diagnoses, patients with a Stage 3 or 4 or unstageable
pressure ulcer on the sacrum.

The UC group will receive current UPMC ICU guideline-based care with daily assessments for
sacral pressure ulcers. Nursing care guidelines will be applied including frequent patient
turning, pressure alleviation, moisture control, and friction relief applications. Patients
in this group may receive a specialty bed or overlay mattress without cooling if recommended
by wound care specialist. The TCOM group will receive UC plus overlay mattress with targeted
sacral cooling.

Wound care as well as assessment will be performed daily by the non-wound care nurses ( ie.
ICU nurse while under ICU care and Floor nurses while under non-ICU care) as part of their
regular daily assessment for both non-target cooling and targeted cooling patients. Wound
care specialist will assess the wound on Mon/Wed/Fri for any progression or deterioration of
the wounds. These wound care nurses are specialty trained in stage decubitus as well as
recommending changes in care to promote healing. Additionally they will record the data as
part of their routine care of patient with wounds. Theses types of wound assessments are best
performed every 2-3 days in order to see any significant change of therapy and data will be
recorded.

Data collected on Monday, Wednesday and Friday of each week including Braden score, pressure
ulcer stage, healing progression (or deterioration) with measurements (e.g., size), and
evidence of infection. Additionally, frequency of patient reposition will be recorded and if
not, documentation of justification will be provided. Other data collected will include
demographics, vitals, comorbidities, length of times (prior incapacitation at home or nursing
facility, transport, emergency department, operative room), ventilation and oxygenation
requirement, ventilator days, ICU LOS, need for dialysis, vasopressors, and labs including
nutritional labs. Data will be collected until study endpoint of discharge from hospital.
Final cost analysis will be performed to compile a cost-benefit of each arm. Accrual will be
6 months.

Inclusion Criteria:

- Patients 18-100 years of age

- Patients with Stage 1 or 2 pressure ulcers

Exclusion Criteria:

- Patients < 18 years old

- Patients admitted directly to non-critical care beds

- Patients with undetermined stage or late stage (3 or 4) pressure ulcers

- Patients with Raynauds disease

- Patients with spina bifida