AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries

Patients admitted to the LTACH with at least one stage 3 or 4 PI will be evaluated for
possible inclusion/exclusion criteria. Patients will be approached by the investigator, or
their designee to acquire patient informed consent. If provided, patients will be randomized
to their designated support surface, the bed will be ordered and patients will begin the
study with a baseline study visit (week 0) that will include:

- Date and time of study bed placement

- A brief medical history, that includes current diagnoses, assessment of co-morbidities,
an assessment of neurologic status, nutritional status, level of mobility, history of
current PI's, documentation of treatments that have been applied to PI(s) prior to study
entry

- Braden PU risk assessment (overall and subscores)

- Assessment of pain associated with the PI using a pain numeric rating scale (NRS), where
patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible
pain") [21]

- Blood for CBC, Albumin, Pre-Albumin, CRP will be collected.

- PI assessments: all PI's located on the lower truncal region of the patient's body will
be assessed both subjectively by the treating clinicians for clinical signs of
infection, as well as by a 3D wound assessment tool.

- Overall health status assessment

Subsequent weekly study visits will continue for a maximum of 12 weeks. The interim study
visit documentation will include:

- Overall health status assessment of health (whether the patient's health is improving,
maintaining, or worsening)

- Skin assessment to document any new PI's that may have developed,

- Braden PU risk assessment (overall and subscores)

- 3D Wound assessments of all lower truncal PI's,

- Clinical Assessment of signs and symptoms of wound infection

- Confirmation of support surface type,

- Documentation of adverse device effects, device-related complaints (within 24 hours of
effect/complaint).

Clinical Resource Utilization Data: documentation of the following data will aim to achieve
estimated clinical resources associated with caring for PIs:

- Documentation of dressing supplies,

- Debridement method, duration and frequency

- Type of antibiotics dosage, frequency, and duration

- Other pharmacologic agents used for wounds with dosage, frequency, and duration

- Assessment of pain

- Rental bed cost estimates

- Documentation of professional healthcare visits and/or types of healthcare services in
the preceding week.

- Documentation of acute care hospitalizations

- An estimate of LTACH staff time devoted to wound care per day for that study week.

At study discharge, which may occur at the time of study PI healing, LTACH discharge, or upon
stepdown from the randomized study surface) or for other reasons, a final study visit will be
completed that includes:

- Date and time of study bed removal

- Overall health status assessment,

- Skin assessment to document any new PI's that may have developed,

- Braden PU risk assessment (includes subscores),

- 3D wound assessments of all truncal PI's,

- Clinical assessment of signs and symptoms of wound infection

- Confirmation of bed support surface type

- Documentation of adverse device effects, device related complaints (within 24 hours of
effect/complaint).

- Clinical Resource Utilization Data:

- documentation of dressing supplies,

- debridement method, duration and frequency

- type of antibiotics, dosage, frequency, and duration

- other pharmacologic agents used for wounds with dosage, frequency, and duration,

- rental bed cost estimates

- documentation of professional healthcare visits and/or types of healthcare services
in the preceding week.

- documentation of acute care hospitalizations

- an estimate of LTACH staff time devoted to wound care per day for that study week.

- Assessment of pain

- A patient bed satisfaction assessment will be completed if the patient is able to
communicate

- Blood for CBC, Albumin, Pre-Albumin, CRP will be collected

Inclusion Criteria:

1. Patient's treatment goals are curative or maintaining, and not palliative in nature.

2. Patient is compliant with standard clinical care for their admitted condition.

3. Patient's age is between 18 and 85 years

4. Patient is expected to have at least a 3-4-week length of stay (from date of
assessment) in the treating LTACH

5. Patient must have at least one stage 3 or 4 PI located on the weight bearing aspect of
the patient's truncal /pelvic region

6. Patients or their legal authorized representative must be willing and able to provide
written informed consent.

Exclusion Criteria:

1. Patient has an unstable spinal cord injury

2. Patient weighs less than 70 lbs or more than 350 lbs.

3. The primary study PI site has had previous flaps or grafts with significant associated
scarring which is clinically thought to impede wound contracture.

4. Patients with PIs where bone exposure is > 2 cm2 in area.

5. Patients with active osteomyelitis (via clinical assessment) or patients who have been
diagnosed with osteomyelitis and have not yet completed a 6-8-week course of
antibiotics

6. The primary study PI is located over the trochanteric head of the femur.

7. Patients that are currently taking or have taken in the last 6 weeks chemotherapy
which is known to be cyto-toxic, or anti-angiogenic

8. Patients currently require immune modulating drugs (Humira (alalimumab), Orencia
(abatacept), etc.)