ENGLISH OUS indications
Page 39 of 50
OTH-SEM-IFU-OUS-0359 Rev I
subjects were at varying risk for developing pressure injuries/ulcers (as defined by current risk
assessment tools) and thus interventions were made.
According to the study protocol’s inclusion criteria, these patients were defined as be
ing
“at
risk” if they met one of the following criteria:
•
Pressure Injuries/Ulcer Risk Score
–
Braden < 15; Waterlow ≥ 10; or Norton ≤ 18;
•
Poor mobility; e.g., Braden mobility sub-
score ≤2; Waterlow mobility sub
-score >2;
Norton mobility sub-
score ≤2; or po
or mobility according to clinical judgement
(chair- or bed-bound);
•
Poor nutrition; e.g., Braden nutrition sub-
score ≤2; Waterlow nutrition sub
-score >2;
or other indicator of poor nutrition; and/or
•
Medical procedure (e.g., surgery, x-ray, etc.) involving immobility and inability to change
position lasting 4 hours or longer.
One hundred eighty-two (182) subjects were listed as Intent to Treat (ITT). Of those,
170 were included in the sensitivity and specificity calculations with 48 pressure ulcers
forming in 36 subjects.
Subject enrolment occurred across a range of types of study institutions:
1.
Orthopaedic trauma: 14% (n=26 subjects)
2.
Medical surgery: 27% (n=50 subjects)
3.
Long-term care: 32% (n=58 subjects)
4.
ICU: 9% (n=17 subjects)
5.
Rehab: 4% (n=7 subjects)
6.
Neurologic Care: 8% (n=15 subjects)
7.
Other/mixed: 5% (n=9 subjects)
8.1.2
SEM200-008
–
Results
Sensitivity and specificity data presented in Table 10 and Table 11 shows how the SEM Scanner
200 compares to visual skin assessment in identifying patients with tissue at risk of developing
pressure injuries/ulcers at the heels or sacrum.
