Table 4.
Baseline skin profile of enrolled subjects at day 0 (enrollment)
| Skin characteristics | ITT (N = 182) | ||
|---|---|---|---|
| Sacrum (n = 127) | Left heel (n = 165) | Right heel (n = 164) | |
| Skin color | n (%) | n (%) | n (%) |
| Cyanosis | 0 (0%) | 1 (0.61%) | 1 (0.61%) |
| Darker tone | 2 (1.57%) | 2 (1.21%) | 2 (1.22%) |
| Normal color | 109 (85.83%) | 143 (86.67%) | 144 (87.80%) |
| Paleness | 3 (2.36%) | 11 (6.67%) | 11 (6.71%) |
| Redness | 16 (12.60%) | 11 (6.67%) | 8 (4.88%) |
| Blanching | |||
| Blanchable | 126 (99.21%) | 165 (100.0%) | 164 (100.0%) |
| Nonblanchable | 1 (0.79%) | 0 (0%) | 0 (0%) |
| Skin characteristics | |||
| Skin temperature—normal | 116 (91.34%) | 143 (86.67%) | 144 (87.80%) |
| No edema | 121 (95.28%) | 141 (85.45%) | 140 (85.37%) |
| No induration | 126 (99.21%) | 165 (100.0%) | 163 (99.39%) |
| Skin moisture—normal | 113 (88.98%) | 134 (81.21%) | 134 (81.71%) |
| Skin turgor—normal | 125 (98.43%) | 160 (96.97%) | 158 (96.34%) |
| Tissue health—skin intact | 125 (98.43%) | 164 (99.39%) | 164 (100.0%) |
| No other characteristics | 119 (93.70%) | 152 (92.12%) | 149 (90.85%) |
| Pain free (score 0) | 107 (84.25%) | 107 (64.85%) | 107 (65.24%) |
| Moisture lesion—absent | 125 (98.43%) | 0 (0%) | 0 (0%) |
Note: Percentages for STA data were calculated using number of accessible anatomical locations at the time of assessment as the denominator.
Abbreviations: STA, skin and tissue assessment; ITT, intent‐to‐treat.