Table 1.
Baseline patient characteristics
| Patient characteristic | BLCC treatment group (n = 1,187) | SIS treatment group (n = 302) | p-Value* |
|---|---|---|---|
| Age (years), n | 1,185 | 300 | 0.655 |
| Mean ± SD | 69.5 ± 13.9 | 69.1 ± 14.4 | |
| Median | 71.0 | 71.0 | |
| Gender, n (%) | 0.217 | ||
| Male | 551 (47.2) | 129 (43.1) | |
| Female | 616 (52.8) | 170 (56.9) | |
| Race, n (%) | 0.501 | ||
| Caucasian | 571 (73.7) | 148 (72.5) | |
| Black | 103 (13.3) | 33 (16.2) | |
| Other | 101 (13.0) | 23 (11.3) | |
| BMI (kg/m2), n | 859 | 209 | 0.460 |
| Mean ± SD | 32.8 ± 11.1 | 32.1 ± 11.0 | |
| Median | 30.5 | 29.8 | |
| Number of wounds per patient, n | 1,187 | 302 | 0.041 |
| Mean ± SD | 1.22 ± 0.6 | 1.16 ± 0.5 | |
| Median | 1.0 | 1.0 | |
| Single/multiple wounds per patient, n (%) | 0.189 | ||
| Single wound | 988 (83.2) | 261 (86.4) | |
| Multiple wounds | 199 (16.8) | 41 (13.6) |
*
For BMI, the p-value is from the Wilcoxon rank-sum test testing for a difference in distribution between treatments. For other categorical variables, the p-value is from a two-tailed Fisher's exact test testing for a difference in proportions between treatments. For continuous variables, the p-value is from a two-tailed, two-sample t test, testing for a difference in means between treatments.
BLCC, Apligraf; SIS, Oasis. BLCC, bilayered living cellular construct; BMI, body mass index; SD, standard deviation; SIS, small intestine submucosa.