Table 1.
Demographics and baseline characteristics (ITT population)
| Parameter | MATRIX-1 | MATRIX-2 | ||
|---|---|---|---|---|
| INL-001 (n = 204) | Placebo collagen-matrix (n = 101) | INL-001 (n = 213) | Placebo collagen-matrix (n = 106) | |
| Age (years) | ||||
| Mean (SD) | 53.1 (12.82) | 53.3 (14.01) | 50.7 (13.69) | 48.5 (13.94) |
| Median | 55.0 | 54.0 | 52.0 | 50.0 |
| Minimum, maximum | 19, 83 | 21, 86 | 18, 85 | 19, 75 |
| Sex, n (%) | ||||
| Male | 196 (96) | 97 (96) | 208 (98) | 103 (97) |
| Female | 8 (4) | 4 (4) | 5 (2) | 3 (3) |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 77 (38) | 38 (38) | 44 (21) | 23 (22) |
| Not Hispanic or Latino | 127 (62) | 62 (61) | 169 (79) | 83 (78) |
| Missing | 0 | 1 (1) | 0 | 0 |
| Race, n (%) | ||||
| American Indian or Alaskan Native | 1 (< 1) | 1 (1) | 2 (< 1) | 1 (< 1) |
| Asian | 2 (1) | 2 (2) | 4 (2) | 3 (3) |
| Black or African American | 15 (7) | 7 (7) | 23 (11) | 12 (11) |
| Native Hawaiian or Pacific Islander | 1 (< 1) | 0 | 1 (< 1) | 0 |
| White | 185 (91) | 91 (90) | 182 (85) | 90 (85) |
| Missing | 0 | 0 | 1 (< 1) | 0 |
| Body mass index (kg/m2) | (n = 202) | (n = 100) | (n = 209) | (n = 106) |
| Mean (SD) | 27.05 (3.899) | 27.26 (4.596) | 26.84 (4.025) | 27.22 (5.062) |
| Median | 26.60 | 26.49 | 26.66 | 26.64 |
| Minimum, maximum | 18.7, 39.6 | 19.2, 42.1 | 17.8, 40.8 | 17.4, 45.9 |
| Previous ipsilateral hernia repair using mesh, n (%) | ||||
| Yes | 20 (10) | 12 (12) | 22 (10) | 10 (10) |
| No | 184 (90) | 89 (88) | 189 (89) | 96 (91) |
| Missing | 0 | 0 | 2 (< 1) | 0 |
| Multiple hernias, n (%) | ||||
| Yes | 13 (6) | 4 (4) | 5 (2) | 4 (4) |
| No | 190 (93) | 96 (95) | 204 (96) | 102 (96) |
| Missing | 1 (< 1) | 1 (1) | 4 (2) | 0 |
| Incision duration (h) | (n = 203) | (n = 100) | (n = 209) | (n = 106) |
| Mean (SD) | 0.80 (0.432) | 0.75 (0.379) | 0.80 (0.327) | 0.84 (0.352) |
| Median | 0.72 | 0.67 | 0.75 | 0.77 |
| Minimum, maximum | 0.2, 3.0 | 0.2, 1.8 | 0.2, 2.1 | 0.2, 2.5 |
SD standard deviation, ITT intent-to-treat