Table 3.
Primary & secondary study endpoints (p < 0.05 compared to Baseline).
| Study Endpoints: | Primary: SSO ≤45-day | Secondary: SSO >45-day |
|---|---|---|
| SSI, n (%) | 0 (0.0%) | 0 (0.0%) |
| Seroma, n (%) | 0 (0.0%) | 0 (0.0%) |
| Hematoma, n (%) | 1 (0.8%) | 0 (0.0%) |
| Wound Dehiscence, n (%) | 0 (0.0%) | 0 (0.0%) |
| Skin Necrosis, n (%) | 0 (0.0%) | 0 (0.0%) |
| Mesh Infection, n (%) | 0 (0.0%) | 0 (0.0%) |
| Fistula, n (%) | 0 (0.0%) | 0 (0.0%) |
| Other Secondary Endpoints: | ||
| Surgical procedure time, min (mean ± SD) | 85.9 ± 43.0 | |
| Length of stay, days (mean ± SD) | 1.0 ± 1.4 | |
| Hernia recurrence rate, n (%) | 38 (31.7%) | |
| Reoperation rate, n (%) | 22 (18.3%) | |
| Reason for Reoperation | ||
| Hernia recurrence, n | 22 | |
| Additional procedures, n | 2 | |
|
Device-related adverse events, n (%) (excluding recurrence) |
2 (1.7%) | |
| Small bowel obstruction, n | 1 | |
| Abdominal pain, n | 1 | |
| Baseline | 24 months | |
| Visual Analog Scale – Pain, cm (mean ± SD) | 1.99 ± 2.4 | 0.60 ± 1.5* |
| Carolinas Comfort Scale® – Total Score (mean ± SD) | 1.15 ± 1.1 | 0.17 ± 0.4* |
| SF-12® Physical Component Score (mean ± SD) | 44.4 ± 9.6 | 48.0 ± 9.7* |
| SF-12® Mental Component Score (mean ± SD) | 53.5 ± 9.5 | 52.3 ± 9.6 |