Outcome
| Total* | |
| Primary composite endpoint† | 0 (0; 0–8.8) |
| Postoperative percutaneous CSF leak (90-day FU) | 0 (0; 0–8.8) |
| Wound infection (90-day FU) | 0 (0; 0–8.8) |
| Intraoperative CSF leakage‡ | 0 (0; 0–8.8) |
| Device-related SAEs | 0 (0; 0–8.8) |
| Device-related AEs | 0 (0; 0–8.8) |
| Pseudomeningocele | |
| Treated§ | 0 (0; 0–8.8) |
| >20 cc | 2 (5; 1–16,9) |
| Thickness dura mater and DSP (mm) | |
| Day 7, mean (SD) | 3.5 (2.0) |
| Day 90, mean (SD) | 2.1 (1.2) |
| User satisfaction ‘good’ or ‘excellent’ | 40 (100; 91.2–100) |
*Data are presented as ‘number (percentage of total of 40 patients; 95% CI based on the exact Clopper-Pearson method)’ unless stated otherwise.
†Composite of three primary outcome measures; intraoperative CSF leak at 20 cm H2O positive end-expiratory pressure (PEEP) for 20 s or wound infection within 30 days or postoperative percutaneous CSF leak.
‡Measured at 20 PEEP for 20 s.
§Treated with puncture, lumbar drainage or reoperation.
AEs, adverse events; CSF, cerebrospinal fluid; DSP, dural sealant patch; FU, follow-up; SAEs, serious adverse events.