Table 1.
Intention-to-treat populationa | Evaluable populationb | |||||
---|---|---|---|---|---|---|
Incidence, no. (column %) | Incidence, no. (column %) | |||||
Endpoint | Test system (n = 49) | Control system (n = 46) | P value | Test system (n = 30) | Control system (n = 31) | P value |
ABU | 3 (6) | 8 (17) | 0.11 | 2 (7) | 8 (26) | 0.06 |
SUTI | 1 (2) | 0 (0) | 0.90 | 1 (3) | 0 (0) | 0.96 |
The intention-to-treat population included the 95 subjects who underwent randomization.
The evaluable population included the 61 subjects who had a catheter indwelling for at least 24 hours without post-operative systemic antibiotics.