Table 2. Secondary End Points by Wound Irrigation Group.
| End point | Treatment group, No. (%) | P valuea | |||
|---|---|---|---|---|---|
| Polyhexanide (n = 292) | Saline (n = 295) | No irrigation (n = 102) | Polyhexanide vs no irrigation | Polyhexanide vs saline | |
| Surgical site infection | 31 (10.6) | 37 (12.5) | 13 (12.8) | .58 | .52 |
| Type of surgical site infection | .51b | .70b | |||
| None | 254 (87.0) | 248 (84.1) | 85 (83.3) | NA | NA |
| Superficial | 15 (5.1) | 22 (7.5) | 9 (8.8) | NA | NA |
| Deep | 7 (2.4) | 6 (2.0) | 1 (1.0) | NA | NA |
| Organ/space | 9 (3.1) | 9 (3.1) | 3 (2.9) | NA | NA |
| Missing | 7 (2.4) | 10 (3.4) | 4 (3.9) | NA | NA |
| Relaparotomy | 27 (9.2) | 31 (10.5) | 15 (14.7) | .12 | .61 |
| 30-d Mortality | 2 (0.7) | 6 (2.0) | 2 (2.0) | .28b | .29b |
| Noninfectious wound complications | 53 (18.2) | 51 (17.3) | 21 (20.1) | .54 | .83 |
| Seroma | 12 (4.1) | 11 (3.7) | 3 (2.9) | .77b | .83 |
| Hematoma | 14 (4.8) | 14 (4.8) | 5 (4.9) | >.99b | >.99b |
| Delayed wound healing | 19 (6.5) | 17 (5.8) | 6 (5.9) | .85 | .73 |
| Necrosis | 0 | 2 (0.7) | 1 (1.0) | .26b | .16 |
| Other | 15 (5.1) | 15 (5.1) | 8 (7.8) | .30 | >.99 |
| Duration of hospital stay, median (range), d | 14.5 (4-45) | 15 (5-41) | 13 (5-46) | .56c | .23c |
| No. of AEs per patient, median (range) | 2 (0-18) | 2 (0-15) | 1 (0-20) | .82c | .13c |
| No. of serious AEs per patient, median (range) | 0 (0-8) | 0 (0-5) | 0 (0-7) | .29c | .52c |
Abbreviations: AE, adverse event; NA, not applicable.
a
χ2 Test, unless indicated otherwise.
b
Fisher exact test.
c
Mann-Whitney U test.