Table 3.
Safety and adverse events in per protocol population*. Values are numbers (percentages) unless stated otherwise
| Clinical outcomes | All (n=1979) | Closed incision NPWT (n=996) | Standard dressing (n=983) | Relative risk (95% CI) | P value† |
|---|---|---|---|---|---|
| Dressing related adverse events | |||||
| Blistering | 63 (3.2) | 40 (4.0) | 23 (2.3) | 1.72 (1.04 to 2.85) | 0.03 |
| SSI and blistering | 21/174 (12) | 12/75 (16) | 9/99 (9) | 1.77 (0.79 to 3.97) | 0.16 |
| Itchiness and/or rash | 13 (0.7) | 10 (1.0) | 3 (0.3) | 3.29 (0.91 to 11.91) | 0.09 |
| Serious adverse events | |||||
| All | 17 (0.9) | 12 (1.2) | 5 (0.5) | 2.57 (0.92 to 7.17) | 0.06 |
| Neonatal deaths | 3 (0.2) | 2 (0.2) | 1 (0.1) | 1.97 (0.18 to 21.73) | 1.00 |
| ICU admissions | 13 (0.7) | 9 (0.9) | 4 (0.4) | 2.22 (0.69 to 7.19) | 0.17 |
| Life threatening condition | 1 (0.1) | 1 (0.1) | 0 (0) | - | - |
ICU=intensive care unit; NPWT=negative pressure wound therapy; SSI=surgical site infection.
*
Per protocol population excludes participants (n=56) who were lost to follow-up (12 (<1%) participants), did not receive treatment to which they were originally allocated (28 (1%) participants), or subsequently withdrew from study (16 (<1%) participants). 1 participant withdrawn from study did not receive treatment to which she was originally allocated.
†
Using χ2 test or Fisher’s exact test.