TABLE 2.
Statistical analysis of post‐operative adverse outcomes within 30, 60, & 90 days of microsurgery
| 30 Days (N = 818) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No vaccine | Vaccine | Risk difference | 95% CI | p‐value | Risk ratio | 95% CI | Odds ratio | 95% CI | NNV | |
| *Death | 2.463% | 0.000% | 2.463% | (0.955, 3.971) | .0014 | — | — | — | — | 40.6 |
| *Flap failure | 2.494% | 0.000% | 2.494% | (0.968, 4.02) | .0019 | — | — | — | — | 40.1 |
| *Hospital admission | 35.833% | 7.353% | 28.480% | (20.994, 35.967) | <.0001 | 4.873 | (2.621, 9.06) | 7.036 | (3.509, 14.111) | 3.5 |
| *ICU admission | 12.754% | 3.226% | 9.528% | (5.496, 13.56) | <.0001 | 3.954 | (2.025, 7.721) | 4.385 | (2.167, 8.875) | 10.5 |
| *Infection | 12.226% | 4.545% | 7.681% | (3.153, 12.208) | .0023 | 2.690 | (1.372, 5.273) | 2.925 | (1.427, 5.994) | 13.0 |
| *SSI | 6.494% | 2.695% | 3.799% | (0.836, 6.76) | .013 | 2.409 | (1.173, 4.946) | 2.507 | (1.187, 5.295) | 26.3 |
| Dehiscence | 4.905% | 3.049% | 1.856% | (−1.033, 4.744) | .2142 | 1.609 | (0.753, 3.435) | 1.640 | (0.746, 3.606) | |
| DVT | 2.538% | 2.639% | −0.101% | (−2.34, 2.139) | .9299 | 0.962 | (0.405, 2.285) | 0.961 | (0.395, 2.336) | |
| ED visit | 7.631% | 5.181% | 2.450% | (−2.095, 6.994) | .3023 | 1.473 | (0.701, 3.094) | 1.512 | (0.686, 3.331) | |
| Gangrene | 2.618% | 2.660% | −0.042% | (−2.324, 2.24) | .9714 | 0.984 | (0.414, 2.337) | 0.984 | (0.405, 2.392) | |
| Hematoma | 2.469% | 2.519% | −0.050% | (−2.209, 2.109) | .9640 | 0.980 | (0.413, 2.329) | 0.980 | (0.403, 2.38) | |
| PE | 2.494% | 2.538% | −0.044% | (−2.222, 2.133) | .9682 | 0.983 | (0.414, 2.335) | 0.982 | (0.404, 2.386) | |
| Sepsis | 2.577% | 2.778% | −0.201% | (−2.517, 2.116) | .8652 | 0.928 | (0.391, 2.203) | 0.926 | (0.381, 2.251) | |
| Seroma | 2.488% | 2.577% | −0.089% | (−2.282, 2.102) | .9360 | 0.965 | (0.406, 2.293) | 0.964 | (0.397, 2.343) | |
| Stroke | 0.000% | 0.000% | 0.000% | — | — | — | — | — | — | |
| 60 Days (N = 818) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No vaccine | Vaccine | Risk difference | 95% CI | p‐value | Risk ratio | 95% CI | Odds ratio | 95% CI | NNV | |
| *Death | 2.463% | 0.000% | 2.463% | (0.955, 3.971) | .0014 | — | — | — | — | 40.6 |
| *Flap failure | 2.494% | 0.000% | 2.494% | (0.968, 4.02) | .0019 | — | — | — | — | 40.1 |
| *Hospital admission | 35.833% | 7.353% | 28.480% | (20.994, 35.967) | <.0001 | 4.873 | (2.621, 9.06) | 7.036 | (3.509, 14.111) | 3.5 |
| *ICU admission | 13.043% | 3.226% | 9.817% | (5.756, 13.879) | <.0001 | 4.043 | (2.074, 7.885) | 4.500 | (2.226, 9.095) | 10.2 |
| *Infection | 14.420% | 4.545% | 9.875% | (5.138, 14.611) | .0002 | 3.172 | (1.636, 6.15) | 3.538 | (1.745, 7.177) | 10.1 |
| *SSI | 8.052% | 2.695% | 5.357% | (2.178, 8.535) | .0012 | 2.987 | (1.486, 6.006) | 3.161 | (1.527, 6.545) | 18.7 |
| *Dehiscence | 7.084% | 3.049% | 4.035% | (0.818, 7.253) | .0166 | 2.324 | (1.138, 4.745) | 2.425 | (1.151, 5.108) | 24.8 |
| DVT | 2.538% | 2.639% | −0.101% | (−2.34, 2.139) | .9299 | 0.962 | (0.405, 2.285) | 0.961 | (0.395, 2.336) | |
| ED visit | 9.237% | 5.181% | 4.056% | (−0.71, 8.821) | .1076 | 1.783 | (0.869, 3.656) | 1.862 | (0.864, 4.013) | |
| Gangrene | 2.618% | 2.660% | −0.042% | (−2.324, 2.24) | .9714 | 0.984 | (0.414, 2.337) | 0.984 | (0.405, 2.392) | |
| Hematoma | 2.469% | 2.519% | −0.050% | (−2.209, 2.109) | .9640 | 0.980 | (0.413, 2.329) | 0.980 | (0.403, 2.38) | |
| PE | 2.494% | 2.538% | −0.044% | (−2.222, 2.133) | .9682 | 0.983 | (0.414, 2.335) | 0.982 | (0.404, 2.386) | |
| Sepsis | 2.577% | 2.778% | −0.201% | (−2.517, 2.116) | .8652 | 0.928 | (0.391, 2.203) | 0.926 | (0.381, 2.251) | |
| Seroma | 2.488% | 2.577% | −0.089% | (−2.282, 2.102) | .9360 | 0.965 | (0.406, 2.293) | 0.964 | (0.397, 2.343) | |
| Stroke | 0.000% | 0.000% | 0.000% | — | — | — | — | — | — | |
| 90 Days (N = 818) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No vaccine | Vaccine | Risk difference | 95% CI | p‐value | Risk ratio | 95% CI | Odds ratio | 95% CI | NNV | |
| *Dehiscence | 7.297% | 3.040% | 4.257% | (1.023, 7.493) | .0121 | 2.401 | (1.18, 4.884) | 2.511 | (1.196, 5.27) | 23.5 |
| *ED visit | 12.549% | 5.102% | 7.447% | (2.346, 12.548) | .0070 | 2.46 | (1.24, 4.88) | 2.669 | (1.278, 5.573) | 13.4 |
| *Hospital admission | 39.918% | 7.353% | 32.565% | (25.004, 40.125) | <.0001 | 5.429 | (2.932, 10.054) | 8.371 | (4.185, 16.744) | 3.1 |
| *ICU admission | 12.680% | 3.215% | 9.465% | (5.452, 13.477) | <.0001 | 3.944 | (2.019, 7.702) | 4.371 | (2.16, 8.845) | 10.6 |
| *Infection | 14.420% | 4.505% | 9.915% | (5.193, 14.638) | .0002 | 3.201 | (1.651, 6.207) | 3.572 | (1.761, 7.244) | 10.1 |
| *SSI | 7.772% | 2.695% | 5.077% | (1.938, 8.215) | .0018 | 2.883 | (1.43, 5.814) | 3.042 | (1.465, 6.316) | 19.7 |
| Death | 2.445% | 2.451% | −0.006% | (−2.125, 2.113) | .9956 | 0.998 | (0.42, 2.371) | 0.997 | (0.411, 2.423) | |
| DVT | 2.513% | 2.632% | −0.119% | (−2.345, 2.107) | .9165 | 0.955 | (0.402, 2.268) | 0.954 | (0.392, 2.318) | |
| Flap failure | 2.519% | 2.611% | −0.092% | (−2.312, 2.128) | .9352 | 0.965 | (0.406, 2.292) | 0.964 | (0.397, 2.342) | |
| Gangrene | 2.591% | 2.653% | −0.062% | (−2.33, 2.206) | .9574 | 0.977 | (0.411, 2.32) | 0.976 | (0.402, 2.373) | |
| Hematoma | 2.488% | 2.513% | −0.025% | (−2.189, 2.139) | .9819 | 0.990 | (0.417, 2.353) | 0.990 | (0.407, 2.405) | |
| PE | 2.519% | 2.532% | −0.013% | (−2.198, 2.173) | .9909 | 0.995 | (0.419, 2.364) | 0.995 | (0.409, 2.417) | |
| Sepsis | 2.584% | 2.770% | −0.186% | (−2.502, 2.13) | .8747 | 0.933 | (0.393, 2.215) | 0.931 | (0.383, 2.264) | |
| Seroma | 2.488% | 2.571% | −0.083% | (−2.272, 2.106) | .9406 | 0.968 | (0.407, 2.299) | 0.967 | (0.398, 2.349) | |
| Stroke | 0.000% | 0.000% | 0.000% | — | — | — | — | — | — | |
Note: Each analysis excluded subjects that experienced each individual adverse outcome prior to the time window of interest (i.e., experienced the adverse outcome on the same day as surgery), thus some cohorts may be less than the full 409 subjects for each adverse outcome of interest.
*
Statistically significant (p < .05).