Table 3

Primary and secondary outcome measures per protocol analysis*

Cephalexin (n=23)Placebo (n=25)Risk difference (95% CI)p Value
Number of infections290.24 (0.06 to 1.00)0.039
Infection rate (95% CI)8.7 (1.1 to 28.0)36.0 (18 to 57.5)NA
Prescription of antibiotics2 (8.7%)6(24.0%)0.36 (0.08 to 1.62)0.249
Number of additional follow-up visits required
 Median0 [0–0]0 [0–1]NA0.058
  • 95% CI for infection rates are the Clopper-Pearson interval.

  • *Data are median [IQR] or number (%) unless otherwise stated; 95% CI for infection rate are the Clopper-Pearson interval; p values are Fisher’s exact test or the Mann-Whitney U test for categorical and continuous variables, respectively.

  • NA, not available.