Octenidine wipes no better than sterile water for preventing late-onset sepsis in neonates

Daily skin cleansing with octenidine wipes holds no advantage over sterile water in reducing the incidence of late-onset sepsis in neonates admitted to the neonatal intensive care unit (NICU), according to a study.

The study included 530 neonates (median gestational age 35 weeks, 56.4 percent male) admitted to the NICU within 48 h of birth without early-onset sepsis or pre-existing skin lesions. They were randomly assigned to receive full-body cleansing with either 0.1% octenidine dihydrochloride antimicrobial wipes (n=266) or sterile water (n=264) applied with sterile gauze. Cleansing was performed once daily until discharge, transfer to another facility, or death.

Researchers evaluated skin condition daily using the Neonatal Skin Condition Score. The primary endpoint was late-onset sepsis (ie, occurring >72 h after birth through 28 days of life). Secondary endpoints included late-onset sepsis at 7 and 14 days, all-cause mortality, duration of NICU stay, and adverse skin reactions.

The primary endpoint occurred in 14.7 percent of children in the octenidine group vs 12.9 percent in the sterile water group (relative risk [RR], 1.10, 95 percent confidence interval [CI], 0.75–1.70; p=0.60). Time to late-onset sepsis did not significantly differ between the two groups (hazard ratio, 1.11, 95 percent CI, 0.71–1.78; p=0.63).

Results for the secondary outcomes were also similar between the octenidine and sterile water groups, as follows: late-onset sepsis by 7 days (9 percent vs 8.7 percent) and 14 days (5.6 percent vs 4.2 percent), all-cause mortality (4.5 percent vs 1.9 percent), and duration of NICU stay (median 11 vs 10 days).

In terms of safety, adverse skin reactions were documented in 5.6 percent of neonates in the octenidine group and 6.1 percent in the sterile water group (RR, 1.10, 95 percent CI, 0.55–2.10).