Skin injuries related to Octenidine-based antisepsis in neonatal and pediatric populations: a scoping review

Background: Octenidine-based antiseptics are increasingly used in neonatal and pediatric care for skin antisepsis and wound care, yet their cutaneous safety has not been systematically profiled.

Methods: This scoping review, based on JBI methodology, mapped evidence on skin injuries and local complications in neonates and children after octenidine-based use on intact skin or wounds.

Results: Of 242 records, six studies, all conducted in Europe (Germany 66.7%, Switzerland 16.7%, Poland 16.7%), were included (n = 30 patients). Two studies reported intact-skin antisepsis before procedures in 18 neonates while four papers addressed cleansing of traumatic, surgical, or infectious wounds in 12 infants or children. Formulations were mainly octenidine 0.1% with phenoxyethanol 2% (22/30; 73.3%), with aqueous 0.1% (6/30; 20.0%) and alcohol-based 0.1% (2/30; 6.7%) less frequent. Reported events ranged from transient erythema to bullous/erosive dermatitis, subcutaneous edema, fatty tissue necrosis, and phlegmon-like reactions. Management varied from conservative care to surgery, with scarring or contractures in some cases.

Conclusion: The available evidence, limited to case reports, case series, a survey and one small cohort, thereby preventing causal inference and incidence or prevalence estimates due to the absence of denominator data, nonetheless indicates injuries with both aqueous and alcohol-based products, raising concern for a potentially compound-related, rather than vehicle-specific, risk. Clinicians should consider judicious use of octenidine, monitor closely, and consider the potential utility of patch testing for delayed allergic reactions. Priority needs include multicenter studies, standardized skin outcomes, detailed exposure reporting, and pharmacovigilance or registries.