Cutaneous safety evaluation of pure hypochlorous acid solution in preterm infants and neonates with complex wounds.

Abstract

Background: Preterm infants are at heightened risk of skin injury and infection due to the immaturity of their epidermal barrier and immune defenses. Safe wound cleansing options remain limited in this population.

Objective: To evaluate cutaneous safety and tolerability associated with use of a pure hypochlorous acid-preserved cleanser (pHA) in preterm and neonatal patients with complex wounds.

Materials and methods: This retrospective study evaluated the cutaneous safety of a pHA in 100 preterm and neonatal patients with complex wounds admitted to a tertiary care facility between January 2023 and July 2025. Demographic, clinical, and wound data were extracted from the electronic medical record. pHA was applied at each wound care encounter and was continued until wound closure, discharge, or transfer of care.

Results: Patients received a mean of 7.6 pHA applications over a mean treatment duration of 18.7 days. The youngest treated infant was born at 21 weeks' gestation. Across 766 cumulative applications, no cutaneous adverse effects or wound-related complications were observed, including contact dermatitis, erythema, chemical burns, infection, or secondary breakdown. In patients receiving pHA concurrently with other advanced wound therapies, no cutaneous adverse effects attributable to combined use were identified.

Conclusion: This retrospective series represents the largest reported evaluation to date of cutaneous safety and tolerability associated with pHA use in neonatal patients. Future prospective multicenter studies are warranted to further characterize cutaneous safety of pHA use and to evaluate efficacy outcomes in neonatal wound care.