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Cutaneous safety evaluation of pure hypochlorous acid solution in preterm infants and neonates with complex wounds
1Pediatrix Neonatology of Houston, Houston, TX, USA; Department of Pediatrics, The Woman's Hospital of Texas, Houston, TX; rene.amaya@pediatrix.com.
Insights
Pure hypochlorous acid (pHA) cleanser demonstrated excellent cutaneous safety and tolerability in preterm and neonatal patients with complex wounds. No adverse effects were observed across hundreds of applications, supporting its use in this vulnerable population.
Area of Science:
- Neonatal dermatology
- Wound care science
- Pediatric skin health
Background:
- Preterm infants possess immature skin barriers, increasing susceptibility to injury and infection.
- Limited safe wound cleansing options exist for this high-risk neonatal population.
Purpose of the Study:
- To assess the cutaneous safety and tolerability of a pure hypochlorous acid (pHA)-preserved cleanser.
- To evaluate pHA use in preterm and neonatal patients with complex wounds.
Main Methods:
- Retrospective analysis of 100 preterm and neonatal patients with complex wounds.
- pHA cleanser applied during wound care encounters until wound closure or discharge.
- Data collected on demographics, clinical factors, and wound outcomes.
Main Results:
- A total of 766 pHA applications were administered to 100 patients.
- No cutaneous adverse effects (e.g., dermatitis, erythema, burns, infection) were recorded.
- Concurrent use with other advanced therapies showed no adverse effects.
Conclusions:
- This study represents the largest evaluation of pHA safety in neonatal patients.
- pHA demonstrates favorable cutaneous safety and tolerability in this population.
- Further prospective studies are recommended to confirm efficacy in neonatal wound care.
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.
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