Clinical Efficacy and Broad-Spectrum Antimicrobial Activity of pH-Controlled Sodium Hypochlorite Solution (HACCP'ER) in Acute and Chronic Wound Management: A Retrospective Cohort Study.

Background/

Objectives

Effective wound antisepsis and infection control remain central challenges in both acute and chronic wound management. pH-controlled sodium hypochlorite solution (HACCP'ER®) is a novel agent that optimizes the proportion of bactericidal hypochlorous acid (HOCl) by maintaining pH at 6.0-7.3. The present preliminary study aimed to evaluate its broad-spectrum antimicrobial activity in vitro and clinical outcomes in a retrospective cohort of patients with diverse acute and chronic wounds.

Methods

A retrospective observational study was conducted, involving 193 consecutive patients who received HACCP'ER-based wound care between May 2022 and February 2023. Wound categories included pressure ulcers (n = 61), foot ulcers (n = 44), burns (n = 42), acute traumatic wounds (n = 29), and other chronic wounds (n = 17). HACCP'ER was applied at a free available chlorine (FAC) concentration of 50-200 ppm at pH = 6.0-7.3. In vitro antimicrobial suspension testing against ten microbial species was performed at 57 ppm (pH = 5.2, 23 °C) according to Japanese Industrial Standards.

Results

HACCP'ER at 57 ppm eliminated Escherichia coli, Staphylococcus aureus, methicillin-resistant S. aureus (MRSA), Streptococcus spp., Salmonella spp., and Pseudomonas aeruginosa to below the detection limit (<10 CFU/mL) within 1 min, Candida within 3 min, and black Aspergillus within 5 min. In clinical wound cultures, bacterial burden was reduced in 6 of 10 (60%) patients. The mean patient age was 67.4 years. No adverse events attributable to HACCP'ER were recorded. Progressive wound healing was documented across all wound categories, with representative cases achieving closure at 1-11 months.

Conclusions

HACCP'ER demonstrates potent broad-spectrum antimicrobial activity at wound-relevant concentrations and is clinically safe in acute and chronic wound care. Its physiologically aligned mechanism of HOCl generation supports both efficacy and biocompatibility. Prospective randomized controlled trials are warranted to definitively establish clinical efficacy.