Hard-to-heal ulcers treated with hypochlorous acid oxidising solution and standard of care: a 32-week follow-up

Abstract

Objective: Immediately following a two-year prospective case series in which the wounds of 60 patients with hard-to-heal ulcers were treated with a hypochlorous acid oxidising solution (AOS) in addition to standard of care (SoC) for 70 days (T0–T70), a subset of 31 patients (51.7%) whose wounds had not fully healed by T70 opted to continue with treatment for a further 22 weeks (days T70–T224, a total treatment time of 32 weeks (224 days). The objective was to provide long-term evidence on the clinical performance and safety of AOS when used in association with the usual SoC in patients with stalled, hard-to-heal ulcers of various aetiologies. Method: As per the main study, wounds were formally assessed by the study lead at 28 days (±14 days, depending on patient attendance). Parameters assessed at fortnightly visits included area, depth and duration of ulcer; pain; wound bed preparation (WBP) score; and infection status. Wounds were managed in accordance with the SoC protocol. Results: By T224, 35.5% (n=11) of wounds healed completely and 83.9% showed some types of improvement. All wounds were free of infection and colonisation, the WBP score improved (100% A1–A2 at T196), and pain scores fell. Use of AOS in combination with several types of dressing (SoC) for such a long period confirmed a good safety profile. Conclusion: This follow-up evaluation, coupled with the primary study, suggests that AOS might represent a valuable therapeutic addition for the management of hard-to-heal ulcers for long periods of treatment. Declaration of interest: ER worked as a consultant for APR Applied Pharma Research S.A. The authors have no other conflicts of interest.