Debriding effect of amino acid-buffered hypochlorite on hard-to-heal wounds covered by devitalised tissue: pilot study

Abstract

Objective: Wounds such as lower extremity ulcers are serious, costly and frequently hard to heal. Guidelines conclude that new dressings and treatments generally fail to show superiority compared with standard of care. Several mechanisms are probably responsible for impaired healing of hard-to-heal wounds, including inflammation and infection. Amino acid-buffered hypochlorite has presumed antiseptic and antibacterial properties and has been shown to be useful in the treatment of diabetic foot ulcers (DFUs). We evaluated the debriding effect of amino acid-buffered hypochlorite (ChloraSolv) on full skin hard-to-heal lower extremity ulcers covered with devitalised tissue (≥50%), with six applications over 5 weeks and follow-up at 12 weeks. Method: This was an open-label, single-arm, multicentre, pre-market pilot investigation. We recruited subjects with a lower extremity ulcer, covered with devitalised tissue (≥50%), who were candidates for cleansing and debridement/desloughing. There was a weekly application of the investigational device for five weeks. Follow-up for wound status evaluation was performed at 12 weeks from baseline. Results: We evaluated 57 subjects (33 males, 24 females, median age 73 years, range 51–90 years) (intention-to-treat). Of these, 61.4% had a leg ulcer and 38.6% a foot ulcer. The median wound size at baseline was 7.7cm2 (range 2.1–52cm2) with devitalised tissue coverage of 76.5%. After 5 weeks, a decrease of 72.7% in devitalised tissue was seen, and 71.4% of the subjects showed a decrease in devitalised tissue of ≥50% (evaluated independently using PictZar). At 12 weeks' follow-up the decrease in devitalised tissue was 84.4%. Wound-related pain was reported by ten subjects, resulting in 17 adverse events (AEs). Among these, 12 AEs from eight subjects were recorded as possibly or probably related to the investigational device and one AE was reported to have a causal relationship with the investigational device. Conclusion: This clinical study suggests that amino acid-buffered hypochlorite can be effective and well tolerated in the treatment of hard-to-heal lower extremity ulcers to dissolve and remove devitalised tissue.