PMID- 34121441 OWN - NLM STAT- MEDLINE DCOM- 20210719 LR - 20210719 IS - 0969-0700 (Print) IS - 0969-0700 (Linking) VI - 30 IP - 6 DP - 2021 Jun 2 TI - Debriding effect of amino acid-buffered hypochlorite on hard-to-heal wounds covered by devitalised tissue: pilot study. PG - 455-464 LID - 10.12968/jowc.2021.30.6.455 [doi] AB - 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 7.7cm(2) (range 2.1-52cm(2)) 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. FAU - Eliasson, Bjorn AU - Eliasson B AD - Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden. FAU - Fagerdahl, Ann-Mari AU - Fagerdahl AM AD - Department of Clinical Science and Education, Karolinska Institutet, Sodersjukhuset and Wound Centre, Sodersjukhuset, Stockholm, Sweden. FAU - Jonsson, Anders AU - Jonsson A AD - Department of Orthopaedic Surgery, Sahlgrenska University Hospital, Molndal, Sweden. FAU - Apelqvist, Jan AU - Apelqvist J AD - Department of Endocrinology, University Hospital of Malmo, Sweden. LA - eng PT - Journal Article PT - Multicenter Study PL - England TA - J Wound Care JT - Journal of wound care JID - 9417080 RN - 0 (Amino Acids) RN - 712K4CDC10 (Hypochlorous Acid) MH - Aged MH - Aged, 80 and over MH - Amino Acids/*therapeutic use MH - Diabetic Foot/*therapy MH - Female MH - Humans MH - Hypochlorous Acid/*therapeutic use MH - Leg Ulcer/*therapy MH - Male MH - Middle Aged MH - Pilot Projects MH - Treatment Outcome MH - Wound Healing/*drug effects OTO - NOTNLM OT - buffered hypochlorite OT - chronic lower leg ulcer OT - clinical study OT - debridement OT - devitalised tissue OT - diabetes OT - hard-to-heal OT - necrotic tissue OT - ulcer OT - wound EDAT- 2021/06/15 06:00 MHDA- 2021/07/20 06:00 CRDT- 2021/06/14 08:54 PHST- 2021/06/14 08:54 [entrez] PHST- 2021/06/15 06:00 [pubmed] PHST- 2021/07/20 06:00 [medline] AID - 10.12968/jowc.2021.30.6.455 [doi] PST - ppublish SO - J Wound Care. 2021 Jun 2;30(6):455-464. doi: 10.12968/jowc.2021.30.6.455.