{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T17:50:12Z","timestamp":1783792212334,"version":"3.55.0"},"reference-count":42,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T00:00:00Z","timestamp":1730419200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Advances in Wound Care"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>Biofilm infections in chronic wounds are common and pose a significant clinical challenge. This challenge was addressed by developing the SoftOx Biofilm Eradicator (SBE) composed of hypochlorous acid (HOCl) and acetic acid with strong broad-spectrum antimicrobial activity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Approach:<\/jats:title>\n                    <jats:p>\n                      First-in-human study investigating the safety and tolerability as primary endpoints and wound size effect and antimicrobial efficacy as secondary endpoints of SBE treatment in chronic leg wound patients. The study was divided into two as follows: a randomized, double-blinded, Single Ascending Dose (SAD) phase (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 16 SBE;\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 4 placebo), where patients were treated with SBE or saline (placebo) only once, followed by an open-label, Multiple Ascending Dose (MAD) phase (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 8), where patients were treated with SBE once daily or twice daily over five days. Reporting is according to CONSORT guidelines.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      SBE was safe and well-tolerated in chronic leg wound patients. There were no significant differences in pain during and after treatment with SBE or the placebo. The SBE treatment reduced bioburden in wounds compared to baseline, with 98% and 49% median reduction after SBE or placebo treatment, respectively. A dose-dependent trend in absolute wound size reduction was observed in the MAD groups with a median (min, max) change of \u22122.99 (\u221214.25, \u22121.5) cm\n                      <jats:sup>2<\/jats:sup>\n                      in the once-daily and \u221210.48 (\u221217.95, \u22120.38) cm\n                      <jats:sup>2<\/jats:sup>\n                      in the twice-daily group, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Innovation and Conclusion:<\/jats:title>\n                    <jats:p>This study demonstrated the safe use of HOCl-based SBE in chronic leg wounds with promising trends of immediate antimicrobial action and beneficial effect on wound healing.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/wound.2024.0040","type":"journal-article","created":{"date-parts":[[2024,5,23]],"date-time":"2024-05-23T11:07:27Z","timestamp":1716462447000},"page":"529-541","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["A First-in-Human Randomized Clinical Study Investigating the Safety and Tolerability of Stabilized Hypochlorous Acid in Patients with Chronic Leg Ulcers"],"prefix":"10.1177","volume":"13","author":[{"given":"Magnus Mustafa","family":"Fazli","sequence":"first","affiliation":[{"name":"SoftOx Solutions AS, Fornebu, Norway."},{"name":"Costerton Biofilm Center, Faculty of Health and Medical Sciences, Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klaus","family":"Kirketerp-M\u00f8ller","sequence":"additional","affiliation":[{"name":"Copenhagen Wound Healing Center, Bispebjerg Hospital, Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David Peick","family":"Sonne","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark."},{"name":"Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Torben","family":"Balchen","sequence":"additional","affiliation":[{"name":"Dan Trials Aps, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Glenn","family":"Gundersen","sequence":"additional","affiliation":[{"name":"SoftOx Solutions AS, Fornebu, Norway."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4314-2602","authenticated-orcid":false,"given":"Elin","family":"J\u00f8rgensen","sequence":"additional","affiliation":[{"name":"Costerton Biofilm Center, Faculty of Health and Medical Sciences, Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark."},{"name":"SoftOx Defense Solutions, Fornebu, Norway."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Bjarnsholt","sequence":"additional","affiliation":[{"name":"Costerton Biofilm Center, Faculty of Health and Medical Sciences, Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark."},{"name":"Department of Clinical Microbiology, Rigshospitalet, Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,11,7]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13643-016-0400-8"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13643-016-0329-y"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-319-56887-4_19"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1296\/8\/jowc.2014.23.11.570"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12590"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/femsre\/fux010"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.tim.2013.06.002"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2007.00283.x"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2007.00321.x"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2017.26.1.20"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.13008"},{"issue":"4","key":"e_1_3_4_13_2","first-page":"171","article-title":"Chronic wounds: Unmet medical needs","volume":"14","author":"Neri L","year":"2016","unstructured":"Neri L, , Fattori A, , Rowan S, et al. 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