Table 1_The safety and efficacy of neutral electrolyzed water solution for wound irrigation: post-market clinical follow-up study.docx

IntroductionChronic wounds are a significant public health challenge, representing a considerable burden on the healthcare system. There are numerous gaps in knowledge in the treatment of chronic wounds. First, it is difficult to follow patients through different types of care. Wounds in polymorbid, elderly patients often remain unhealed due to the patient succumbing to their primary disease. No reliable data exist regarding the time to wound closure, type of interventions, the use of antibiotics, the nature and rate of complications, or the causes of treatment failures.
MethodsThis Post-Market Clinical Follow-Up (PMCF) study is a prospective, multicentric, observational, descriptive, qualitative survey among healthcare professionals that involves 237 patients with acute and chronic wounds treated with superoxide-based wound irrigation solution DebriEcaSan Alfa in real-world settings over 12 weeks, both outpatient and inpatient. The study aimed to collect additional clinical data to confirm the safety, performance, and clinical benefit of DebriEcaSan Alfa.
ResultsThe Manufacturer collected 237 survey forms from 81 healthcare facilities, nursing homes, and outpatient clinics in the Czech Republic. The most common diagnoses were venous leg ulcer, pressure ulcer, diabetic foot ulcer, and traumatic wound. The most common comorbidities and risk factors were obesity, diabetes mellitus, and peripheral artery disease. Significant improvement was observed in all parameters, including pain, malodor, affected tissues, reduction in wound size, and granulation and epithelization. A marked reduction in size was observed in all wound size categories. 19 (8%) patients healed by end of week 6; and 66 (28%) healed by week 9. 130 (55%) patients were considered healed by week 12.
DiscussionThe current clinical practice guidelines refrain from recommending any of the available irrigation solutions and wound dressings due to low-quality evidence. Superoxidized solutions have excellent biocompatibility and are non-cytotoxic, non-sensitizing, not irritating, non-genotoxic, and have broad-spectrum antimicrobial properties. There is no objective baseline to compare the results to, as typical healing times in a comparable population are not accessible. No single standard of care exists in the treatment of chronic wounds, and significant variability in practices exists across the health system.

引言
慢性伤口是一项重大的公共卫生挑战，给医疗保健系统带来了沉重负担。慢性伤口治疗领域仍存在诸多知识空白。其一，难以对接受不同类型护理的患者进行追踪。多病共存的老年患者的伤口往往难以愈合，因为患者会死于基础疾病。目前尚无可靠数据可用于了解伤口闭合所需时间、干预措施类型、抗生素使用情况、并发症的性质与发生率，或是治疗失败的原因。
方法
本上市后临床随访（Post-Market Clinical Follow-Up, PMCF）研究是一项前瞻性、多中心、观察性、描述性的定性调查，针对医疗专业人员开展，纳入了捷克共和国真实临床场景中使用基于超氧化物的伤口冲洗液DebriEcaSan Alfa进行治疗的237例急性与慢性伤口患者，随访时长为12周，涵盖门诊与住院患者。本研究旨在收集额外的临床数据，以验证DebriEcaSan Alfa的安全性、性能与临床获益。
结果
制造商从捷克共和国的81家医疗机构、养老院与门诊诊所共回收了237份调查问卷。最常见的伤口诊断类型为下肢静脉性溃疡、压力性损伤（压疮）、糖尿病足溃疡与创伤性伤口。最常见的合并症与危险因素为肥胖、糖尿病与外周动脉疾病。所有评估参数均出现显著改善，包括疼痛程度、伤口异味、受累组织状态、伤口面积缩小情况，以及肉芽组织形成与上皮化进程。所有伤口尺寸组别均出现了显著的尺寸缩小。第6周结束时，共有19例（8%）患者实现伤口愈合；第9周结束时，愈合患者数量增至66例（28%）；至第12周时，共有130例（55%）患者被判定为伤口愈合。
讨论
当前的临床实践指南因证据质量较低，未推荐任何现有的伤口冲洗液与伤口敷料。超氧化溶液具备优异的生物相容性，且无细胞毒性、无致敏性、无刺激性、无遗传毒性，同时拥有广谱抗菌活性。由于无法获取相似人群的典型愈合时间数据，因此缺乏可用于对比研究结果的客观基线。慢性伤口治疗尚无统一的护理标准，医疗系统内的临床实践存在显著差异。