Verdú-Soriano José, de Cristino-Espinar Marisol, Luna-Morales Silvia, Dios-Guerra Caridad, Caballero-Villarraso Javier, Moreno-Moreno Paloma, Casado-Díaz Antonio, Berenguer-Pérez Miriam, Guler-Caamaño Ipek, Laosa-Zafra Olga, Rodríguez-Mañas Leocadio, Lázaro-Martínez José Luis
Department of Community Nursing, Preventive Medicine, Public Health and History of Science, Faculty of Health Sciences, University of Alicante, 03690 Alicante, Spain.
Nursing Department, Reina Sofia University Hospital, 14004 Córdoba, Spain.
J Clin Med. 2022 Feb 25;11(5):1260. doi: 10.3390/jcm11051260.
This 8-week, multicenter, randomized, active-controlled, observer-blinded clinical trial was designed to demonstrate the accelerating effect on wound healing of the novel Olea europaea leaf extract hydrogel (EHO-85) by comparing it to a widely used amorphous hydrogel. Results showed that EHO-85 significantly accelerated wound healing, regardless of ulcer etiology (pressure, venous leg or diabetic foot) and prognosis, doubling the median wound area reduction compared with a reference amorphous hydrogel (79.4% vs. 39.7%; difference: −39.7%, 95% CI: −71.1 to −21.3%; p < 0.001). The intention-to-treat analysis was conducted on 195 patients from 23 Spanish health centers/nursing homes. This novel treatment balances the ulcer microenvironment by modulating reactive oxygen species and pH. These actions complement the moistening and barrier functions inherent to amorphous hydrogels, whilst also conferring EHO-85 its documented granulation formation and pain relief properties. Furthermore, efficacy was achieved safely and in a cost-efficient manner due to its multi-dose format, which reduced the amount of product needed by 85.8% over 8 weeks compared to single-use hydrogel. The present randomized controlled trial is a relevant milestone in evidence-based practice for being the first to demonstrate (i) the effectiveness of an amorphous hydrogel in accelerating wound healing and (ii) the superiority of a specific hydrogel over another.
这项为期8周的多中心、随机、活性对照、观察者盲法临床试验旨在通过将新型油橄榄叶提取物水凝胶（EHO-85）与广泛使用的无定形水凝胶进行比较，来证明其对伤口愈合的加速作用。结果表明，无论溃疡病因（压力性、下肢静脉性或糖尿病足）和预后如何，EHO-85均能显著加速伤口愈合，与参考无定形水凝胶相比，伤口面积减少中位数增加了一倍（79.4%对39.7%；差异：-39.7%，95%CI：-71.1至-21.3%；p<0.001）。意向性分析纳入了来自23家西班牙医疗中心/疗养院的195例患者。这种新型治疗方法通过调节活性氧和pH值来平衡溃疡微环境。这些作用补充了无定形水凝胶固有的保湿和屏障功能，同时也赋予了EHO-85已被证实的肉芽组织形成和缓解疼痛的特性。此外，由于其多剂量剂型，与一次性使用的水凝胶相比，在8周内所需产品量减少了85.8%，因此该治疗方法安全有效且具有成本效益。本随机对照试验是循证医学实践中的一个重要里程碑，因为它首次证明了（i）一种无定形水凝胶在加速伤口愈合方面的有效性，以及（ii）一种特定水凝胶优于另一种水凝胶。
