Hard-to-Heal Wound Healing: Superiority of Hydrogel EHO-85 (Containing Olea europaea Leaf Extract) vs. a Standard Hydrogel. A Randomized Controlled Trial
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Título: | Hard-to-Heal Wound Healing: Superiority of Hydrogel EHO-85 (Containing Olea europaea Leaf Extract) vs. a Standard Hydrogel. A Randomized Controlled Trial |
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Autor/es: | Verdú, José | Casado-Díaz, Antonio | Cristino-Espinar, Marisol de | Luna-Morales, Silvia | Dios-Guerra, Caridad | Moreno-Moreno, Paloma | Dorado, Gabriel | Quesada-Gómez, José Manuel | Rodríguez-Mañas, Leocadio | Lázaro-Martínez, José Luis |
Grupo/s de investigación o GITE: | Grupo Winter Heridas: Wounds, Innovation, Therapeutics and Research (WINTER HERIDAS) |
Centro, Departamento o Servicio: | Universidad de Alicante. Departamento de Enfermería Comunitaria, Medicina Preventiva y Salud Pública e Historia de la Ciencia |
Palabras clave: | Hard-to-heal wound | EHO-85 | Amorphous hydrogel | Randomized active-controlled trial | Olea europaea leaf extract |
Fecha de publicación: | 8-dic-2023 |
Editor: | MDPI |
Cita bibliográfica: | Verdú-Soriano J, Casado-Díaz A, de Cristino-Espinar M, Luna-Morales S, Dios-Guerra C, Moreno-Moreno P, Dorado G, Quesada-Gómez JM, Rodríguez-Mañas L, Lázaro-Martínez JL. Hard-to-Heal Wound Healing: Superiority of Hydrogel EHO-85 (Containing Olea europaea Leaf Extract) vs. a Standard Hydrogel. A Randomized Controlled Trial. Gels. 2023; 9(12):962. https://doi.org/10.3390/gels9120962 |
Resumen: | Chronic wounds, especially those that are hard-to-heal, constitute a serious public-health problem. Although progress has been made in the development of wound dressings for healing, there is little high-quality evidence of their efficacy, with no evidence of superiority in the use of one hydrogel over another. To evaluate the superiority of a hydrogel (EHO-85), containing Olea europaea leaf extract (OELE), over a standard hydrogel (SH), the promotion and/or improvement of healing of difficult-to-heal wounds was compared in a prospective, parallel-group multicenter, randomized, observer-blinded, controlled trial (“MACAON”). Non-hospitalized patients with pressure, venous or diabetic foot-ulcers difficult-to-heal were recruited and treated with standard care, and EHO-85 (n = 35) or VariHesive (n = 34) as SH. Wound-area reduction (WAR; percentage) and healing rate (HR; mm2/day) were measured. EHO-85 showed a statistically significant superior effect over VariHesive. At the end of the follow-up period, the relative WAR decreased by 51.6% vs. 18.9% (p < 0.001), with a HR mean of 10.5 ± 5.7 vs. 1.0 ± 7.5 mm2/day (p = 0.036). EHO-85 superiority is probably based on its optimal ability to balance the ulcer bed, by modulating pH and oxidative stress. That complements the wetting and barrier functions, characteristics of conventional hydrogels. These results support the use of EHO-85 dressing, for treatment of hard-to-heal ulcers. Trial Registration AEMPS:PS/CR623/17/CE. |
Patrocinador/es: | This research was developed by QUESPER R&D, and partially funded by INNCORPO-RA-TU-2011-1886 subprogram (Ministry of Economy and Competitiveness, Spain) and the programme for the Reinforcement of Research Activity in the Clinical Management Units of the Andalusian Health Service (Department of Health, Regional Government of Andalusia, Spain). |
URI: | http://hdl.handle.net/10045/139160 |
ISSN: | 2310-2861 |
DOI: | 10.3390/gels9120962 |
Idioma: | eng |
Tipo: | info:eu-repo/semantics/article |
Derechos: | © 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
Revisión científica: | si |
Versión del editor: | https://doi.org/10.3390/gels9120962 |
Aparece en las colecciones: | INV - WINTER HERIDAS - Artículos de Revistas |
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Verdu-Soriano_etal_2023_Gels.pdf | 1,22 MB | Adobe PDF | Abrir Vista previa | |
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