Hard-to-Heal Wound Healing: Superiority of Hydrogel EHO-85 (Containing <i>Olea europaea</i> Leaf Extract) vs. a Standard Hydrogel. A Randomized Controlled Trial
José Verdú-Soriano,
Antonio Casado-Díaz,
Marisol de Cristino-Espinar,
Silvia Luna-Morales,
Caridad Dios-Guerra,
Paloma Moreno-Moreno,
Gabriel Dorado,
José Manuel Quesada-Gómez,
Leocadio Rodríguez-Mañas,
José Luis Lázaro-Martínez
Affiliations
José Verdú-Soriano
Department of Community Nursing, Preventive Medicine, Public Health and History of Science, Faculty of Health Sciences, University of Alicante, 03690 Alicante, Spain
Antonio Casado-Díaz
Maimonides Institute of Biomedical Research of Cordoba (IMIBIC), Reina Sofía University Hospital, University of Córdoba, 14004 Córdoba, Spain
Marisol de Cristino-Espinar
Maimonides Institute of Biomedical Research of Cordoba (IMIBIC), Reina Sofía University Hospital, University of Córdoba, 14004 Córdoba, Spain
Silvia Luna-Morales
Maimonides Institute of Biomedical Research of Cordoba (IMIBIC), Reina Sofía University Hospital, University of Córdoba, 14004 Córdoba, Spain
Caridad Dios-Guerra
Maimonides Institute of Biomedical Research of Cordoba (IMIBIC), Reina Sofía University Hospital, University of Córdoba, 14004 Córdoba, Spain
Paloma Moreno-Moreno
Maimonides Institute of Biomedical Research of Cordoba (IMIBIC), Reina Sofía University Hospital, University of Córdoba, 14004 Córdoba, Spain
Gabriel Dorado
Consortium for Biomedical Research in Frailty & Healthy Ageing (CIBERFES), Institute of Health Carlos III, 28029 Madrid, Spain
José Manuel Quesada-Gómez
Maimonides Institute of Biomedical Research of Cordoba (IMIBIC), Reina Sofía University Hospital, University of Córdoba, 14004 Córdoba, Spain
Leocadio Rodríguez-Mañas
Consortium for Biomedical Research in Frailty & Healthy Ageing (CIBERFES), Institute of Health Carlos III, 28029 Madrid, Spain
José Luis Lázaro-Martínez
Diabetic Foot Unit, University Podiatry Clinic, Complutense University of Madrid, 28040 Madrid, Spain
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 2/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.
