Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec 8;9(12):962.
doi: 10.3390/gels9120962.

Hard-to-Heal Wound Healing: Superiority of Hydrogel EHO-85 (Containing Olea europaea Leaf Extract) vs. a Standard Hydrogel. A Randomized Controlled Trial

José Verdú-Soriano  1 , Antonio Casado-Díaz  2   3   4 , Marisol de Cristino-Espinar  2   5 , Silvia Luna-Morales  2   6 , Caridad Dios-Guerra  2   6   7 , Paloma Moreno-Moreno  2   3 , Gabriel Dorado  4   8 , José Manuel Quesada-Gómez  2   4 , Leocadio Rodríguez-Mañas  4   9 , José Luis Lázaro-Martínez  10
Affiliations

Hard-to-Heal Wound Healing: Superiority of Hydrogel EHO-85 (Containing Olea europaea Leaf Extract) vs. a Standard Hydrogel. A Randomized Controlled Trial

José Verdú-Soriano et al. Gels. .

Abstract

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.

Keywords: EHO-85; Olea europaea leaf extract; amorphous hydrogel; hard-to-heal wound; randomized active-controlled trial.

PubMed Disclaimer

Conflict of interest statement

J.V.-S.: Abbreviated contract (2023–24) between Histocell and his institution to advice in a pediatric wound care study; contract for advising on research issues from 2023 with Noventure; honoraria of Urgo Spain for presentations; support of Urgo Medical for travel meetings of advisory boards; support of Noventure for Conference travel and participation in International wound-infection advisory board of Urgo Medical; and executive member of GNEAUPP. A.C.-D.: Funding of a preclinical study in animals on wound healing by Noventure, through the IMIBIC institution. J.M.Q.-G.: Participated as founder of the spin-off Quesper, being currently retired. J.L.L.-M.: Consulting fees of Podartis Srl, Urgo Laboratories and Mölnlycke Heatlhcare; payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events of Urgo Laboratories, Mölnlycke Heatlhcare, Bactiguard, Convatec and 3M; chair of Diabetic Foot Committee in EWMA; and Executive Board Member of Diabetic Foot Study Group.

Figures

Figure 1
Figure 1
Diagram CONSORT profile.
Figure 2
Figure 2
Evolution of reduction in ulcer area. Percentages in both groups of treatment during the eight-week follow-up are shown for ITT, relative to WAR evolution. Results are expressed as mean ± SD. ** p < 0.001 and * p < 0.01 for comparison of EHO-85 vs. VariHesive.
Figure 3
Figure 3
Percentages of patients with hard-to-heal wounds who achieved healing. Data are shown for ≥40%, ≥60%, ≥80% and 100% healing. Analyses by ITT. ** p < 0.001 and * p < 0.01, for the comparison of EHO-85 vs. VariHesive.
Figure 4
Figure 4
Kaplan-Meier’s curves. Cumulated incidence of patients with ulcer healing ≥40% (a), ≥60% (b) and ≥80% (c) for ITT.
See this image and copyright information in PMC

References

    1. Guest J.F., Vowden K., Vowden P. The health economic burden that acute and chronic wounds impose on an average clinical commissioning group/health board in the UK. J. Wound Care. 2017;26:292–303. doi: 10.12968/jowc.2017.26.6.292. - DOI - PubMed
    1. Martinengo L., Olsson M., Bajpai R., Soljak M., Upton Z., Schmidtchen A., Car J., Järbrink K. Prevalence of chronic wounds in the general population: Systematic review and meta-analysis of observational studies. Ann. Epidemiol. 2019;29:8–15. doi: 10.1016/j.annepidem.2018.10.005. - DOI - PubMed
    1. Järbrink K., Ni G., Sönnergren H., Schmidtchen A., Pang C., Bajpai R., Car J. Prevalence and incidence of chronic wounds and related complications: A protocol for a systematic review. Syst. Rev. 2016;5:152. doi: 10.1186/s13643-016-0329-y. - DOI - PMC - PubMed
    1. Falanga V., Isseroff R.R., Soulika A.M., Romanelli M., Margolis D., Kapp S., Granick M., Harding K. Chronic wounds. Nat. Rev. Dis. Prim. 2022;8:50. doi: 10.1038/s41572-022-00377-3. - DOI - PMC - PubMed
    1. Lindholm C., Searle R. Wound management for the 21st century: Combining effectiveness and efficiency. Int. Wound J. 2016;13:5–15. doi: 10.1111/iwj.12623. - DOI - PMC - PubMed

LinkOut - more resources