Olive tree (Olea europaea) leaf extract (OELE) has important antioxidant and anti-inflammatory properties, supporting its use in human clinical practice. We recently designed an amorphous hydrogel ...called EHO-85 (EHO indicates olive leaf extract in Spanish) containing OELE for skin ulcer treatments. Yet, its effectiveness has not been previously compared with other products used in routine clinical practice. This is necessary to evaluate its potential translation to the human clinic. Thus, in this study, the effect of EHO-85 on healing was evaluated in comparison with treatments containing Indian/Asiatic pennywort (Centella asiatica), hyaluronic acid, or dexpanthenol in a rat model. The speed of wound closure and histological parameters after seven and 14 days were analyzed. All treatments accelerated wound closure, but there were differences between them. Dexpanthenol after seven days produced the highest epithelialization and the lowest inflammation and vascularization. EHO-85 also promoted epithelialization and reduced vascularization. After 14 days, wounds treated with EHO-85 showed less inflammation and higher levels of collagen in the extracellular matrix. This indicates a higher degree of maturity in the regenerated tissue. In conclusion, the effect of EHO-85 on healing was equal to or superior to that of other treatments routinely used in human clinical practice. Therefore, these results, together with previous data on the effects of this hydrogel on ulcer healing in humans, indicate that EHO-85 is a suitable, low-cost, and efficient therapeutic option for wound healing.
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.
Aim
The aim of this study was to determine the prevalence of feelings of being a second victim among midwives and obstetricians in Spain and to explore possible differences between the two ...professions.
Design
Cross‐sectional descriptive‐analytical observational study.
Methods
An online survey collecting several variables was administered throughout the Spanish territory. Spanish version of the Second Victim Experience and Support Tool (SVEST) was used. The data collection period was from May to December 2020.
Results
A total sample of 719 obstetricians and midwives were studied. There were significant differences between the two groups with respect to seven dimensions of SVEST: greater feelings of being a second victim among obstetricians in the dimensions physical distress/p ≤ .001, non‐work‐related support/p ≤ .001 and absenteeism/p ≤ .001 and greater feelings of being a second victim among midwives in the dimensions psychological distress/p ≤ .001, supervisor support/p = .011, professional self‐efficacy/p ≤ .001 and intention to change jobs/p ≤ .001.
To determine the number of specialised wound care units/clinics (SWCUs) in Spain, at present, and to describe their most important characteristics.
This was an observational study with a ...descriptive-analytical, cross-sectional, multicentre approach, where the studied population consisted of SWCUs in Spain. A specific data-collection questionnaire was designed using a modified Delphi method, consisting of four rounds, with the collaboration of 10 wound experts. The final questionnaire included 49 items distributed across four dimensions/areas with a content validity index (CVI-Total for pertinence=0.96 and CVI-Total for relevance=0.94.
A total of 42 SWCUs were included in the study. Most SWCUs were based in hospitals (n=15, 35.7%) or healthcare centres, covering a specific healthcare area (n=17, 40.5%). SWCU coordinators were primarily nurses (n=33, 78.6%). Staff members' professions in SWCUs included registered nurses (n=38 units, 92.7%), nursing assistants (n=8 units, 19.5%), podiatrists (n=8 units, 19.5%), vascular surgeons (n=7 units, 17%), osteopaths (n=2 units, 4.8%) and medical doctors from different specialties (n=3 units, 7.2%). For wound aetiology, the most prevalent wounds managed were diabetic foot ulcers (n=38 units, 90.5%), followed by venous leg ulcers (n=36 units, 85.7%) and arterial ischaemic ulcers (n=36 units, 85.7%). A statistically significant association was found between the number of staff members in a SWCU and the existence of resistance/opposition barriers when developing a SWCU (Chi-square test, p=0.049; Cramér's V=0.34; 34%), as well as between resistance/opposition barriers when developing a SWCU and a nurse as coordinator of a SWCU (MacNemar test, p=0.007, Cramér's V=0.35; 35%).
The typical SWCU implemented in Spain is located in a hospital or integrated in a healthcare structure that offers coverage to a whole health area and providing services for people with hard-to-heal wounds (wound management and prevention) and health professionals (advice, consultancy and training/education). Despite the growing number of SWCUs in Spain, the future of this new organisational model is uncertain, as there can be barriers to creating them and some deficiencies, such as low staff numbers, which need to be addressed.
Many advanced wound healing dressings exist, but there is little high-quality evidence to support them. To determine the performance of a novel amorphous hydrogel (EHO-85) in relation to its ...application, we compared its rheological properties with those of other standard hydrogels (SH), and we assessed the induction of acceleration of the early stages of wound healing as a secondary objective of a prospective, multicenter, randomized, observer-blinded, controlled trial. The patients were recruited if they had pressure, venous, or diabetic foot ulcers and were treated with EHO-85 (
= 103) or VariHesive
(SH) (
= 92), and their response was assessed by intention-to-treat as wound area reduction (WAR (%)) and healing rate (HR mm
/day) in the second and fourth weeks of treatment. Results: EHO-85 had the highest shear thinning and G'/G″ ratio, the lowest viscous modulus, G″, and relatively low cohesive energy; EHO-85 had a significantly superior effect over SH in WAR and HR, accelerating wound healing in the second and fourth weeks of application (
: 0.002). This superiority is likely based on its optimal moisturizing capacity and excellent pH-lowering and antioxidant properties. In addition, the distinct shear thinning of EHO-85 facilitates spreading by gentle hand pressure, making it easier to apply to wounds. These rheological properties contribute to its improved performance.
The prevalence of chronic wounds is increasing due to the population aging and associated pathologies, such as diabetes. These ulcers have an important socio-economic impact. Thus, it is necessary to ...design new products for their treatment with an adequate cost/effectiveness ratio. Among these products are amorphous hydrogels. Their composition can be manipulated to provide a favorable environment for ulcer healing. The aim of this study was to evaluate a novel multifunctional amorphous hydrogel (EHO-85), containing
leaf extract, designed to enhance the wound healing process. For this purpose, its moistening ability, antioxidant capacity, effect on pH in the wound bed of experimental rats, and the effect on wound healing in a murine model of impaired wound healing were assessed. EHO-85 proved to be a remarkable moisturizer and its application in a rat skin wound model showed a significant antioxidant effect, decreasing lipid peroxidation in the wound bed. EHO-85 also decreased the pH of the ulcer bed from day 1. In addition, in mice (BKS. Cg-m +/+ Leprdb) EHO-85 treatment showed superior wound healing rates compared to hydrocolloid dressing. In conclusion, EHO-85 can speed up the closure of hard-to-heal wounds due to its multifunctional properties that are able to modulate the wound microenvironment, mainly through its remarkable effect on reactive oxygen species, pH, and moistening regulation.
Midwifery empowerment is an important topic. The most widely used instrument to measure the perceived empowerment of midwives is the Perceptions of Empowerment in Midwifery Scale (PEMS), which has ...not been validated in Spain. The aim of this study was to translate and adapt the PEMS to the Spanish context. This research was carried out in two phases; Phase 1: Methodological study; translation, backtranslation and cross-cultural adaptation of the PEMS and pilot study on the target population (10 midwives) for evaluation of face validity. Phase 2: Cross-sectional observational study to obtain a sample for construct validation by Exploratory Factor Analysis and measurement of PEMS-e reliability. Additionally, an inferential analysis was carried out to study the possible association between several collected variables and PEMS-e subscale-scores. A total of 410 midwives from 18 Spanish regions participated in the study through an online questionnaire. An initial Spanish version of the PEMS scale was produced, demonstrating adequate face validity. A final model was produced for the PEMS-e, which included 17 items classified into two subscales ("Organizational support" and "Own skills and teamwork") with fit indexes RMSEA = 0.062 (95%CI: 0.048-0.065) and AGFI = 0.985 (95%CI: 0.983-0.989) and Cronbach's alpha 0.922 for the total scale. Results showed that one in four midwives had considered abandoning the profession in the last 6 months (
≤ 0.001). This research suggests that Spanish midwives perceive their empowerment level as low. The PEMS-e is a valid tool with solid psychometric properties that can be used in future research to identify factors that contribute to increased empowerment among Spanish midwives and inform strategies to improve job satisfaction and retention in the profession.
The fear of childbirth is a topical concern, yet the issue has barely been studied in Spain, and only one fear of childbirth measurement instrument has been validated in the country. The aim of this ...study was to translate, adapt and validate the Fear of Childbirth Questionnaire (CFQ) for use in Spain, as well as to describe and evaluate the psychometric properties of the Spanish version of this instrument. In a first phase, a methodological study was carried out (translation-backtranslation and cross-cultural adaptation), and pilot study was carried out in the target population. In addition, content validation of the instrument was obtained (CFQ-e) from 10 experts. In the second phase, a cross-sectional study was carried out at several centres in Gran Canaria Island to obtain a validation sample. The evaluation of the psychometric properties of the CFQ-e, including construct validity through exploratory factor analysis and confirmatory factor analysis, the calculation of reliability via factor consistency using the ORION coefficients as well as alpha and omega coefficients were carried out. The CFQ-e showed evidence of content validity, adequate construct validity and reliability. The CFQ-e is composed of 37 items distributed in four subscales or dimensions: "fear of medical interventions"; "fear of harm and dying"; "fear of pain" and "fears relating to sexual aspects and embarrassment". The CFQ-e constitutes a valid and reliable tool to measure the fear of childbirth in the Spanish pregnant population.
Chronic wounds give rise to major costs and resource consumption in health care systems, due to their protracted healing time. Incidence and prevalence data are scarce or nonexistent in community ...settings.
The aim of the present epidemiological study was to analyse and determine the prevalence of chronic wounds in the community in the south of the province of Barcelona (Spain).
A cross-sectional, multicentre secondary data analysis study was conducted in the community (excluding nursing homes) in Barcelona between 16 April and 13 June 2013. It included 52 primary care centres that serve a total population of 1,217,564 inhabitants.
The observed prevalence was 0.11%. Venous ulcers presented the highest prevalence, at 0.04%, followed by pressure injuries, at 0.03%. The >74 age group presented the highest frequency of chronic wounds, accounting for 69.4% of cases.
The results obtained are consistent with those reported in previous similar studies conducted in Spain and elsewhere. As with most studies that adjusted their variables for age and sex, we found that the prevalence of ulcers increased with age and was higher in women, except in the case of diabetic foot ulcers and ischaemic ulcers, which were more frequent in men.
The aims of the study were to describe and analyse the temporal trend of the prevalence and incidence of venous leg ulcers (VLU) over the years 2010 to 2014, to determine healing times and temporal ...trends in the study period, and to evaluate related aspects such as the use of the Ankle‐Brachial Pressure Index (ABPI) in a primary care health centre. This was a retrospective study based on a time series (years 2010‐2014) of the prevalence and incidence of VLUs in people aged over 40 years in a primary care centre in Barcelona City. We reviewed 3920 electronic health records selecting patients, per year (2010‐2014), with VLUs based on the ICD‐10 diagnoses. For prevalence, we took into account any patient with an active VLU in the year of study. For incidence, we took into account patients with a new VLU in the year of study. A descriptive analysis was carried out based on each of the collected variables. The variables were examined according to the years of study (time series) by one‐factor analysis of variance (anova) or Kruskal–Wallis non‐parametric test, as appropriate. A survival analysis by Kaplan–Meier curves and log‐rank test was also performed. A total of 139 patients met the VLU criteria. Among them, only 79.2% were classified as having a VLU and had a correct ICD diagnosis. The prevalence and incidence increased over the years, doubling in patients aged over 65 years. Incidence increased from 0.5 new cases per 1000 people/year in 2010 to 1 new case for every 1000 people/year in 2014. Moreover, the prevalence ranged between 0.8 and 2.2 patients with VLU for every 1000 people/year. During the study period, a total of 84.2% of the VLUs healed (117/139 VLU). Regarding average annual time to healing, the trend indicates that lesions took less time to heal (Kruskal–Wallis test, P = 0.004), ranging between 453,9 weeks in 2005 to 19 weeks in 2014. The use of ABPI also evolved and was found to be increasingly performed prior to the appearance of the lesion. The epidemiological profile of people affected by VLUs continues to be, mainly, that of women of an advanced age, over 70 years. The frequency of VLU occurrence rose continually over the years, but healing took less time, and use of ABPI improved. Assigning a reference nurse in the wounds unit and the organisational structure around this problem may have an influence on improving care and the approach to these types of lesions.