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The role of orthobiologics in chronic wound healing

Abstract

Chronic wounds, characterized by prolonged healing processes, pose a significant medical challenge with multifaceted aetiologies, including local and systemic factors. Here, it explores the complex pathogenesis of chronic wounds, emphasizing the disruption in the normal phases of wound healing, particularly the inflammatory phase, leading to an imbalance in extracellular matrix (ECM) dynamics and persistent inflammation. Senescent cell populations further contribute to impaired wound healing in chronic lesions. Traditional medical management focuses on addressing underlying causes, but many chronic wounds resist to conventional treatments, necessitating innovative approaches. Recent attention has turned to autologous orthobiologics, such as platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and mesenchymal stem cells (MSCs), as potential regenerative interventions. These biologically derived materials, including bone marrow aspirate/concentrate (BMA/BMAC) and adipose tissue-derived stem cells (ADSCs), exhibit promising cytokine content and regenerative potential. MSCs, in particular, have emerged as key players in wound healing, influencing inflammation and promoting tissue regeneration. This paper reviews relevant scientific literature regarding basic science and brings real-world evidence regarding the use of orthobiologics in the treatment of chronic wounds, irrespective of aetiology. The discussion highlights the regenerative properties of PRP, PRF, BMA, BMAC and SVF, showcasing their potential to enhance wound healing. Despite advancements, further research is essential to elucidate the specific roles of each orthobiologic and determine optimal applications for different wound types. The conclusion underscores the evolving landscape in chronic wound management, with a call for more comprehensive studies to refine treatment strategies and maximize the benefits of regenerative medicine.

Integrating factors associated with complex wound healing into a mobile application: Findings from a cohort study

Abstract

Complex, chronic or hard-to-heal wounds are a prevalent health problem worldwide, with significant physical, psychological and social consequences. This study aims to identify factors associated with the healing process of these wounds and develop a mobile application for wound care that incorporates these factors. A prospective multicentre cohort study was conducted in nine health units in Portugal, involving data collection through a mobile application by nurses from April to October 2022. The study followed 46 patients with 57 wounds for up to 5 weeks, conducting six evaluations. Healing time was the main outcome measure, analysed using the Mann–Whitney test and three Cox regression models to calculate risk ratios. The study sample comprised various wound types, with pressure ulcers being the most common (61.4%), followed by venous leg ulcers (17.5%) and diabetic foot ulcers (8.8%). Factors that were found to impair the wound healing process included chronic kidney disease (U = 13.50; p = 0.046), obesity (U = 18.0; p = 0.021), non-adherence to treatment (U = 1.0; p = 0.029) and interference of the wound with daily routines (U = 11.0; p = 0.028). Risk factors for delayed healing over time were identified as bone involvement (RR 3.91; p < 0.001), presence of odour (RR 3.36; p = 0.007), presence of neuropathy (RR 2.49; p = 0.002), use of anti-inflammatory drugs (RR 2.45; p = 0.011), stalled wound (RR 2.26; p = 0.022), greater width (RR 2.03; p = 0.002), greater depth (RR 1.72; p = 0.036) and a high score on the healing scale (RR 1.21; p = 0.001). Integrating the identified risk factors for delayed healing into the assessment of patients and incorporating them into a mobile application can enhance decision-making in wound care.

Preventing chronic malnutrition in children under 2 years in rural Angola (MuCCUA trial): protocol for the economic evaluation of a three-arm community cluster randomised controlled trial

Por: Martin-Canavate · R. · Custodio · E. · Trigo · E. · Romay-Barja · M. · Herrador · Z. · Aguado · I. · Ramirez · F. · Faria · L. M. · Silva-Gerardo · A. · Lima · J. C. · Iraizoz · E. · Marques · T. · Vargas · A. · Gomez · A. · Puett · C. · Molina · I.
Introduction

Chronic malnutrition is a serious problem in southern Angola with a prevalence of 49.9% and 37.2% in the provinces of Huila and Cunene, respectively. The MuCCUA (Mother and Child Chronic Undernutrition in Angola) trial is a community-based randomised controlled trial (c-RCT) which aims to evaluate the effectiveness of a nutrition supplementation plus standard of care intervention and a cash transfer plus standard of care intervention in preventing stunting, and to compare them with a standard of care alone intervention in southern Angola. This protocol describes the planned economic evaluation associated with the c-RCT.

Methods and analysis

We will conduct a cost-efficiency and cost-effectiveness analysis nested within the MuCCUA trial with a societal perspective, measuring programme, provider, participant and household costs. We will collect programme costs prospectively using a combined calculation method including quantitative and qualitative data. Financial costs will be estimated by applying activity-based costing methods to accounting records using time allocation sheets. We will estimate costs not included in accounting records by the ingredients approach, and indirect costs incurred by beneficiaries through interviews, household surveys and focus group discussions. Cost-efficiency will be estimated as cost per output achieved by combining activity-specific cost data with routine data on programme outputs. Cost-effectiveness will be assessed as cost per stunting case prevented. We will calculate incremental cost-effectiveness ratios comparing the additional cost per improved outcome of the different intervention arms and the standard of care. We will perform sensitivity analyses to assess robustness of results.

Ethics and dissemination

This economic evaluation will provide useful information to the Angolan Government and other policymakers on the most cost-effective intervention to prevent stunting in this and other comparable contexts. The protocol was approved by the República de Angola Ministério da Saúde Comité de Ética (27C.E/MINSA.INIS/2022). The findings of this study will be disseminated within academia and the wider policy sphere.

Trial registration number

ClinicalTrials.gov Registry (NCT05571280).

Reportes de casos clínicos de pacientes tras revascularización miocárdica basado en la Teoría de Enfermería de Medio Rango para la Rehabilitación Cardiovascular

El objetivo es describir los planes de atención domiciliaria del paciente después de la revascularización miocárdica (RM) basados en la Teoría de Enfermería de Rango Medio para la Rehabilitación Cardiovascular (TMA Enf-RCV). Se trata de un estudio de caso múltiple en el que la recogida de datos se realizó en el domicilio de siete pacientes en el postoperatorio de RM, en Sobral-Ceará, entre junio y diciembre de 2019. La información recogida se organizó en informes individuales y luego, se realizó la síntesis analítica conjunta. La evaluación de la conducta rehabilitadora y el estímulo para la rehabilitación cardiovascular (RCV) involucró problemas fisiológicos adaptativos, autoconcepto, desempeño de roles e interdependencia, con un 50% de los diagnósticos de enfermería centrados en problemas y asociados con el modo fisiológico y un 57% de los diagnósticos de promoción de la salud se relacionaron con el modo de autoconcepto. La intervención de rehabilitación de enfermería incluyó la promoción de ejercicios físicos, el estímulo del paciente y la familia en el cuidado, educación sobre estrategias adaptativas, apoyo psicosocial, entre otros. Este estudio respalda la aplicabilidad de TMA Enf-RCV como una intervención eficaz para el RCV con un enfoque en la calidad de vida.

Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review protocol

Por: De Oliveira Ascef · B. · Gabriel · F. C. · Suzumura · E. A. · Maia · F. H. d. A. · Bortoluzzi · A. F. R. · Farias · N. S. · Jahn · B. · Siebert · U. · De Soarez · P. C.
Background

Benefit–risk assessment (BRA) is used in multiple phases along the health technology’s life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA’s application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA.

Methods and analysis

This scoping review protocol was developed following the framework proposed by Arksey and O’Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts.

Ethics and dissemination

This review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops.

Trial registration number

Open Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).

The effect of sodium-glucose cotransporter 2 inhibitors in patients with chronic kidney disease with or without type 2 diabetes mellitus on cardiovascular and renal outcomes: A systematic review and meta-analysis

by Carlos Ignacio Reyes-Farias, Marcelo Reategui-Diaz, Franco Romani-Romani, Larry Prokop

Background

Sodium-glucose cotransporter 2 (SGLT-2) inhibitors have shown a favorable effect on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus (T2DM). However, their efficacy in patients with chronic kidney disease (CKD) with or without T2DM has not yet been analyzed.

Objective

To assess the cardiovascular and renal effects of SGLT-2 inhibitors in patients with CKD with and without T2DM, including all CKD patients in the current literature.

Methods

We searched MEDLINE, EMBASE, CENTRAL and Scopus for randomized controlled trials of SGLT-2 inhibitors that evaluated cardiovascular and kidney outcomes in patients with CKD, or trials in which these patients were a subgroup. We defined 2 primary outcomes: a composite of cardiovascular death or hospitalization for heart failure, and a composite renal outcome. For each outcome, we obtained overall hazard ratios with 95% confidence intervals by using a random effects model.

Results

We included 14 randomized controlled trials. SGLT-2 inhibitors decreased the hazard for the primary cardiovascular outcome (HR 0.76; [95% CI 0.72–0.79]) and the primary renal outcome (HR 0.69; [95% CI 0.61–0.79]) in patients with CKD with or without T2DM. We did not find significant differences in the subgroup analyses according to diabetes status, baseline eGFR values or the type of SGLT-2 inhibitor used.

Conclusion

In patients with CKD, treatment with SGLT-2 inhibitors in addition to standard therapy conferred protection against cardiovascular and renal outcomes. Further research on patients with non-diabetic CKD should be done to confirm the utility of these medications in this population. (PROSPERO ID: CRD42021275012).

Changes in the diagnosis of depression among nursing professionals during the COVID‐19 pandemic: A longitudinal study

Abstract

Aims

To identify changes in mental health status among nursing professionals in a Brazilian municipality during the COVID-19 pandemic.

Design

An observational and longitudinal study.

Methods

Using the Patient Health Questionnaire-9, the presence of depressive symptoms was evaluated among 690 nursing professionals in the city of Pelotas, Brazil, at two moments: June/July 2020 and June/July 2021.

Results

13.0% incidence of depressive symptoms was identified; as well as 12.2% remission; 24.1% persistence and 50.7% absence. Among the factors associated with the worst prognoses we can mention female gender, greater workload, feeling of overload, illness of family members or friends due to COVID-19 and use of psychotropic drugs

Conclusions

There was significant mobility in the diagnosis of depression among the professionals studied during the period analysed, with incidence of new cases of significant depression and greater than the number of remissions. In addition to sociodemographic aspects, traumatic experiences and exposure to continuous overload were associated with persistence and incidence of new cases.

Implications for the profession and/or patient care

With the advent of the COVID-19 pandemic, several studies have shown an increase in depressive symptoms among nursing professionals; however, understanding the long-term effects of this scenario is still a challenge.

Impact

What problem did the study address? This study investigates changes in the mental health status of nursing professionals working at different care levels, taking the prevalence of screening for depression as a proxy, during a period of a year during the COVID-19 pandemic.

What were the main findings? Between both data collection moments, 2020 e 2021, there was a significant percentage of professionals with persistent depression, in addition to a significant proportion of incident cases that slightly exceeded the number of remissions and the factors associated with the worst prognoses were sociodemographic aspects such as gender and emotional stressors like illness of family members or close friends due to COVID-19, in addition to those related to the organisation and support provided by the services, such as workload and feeling of overload.

Where and on whom will the research have an impact? This study will impact the nursing professionals and in role of the health services in order to establishing actions that contribute to minimising the deleterious effects of the pandemic on the mental health of their Nursing teams.

Reporting method

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines were adopted in this study.

Patient or public contribution

No Patient or Public Contribution.

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