Cardiac surgical procedures are associated with a high incidence of postoperative infection, a risk attributed to their inherently invasive nature and extended duration. The goal of this study is to evaluate the efficacy of negative pressure wound therapy (NPWT) compared with standard dressings in preventing sternal scar dehiscence in patients undergoing cardiac surgery via complete vertical midline sternotomy, comparing a 3 day change system (NPWT 3/7 d) versus a 7 day wear system (NPWT 7d) versus standard dressings.

The PRISTER study is a prospective open-label multicentre, randomised, controlled, three-arm trial. Patients aged ≥18 years and meeting all the following inclusion criteria: patients undergoing scheduled or semiurgent cardiac surgery, with or without extracorporeal circulation, and patients managed by complete vertical median sternotomy will be recruited. Total sample size will consist of 660 patients. The primary outcome, surgical wound dehiscence after complete median sternotomy, expressed as occurrence or non-occurrence during the first 30 postoperative days, will be assessed by tablet calibrated photos analysed by an independent blinded staff. The secondary outcomes will be the number of dressing repairs between D7 (excluding initial protocol) and D90, length of initial hospital stay, occurrence of surgical site infection and its classification collected on day 90 (D90), use of an anti-infectious treatment and its duration, incidence of postoperative mediastinitis defined by dehiscence of the sternum with positive sternal samples, incidence of surgical revision for dehiscence of the surgical wound at D90 and collection of all operations involving surgical revision of the sternotomy wound, number of rehospitalisations (including hospital consultations) and their duration (evaluated at D90). Medicoeconomic assessment will be assessed by evaluation of hospital and extrahospital costs (number of days in hospital, consultations, rehospitalisations, imaging, biology and drugs), dressing costs and patient quality of life by EQ-5D-5L.

The study was approved by the French Agency for the Safety of Health Products (ANSM, Agence National de Sécurité du Médicament) as well as by the Ethics Committee (CPP Ile de France VIII) N°ID-RCB: 2023-A01782-43. Recruitment began in April 2024 and ended on 26 May 2025.

clinicaltrials.gov NCT06207630.

Refugees experience significant health needs and well-being inequities. Smoking tobacco, nutrition disorders, alcohol use and physical inactivity are potential contributors to developing non-communicable diseases and mental health conditions. This study aims to explore refugees’ health promotion needs in a regional town in New South Wales (NSW), Australia, suggest appropriate health promotion methods, and co-design a health promotion intervention. Privileging refugees’ voices and experiences is central to co-designing appropriate health promotion interventions.

We will employ a two-phase participatory qualitative co-design method. As there is a lack of knowledge about refugees’ health needs, a participatory research design has the potential to explore the topics holistically. The social–ecological model and the behaviour change wheel model will guide this study. During Phase 1, a semistructured interview guide will be used for in-depth interviews and focus group discussions with refugees. A deductive reflexive thematic analysis will be applied to analyse data using NVivo. In Phase 2, two workshops will be conducted with refugees and health professionals. A reflexive thematic analysis will be performed to identify the top health promotion strategies.

Ethical approval was obtained from the Human Research Ethics Committee (HREC) of the North Coast NSW Local Health District (HREA370 2023/ETH00444). The Human Research Ethics Committee approved a minimisation of duplication at a regional university in Australia (SCU HREC 2024/106). Study findings will be disseminated through embedding chapters in the PhD thesis, publishing high-quality papers and presenting at conferences, lay reports, newsletters and media.

Over 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.

We will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.

Ethical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.

NCT06156176

Despite the growing volume of research in surgical education (SurgED), the integration of evidence into teaching practice remains fragmented and inconsistent. A structured and continuously updated synthesis is needed to support data-informed curriculum development and promote best practices across training programmes.

This protocol describes the development of a living systematic review and evidence map of SurgED research. Studies will be identified through comprehensive searches of CENTRAL, PubMed and Web of Science, and screened independently by two reviewers, supported by an Artificial Intelligence (AI)-assisted screening tool to improve efficiency. Eligible studies will include both quantitative and qualitative designs involving medical students, surgical residents and faculty. Studies will be categorised across key educational domains such as simulation-based training, competency-based assessment, feedback, mentoring and technology-enhanced learning. The evidence map will be updated at least quarterly, with new studies screened and added in near real-time to ensure that the map remains current and actionable.

As this study does not involve human participants, ethical approval is not required. Findings will be disseminated through peer-reviewed publications, presentations at national and international conferences and open access integration into the Evidence at a glance (EVIglance) evidence platform.

During the first wave of the COVID-19 pandemic, there was a notable decline in emergency department (ED) usage in many jurisdictions. This study assessed changes in ED use during this period and explored how the pandemic may have aggravated existing healthcare access inequities.

Our primary objective was to assess pandemic-related changes to ED visits and emergency hospitalisations for distinct demographic groups.

We conducted a retrospective observational study using population-based provincial administrative data.

We analysed data from all the 109 EDs and urgent care centres in Alberta, Canada, during the first wave of the COVID-19 pandemic (15 March 2020 to 30 June 2020), and during the corresponding (control) period 1 year earlier. We conducted subgroup analyses by age, First Nations status, sex, location and material deprivation. We repeated all analyses for pre-selected life-threatening emergency diagnoses.

We examined outcomes for a priori subgroups, including female and ‘other’ sex patients, paediatric patients (age 0–17 years), seniors (age 65 years and older), patients living in remote areas (greater than 200 km from an urban centre), First Nations members and patients living in materially deprived postal codes falling into the two most deprived Pampalon Index quintiles.

Primary outcomes were number of ED visits, number of ED visits with admission to hospital and number of ED visits resulting in patient death in the ED. A secondary outcome was change in ED use for life-threatening diagnoses (eg, cardiac conditions and hepatic disease).

ED visits in the COVID-19 period decreased by 34% (Poisson means test p

Reductions in critical emergency care and emergency hospital admissions were unequally distributed across demographic groups during the COVID-19 period. Study methods could be used to monitor and support equitable access to emergency care among distinct populations.

Preterm infants are at risk of developmental impairment, especially those born before 33 weeks gestational age. Many studies have shown a positive impact of early interventions on medical outcomes during hospitalisation, long-term cognitive development and parental anxiety. Infant Behavioral Assessment and Intervention Program (IBAIP) has shown positive effects on cognitive development but also on motor impairment in a Dutch cohort. We aim to confirm these results in a multicentric, cluster randomised controlled trial in a French setting.

Eight French neonatal intensive care units (NICUs) will be randomised before study initiation to intervention or control group. We aim to include 240 infants born between 25 weeks and 33 weeks gestational age. IBAIP intervention comprises monthly home visits with a trained professional from hospital discharge until 6 months corrected age. Both groups receive standard care according to local organisation. The primary endpoint is composite cognitive score at 2 years corrected age using Bayley Scale of Infant Development Fourth Edition (BSID IV). Secondary endpoints include BSID IV subscores, Ages and Stages Questionnaire scores and parental stress. Analysis is in intention to treat. Univariate and multivariate analysis will be performed on primary and secondary endpoints.

Informed consent from one or both parents will be necessary for all patients. Study results will be published in peer-reviewed scientific journals. If our hypothesis is confirmed, IBAIP could be implemented on a nationwide scale. The study was registered with clinicaltrials.gov (ID: 29BRC17.0219).

NCT04685356.

Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50–78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[¹⁸F]fluoroglucose positron emission tomography/CT ([¹⁸F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [¹⁸F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.

In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([¹⁸F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.

The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences. Data will be published in a data repository or other online data archive.

NCT06082492.

Severe perinatal asphyxia at term or near term remains a critical public health issue, associated with high risks of neonatal death and hypoxic-ischaemic encephalopathy (HIE). Despite improved clinical guidelines, suboptimal care persists in many cases, and previous audits have demonstrated that up to 50% of asphyxia cases could be associated with suboptimal care. OptiNeoCare is a French study which aims to assess the prevalence and determinants of suboptimal obstetric and neonatal care and evaluate its potential impact on neonatal outcomes.

This prospective, population-based observational study will include newborns ≥36 weeks’ gestation with severe perinatal asphyxia across 12 French perinatal networks (213 maternity units). Inclusion criteria comprise neonatal death or moderate/severe HIE with confirmed biochemical markers of asphyxia. Data will be collected prospectively from labour wards, transport teams and neonatal intensive care units using an electronic case report form, and the in-situ team will be invited to complete a morbi-mortality review (MMR). Approximately 336 cases will be included over 12 months, with 25% randomly selected for confidential enquiry by two experts. The quality of care will be assessed based on a structured classification of medical errors (diagnostic, therapeutic, preventive and systemic) by a panel of experts including an obstetrician or midwife and a paediatrician. Root cause analysis will identify determinants of suboptimal care. A concordance analysis will compare findings from MMRs and confidential enquiries. Statistical analysis will include multivariable logistic regression to explore associations between care quality and neonatal outcomes.

Ethical approval was granted by the Ethics Committee for Research in Obstetrics and Gynaecology. Informed non-opposition is required from participants. Results will be shared with participating centres, healthcare professionals and through scientific dissemination.

ClinicalTrials.gov ID: NCT06322732.