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.

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder primarily affecting motor neurons. In addition to motor impairments, ALS frequently involves cognitive and behavioural disturbances, including deficits in social cognition, which can impact interpersonal interactions and decision-making. Despite increasing recognition of these impairments, existing assessment tools often rely on static stimuli, limiting their ecological validity.

This cross-sectional, single-centre study aims to assess social cognition abilities in patients with ALS compared with healthy controls using a combination of dynamic and static neuropsychological tools. The primary outcome measure will be performance on the Movie for the Assessment of Social Cognition, an ecologically valid test evaluating theory of mind. Secondary outcomes will include emotion recognition (static and dynamic tasks: Ekman Faces and French Emotion Evaluation Test), mood assessments (Hospital Anxiety and Depression Scale) and clinical variables such as disease severity (ALS Functional Rating Scale-Revised), cognitive function (Edinburgh Cognitive and Behavioural Screen, Mini–Mental State Examination) and disease staging (King’s ALS Clinical Staging System). A total of 74 participants (37 patients with ALS and 37 matched healthy controls) will be recruited. Group differences will be analysed using analysis of variance, while regression models will explore associations between social cognitive deficits and clinical markers of ALS progression.

This study has been approved by the French Ethics Committee (CPP) Ouest I under reference 2020-A01213-36. Data collection and processing comply with French and European data protection regulations (GDPR, Loi Informatique et Libertés). Findings will be disseminated through peer-reviewed journals and scientific conferences and will contribute to improving neuropsychological assessment methods for ALS.

NCT04406675.