{
  "abstract": "Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number clinicaltrials.gov NCT06207630.",
  "authors": [
    {
      "affiliations": [
        "service de chirurgie thoracique et cardio-vasculaire, CHU Poitiers, Poitiers, France",
        "INSERM, Centre d’Investigation Clinique domaine d’Innovation Technologique (CIC-IT) 1402, Université de Poitiers, CHU de Poitiers, Poitiers, France"
      ],
      "name": "Christophe Jayle"
    },
    {
      "affiliations": [
        "service de chirurgie thoracique et cardio-vasculaire, CHU Poitiers, Poitiers, France"
      ],
      "name": "Géraldine Allain"
    },
    {
      "affiliations": [
        "INSERM, Centre d’Investigation Clinique domaine d’Innovation Technologique (CIC-IT) 1402, Université de Poitiers, CHU de Poitiers, Poitiers, France"
      ],
      "name": "Amandine Buono"
    },
    {
      "affiliations": [
        "service de chirurgie cardiaque, Angers University Hospital, Angers, France"
      ],
      "name": "Simon Dang Van"
    },
    {
      "affiliations": [
        "service de chirurgie Cardio-Vasculaire, CHU Clermont-Ferrand, Clermont-Ferrand, France"
      ],
      "name": "Nicolas D’Ostrevy"
    },
    {
      "affiliations": [
        "service de chirurgie cardiaque, CHU de Tours, Tours, France"
      ],
      "name": "Stéphane Kermen"
    },
    {
      "affiliations": [
        "service de chirurgie thoracique et cardio-vasculaire, CHU Limoges, Limoges, France"
      ],
      "name": "Alessandro Picardo"
    },
    {
      "affiliations": [
        "CHU Poitiers, Poitiers, France"
      ],
      "name": "Antoine Pelras"
    },
    {
      "affiliations": [
        "service de chirurgie thoracique et cardio-vasculaire, CHU Poitiers, Poitiers, France"
      ],
      "name": "Julie Drux"
    },
    {
      "affiliations": [
        "service de chirurgie thoracique et cardio-vasculaire, CHU Poitiers, Poitiers, France"
      ],
      "name": "Pierre Corbi"
    },
    {
      "affiliations": [
        "INSERM, Centre d’Investigation Clinique domaine d’Innovation Technologique (CIC-IT) 1402, Université de Poitiers, CHU de Poitiers, Poitiers, France",
        "Centre de Recherche sur la Cognition et l’Apprentissage UMR7295, CNRS, Universite de Poitiers, Poitiers, France"
      ],
      "name": "Maxime Billot"
    },
    {
      "affiliations": [
        "service d’anesthésie réanimation et médecine péri-opératoire, CHU Poitiers, Poitiers, France"
      ],
      "name": "Denis Frasca"
    }
  ],
  "title": "Reduction of the risk of complete sternotomy scar dehiscence in cardiac surgery: a protocol for a randomised, open-label multicentre clinical investigation comparing negative pressure wound therapy (NPWT) versus standard dressing (PRISTER study)",
  "uid": "a118cfd9-fbb8-5818-a998-73794f45293b"
}