Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery: A Clinical Investigation Comparing Negative Pressure Wound Therapy (NPWT) vs. Standard Dressing (PRISTER)

Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery: A Randomized, Open-label Multicenter Clinical Investigation Comparing Negative Pressure Wound Therapy (NPWT) vs. Standard Dressing

Mediastinitis is the most feared infectious complication after cardiac surgery. Several risk factors are known such as: obesity, diabetes, chronic obstructive pulmonary disease, double breast sampling, immunodeficiency, corticosteroid therapy, reoperation, chest radiotherapy, and dialysis. Three modes of contamination are described: intraoperative contamination, hematogenous dissemination during sepsis, gradual contamination from cutaneous dehiscence. It is important and simple to fight against this third mode. The dehiscence of the sternotomy scar represents a gateway and facilitates bacterial colonization and is a risk factor for infection of the surgical site. These skin disunities lead to an increase in health care costs due to extension of hospital stay, the cost of repeated nursing care, surgical revision, and the need for increased follow-up. They delay cardiac rehabilitation and return home. It is estimated that these simple disunities occur in more than 15% of cases, although fortunately they rarely result in mediastinitis. While the use of NPWT for the prevention of wound healing complications is permitted, its benefit has not been demonstrated. Its action is multiple with a reduction in the rate of repair of dressings and therefore of soiling, drainage of the wound, limitation of maceration, acceleration of healing. The use of NPWT as a dressing for sternotomies could prevent skin breakdown, and therefore superficial and deep surgical site infections.

Two types of NPWT devices exist, corresponding to 2 different types of treatment: the 7-day NPWT without dressing repair but with reservoir (PREVENA®), the NPWT with 3-day repair without reservoir (PICO®).

Given the cost and widespread use of NPWT for chirurgical site infection prophylaxis, it is important to conduct randomized trials to assess the expected benefit of these NPWTs designed for use on clean, closed surgical incisions. In cardiac surgery, its benefit has only been shown in a high-risk population: surgery for Coronary Artery Bypass Graft (CABG).

The present clinical investigation will be the first randomized, multicenter trial comparing the efficacy and safety of NPWT versus standard dressing in preventing the risk of scar dehiscence after cardiac surgery, in a standard population.

The patients will be followed for 90 days (3 months).

Study Overview

• Status: Completed
• Conditions: Complete Vertical Midline Sternotomy / Cardiac Surgery
• Intervention / Treatment: Device: Dressing Device

• Study Type: Interventional
• Enrollment (Actual): 660
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • C.H.U. of Angers
  • Clermont-Ferrand, France, 63000
    • C.H.U. of Clermont-Ferrand
  • Limoges, France, 87042
    • C.H.U. of Limoges
  • Poitiers, France, 86000
    • C.H.U. of Poitiers
  • Tours, France, 37044
    • C.H.U. Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients undergoing scheduled or semi-urgent cardiac surgery, with or without extracorporeal circulation.
• Patients managed by complete vertical median sternotomy.
• Patients benefiting from a Social Security scheme or benefiting from it through a third party.
• Informed consent signed by the patient after clear and complete information about the clinical investigation.

All patients included in this clinical investigation must not have any of the non-inclusion criteria listed below:

Exclusion Criteria:

• Known allergy to one of the dressings: PREVENA®, PICO® or standard dressing
• Patient with a contraindication to PICO® dressing

• Patient with a contraindication to PREVENA® dressing:

  • Sensitivity to silver
• Patient with a history of cardiac surgery prior to inclusion
• Patient with skin infection (folliculitis) of the sternotomy site before the operation.
• Urgency and extreme urgency (patient operated within 24 hours of admission).
• Patient already participating in a clinical investigation whose main objective or secondary objectives are likely to have an impact on the main objective of this clinical investigation
• Patient with antibiotherapy ongoing (endocarditis patients)
• Minimal sternotomy (8-10 cm)
• Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy), or having a positive pregnancy test at inclusion
• The inability of the patient to complete informed consent before any study procedure
• Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard dressing group; Use dry dressing, made with sterile compresses, then a glued dressing	Device: Dressing Device; Use of a dress at the end of surgery in the operating room, making sure not to stick it on the openings of the chest drains.
Experimental: NPWT 3/7d dressing group; Use of a PICO® dressing	Device: Dressing Device; Use of a dress at the end of surgery in the operating room, making sure not to stick it on the openings of the chest drains.
Experimental: NPWT 7d dressing group; Use of a PREVENA® dressing	Device: Dressing Device; Use of a dress at the end of surgery in the operating room, making sure not to stick it on the openings of the chest drains.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete median sternotomy wound cutaneous dehiscence	Complete median sternotomy wound cutaneous dehiscence in cardiac surgery during the first 30 postoperative days will be assessed by tablet calibrated photos analyzed by an independent blinded staff.	30 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of dressing repairs		Between 7 and 90 postoperative days
The length of initial hospital stay		Between 7 and 90 postoperative days
The occurrence of an infection of the surgical site and its classification		At Day 90
The use of an anti-infectious treatment and its duration.		Between 7 and 90 postoperative days
The incidence of postoperative mediastinitis defined by dehiscence of the sternum with positive sternal samples.		At Day 90
The incidence of surgical revision for dehiscence of the surgical wound at D90.	Collection of all operations involving surgical revision of the sternotomy wound.	At Day 90
The number of rehospitalizations (including consultations), and their duration.		At Day 90
The nurse's satisfaction with the use of the 3 types of dressing during dressing repair by means of a standardized questionnaire.	The nurse's satisfaction with the use of the 3 types of dressing during dressing repair by means of a standardized questionnaire consisting in four questions rated from 1 (not satisfied) to 5 (totally satisfied): Are you satisfied with application of this dressing? Are you satisfied with management of the surgical wound? Are you satisfied with follow-up on the wound? Are you satisfied with the visual appearance of the surgical wound?	7 postoperative days
The surgeon's satisfaction with the wound by means of a standardized questionnaire.	The surgeon's satisfaction with the wound by means of a standardized questionnaire consisting in four questions rated from 1 (not satisfied) to 5 (totally satisfied): Are you satisfied with application of this dressing? Are you satisfied with management of the surgical wound? Are you satisfied with follow-up on the wound? Are you satisfied with the visual appearance of the surgical wound? .	7 postoperative days
The incremental cost-utility ratio expressed in costs per quality-adjusted life-year (QALY) gained.	Medico-economic assessment will be assessed by evaluation of hospital and extra-hospital costs (number of days in hospital, consultations, re-hospitalisations, imaging, biology and drugs), dressing costs and patient quality of life by EQ-5D-5L. The proposed analysis will be a cost-utility analysis because health-related quality of life is a significant outcome of the studied interventions.	Between 7 and 90 postoperative days
The incremental cost-effectiveness ratio expressed in costs per post-operative complication avoided	Resource utilization data will be collected prospectively for all patients enrolled in the clinical investigation. The collected metrics will include costs associated with initial hospitalization, surgical duration, devices utilized during the procedure, length of stay, and readmissions.	Between 7 and 90 postoperative days

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Publications and helpful links

General Publications

• Jayle C, Allain G, Buono A, Dang Van S, D'Ostrevy N, Kermen S, Picardo A, Pelras A, Drux J, Corbi P, Billot M, Frasca D. 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). BMJ Open. 2025 Nov 19;15(11):e104226. doi: 10.1136/bmjopen-2025-104226.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Actual): August 25, 2025
• Study Completion (Actual): August 25, 2025

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PRISTER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No