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)

December 3, 2025 updated by: Poitiers University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
660

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete median sternotomy wound cutaneous dehiscence
Time Frame: 30 postoperative days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of dressing repairs
Time Frame: Between 7 and 90 postoperative days
Between 7 and 90 postoperative days
The length of initial hospital stay
Time Frame: Between 7 and 90 postoperative days
Between 7 and 90 postoperative days
The occurrence of an infection of the surgical site and its classification
Time Frame: At Day 90
At Day 90
The use of an anti-infectious treatment and its duration.
Time Frame: Between 7 and 90 postoperative days
Between 7 and 90 postoperative days
The incidence of postoperative mediastinitis defined by dehiscence of the sternum with positive sternal samples.
Time Frame: At Day 90
At Day 90
The incidence of surgical revision for dehiscence of the surgical wound at D90.
Time Frame: At Day 90
Collection of all operations involving surgical revision of the sternotomy wound.
At Day 90
The number of rehospitalizations (including consultations), and their duration.
Time Frame: At Day 90
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.
Time Frame: 7 postoperative days
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.
Time Frame: 7 postoperative days
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.
Time Frame: Between 7 and 90 postoperative days
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
Time Frame: Between 7 and 90 postoperative days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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