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Vacuum dressing may keep heart surgery scars closed

NCT ID NCT06207630

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether using a negative pressure wound therapy (NPWT) device on the chest after heart surgery can prevent the scar from reopening, compared to a standard bandage. About 660 adults having planned or semi-urgent heart surgery through a breastbone incision took part. The goal was to see if the vacuum dressing reduces skin separation and infection risk in the first month after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

660 people

The number who actually took part.

Started

Mar 2024

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • C.H.U. Tours

    Tours, 37044, France

  • C.H.U. of Angers

    Angers, 49933, France

  • C.H.U. of Clermont-Ferrand

    Clermont-Ferrand, 63000, France

  • C.H.U. of Limoges

    Limoges, 87042, France

  • C.H.U. of Poitiers

    Poitiers, 86000, France