Vacuum dressing may keep heart surgery scars closed
NCT ID NCT06207630
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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660 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Aug 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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C.H.U. Tours
Tours, 37044, France
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C.H.U. of Angers
Angers, 49933, France
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C.H.U. of Clermont-Ferrand
Clermont-Ferrand, 63000, France
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C.H.U. of Limoges
Limoges, 87042, France
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C.H.U. of Poitiers
Poitiers, 86000, France