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Can a vacuum dressing stop wound infections after breast cancer surgery?

NCT ID NCT06265558

Disease control Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a special vacuum dressing (negative pressure therapy) can reduce wound complications like infection, reopening, or slow healing after complex breast cancer surgery with reconstruction. About 254 women with risk factors like obesity or smoking will be randomly assigned to get either the vacuum dressing or a standard dressing. The goal is to see if the vacuum dressing leads to fewer wound problems within 30 days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Negative pressure therapy (a special dressing connected to a vacuum to help wounds heal)
What this could lead to
If it works, this could offer a simple way to reduce infections, wound reopening, and slow healing after breast cancer surgery with reconstruction.
What could go wrong
This is a relatively small, early-stage trial. Previous studies had serious limitations, so results may not be conclusive. The therapy is a procedure, not a drug, so benefits may be modest.

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

About 254 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

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

Female participants only

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: 1. Female ≥ 18 years 2. Patient with unilateral invasive or in situ breast carcinoma 3. Patient with or without neoadjuvant treatment 4. Patient presenting an indication for complex breast surgery by mastectomy with immediate breast reconstruction by implant or oncoplasty by T-shaped mammoplasty. 5. Patient presenting at least one of the following risk factors for scarring disorders: * Obesity with Body Mass Index BMI ≥ 30 and/or Cup size ≥ E * Active smoking or smoking cessation for less than one month * Diabetes * History of homolateral breast radiotherapy * Long-term corticosteroid therapy 6. Patient to have signed informed consent prior to study entry 7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 8. Patient affiliated with a health insurance plan. Exclusion Criteria: 1. Legal incapacity or limited legal capacity. Medical or psychological conditions preventing the patient from completing the study or signing the consent form. 2. Pregnant or breast-feeding patient as determined in medical records as part of standard patients care and follow-up 3. Patient under guardianship or safeguard of justice 4. Patient participating in an interventional study with the objective of wound healing 5. Any concurrent or planned surgical procedure on the contralateral breast

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

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

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Georges-François Leclerc

    NOT_YET_RECRUITING

    Dijon, Côte d'Or, 21079, France

  • Centre Hospitalier de Montpellier

    RECRUITING

    Montpellier, Hérault, 34090, France

  • Centre Hospitalier de Nîmes

    RECRUITING

    Nîmes, GARD, 30900, France

  • Centre Léon Bérard

    NOT_YET_RECRUITING

    Lyon, Rhône, 69373, France

  • Institut Bergonié

    NOT_YET_RECRUITING

    Bordeaux, Gironde, 33076, France

  • Institut de Cancérologie de l'Ouest

    RECRUITING

    Angers, Maine Et Loire, 49055, France

  • Institut régional du Cancer de Montpellier

    RECRUITING

    Montpellier, Hérault, 34298, France

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