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Bandage may cut needle drains after breast removal

NCT ID NCT03598712

Symptom relief Sponsor: Centre Francois Baclesse Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 wearing a special chest bandage after mastectomy could reduce the number of times doctors need to drain fluid buildup (seroma). Half of the 60 participants got the bandage plus standard drainage, while the other half had only drainage. The study was stopped early, so the results are not conclusive.

What this could mean

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

Active substance
chest bandage (urgo K2® kit)
What this could lead to
If effective, this bandage could reduce the number of needle drainages needed for fluid buildup after mastectomy, making recovery easier.
What could go wrong
The study was terminated early with only 60 participants, so we don't have enough data to know if the bandage truly helps. It may not work for everyone.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Started

Nov 2018

Finished

Aug 2020

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: * Patient followed for histologically proven breast cancer treated by total mastectomy, whether or not dissociated from the sentinel node technique, with or without axillary curing. * Patient with a second seroma puncture with a volume greater than or equal to 250 ml. * Neo adjuvant chemotherapy authorized. * Absence of known metastases. * Patient has given written consent. Exclusion Criteria: * Mastectomy with immediate reconstruction. * Partial mastectomy. * Concurrent bilateral mastectomy. * Delay in healing observed at inclusion. * Patient under legal protection. * Chronic respiratory failure. * Patient with a pacemaker. * Personality disorders and known progressive psychiatric pathology. * Inability to submit to trial follow-up

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Seroma

As listed by the trial registrant

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

Breast cancer Mastectomy SEROMA

Contacts and locations

Locations

  • Centre Françis Baclesse

    Caen, France

  • TANQUEREL Julie

    Caen, 14400, France

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