TerminatedPhase 3

Local Compression Seroma DIminution Objective (CLODIS)

Stopped: Surgical practices have evolved as surgeons practice immediate reconstructive surgery. We have not been able to meet the recruitment target.

France60 participantsStarted 2018-11-18

Plain-language summary

This study evaluates the impact of local compression by chest bandage on the number of seroma punctures in patients treated by mastectomy with or without lymphadectomy. Half of the participants will have local compression by chest bandage in addition to seroma punctures while the other half will only have punctures.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of puncture(s) after inclusion in both patient groups

Timeframe: 180 days

Trial details

NCT IDNCT03598712

SponsorCentre Francois Baclesse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-18

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