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 range18 Years

SexFEMALE

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

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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