Local Compression Seroma DIminution Objective (CLODIS)

Centre Francois Baclesse

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer; Mastectomy; Seroma

Treatments: Device: Compression by chest bandage urgo K2®; Procedure: punctures

Study type: Interventional

Funder types: Other

Identifiers

NCT03598712

CLODIS

Details and patient eligibility

About

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.

Full description

The most common complication induced by mastectomy is seroma formation. This seroma is a serolymphatic effusion that is created in the days following surgery. Iterative puncture is the only treatment for seroma mentioned in the literature. A retrospective study in the investigator's establishment on 1800 patients determined that a second puncture greater than 250ml is predictive of a chronicisation of punctures. The research hypothesis is that by applying local compression by chest bandaging with the Urgo® K2 kit, the "dead space" created by surgery would be removed. This would help resorb the seroma and reduce the number of punctures.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Compression by chest bandage urgo K2®

Experimental group

Description:

After the second puncture, the local compression by thoracic bandage will be put in place. The system being effective 7 days, it will be left in place between each visit. A visit will be made for all patients 7 days after the installation of the device. However, if necessary, an intermediate visit may be carried out. During these visits, a puncture will be made according to the criteria mentioned above. The bandage will be renewed after each visit. The device will be removed after 15 days without indication of a new puncture. The patient will be seen again between 10 and 15 days after the bandage is removed for a final evaluation.

Treatment:

Procedure: punctures

Device: Compression by chest bandage urgo K2®

punctures

Active Comparator group

Description:

After the second puncture, the patient will be seen at the same frequency as in the experimental arm. The decision to perform a puncture will be made according to the same criteria and the follow-up conditions will be identical.

Treatment:

Procedure: punctures