Clinical trial NCT03598712: Local Compression Seroma DIminution Objective (CLODIS)
Official title: Interest of Local Compression by Thoracic Bandage on the Management of Seroma in Patients Treated by Mastectomy With or Without Lymphadenectomy. Local Compression Seroma DIminution Objective
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Mastectomy
Seroma
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 3 prospective, randomized, monocentric controlled study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of puncture(s) after inclusion in both patient groups
timeFrame: 180 days
Secondary outcomes:
measure: The time required to take charge of adjuvant treatments
timeFrame: 180 days
measure: Volume punctured after inclusion in both patient groups.
timeFrame: 180 days
measure: comparison of the average change Quality of life scores between each arm
timeFrame: 180 days
measure: comparison of the average change anxiety scores between each arm
timeFrame: 180 days
measure: comparison of the average change Pain scores between each arm
timeFrame: 180 days
measure: The aesthetic impact on the puncture site.
timeFrame: 180 days
measure: Validation of a score allowing the description of the seroma of grades 2 and the indication of a puncture
timeFrame: 180 days
Other outcomes:
Locations:
city: Caen
country: France
facility: TANQUEREL Julie
city: Caen
country: France
facility: Centre Françis Baclesse
Study officials:
References: