Clinical trial NCT04819542: Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
Official title: Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphocele
Keywords: mastectomy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lymphocele secondary to a mastectomy whether or not associated with a lymph node procedure (sentinel lymph node or axillary dissection) is an almost systematic consequence observed in the postoperative situation in this type of surgery.

This can be the source of pain, skin complications, and infection with a significant impact on the length of hospitalization for patients treated for breast cancer.

There is no consensus regarding the management of lymphocele. The placement of a compression bandage after mastectomy and / or axillary dissection would allow a more efficient and rapid reduction of the lymphocele and a reduction in recurrences.

This would make it possible to reduce the duration of the wearing of the drain, which determines the length of hospitalization and reduce the recurrence of lymphoceles, the punctures of which can be one of the risk factors for secondary lymphedema.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old,
* Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer
* Affiliated with a health insurance plan

Exclusion Criteria:

* Recurrence of breast cancer,
* Mastectomy with RMI (immediate breast reconstruction) at the same time of operation
* Anticoagulant treatment at curative dose
* Arteritis obliterans of the upper limbs,
* Other cancer during treatment,
* Decompensated heart failure,
* Acute infectious episode (cellulitis, erysipelas, lymphangitis)
* Acute deep vein thrombosis upper limb ipsilateral to mastectomy,
* Cutaneous atrophy of the upper limb,
* Bullous dermatoses,
* Hyperalgesia of the shoulder
* Inability to submit to the constraints of the protocol,
* Impossibility for the patient to achieve self-restraint at the thoracic level
* Pregnancy,
* Feeding with milk
* BMI\> 35
* Adult protected by law (guardianship, curatorship and safeguard of justice).
* Anyone who is not in a position to give their consent in writing

Primary outcomes:
measure: Proportion in percentage of patients treated successfully
timeFrame: 6 months
Secondary outcomes:
measure: Lymphocele volume in milliliter
timeFrame: 6 months
measure: Number of lymphocele punctures
timeFrame: 6 months
measure: Clinical signs associated with lymphocele
timeFrame: 8 days
measure: Frequency of adverse events
timeFrame: 6 months
measure: Clinical signs associated with lymphocele
timeFrame: 8 days
measure: Clinical signs associated with lymphocele
timeFrame: 8 days
measure: Changes in quality of life
timeFrame: 6 months
measure: Changes in quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Julie MALLOIZEL DELAUNAY, MD
role: PRINCIPAL_INVESTIGATOR
References: