Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles (BANDOCELE)

Toulouse University Hospital

Status: Enrolling

Conditions: Lymphocele

Treatments: Device: Bandage; Device: No bandage

Study type: Interventional

Funder types: Other

Identifiers

NCT04819542

RC31/17/0350

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

drain + compression bandage

Experimental group

Treatment:

Device: Bandage

drain without compression bandage

Active Comparator group

Treatment:

Device: No bandage