Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles

NCT04819542 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Toulouse

Phase

Not applicable

Started

2021-08-16

Last updated

2026-06-01

Condition(s) studied

Lymphocele

Investigational drug(s) / intervention(s)

BandageNo bandage

Bandage: Bandage

No bandage: No bandage

Study 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

Sex

FEMALE

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Proportion in percentage of patients treated successfully — 6 months
Provide an estimate of the proportion of patients treated successfully (success rate defined by the absence of lymphocele on D4 post mastectomy) in two groups of patients (drain + compression bandage vs drain without compression bandage).

Trial sites (1)

Facility	City	Region	Status
University Hospital	Toulouse	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04819542 on ClinicalTrials.gov ↗ ← All trials in France