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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lymphocele

Intervention / Treatment
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* Device: Bandage
* Device: No bandage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drain + compression bandage<br> | Device: Bandage<br>* Bandage<br>|
| Active Comparator: drain without compression bandage<br> | Device: No bandage<br>* No bandage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion in percentage of patients treated successfully | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphocele volume in milliliter | Lymphocele volume at day 4, day 8 and 6 months post mastectomy | 6 months | 
| Number of lymphocele punctures | Number of lymphocele punctures possibly performed during the 6 months of follow-up | 6 months | 
| Clinical signs associated with lymphocele | Clinical signs associated with lymphocele at day 4 and day 8 (redness, blister, local inflammation (erythema + redness + warmth), rash, pruritus, ecchymosis, wound, allergic reaction, presence of clinical lymphocele, pain in the limb ipsilateral on surgery, heaviness in the ipsilateral limb discomfort when using the ipsilateral limb, perimeter measurements (in centimeters) at the level of both upper limbs using a standard seamstress ruler, measurement of joint amplitudes (in centimeters). | 8 days | 
| Frequency of adverse events | The frequency of adverse events during the 6-month follow-up | 6 months | 
| Clinical signs associated with lymphocele | Clinical signs associated with lymphocele at day 4 and day 8 : perimeter measurements (in centimeters) at the level of both upper limbs using a standard seamstress ruler | 8 days | 
| Clinical signs associated with lymphocele | Clinical signs associated with lymphocele at day 4 and day 8 : measurement of joint amplitudes (in centimeters). | 8 days | 
| Changes in quality of life | Changes in quality of life, with QLQ-C30 questionnaire, (specifically linked to breast cancer and overall quality of life) at day 8, day 21 and at 6 months post mastectomy, compared to an assessment before mastectomy | 6 months | 
| Changes in quality of life | Changes in quality of life, with 5Q-5D-5L questionnaire, (specifically linked to breast cancer and overall quality of life) at day 8, day 21 and at 6 months post mastectomy, compared to an assessment before mastectomy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mastectomy