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

Not Applicable

Recruiting

• Conditions: Lymphocele
• Interventions: Device: No bandage; Device: Bandage

• Registration Number: NCT04819542
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Study Start: 2021-08-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drain without compression bandage	No bandage	-
drain + compression bandage	Bandage	-

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Lymphocele volume in milliliter	6 months	Lymphocele volume at day 4, day 8 and 6 months post mastectomy
Number of lymphocele punctures	6 months	Number of lymphocele punctures possibly performed during the 6 months of follow-up
Clinical signs associated with lymphocele	8 days	Clinical signs associated with lymphocele at day 4 and day 8 : measurement of joint amplitudes (in centimeters).
Frequency of adverse events	6 months	The frequency of adverse events during the 6-month follow-up
Changes in quality of life	6 months	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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France