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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphocele
• Intervention / Treatment: Device: Bandage; Device: No bandage

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie MALLOIZEL DELAUNAY, MD; Phone Number: +33 5 61 32 30 33; Email: malloizel-delaunay.j@chu-toulouse.fr
• Study Contact Backup: Name: Charlotte VAYSSE; Phone Number: +33 5 31 15 53 84; Email: vaysse.c@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • University Hospital
    • Contact: Julie MALLOIZEL, MD; Email: malloizel.j@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: drain + compression bandage	Device: Bandage; Bandage
Active Comparator: drain without compression bandage	Device: No bandage; No bandage

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Julie MALLOIZEL DELAUNAY, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: mastectomy
• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Cysts; Lymphocele
• Other Study ID Numbers: RC31/17/0350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No