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

Lymphocele Clinical Trial

— BANDOCELE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04819542
• Other study ID #: RC31/17/0350
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: November 1, 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Julie MALLOIZEL DELAUNAY, MD
• Phone: 5 61 32 30 33
• Email: malloizel-delaunay.j[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphocele

Intervention

Device:
• Bandage
Bandage
• No bandage
No bandage

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lymphocele volume in milliliter	Lymphocele volume at day 4, day 8 and 6 months post mastectomy	6 months
Secondary	Number of lymphocele punctures	Number of lymphocele punctures possibly performed during the 6 months of follow-up	6 months
Secondary	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
Secondary	Frequency of adverse events	The frequency of adverse events during the 6-month follow-up	6 months
Secondary	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
Secondary	Clinical signs associated with lymphocele	Clinical signs associated with lymphocele at day 4 and day 8 : measurement of joint amplitudes (in centimeters).	8 days
Secondary	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
Secondary	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