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NCT Number: NCT04819542

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

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.

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Key information

Conditions

Lymphocele Cysts Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Toulouse, 31059, France

Location status: Recruiting

Location contact

Julie MALLOIZEL, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bandage

Device

Bandage

No bandage

Device

No bandage

Primary outcomes

  1. Proportion in percentage of patients treated successfully

    Time frame: 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 outcomes

  1. Lymphocele volume in milliliter

    Time frame: 6 months

    Lymphocele volume at day 4, day 8 and 6 months post mastectomy

  2. Number of lymphocele punctures

    Time frame: 6 months

    Number of lymphocele punctures possibly performed during the 6 months of follow-up

  3. Clinical signs associated with lymphocele

    Time frame: 8 days

    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).

  4. Frequency of adverse events

    Time frame: 6 months

    The frequency of adverse events during the 6-month follow-up

  5. Clinical signs associated with lymphocele

    Time frame: 8 days

    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

  6. Clinical signs associated with lymphocele

    Time frame: 8 days

    Clinical signs associated with lymphocele at day 4 and day 8 : measurement of joint amplitudes (in centimeters).

  7. Changes in quality of life

    Time frame: 6 months

    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

  8. Changes in quality of life

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte VAYSSE

CONTACT

[email protected]

5 31 15 53 84 ext. +33

Julie MALLOIZEL DELAUNAY, MD

CONTACT

[email protected]

5 61 32 30 33 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: BANDOCELE

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2021
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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