Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bandage, No bandage.
- Who it may be relevant to
- Registry conditions: Lymphocele. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Bandage
Bandage - Device No bandage
No bandage
Primary outcome measures
- Proportion in percentage of patients treated successfully [Time frame: 6 months]
Secondary outcome measures (8)
- Lymphocele volume in milliliter [Time frame: 6 months]
- Number of lymphocele punctures [Time frame: 6 months]
- Clinical signs associated with lymphocele [Time frame: 8 days]
- Frequency of adverse events [Time frame: 6 months]
- Clinical signs associated with lymphocele [Time frame: 8 days]
- Clinical signs associated with lymphocele [Time frame: 8 days]
- Changes in quality of life [Time frame: 6 months]
- Changes in quality of life [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- University Hospital — Toulouse
Identifiers
NCT: NCT04819542 · RC31/17/0350