Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
NCT ID: NCT04819542
Last Updated: 2024-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2021-08-16
2025-11-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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drain + compression bandage
Bandage
Bandage
drain without compression bandage
No bandage
No bandage
Interventions
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Bandage
Bandage
No bandage
No bandage
Eligibility Criteria
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Inclusion Criteria
* Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer
* Affiliated with a health insurance plan
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Julie MALLOIZEL DELAUNAY, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC31/17/0350
Identifier Type: -
Identifier Source: org_study_id
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