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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TERMINATED
PHASE3
60 participants
INTERVENTIONAL
2018-11-18
2020-08-30
Brief Summary
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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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Compression by chest bandage urgo K2®
After the second puncture, the local compression by thoracic bandage will be put in place.
The system being effective 7 days, it will be left in place between each visit. A visit will be made for all patients 7 days after the installation of the device. However, if necessary, an intermediate visit may be carried out.
During these visits, a puncture will be made according to the criteria mentioned above. The bandage will be renewed after each visit.
The device will be removed after 15 days without indication of a new puncture. The patient will be seen again between 10 and 15 days after the bandage is removed for a final evaluation.
Compression by chest bandage urgo K2®
1. \- Installation of a short stretch belt (urgo K2® kit)
2. \- Installation of a long stretch cohesive band providing additional pressure necessary to reach therapeutic pressure and maintain the device (urgo K2® kit).
3. \- Control of the pressure exerted by the bandage by the "KIKUHIME® Sub Bandge pressure Monitor" device
punctures
Every 7 days after the second puncture of a volume \> 250ml of seroma, the patients are examined by 2 practitioners. They define the indication of the puncture. The seroma is aspirated after a skin puncture with a needle connected with a Redon® drain.
punctures
After the second puncture, the patient will be seen at the same frequency as in the experimental arm.
The decision to perform a puncture will be made according to the same criteria and the follow-up conditions will be identical.
punctures
Every 7 days after the second puncture of a volume \> 250ml of seroma, the patients are examined by 2 practitioners. They define the indication of the puncture. The seroma is aspirated after a skin puncture with a needle connected with a Redon® drain.
Interventions
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Compression by chest bandage urgo K2®
1. \- Installation of a short stretch belt (urgo K2® kit)
2. \- Installation of a long stretch cohesive band providing additional pressure necessary to reach therapeutic pressure and maintain the device (urgo K2® kit).
3. \- Control of the pressure exerted by the bandage by the "KIKUHIME® Sub Bandge pressure Monitor" device
punctures
Every 7 days after the second puncture of a volume \> 250ml of seroma, the patients are examined by 2 practitioners. They define the indication of the puncture. The seroma is aspirated after a skin puncture with a needle connected with a Redon® drain.
Eligibility Criteria
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Inclusion Criteria
* Patient with a second seroma puncture with a volume greater than or equal to 250 ml.
* Neo adjuvant chemotherapy authorized.
* Absence of known metastases.
* Patient has given written consent.
Exclusion Criteria
* Partial mastectomy.
* Concurrent bilateral mastectomy.
* Delay in healing observed at inclusion.
* Patient under legal protection.
* Chronic respiratory failure.
* Patient with a pacemaker.
* Personality disorders and known progressive psychiatric pathology.
* Inability to submit to trial follow-up
18 Years
FEMALE
No
Sponsors
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Centre Francois Baclesse
OTHER
Responsible Party
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Locations
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TANQUEREL Julie
Caen, , France
Centre Françis Baclesse
Caen, , France
Countries
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Other Identifiers
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CLODIS
Identifier Type: -
Identifier Source: org_study_id
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