Mastectomy Clinical Trial
Official title:
PREvention of Post-mastectomy LYMphoceles by PAdding. A Randomized Prospective Multicenter Study
Lymphoceles, or seromas, are the most frequent complication following mastectomy and are
associated or not with axillary dissection occurring in 10 to 90% of cases. It is defined as
the presence of a palpable post operative serous accumulation that is bothersome for the
patient and requires a puncture and drainage or even several repeated punctures. The
presence of seromas is therefore associated with discomfort and pain. Seromas could also be
responsible for increased morbidity due to complications such as infection, suture
separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct
treatment (e.g. chemotherapy, radiotherapy). Some risk factors have been identified, such as
obesity, increased post operative drainage of J1 to J3, and arterial hypertension.
Different measures have demonstrated the benefits of limiting axillary lymphoceles after
dissection : placement of a drain, padding and delay in shoulder mobility.
Studies have shown that axillary padding decreases lymphocele development and shortens the
length of hospital stay. Some studies based on padding of the mastectomy site also have
shown a decrease in post operative seromas; however no study has been done on the usefulness
of padding in the mastectomy site alone because they include both padding and a drain or
padding of the axillary area.
The padding technique the investigators employ is performed at the donor site in breast
reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of
seromas.
In this study, the classic technique will be compared to padding in the mastectomy site with
short drainage (48h).
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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