Breast Reconstruction Clinical Trial
Official title:
Complications of Breast Reconstruction With Silicone Prosthesis in Relation to Closed Suction Drains
The purpose of this study is to describe the relations between closed suction drains placement in breast reconstructions procedures with silicone prothesis to the development of local wound complications (seroma, hematoma, infections).
Breast reconstruction with silicone prosthesis can be divided into two groups: immediate and
late reconstructions. The complications rates reported in the literature are around 30% for
delayed reconstructions and 50% for immediate reconstructions. The estimated surgical site
infection rate is approximately 7% and seroma formation rate is approximately 1.2%.
In many of the procedures closed suction drains are left for fluid drainage, in order to
reduce seroma formation. Still, the timing of drains' removal is controversial. Our aim in
this study is to describe the relation between the placement of closed suction drains, the
timing for their removal, and immediate post operative complications.
Patients that underwent breast reconstruction with silicone prosthesis and in which drains
will be left in the surgical field would be randomly assigned into two groups: a control
group, in which drains will be removed when the daily discharge will be below 20 cc for two
consecutive days and the study group, in which drains will be removed on post operative day
(POD) 10. All patients will receive the same antibiotic prophylaxis regimen. Cultures will
be taken from fluid discharge POD 4,8,10 and 12. The incidence of local wound complications
such as infection, seroma, hematoma and skin necrosis was record and analyzed.
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Observational Model: Cohort, Time Perspective: Prospective
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