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Clinical Trial Summary

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).


Clinical Trial Description

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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00973544
Study type Observational
Source Sheba Medical Center
Contact Eyal Winkler, MD
Phone 972-3-5302416
Status Not yet recruiting
Phase N/A
Start date September 2009

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