An observational study in Breast Reconstruction, sponsored by Sheba Medical Center. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-09-09.
Sponsored by Sheba Medical Center · Observational
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.
Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
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Patients that underwent breast reconstruction with silicone prosthesis and in which drains were left in the surgical field. patients will signed an informed consent form
Exclusion Criteria:
drains would be removed when daily discharge will be below 20 cc for 2 consecutive days
Other: Cultures taken from the drain discharge
drains will be removed on post operative day (POD) 10
Other: Cultures taken from the drain discharge
Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12. When drain is removed cultures of the drain tip are taken. Clinical signs of surgical signs infections will be observed.
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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