Fatgrafting to a Breast After Breast Conserving Therapy Clinical Trial
Official title:
Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast After Breast-conserving Therapy
Breast-conserving treatment (BCT) leads to a progressive and deteriorating breast deformity.
Fatgrafting is ideal for breast reconstruction after BCT. The most frequently utilized
technique for fat processing is centrifugation. The PureGraft device (Cytori Therapeutics,
USA) is a new method that involves washing and filtering the fat to prepare the graft. The
investigators compared the subjective and objective outcomes of two fat-processing methods,
centrifugation and PureGraft filtration.
Thirty patients underwent breast reconstruction performed by a single surgeon (OM) after BCT
in our department between April 2011 and September 2012. The patients were preoperatively
divided into two groups randomly: 15 received fatgrafts processed by centrifugation, and 15
received fatgrafts processed by washing in PureGraft bags. The patients were followed up for
12-30 months.To measure the subjective outcome, the investigators distributed the BREAST-Q
questionnaire to all the patients both preoperatively and one year postoperatively. The
BCCT.core software evaluated the objective outcome of breast reconstruction by fatgrafting.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment