Mastectomy and Breast Reconstruction Clinical Trial
Official title:
A Prospective, Multicenter, Controlled Study of Implant-based Breast Reconstruction, Measuring the Safety, Efficacy and Outcomes, of Immediate Single Stage Breast Reconstruction With Strattice™ Reconstructive Tissue Matrix Versus Immediate Two Stage Breast Reconstruction Without Strattice™ TM (ESSBR-Efficacy of Single Stage Breast Reconstruction)
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant only, without any type of reinforcement.
The primary objective of this study is to compare the efficacy of immediate single-stage
post-mastectomy breast reconstruction with Strattice™ TM, otherwise referred to as DTI as
compared to immediate two-stage post-mastectomy breast reconstruction where the initially
placed expander will be exchanged for a breast implant only, without any type of a
reinforcement. The objective will be achieved by prospectively assessing the number of
planned and unplanned post-mastectomy surgical interventions within 12 months of the
mastectomy.
Two-stage breast reconstruction will include the initial placement of a tissue expander in a
total or partial submuscular position. In the case of partial muscle coverage, this will be
without the support of any mesh or autologous flap to reinforce the lower pole. The expander
will be inflated over approximately the next one to six months, and then replaced with an
implant.
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