36
Participants
Start Date
March 31, 2013
Primary Completion Date
April 30, 2017
Study Completion Date
July 31, 2017
Strattice™ Reconstructive Tissue Matrix
Experimental arm: Device: Strattice Reconstructive Tissue Matrix Unilateral or bilateral mastectomy. Immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant with ADM, single stage reconstruction technique. Control arm: Device: no device. Immediate breast tissue expander/implant based reconstruction with a two-stage reconstruction technique.
Fondazione IRCCS Instituto Nazionale dei Tumori, Milan
Lead Sponsor
LifeCell
INDUSTRY