Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)

NATerminatedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

April 30, 2017

Study Completion Date

July 31, 2017

Conditions
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Interventions
DEVICE

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.

Trial Locations (1)

Unknown

Fondazione IRCCS Instituto Nazionale dei Tumori, Milan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LifeCell

INDUSTRY