Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy

This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.

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Inclusion Criteria:

• A candidate for immediate, two-stage breast reconstruction using LTM following a skin sparing mastectomy
• An ASA Physical Status Classification5 of 1 or 2 (see App I)
• Estimated life expectancy > 1 year

Exclusion Criteria:

• Clinically significant systemic disease
• Received inductive chemo-therapy within 2 months prior to mastectomy or radiation therapy to the region at any time
• Predicted excised breast mass of >750 gms
• Co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, smoking, chronic steroid use, malnourishment, or co-existent infection
• Need for tissue flap in addition to expander
• History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
• Enrollment or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial
• Any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate