Breast Cancer Clinical Trial
Immediate Postmastectomy Breast Reconstruction (Strattice Breast)
Summary
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.
Full Description
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Eligibility Criteria
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
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There is 1 Location for this study
Washington District of Columbia, , United States
Chicago Illinois, , United States
Great Neck New York, , United States
Willow Grove Pennsylvania, , United States
McLean Virginia, , United States
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