Status:
COMPLETED
Immediate Postmastectomy Breast Reconstruction (Strattice Breast)
Lead Sponsor:
LifeCell
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 clini...
Detailed Description
nothing to add
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00619762
Start Date
October 1 2007
End Date
December 1 2009
Last Update
November 8 2016
Active Locations (5)
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1
Washington D.C., District of Columbia, United States
2
Chicago, Illinois, United States
3
Great Neck, New York, United States
4
Willow Grove, Pennsylvania, United States