Status:
COMPLETED
The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Lead Sponsor:
University of Utah
Conditions:
Breast Cancer
Reconstructive Surgery
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
Brief Summary
Primary Hypothesis: 1\. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction Secondary hypotheses: 1. The complication rates following staged breas...
Eligibility Criteria
Inclusion
- Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy
- Female gender
- Age between 18 and 80
- Consent to participate in the study
Exclusion
- Patients not undergoing breast reconstruction following mastectomy
- Patients undergoing delayed breast reconstruction following mastectomy
- Patients undergoing immediate definitive breast reconstruction after mastectomy
- Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction
- Medical debility precluding surgical treatment
- Prior breast or chest wall irradiation
- Pregnant patients
- Male gender
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00872859
Start Date
October 1 2008
End Date
February 1 2015
Last Update
May 18 2017
Active Locations (1)
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1
University of Utah Hospital/ Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112