Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
NCT01781299 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2017-05-12
Summary
The purpose of this study is to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of these two treatment options.
Conditions
- Breast Cancer
- Mastectomy
Interventions
- DEVICE
-
AlloDerm RTU
- DEVICE
-
SurgiMend PRS
Sponsors & Collaborators
-
University of Pittsburgh
lead OTHER
Principal Investigators
-
Kenneth Shestak, MD · University of Pittsburgh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-09-30
- Primary Completion
- 2015-09-30
- Completion
- 2015-09-30
Countries
- United States
Study Locations
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