Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study
The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. The study will determine if gamma radiation, as a method of terminally sterilizing human acellular dermal matrix, has a negative impact on graft incorporation into the host tissue.
Malignant Neoplasm of the Breast
Acquired Absence of the Breast
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multi-centered Prospective Cohort Study|
A 1 cm square of AlloMax will be harvested from the first 20 patients for histologic examination to determine wether or not there is neovascularization and collagen deposition.
|Study Start Date:||January 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
The cohort consists of immediate breast reconstruction patients who have AlloMax placed at the time of their tissue expander based immediate breast reconstruction.
|United States, Virginia|
|National Center for Plastic Surgery|
|McLean, Virginia, United States, 22102|