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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372917
|United States, Virginia|
|National Center for Plastic Surgery|
|McLean, Virginia, United States, 22102|