Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

Malignant Neoplasm of the Breast Clinical Trial

Official title: Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multi-centered Prospective Cohort Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acquired Absence of the Breast
• Breast Neoplasms
• Malignant Neoplasm of the Breast
• Neoplasms

• NCT number: NCT01372917
• Study type: Observational
• Source: National Center for Plastic Surgery, Virginia
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Completion date: August 2011