Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

Completed

Conditions studied: Malignant Neoplasm of the Breast, Acquired Absence of the Breast

In brief

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.

Key facts

Study ID

NCT01372917

Run by

National Center for Plastic Surgery, Virginia

People needed

39

Starts

2010-01-01

Expected to finish

2011-08-01

Last updated by the study team

2012-06-13

Who can join

Age: 25 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Patients having immediate breast reconstruction with tissue expanders
• Unilateral or bilateral reconstructions
• Ages 25 - 65
• All breast cancer stages and types

You may not qualify if…

• BMI > 35
• Active smokers
• Diabetics
• History of radiation or planned radiation
• Immunocompromised patients

Where it is running

• National Center for Plastic Surgery — McLean, Virginia, United States

Full record on ClinicalTrials.gov

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