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.

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Key information

Conditions

Malignant Neoplasm of the Breast Acquired Absence of the Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

National Center for Plastic Surgery

McLean, Virginia, 22102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Sponsors and collaborators

Lead sponsor

National Center for Plastic Surgery, Virginia

Other

Collaborators

C. R. Bard
Inova Health Care Services
Ohio State University Comprehensive Cancer Center
Walter Reed Army Medical Center

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jun 14, 2011
Registry last updated: Jun 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed