Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

National Center for Plastic Surgery, Virginia39 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Malignant Neoplasm of the Breast Acquired Absence of the Breast

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Center for Plastic Surgery

McLean, Virginia, United States

Data from ClinicalTrials.gov

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