Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Malignant Neoplasm of the Breast Acquired Absence of the Breast

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Allomax

The cohort consists of immediate breast reconstruction patients who have AlloMax placed at the time of their tissue expander based immediate breast reconstruction.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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