Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01372917

Enrollment

Registered

2011-06-14

Start date

2010-01-31

Completion date

2011-08-31

Last updated

2012-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Absence of the Breast, Malignant Neoplasm of the Breast

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 65 Years

Healthy volunteers

Yes

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

Countries

United States

Outcome results