Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

National Center for Plastic Surgery, Virginia

Status: Completed

Conditions: Acquired Absence of the Breast; Malignant Neoplasm of the Breast

Study type: Observational

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT01372917

11.064

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

39 participants in 1 patient group

Allomax

Description:

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