Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

Completed

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

• Registration Number: NCT01372917
• Lead Sponsor: National Center for Plastic Surgery, Virginia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-02
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Study Completion: 2011-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-11
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Center for Plastic Surgery; 🇺🇸 McLean, Virginia, United States