Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

Malignant Neoplasm of the Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372917
• Other study ID #: 11.064
• Status: Completed
• Phase: N/A
• First received: June 13, 2011
• Last updated: June 11, 2012
• Start date: January 2010
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: National Center for Plastic Surgery, Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acquired Absence of the Breast
• Breast Neoplasms
• Malignant Neoplasm of the Breast
• Neoplasms

Locations

Country	Name	City	State
United States	National Center for Plastic Surgery	McLean	Virginia

Sponsors (5)

Lead Sponsor	Collaborator
National Center for Plastic Surgery, Virginia	C. R. Bard, Inova Health Care Services, Ohio State University Comprehensive Cancer Center, Walter Reed Army Medical Center

Country where clinical trial is conducted

United States,