Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

This study has been completed.
Sponsor:
Collaborators:
Inova Health Care Services
Ohio State University Comprehensive Cancer Center
Walter Reed Army Medical Center
C. R. Bard
Information provided by (Responsible Party):
Mark L. Venturi, MD FACS, National Center for Plastic Surgery, Virginia
ClinicalTrials.gov Identifier:
NCT01372917
First received: June 13, 2011
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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.


Condition
Malignant Neoplasm of the Breast
Acquired Absence of the Breast

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multi-centered Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by National Center for Plastic Surgery, Virginia:

Biospecimen Retention:   Samples Without DNA

A 1 cm square of AlloMax will be harvested from the first 20 patients for histologic examination to determine wether or not there is neovascularization and collagen deposition.


Enrollment: 39
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Allomax
The cohort consists of immediate breast reconstruction patients who have AlloMax placed at the time of their tissue expander based immediate breast reconstruction.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer patients who opt for immediate breast reconstruction with tissue expanders from clinic.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372917

Locations
United States, Virginia
National Center for Plastic Surgery
McLean, Virginia, United States, 22102
Sponsors and Collaborators
National Center for Plastic Surgery, Virginia
Inova Health Care Services
Ohio State University Comprehensive Cancer Center
Walter Reed Army Medical Center
C. R. Bard
  More Information

No publications provided by National Center for Plastic Surgery, Virginia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark L. Venturi, MD FACS, Physician, National Center for Plastic Surgery, Virginia
ClinicalTrials.gov Identifier: NCT01372917     History of Changes
Other Study ID Numbers: 11.064
Study First Received: June 13, 2011
Last Updated: June 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014