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

June 13, 2011
June 11, 2012
January 2010
February 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01372917 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

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.

Non-Probability Sample

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

  • Malignant Neoplasm of the Breast
  • Acquired Absence of the Breast
Not Provided
Allomax
The cohort consists of immediate breast reconstruction patients who have AlloMax placed at the time of their tissue expander based immediate breast reconstruction.
Venturi ML, Mesbahi AN, Boehmler JH 4th, Marrogi AJ. Evaluating sterile human acellular dermal matrix in immediate expander-based breast reconstruction: a multicenter, prospective, cohort study. Plast Reconstr Surg. 2013 Jan;131(1):9e-18e. doi: 10.1097/PRS.0b013e3182729d4f.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
August 2011
February 2011   (final data collection date for primary outcome measure)

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
Female
25 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01372917
11.064
No
Mark L. Venturi, MD FACS, National Center for Plastic Surgery, Virginia
National Center for Plastic Surgery, Virginia
  • Inova Health Care Services
  • Ohio State University Comprehensive Cancer Center
  • Walter Reed Army Medical Center
  • C. R. Bard
Not Provided
National Center for Plastic Surgery, Virginia
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP