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Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01372917
First Posted: June 14, 2011
Last Update Posted: June 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
June 13, 2011
June 14, 2011
June 13, 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. Erratum in: Plast Reconstr Surg. 2013 Mar;131(3):669.

*   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
Sexes Eligible for Study: Female
25 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01372917
11.064
No
Not Provided
Not Provided
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