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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 13, 2011
Last Updated Date	June 11, 2012
Start Date ^ICMJE	January 2010
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01372917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study
Official Title ^ICMJE	Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multi-centered Prospective Cohort Study
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	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.
Sampling Method	Non-Probability Sample
Study Population	Breast cancer patients who opt for immediate breast reconstruction with tissue expanders from clinic.
Condition ^ICMJE	Malignant Neoplasm of the Breast Acquired Absence of the Breast
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Allomax The cohort consists of immediate breast reconstruction patients who have AlloMax placed at the time of their tissue expander based immediate breast reconstruction.
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	39
Completion Date	August 2011
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	25 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01372917
Other Study ID Numbers ^ICMJE	11.064
Has Data Monitoring Committee	No
Responsible Party	Mark L. Venturi, MD FACS, National Center for Plastic Surgery, Virginia
Study Sponsor ^ICMJE	National Center for Plastic Surgery, Virginia
Collaborators ^ICMJE	Inova Health Care Services Ohio State University Comprehensive Cancer Center Walter Reed Army Medical Center C. R. Bard
Investigators ^ICMJE	Not Provided
Information Provided By	National Center for Plastic Surgery, Virginia
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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