Clinical and Histologic Evaluation of Acellular Dermal Matrix Substitute in Breast Reconstruction



Status:Archived
Conditions:Breast Cancer, Cancer, Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2008
End Date:October 2012

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Primary Hypothesis:

1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast
reconstruction

Secondary hypotheses:

1. The complication rates following staged breast reconstruction using Alloderm or
Dermamatrix are higher if the patient requires radiation compared to those who do not
require radiation.

2. Dermal matrix incorporation is not altered in patients requiring radiation compared to
those who do not require radiation.

3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix

Specific aims:

1. Evaluate the complication rates in women undergoing staged breast reconstruction with
acellular dermal matrix with or without radiation

2. Compare the complication rates between the two types of acellular dermal matrix

3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation
compared to that not exposed to radiation.

4. Compare the rates of incorporation of the dermal substance into surrounding tissues of
those patients undergoing radiation to those not undergoing radiation



We found this trial at
1
site
Salt Lake City, Utah 84112
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from
Salt Lake City, UT
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