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The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

Breast Cancer Clinical Trial

Official title:
The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00872859
Study type Interventional
Source University of Utah
Contact
Status Completed
Phase Phase 4
Start date October 2008
Completion date February 2015
View Details
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