The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
This trial is active, not recruiting.
|Conditions||breast cancer, reconstructive surgery|
|Treatment||implantation of dermal matrix substitute|
|Sponsor||University of Utah|
|Start date||October 2008|
|End date||May 2011|
|Trial size||196 participants|
|Trial identifier||NCT00872859, 26658|
1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction
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
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
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Effects of radiation on acellular dermal matrix
time frame: four years
Female participants from 18 years up to 80 years old.
Inclusion Criteria: - Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy - Female gender - Age between 18 and 80 - Consent to participate in the study Exclusion Criteria: - Patients not undergoing breast reconstruction following mastectomy - Patients undergoing delayed breast reconstruction following mastectomy - Patients undergoing immediate definitive breast reconstruction after mastectomy - Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction - Medical debility precluding surgical treatment - Prior breast or chest wall irradiation - Pregnant patients - Male gender
|Official title||The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial|
|Principal investigator||Jayant Agarwal, MD|
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