The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Completed · Phase 4
Conditions studied: Breast Cancer, Reconstructive Surgery
In brief
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
Key facts
- Study ID
- NCT00872859
- Run by
- University of Utah
- People needed
- 128
- Starts
- 2008-10-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2017-05-18
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Utah Hospital/ Huntsman Cancer Institute — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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