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Spots Global Cancer Trial Database for The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

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Trial Identification

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

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

Study ID: NCT00872859

Study Description

Brief 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

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Utah Hospital/ Huntsman Cancer Institute, Salt Lake City, Utah, United States

Contact Details

Name: Jayant Agarwal, MD

Affiliation: University of Utah Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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