NCT00872859

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer
• Reconstructive Surgery

Interventions

Type	Name	Description
PROCEDURE	Implantation of Dermal Matrix substitute	Dermal Matrix implanted in post mastectomy pts at time of mastectomy.

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-05-01
• Completion: 2015-02-01
• First posted: 2009-03-31
• Last updated: 2017-05-18

Locations

1 site across 1 country: United States