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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872859
First Posted: March 31, 2009
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jay Agarwal, University of Utah
  Purpose

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

Condition Intervention Phase
Breast Cancer Reconstructive Surgery Procedure: Implantation of Dermal Matrix substitute Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

Resource links provided by NLM:


Further study details as provided by Jay Agarwal, University of Utah:

Primary Outcome Measures:
  • Effects of radiation on acellular dermal matrix [ Time Frame: four years ]

Enrollment: 128
Study Start Date: October 2008
Study Completion Date: February 2015
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dermamatrix with radiation
Procedure: Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
Other Names:
  • Dermamatrix
  • Alloderm
  • Dermal Matrix
Experimental: 2
Dermamatrix without radiation
Procedure: Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
Other Names:
  • Dermamatrix
  • Alloderm
  • Dermal Matrix
Experimental: 3
Alloderm with radiation
Procedure: Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
Other Names:
  • Dermamatrix
  • Alloderm
  • Dermal Matrix
Experimental: 4
Alloderm without radiation
Procedure: Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
Other Names:
  • Dermamatrix
  • Alloderm
  • Dermal Matrix

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872859


Locations
United States, Utah
University of Utah Hospital/ Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Jayant Agarwal, MD University of Utah Hospital
  More Information

Responsible Party: Jay Agarwal, Chief of the Division of Plastic Surgery, Associate Professor of Surgery, University of Utah
ClinicalTrials.gov Identifier: NCT00872859     History of Changes
Other Study ID Numbers: 26658
First Submitted: March 30, 2009
First Posted: March 31, 2009
Last Update Posted: May 18, 2017
Last Verified: May 2017

Keywords provided by Jay Agarwal, University of Utah:
Breast Cancer
Cancer of Breast
Reconstructive Surgery