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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00872859
First received: March 30, 2009
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Effects of radiation on acellular dermal matrix [ Time Frame: four years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 196
Study Start Date: October 2008
Estimated Study Completion Date: October 2013
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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jayant Agarwal MD, University of Utah/Huntsman Cancer Institute
ClinicalTrials.gov Identifier: NCT00872859     History of Changes
Other Study ID Numbers: 26658
Study First Received: March 30, 2009
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Breast Cancer
Cancer of Breast
Reconstructive Surgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013