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

May 16, 2017 updated by: Jay Agarwal, University of Utah

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Hospital/ Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Dermamatrix with radiation
Procedure: Implantation of Dermal Matrix substitute
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
Other Names:
  • Alloderm
  • Dermamatrix
  • 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:
  • Alloderm
  • Dermamatrix
  • 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:
  • Alloderm
  • Dermamatrix
  • 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:
  • Alloderm
  • Dermamatrix
  • Dermal Matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of radiation on acellular dermal matrix
Time Frame: four years
four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Jayant Agarwal, MD, University of Utah Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 30, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (Estimate)

March 31, 2009

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26658

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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