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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Reconstructive Surgery Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Utah Hospital/ Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of Dermal Matrix substitute

Procedure

Dermal Matrix implanted in post mastectomy pts at time of mastectomy.

Other names: Dermamatrix, Alloderm, Dermal Matrix

Primary outcomes

Effects of radiation on acellular dermal matrix

Time frame: four years

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2015
First posted: Mar 31, 2009
Registry last updated: May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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