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

Study Overview
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Brief Summary
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Primary Hypothesis: 1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction Secondary hypotheses: 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. Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix Specific aims: Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation Compare the complication rates between the two types of acellular dermal matrix Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation. Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation

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

Conditions
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Breast Cancer, Reconstructive Surgery

Intervention / Treatment
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* Procedure: Implantation of Dermal Matrix substitute


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dermamatrix with radiation | Procedure: Implantation of Dermal Matrix substitute<br>* Dermal Matrix implanted in post mastectomy pts at time of mastectomy.<br>* Other names: Dermal Matrix;|
| Experimental: 2<br>Dermamatrix without radiation | Procedure: Implantation of Dermal Matrix substitute<br>* Dermal Matrix implanted in post mastectomy pts at time of mastectomy.<br>* Other names: Dermal Matrix;|
| Experimental: 3<br>Alloderm with radiation | Procedure: Implantation of Dermal Matrix substitute<br>* Dermal Matrix implanted in post mastectomy pts at time of mastectomy.<br>* Other names: Dermal Matrix;|
| Experimental: 4<br>Alloderm without radiation | Procedure: Implantation of Dermal Matrix substitute<br>* Dermal Matrix implanted in post mastectomy pts at time of mastectomy.<br>* Other names: Dermal Matrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of radiation on acellular dermal matrix |  | four years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Cancer of Breast, Reconstructive Surgery