Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

Study Overview
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Brief Summary
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Evaluation and comparison of clinical and aesthetic outcomes associated with the use of two allograft dermal matrices (ADMs) currently in use for tissue assisted immediate post-mastectomy breast reconstruction.

Detailed Description
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This is a level one, prospective, randomized, controlled multi-center clinical study comparing two types of acellular dermal matrices (ADMs) currently used in immediate post-mastectomy prosthetic breast reconstruction. Comparison of these two ADMs will be made in the areas of reconstructive clinical outcomes and aesthetic outcomes. Patients will be randomized into one of two ADM groups as part of their immediate post-mastectomy breast reconstruction. Patients in both groups will be followed for twelve months after their reconstructive surgery. Clinical outcomes will be documented at 1 month, 3 months, 6 months and 12 months following breast reconstructive surgery. For one-stage breast reconstruction, aesthetic outcomes will be assessed and documented at 6 and 12 months following implant placement. For two-stage reconstruction, patients will be evaluated for aesthetic outcomes at a time point 6-12 months following expander-to-implant exchange if it does not coincide with the 12 month post-mastectomy visit.

Official Title
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A Prospective, Randomized, Multi-Center Clinical Study Comparing Outcomes in Patients Undergoing Prosthetic, Acellular Dermal Matrix (ADM) Assisted, Immediate Post-Mastectomy Breast Reconstruction

Conditions
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Breast Reconstruction

Intervention / Treatment
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* Biological: FlexHD ADM (Cohort A)
* Biological: AlloDerm RTU ADM (Cohort B)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo immediate, post-mastectomy, tissue assisted breast reconstruction, Reconstruction shall be either one-stage (direct-to-implant) or two-stage, unilateral or bilateral, prophylactic or therapeutic Females at least 18 years of age Non-smokers, former smokers and/or smokers who have not smoked within 1 month before surgery, and who agree to not smoke or utilize e-cigarettes during the post-operative period Have signed a written informed consent Have the ability to understand and comply with the requirements and follow-up time points of the study Exclusion Criteria: Previous breast surgery with the exception of biopsy Previous radiation treatment in either breast at any time Undergoing autologous breast reconstruction Pre-pectoral implant placement Undergoing delayed reconstruction Requiring Wise pattern reduction of mastectomy skin flap History of chronic steroid use within the past 6 months History of HIV positive Previous organ transplant Pregnant or lactating females Clinically significant systemic disease, as determined by the investigator, which could affect study participation or study results

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Prospective, randomized, controlled
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort A<br>FlexHD ADM | Biological: FlexHD ADM (Cohort A)<br>* Tissue assisted breast reconstruction with FlexHD pliable perforated ADM<br>* Other names: FlexHD ADM;|
| Active Comparator: Cohort B<br>AlloDerm RTU ADM | Biological: AlloDerm RTU ADM (Cohort B)<br>* Tissue assisted breast reconstruction with AlloDerm RTU perforated ADM<br>* Other names: AlloDerm RTU ADM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Reconstruction Complication Rates | To compare the overall complication rate between the cohorts defined as either 1) post-operative infection specific to the reconstructed breast(s) requiring either intravenous antibiotic treatment or operative intervention, 2) seroma, and/or 3) reconstructive failure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Each Complication Rate | To compare each complication rate between the cohorts defined as 1) post-operative infection specific to the reconstructed breast(s) requiring either intravenous antibiotic treatment or operative intervention 20 seroma 3) reconstructive failure and 4) reoperation for reasons other than infection | 12 months | 
| Comparison of Aesthetic Outcomes (Photographs) | A blinded comparison of aesthetic outcomes (photographs) using pre-defined criteria | 12 months |