Feasibility Study of Meso BioMatrix Device for Breast Reconstruction

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast reconstruction.

Detailed Description
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Following mastectomy, women may elect to have breast reconstruction with autologous tissue or breast implants. Two-stage, tissue expander assisted breast reconstruction is one of the common surgical methods that could be selected to reconstruct the breast. This method either begins immediately after mastectomy (known as immediate breast reconstruction) or at some time afterward (known as delayed breast reconstruction). Historically, surgeons placed a tissue expander followed by the breast implant either completely or partially under the pectoralis muscle. However, this method of breast reconstruction has been associated with less favorable aesthetic outcomes. Recently, surgeons started adding a surgical mesh derived from human cadaver skin during breast reconstruction procedures. In summary, during the first stage of the breast reconstruction, the plastic surgeon releases the pectoralis muscle from the chest wall. The surgeon then attaches the surgical mesh to the pectoralis muscle and to the chest wall just below the breast. This is done to create a pocket for the tissue expander. The tissue expander is implanted in the pocket and partially inflated. The tissue expander is gradually filled with saline over several weeks or months. Once the desired breast volume has been achieved, the second stage of the reconstruction takes place. In the second stage, the tissue expander is removed and replaced with a permanent saline or silicone gel breast implant. Use of the human cadaver skin surgical mesh during breast reconstruction has been associated with less pain, fewer tissue expansion visits and improved aesthetic outcomes. However, the human cadaver skin surgical mesh adds significant cost to the procedure and some surgeons have reported an increased rate of post-operative complications. Over the last 10 years, a number of surgical mesh devices have been cleared by the U.S. Food & Drug Administration (FDA) for the reinforcement and repair weak soft tissue or became available as tissue grafts from human donors. Some surgeons have published their experience with a number of these surgical mesh devices for breast reconstruction. However, at present, no surgical mesh device is approved or cleared by the FDA for use in breast reconstruction. The Meso BioMatrix device was recently cleared by the FDA for reinforcement and repair of weak soft tissue. It is a surgical mesh device that is made from pig peritoneum, the tissue that lines the abdominal cavity. The tissue is thoroughly cleaned and sterilized before use. When implanted, the Meso BioMatrix device provides structural and mechanical support to weak soft tissue during the healing process. This clinical trial is a feasibility trial. A feasibility trial is a clinical trial in which a device is being studied in a small group of people for a new use. Since the Meso BioMatrix device is not cleared specifically for use in breast reconstruction, it is considered investigational and must be studied in a controlled, step-wise series of clinical trials. Therefore, the results of this trial, if successful, may be used to design a larger clinical trial in the future.

Official Title
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Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Meso BioMatrix Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smoker Undergoing unilateral or bilateral, two-stage, tissue expander-assisted breast reconstruction Life expectancy greater than 18 months Agreement to return for the trial required follow-up visits Exclusion Criteria: Body mass index ≥ 35 Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction mammoplasty History of chronic corticosteroid use Type I Diabetes History of radiation therapy to the chest Pre-operative treatment with induction chemotherapy for breast cancer Pregnancy Participating in another investigational drug or device trial that has not completed the follow-up period

Ages Eligible for Study
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Minimum Age: 21 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meso BioMatrix Device<br>All subjects will have the Meso BioMatrix device implanted along with a tissue expander during the first stage of breast reconstruction. During the second stage of breast reconstruction, the tissue expander is replaced with a breast implant. | Device: Meso BioMatrix Device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Breast Related Adverse Events | Investigators evaluated each subject and each reconstructed breast for the occurrence of an adverse event from the first stage of reconstruction through the final follow-up visit. A breast related adverse event was defined as any untoward medical occurrence related to a reconstructed breast. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Aesthetic Satisfaction With the Use of the Breast-Q Survey | Subjects completed the reconstructive module of the BREAST-Q, a standardized instrument measuring patient satisfaction and health-related quality of life on a scale of 1 to 100, with higher scores indicating higher satisfaction. Completed Breast-Q questionnaires were scored according to the author's instructions. Aesthetic satisfaction was measured using the Breast-Q Satisfaction with Breasts subscale score. | 18 months (12 months after second stage reconstruction) | 
| Rate of Reconstruction Failure | Reconstruction failure was defined as a serious adverse event in a reconstructed breast resulting in unplanned removal of the prosthesis and/or Meso BioMatrix Acellular Peritoneum Matrix. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meso BioMatrix, Breast, Breast Cancer, Mastectomy, Biologic Mesh, Breast Reconstruction