Feasibility Study of Meso BioMatrix Device for Breast Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01823107
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : August 3, 2017
Information provided by (Responsible Party):
Kensey Nash Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Meso BioMatrix Device Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial
Actual Study Start Date : October 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 29, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Meso BioMatrix Device
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

Primary Outcome Measures :
  1. Rate of breast related adverse events [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Measurement of aesthetic satisfaction with the use of the Breast-Q survey [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01823107

United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Long Island Plasic Surgical Group, PC
Garden City, New York, United States, 11530
Long Island Plastic Surgical Group, PC
Garden City, New York, United States, 11530
United States, Pennsylvania
Cancer Center of America at Eastern Regional Medical Center / Dr. Glat Plastic & Reconstructive Surgery
Bala-Cynwyd, Pennsylvania, United States, 19004
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Utah
University of Utah (Huntsman Cancer Hospital)
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Kensey Nash Corporation
Study Director: Forde Hansell DSM Biomedical

Responsible Party: Kensey Nash Corporation Identifier: NCT01823107     History of Changes
Other Study ID Numbers: MESO-001
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Kensey Nash Corporation:
Meso BioMatrix
Breast Cancer
Biologic Mesh
Breast Reconstruction