Feasibility Study of Meso BioMatrix Device for Breast Reconstruction

This study is currently recruiting participants.
Verified March 2014 by Kensey Nash Corporation
Sponsor:
Information provided by (Responsible Party):
Kensey Nash Corporation
ClinicalTrials.gov Identifier:
NCT01823107
First received: March 26, 2013
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Breast Cancer
Breast Reconstruction
Device: Meso BioMatrix Device
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial

Resource links provided by NLM:


Further study details as provided by Kensey Nash Corporation:

Primary Outcome Measures:
  • Rate of breast related adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurement of aesthetic satisfaction with the use of the Breast-Q survey [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01823107

Locations
United States, Georgia
Atlanta Plastic Surgery, PC Recruiting
Atlanta, Georgia, United States, 30342
Contact: Allison Manning, RN    404-256-1311    amanning@atlplastic.com   
Principal Investigator: James D Namnoum, MD         
United States, New York
Long Island Plasic Surgical Group, PC Recruiting
Garden City, New York, United States
Contact: Tammy Manchester, RN, BSN, CCRC    516-742-3404 ext 338    tmanchester@lipsg.com   
Principal Investigator: Tommaso Addona, MD, FACS         
Long Island Plastic Surgical Group, PC Recruiting
Garden City, New York, United States, 11530
Contact: Tammy Manchester, RN, BSN, CCRC    516-742-3404 ext 338    tmanchester@lipsg.com   
Principal Investigator: Matthew S Kilgo, MD, FACS         
Long Island Plastic Surgical Group, PC Recruiting
Manhasset, New York, United States
Contact: Shawna Moscowitz    516-535-6707    smoscowitz@lipsg.com   
Principal Investigator: Tommaso Addona, MD, FACS         
NYU Langone Medical Center Recruiting
New York, New York, United States, 10017
Contact: Gina Bradshaw    212-355-5779    gina.bradshaw@nyumc.org   
Principal Investigator: Nolan S. Karp, MD, FACS         
United States, Pennsylvania
Dr. Glat Plastic & Reconstructive Surgery Recruiting
Bala Cynwyd, Pennsylvania, United States, 19004
Contact: Paul M Glat, M.D., F.A.C.S.    610-980-4000    drglat@drglat.com   
Principal Investigator: Paul M Glat, MD, FACS         
Sponsors and Collaborators
Kensey Nash Corporation
  More Information

No publications provided

Responsible Party: Kensey Nash Corporation
ClinicalTrials.gov Identifier: NCT01823107     History of Changes
Other Study ID Numbers: MESO-001
Study First Received: March 26, 2013
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014