Clinical trial NCT01823107: Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
Official title: Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Meso BioMatrix
Breast
Breast Cancer
Mastectomy
Biologic Mesh
Breast Reconstruction
Lead sponsor: Kensey Nash Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Rate of Breast Related Adverse Events
timeFrame: 18 months
Secondary outcomes:
measure: Measurement of Aesthetic Satisfaction With the Use of the Breast-Q Survey
timeFrame: 18 months (12 months after second stage reconstruction)
measure: Rate of Reconstruction Failure
timeFrame: 18 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Garden City
country: United States
facility: Long Island Plasic Surgical Group, PC
state: New York
city: Garden City
country: United States
facility: Long Island Plastic Surgical Group, PC
state: New York
city: Bala-Cynwyd
country: United States
facility: Cancer Center of America at Eastern Regional Medical Center / Dr. Glat Plastic & Reconstructive Surgery
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah (Huntsman Cancer Hospital)
state: Utah
Study officials:
affiliation: DSM Biomedical
name: Forde Hansell
role: STUDY_DIRECTOR
References:
citation: Simpson AM, Higdon KK, Kilgo MS, Tepper DG, Alizadeh K, Glat PM, Agarwal JP. Porcine Acellular Peritoneal Matrix in Immediate Breast Reconstruction: A Multicenter, Prospective, Single-Arm Trial. Plast Reconstr Surg. 2019 Jan;143(1):10e-21e. doi: 10.1097/PRS.0000000000005095.