NCT01823107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 10, 2019

Completed
Last Updated

September 10, 2019

Status Verified

August 1, 2018

Enrollment Period

4.7 years

First QC Date

March 26, 2013

Results QC Date

August 20, 2019

Last Update Submit

August 20, 2019

Conditions

Breast Cancer

Keywords

Meso BioMatrixBreastBreast CancerMastectomyBiologic MeshBreast Reconstruction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Measurement of Aesthetic Satisfaction With the Use of the Breast-Q Survey

    18 months (12 months after second stage reconstruction)

  • Rate of Reconstruction Failure

    18 months

Study Arms (1)

Meso BioMatrix Device

EXPERIMENTAL

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

Interventions

Meso BioMatrix DeviceDEVICE
Meso BioMatrix Device

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Long Island Plasic Surgical Group, PC

Garden City, New York, 11530, United States

Location

Long Island Plastic Surgical Group, PC

Garden City, New York, 11530, United States

Location

Cancer Center of America at Eastern Regional Medical Center / Dr. Glat Plastic & Reconstructive Surgery

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Utah (Huntsman Cancer Hospital)

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • 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.

    PMID: 30589773DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

The trial allowed investigator discretion for perioperative medical management, including antibiotic administration, tissue expansion protocol, surgical drain placement, and drain duration.

Results Point of Contact

Title
Forde Hansell
Organization
DSM Biomedical
forde.hansell@dsm.com
484-713-2152

Study Officials

  • Forde Hansell

    DSM Biomedical

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2013

First Posted

April 4, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 29, 2017

Last Updated

September 10, 2019

Results First Posted

September 10, 2019

Record last verified: 2018-08

Locations

US(6)