Mesh Reconstruction for Breast Cancer
Trial Summary
What is the purpose of this trial?
Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Acellular Dermal Matrix in breast reconstruction?
Research shows that Acellular Dermal Matrix (ADM) is widely used in breast reconstruction surgeries, helping to support implants and improve outcomes with low risk of complications like infection and skin flap necrosis (tissue death). ADM has been effective in reducing issues such as fold malposition and capsular contracture (tightening of scar tissue around an implant), making it a beneficial option in breast surgery.12345
Is acellular dermal matrix (ADM) safe for use in breast reconstruction?
Acellular dermal matrix (ADM) is commonly used in breast reconstruction, but studies show mixed results regarding safety. Some research indicates higher complication rates, such as infection and skin irritation, when ADM is used, while others suggest it is generally safe, though more controlled studies are needed to confirm this.678910
How is the treatment Acellular Dermal Matrix (ADM) unique for breast cancer reconstruction?
Acellular Dermal Matrix (ADM) is unique in breast cancer reconstruction because it provides additional coverage and support for implants, which can improve the aesthetic outcome and potentially enhance the patient's quality of life. Unlike traditional methods, ADM is used to cover the lower part of the breast pocket, offering a novel approach to implant-based reconstruction.1112131415
Research Team
Michael Delong, MD
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
This trial is for women aged 22-75 who are undergoing immediate breast reconstruction with tissue expanders after a mastectomy due to cancer or as a preventive measure. It's open to those having the implant placed above the chest muscle and can be for one or both breasts. Women who are pregnant, have poor skin conditions post-mastectomy, or plan on direct-to-implant or mixed reconstruction methods cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo initial tissue expander placement with or without acellular dermal matrix (ADM) assistance
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of complication rates and capsular contracture
Treatment Details
Interventions
- Acellular Dermal Matrix
- Reconstruction without ADM
Acellular Dermal Matrix is already approved in United States, European Union for the following indications:
- Soft tissue reinforcement
- Other non-breast related indications
- Soft tissue reinforcement
- Other non-breast related indications
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborator
University of Michigan
Collaborator
Yale University
Collaborator
University of California, Davis
Collaborator
University of Utah
Collaborator
University of California, San Francisco
Collaborator
Weill Medical College of Cornell University
Collaborator