120 Participants Needed

Mesh Reconstruction for Breast Cancer

MD
JF
Overseen ByJaco Festekjian, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

MD

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

I have had a mastectomy for prevention or cancer treatment.
I am a woman aged 22-75 planning immediate breast reconstruction with tissue expanders.
My surgery will save the nipple and skin.

Exclusion Criteria

I am having breast reconstruction with an implant in one surgery.
My surgery showed that immediate reconstruction in front of the chest muscle isn't suitable due to poor skin condition.
I plan to have reconstruction surgery at a later time.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo initial tissue expander placement with or without acellular dermal matrix (ADM) assistance

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of complication rates and capsular contracture

2 years

Treatment Details

Interventions

  • Acellular Dermal Matrix
  • Reconstruction without ADM
Trial OverviewThe study is testing if using surgical mesh (ADM) helps in breast reconstruction when implants are placed over the chest muscle. This randomized trial will compare outcomes of reconstructions done with ADM assistance against those without it, aiming to provide evidence about their effectiveness and safety.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Acellular Dermal MatrixExperimental Treatment1 Intervention
Patients will receive ADM during their initial tissue expander placement.
Group II: ControlActive Control1 Intervention
Patients will not receive ADM during their initial tissue expander placement.

Acellular Dermal Matrix is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Acellular Dermal Matrix for:
  • Soft tissue reinforcement
  • Other non-breast related indications
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Acellular Dermal Matrix for:
  • 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

Trials
1,594
Recruited
10,430,000+

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborator

Trials
105
Recruited
46,600+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

Yale University

Collaborator

Trials
1,963
Recruited
3,046,000+

University of California, Davis

Collaborator

Trials
958
Recruited
4,816,000+

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Weill Medical College of Cornell University

Collaborator

Trials
1,103
Recruited
1,157,000+

Findings from Research

Acellular dermal matrices, like AlloDerm, are increasingly used in breast surgery, providing benefits such as improved surgical outcomes and enhanced tissue support.
The article discusses the potential complications associated with their use and emphasizes best practices to optimize results in breast surgery.
Evolving role of alloderm in breast surgery.Gabriel, A., Maxwell, GP.[2011]
Acellular dermal matrices have become increasingly effective in both primary and secondary breast reconstruction, particularly in correcting deformities like symmastia and rippling that arise after breast implant placement.
While short-term results (1 to 2 years) show improved aesthetic outcomes and expanded treatment options, there are still risks of complications such as seroma and infection, highlighting the need for long-term studies to assess the durability of these matrices.
The use of acellular dermal matrices in revisional breast reconstruction.Slavin, SA., Lin, SJ.[2021]
In a study of 24 patients undergoing immediate breast reconstruction (IBR) using Tutomesh acellular dermal matrix (ADM), the overall complication rates were low, with seroma formation occurring in 20.8% of cases, and no instances of skin flap necrosis reported.
The use of fibrin sealant during the procedure was associated with a reduction in seroma formation, suggesting that combining ADM with fibrin sealant may enhance the safety and efficacy of IBR.
Acellular bovine pericardium dermal matrix in immediate breast reconstruction after Skin Sparing Mastectomy.Gubitosi, A., Docimo, G., Parmeggiani, D., et al.[2018]

References

Evolving role of alloderm in breast surgery. [2011]
The use of acellular dermal matrices in revisional breast reconstruction. [2021]
Acellular bovine pericardium dermal matrix in immediate breast reconstruction after Skin Sparing Mastectomy. [2018]
Imaging features of volume replacement using an acellular dermal matrix in oncoplastic breast conserving surgery: A case report. [2022]
Acellular dermal matrices: Use in reconstructive and aesthetic breast surgery. [2023]
Early complications and implant loss in implant-based breast reconstruction with and without acellular dermal matrix (Tecnoss Protexaยฎ): a comparative study. [2022]
The Use of Acellular Dermal Matrices (ADM) in Breast Reconstruction: A Review. [2018]
Biologic meshes and synthetic meshes in cancer patients: a double-edged sword: differences in production of IL-6 and IL-12 caused by acellular dermal matrices in human immune cells. [2019]
Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Complications following Nipple-Sparing Mastectomy and Immediate Acellular Dermal Matrix Implant-based Breast Reconstruction-A Systematic Review and Meta-analysis. [2022]
A controlled cost and outcomes analysis of acellular dermal matrix and implant-based reconstruction. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Passot-Type Immediate Breast Reconstruction Obviates the Use of Aceullular Dermal Matrix in Grades 2 and 3 Ptosis. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Comparison of implant-based immediate breast reconstruction with and without acellular dermal matrix. [2022]
Use of Acellular Dermal Matrices in One-stage Implant-based Breast Reconstruction. [2018]
15.United Statespubmed.ncbi.nlm.nih.gov
Impact of Dermal Matrix Brand in Implant-Based Breast Reconstruction Outcomes. [2022]