Mesh Reconstruction for Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Disqualifiers: Pregnancy, Delayed reconstruction, others
No Placebo Group
Approved in 2 jurisdictions
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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.
+2 more
Trial 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
Participant Groups
The 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.
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:
🇺🇸 Approved in United States as Acellular Dermal Matrix for:
- Soft tissue reinforcement
- Other non-breast related indications
🇪🇺 Approved in European Union as Acellular Dermal Matrix for:
- Soft tissue reinforcement
- Other non-breast related indications
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California Los AngelesLos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterCollaborator
University of MichiganCollaborator
Weill Medical College of Cornell UniversityCollaborator
References
Evolving role of alloderm in breast surgery. [2011]The adjunctive use of acellular dermal matrices in breast surgery is expanding. The purpose of this article is to provide an overview of the various applications of acellular dermal matrices in breast surgery, the benefits and complications associated with their use, and best practices to optimize outcomes using a human acellular dermal matrix (AlloDerm [LifeCell Corp., Branchburg, NJ]) as an example.
The use of acellular dermal matrices in revisional breast reconstruction. [2021]The use of acellular dermal matrices in breast surgery has become popular in the last two decades, with a corresponding increase in experience and literature. The authors reviewed the literature and summarize key technical points regarding use of acellular dermal matrices in reconstructive breast surgery.
Acellular bovine pericardium dermal matrix in immediate breast reconstruction after Skin Sparing Mastectomy. [2018]Mastectomy for breast cancer may bring the patient to develop long term issues concerning the psychological and physical status. Immediate breast reconstruction (IBR) should be considered and proposed by physicians as an integrated procedure in the surgical approach to breast cancer to reduce further surgery. Acellular dermal matrix (ADM) has been used in revision breast reconstruction for fold malposition, capsular contracture and rippling also, showing good outcomes with low risk of complications. Aim of this study was to verify if the known advantages in using ADM for IBR would led to lower rates of seroma formation, infection, skin flap necrosis and overall complication related to the implant.
Imaging features of volume replacement using an acellular dermal matrix in oncoplastic breast conserving surgery: A case report. [2022]An acellular dermal matrix (ADM) is a type of allograft that can be made from human, bovine, or porcine dermis and is used to support or reconstruct soft tissue. During breast reconstructive surgeries, ADMs are widely used to partially cover breast implants following a mastectomy to correct for insufficient subcutaneous tissue. Recently, ADMs have been used as a filling material for volume replacement in oncoplastic breast conserving surgery. In this report, we present the case of a female, middle-aged patient who underwent breast conserving surgery with volume replacement using an ADM.
Acellular dermal matrices: Use in reconstructive and aesthetic breast surgery. [2023]Acellular dermal matrices (ADMs) were first described for use in breast surgery in 2001. Since this initial report, ADMs have become an increasingly common component of implant-based breast procedures. ADMs have shown promise for use in both aesthetic and reconstructive breast surgery; however, concerns about their use remain because of the significant costs associated with these products. The present article reviews the history of ADM use in breast surgery and the outcomes reported to date. Common techniques for placement of ADMs in aesthetic revisionary and breast reconstruction surgery are provided, and use in the setting of chest wall irradiation and capsular contracture is discussed. Finally, the authors comment on the cost implications of these products in the Canadian and American health care systems.
Early complications and implant loss in implant-based breast reconstruction with and without acellular dermal matrix (Tecnoss Protexa®): a comparative study. [2022]Acellular dermal matrix (ADM) may improve outcomes in implant-based breast reconstruction, but recent evidence suggests complication rates may be higher when ADM is used. We retrospectively compared early complications and implant loss in implant-based breast reconstruction (BR) with and without ADM to evaluate the safety of the procedure in our centre.
The Use of Acellular Dermal Matrices (ADM) in Breast Reconstruction: A Review. [2018]The use of acellular dermal matrices (ADM), sometimes referred to as extracellular matrix (ECM), has become an interesting aspect of breast reconstruction. A great deal of literature is available, totaling over 7000 ADM-based reconstructions. Most often, ADMs are used in a skin sparing mastectomy (SSM) scenario, although heterologous breast augmentation with a sub-pectoral fixation may also require an ADM application. Their use has become an attractive, but expensive option. Available data shows head to head comparisons between individual ADMs to be mostly retrospective in nature with only a few prospective trials available. Points of interest include postoperative hematoma, postoperative skin irritation, infection, red breast syndrome, and revision surgery. This work will, therefore, highlight the individual properties of ADMs used in breast reconstruction and compare the available data on complication rates and costs for these devices.
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]In 2005, Breuing et al. first described the use of acellular dermal matrices (ADMs) in breast cancer patients. ADMs are assumed to be safe to use in an oncologic setting, but data from controlled studies are still needed. Here, we investigate the effects of ADMs on the production of interleukin (IL)-6 and IL-12, key regulators of immune suppression and activation.
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]The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR.
Complications following Nipple-Sparing Mastectomy and Immediate Acellular Dermal Matrix Implant-based Breast Reconstruction-A Systematic Review and Meta-analysis. [2022]Acellular dermal matrix was introduced in breast reconstruction in 2001 and is gradually becoming a standard component for immediate breast reconstruction and nipple-sparing mastectomy. The reconstructive technique allows for improved aesthetic outcomes. However, there seems to be uncertainty regarding complication rates. The aim of this review was to systematically evaluate complication rates related to this method.
A controlled cost and outcomes analysis of acellular dermal matrix and implant-based reconstruction. [2021]The use of acellular dermal matrix (ADM) for breast reconstruction continues to change in both single- and two-stage reconstruction. Determining optimal outcomes clinically, aesthetically, financially as well as for the patient's quality of life has become a priority.
Passot-Type Immediate Breast Reconstruction Obviates the Use of Aceullular Dermal Matrix in Grades 2 and 3 Ptosis. [2020]Acellular dermal matrices (ADMs) are commonly used for immediate breast reconstruction after skin-sparing mastectomy (SSM). Regnault grades 2 and 3 ptotic breasts feature significant mastectomy flap redundancy that may be incorporated into the reconstruction. This allows surgeons to use patients' de-epithelialized inferior dermal pedicle instead of ADM.
Comparison of implant-based immediate breast reconstruction with and without acellular dermal matrix. [2022]Acellular dermal matrix is frequently used in implant-based breast reconstruction to cover the inferior aspect of the breast pocket. Its performance profile remains equivocal. The authors studied whether adding it in implant-based immediate breast reconstruction improved outcomes when compared with non-acellular dermal matrix reconstruction.
Use of Acellular Dermal Matrices in One-stage Implant-based Breast Reconstruction. [2018]Implant-based breast reconstruction is the most common choice in breast cancer patients. Recently,the acellular dermal matrix (ADM) technique has been widely used in implant-based breast reconstruction in the western countries. This article briefly reviews the biological characteristics,history,types,surgical techniques,and postoperative complications of ADM.
Impact of Dermal Matrix Brand in Implant-Based Breast Reconstruction Outcomes. [2022]Implant-based reconstruction is the most common procedure for breast reconstruction after mastectomy. Acellular dermal matrix is used to provide additional coverage in subpectoral and prepectoral implant placement. In this study, the authors compared postoperative outcomes between AlloDerm (LifeCell, Branchburg, N.J.) and DermACELL (Stryker, Kalamazoo, Mich.), two acellular dermal matrix brands.