Mesh Reconstruction for Breast Cancer

Overseen By Jaco Festekjian, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Pregnancy, Delayed reconstruction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special surgical mesh, called acellular dermal matrix (ADM), benefits breast reconstruction surgeries after mastectomy. The study compares two groups: one will receive ADM during surgery, while the other will not. This research holds significance because, although many surgeons use ADM, it lacks official approval for this purpose, and its risks and benefits remain unclear. Women who have had or will have a mastectomy and plan immediate breast reconstruction with tissue expanders might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to research that could enhance future breast reconstruction techniques.

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 prior data suggests that acellular dermal matrices are safe for breast reconstruction?

Research has shown that using Acellular Dermal Matrix (ADM) in breast reconstruction may raise safety concerns. Some studies have reported issues like fluid buildup, infection, and skin problems. One study found safety concerns within six months of using ADM in breast cancer treatment. Another study noted complications such as tissue death and slow healing.

It's important to note that the FDA has not approved ADM specifically for breast reconstruction, indicating a lack of strong evidence about its safety for this use. Prospective trial participants should discuss these safety findings with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for breast reconstruction, which often relies on synthetic materials or the patient's own tissue, Acellular Dermal Matrix (ADM) provides a scaffold made from donated human skin that's been processed to remove cells. This unique structure supports tissue integration and healing, potentially leading to better outcomes in breast reconstruction post-cancer surgery. Researchers are excited about ADM because it might reduce complications like infection and improve the aesthetic results, offering a promising alternative to current reconstruction methods.

What evidence suggests that this trial's treatments could be effective for breast reconstruction?

Research has shown that using Acellular Dermal Matrix (ADM) in breast reconstruction yields mixed results. In this trial, some participants will receive ADM during their initial tissue expander placement, while others will not. One study found that using ADM did not significantly alter the rate of complications compared to not using it, particularly when implants are placed above the chest muscle. However, certain types of ADM were linked to a slightly higher chance of wound problems and implant failures. On the positive side, ADM can lead to good cosmetic results and high patient satisfaction. Overall, ADM is considered safe, but its advantages over other methods remain debated. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Delong, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Acellular Dermal Matrix
• Reconstruction without ADM

Trial Overview 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.

How Is the Trial Designed?

Group I: Acellular Dermal Matrix Experimental Treatment 1 Intervention

Patients will receive ADM during their initial tissue expander placement.

Group II: Control Active Control 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of acellular dermal matrices in revisional breast reconstruction. Slavin, SA., Lin, SJ.[2021]

In a study of 150 patients undergoing implant-based breast reconstruction, AlloDerm was associated with a significantly higher incidence of seroma formation (21.7%) compared to DermACELL (8.2%), indicating a potential risk factor for this complication when using AlloDerm.

Both AlloDerm and DermACELL showed similar rates of infection post-surgery, suggesting that the choice of acellular dermal matrix does not impact infection risk, but body mass index was identified as a contributing factor for infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Dermal Matrix Brand in Implant-Based Breast Reconstruction Outcomes. Johnson, AC., Colakoglu, S., Siddikoglu, D., et al.[2022]

In a study involving 142 women undergoing breast reconstruction, immediate one-stage implant-based breast reconstruction (IBBR) with acellular dermal matrix (ADM) showed a significantly higher risk of surgical complications and reoperations compared to the two-stage IBBR approach.

The one-stage IBBR with ADM resulted in severe adverse events in 29% of cases, while only 5% of the two-stage group experienced similar severe complications, indicating that the one-stage method carries considerable risks that need careful consideration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Dikmans, RE., Negenborn, VL., Bouman, MB., et al.[2022]

A systematic review of 778 procedures using acellular dermal matrix in breast reconstruction found acceptable complication rates, with skin necrosis at 11%, infection at 12%, and nipple necrosis at 5%.

The study suggests that acellular dermal matrix can improve aesthetic outcomes in nipple-sparing mastectomy and immediate breast reconstruction, but emphasizes the need for clearer reporting of complications and patient demographics in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications following Nipple-Sparing Mastectomy and Immediate Acellular Dermal Matrix Implant-based Breast Reconstruction-A Systematic Review and Meta-analysis. Heidemann, LN., Gunnarsson, GL., Salzberg, CA., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular bovine pericardium dermal matrix in immediate breast reconstruction after Skin Sparing Mastectomy. Gubitosi, A., Docimo, G., Parmeggiani, D., et al.[2018]

In a study of 38 patients undergoing immediate breast reconstruction after skin-sparing mastectomy, using a de-epithelialized inferior dermal pedicle instead of acellular dermal matrices (ADMs) resulted in significant cost savings of $89,724 overall, averaging $2361 per case.

The Passot-type immediate breast reconstruction technique showed acceptable complication rates, with 92.1% of patients successfully completing the reconstruction, suggesting it is a safe and effective alternative to traditional methods that use ADMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passot-Type Immediate Breast Reconstruction Obviates the Use of Aceullular Dermal Matrix in Grades 2 and 3 Ptosis. Rivet, JJ., Day, KM., Rau, JF., et al.[2020]

Acellular dermal matrices (ADMs) have become widely used in breast surgery since their introduction in 2001, showing promise in both aesthetic and reconstructive procedures.

Despite their benefits, the high costs of ADMs raise concerns regarding their use in healthcare systems, particularly in Canada and the United States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular dermal matrices: Use in reconstructive and aesthetic breast surgery. Macadam, SA., Lennox, PA.[2023]

In a study of 203 patients undergoing immediate breast reconstruction, the use of acellular dermal matrix (ADM) resulted in fewer overall complications compared to non-acellular dermal matrix, with an odds ratio of 0.61, indicating a safer profile.

Acellular dermal matrix use was associated with significantly improved aesthetic outcomes and a lower incidence of capsular contracture and mechanical shift, suggesting it enhances the quality of breast reconstruction without increasing postoperative risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of implant-based immediate breast reconstruction with and without acellular dermal matrix. Vardanian, AJ., Clayton, JL., Roostaeian, J., et al.[2022]

Acellular dermal matrices (ADMs) are increasingly used in breast reconstruction, particularly after skin-sparing mastectomies, with over 7000 procedures documented, indicating their growing popularity despite high costs.

Current literature primarily consists of retrospective studies, with limited prospective trials, highlighting the need for more rigorous research to better understand complication rates such as hematoma, infection, and skin irritation associated with different ADMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Acellular Dermal Matrices (ADM) in Breast Reconstruction: A Review. Eichler, C., Schulz, C., Vogt, N., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving role of alloderm in breast surgery. Gabriel, A., Maxwell, GP.[2011]

A study comparing acellular dermal matrices (ADMs) and synthetic mesh (TiLoop) showed that ADMs significantly increased the production of immune-regulating cytokines IL-6 and IL-12 in B cells and T cells, indicating an immunological response that was previously assumed to be absent.

These findings suggest that the use of ADMs in breast cancer patients may influence immune responses, potentially affecting post-surgical outcomes like skin rash and seroma, highlighting the need for further investigation into their safety in oncologic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Karsten, MM., Enders, S., Knabl, J., et al.[2019]

Acellular dermal matrices (ADMs) are effective allografts used in breast reconstructive surgeries to support implants and correct tissue deficiencies after mastectomy.

ADMs have recently been utilized as a filling material for volume replacement in oncoplastic breast conserving surgery, demonstrating their versatility in breast tissue reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging features of volume replacement using an acellular dermal matrix in oncoplastic breast conserving surgery: A case report. Lee, CB., Kim, YS., Lee, SE.[2022]

Acellular dermal matrix (ADM) in single-stage breast reconstruction is associated with fewer surgeries and postoperative visits compared to two-stage reconstructions, indicating a potential for improved patient convenience and reduced healthcare costs.

Despite higher costs associated with ADM, the study found no significant difference in reconstructive success among different reconstruction methods, and ADM use led to better aesthetic outcomes and higher patient-reported quality of life scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled cost and outcomes analysis of acellular dermal matrix and implant-based reconstruction. Aliotta, RE., Duraes, EFR., Scomacao, I., et al.[2021]

Acellular dermal matrix (ADM) is increasingly used in implant-based breast reconstruction, which is the most common method for breast cancer patients, indicating its growing acceptance in surgical practice.

The review covers various aspects of ADM, including its biological characteristics and potential postoperative complications, highlighting the importance of understanding these factors for improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Acellular Dermal Matrices in One-stage Implant-based Breast Reconstruction. Dong, JY., Yan, Y., Liu, MF., et al.[2018]

In a study of 46 women undergoing implant-based breast reconstruction, the use of acellular dermal matrix (ADM) did not significantly increase the rate of early complications or implant loss compared to standard procedures, suggesting it is a safe option.

While ADM was associated with a higher rate of implant loss, all cases were linked to prior radiotherapy, indicating that the complications may be more related to patient history than the ADM itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early complications and implant loss in implant-based breast reconstruction with and without acellular dermal matrix (Tecnoss Protexa®): a comparative study. Potter, S., Chambers, A., Govindajulu, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11686910/

A comparison of acellular dermal matrices (ADM) efficacy and ... AlloDerm FD had the highest rate of wound dehiscence (3.1%). Implant failure was highest in AlloDerm FD ADMs (11.8%), followed by Porcine ADMs ( ...

2. abs.amegroups.org abs.amegroups.org/article/view/9443/html

Long-term outcomes and cost effectiveness of dermal ... Conclusions: DA is a safe, cost-saving alternative to ADM in breast reconstruction, with comparable complication rates and superior economic ...

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12978-0

Does the use of Acellular Dermal Matrices (ADM) in women ... This review suggests a lack of significant differences in most complications between ADM use and non-use for pre-pectoral IBBR.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681520305763

A controlled cost and outcomes analysis of acellular ... This is the first study to incorporate clinical outcomes, esthetic visual grading, and patient-reported quality within the same cohort of individuals.

5. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2019/05000/implant_based_breast_reconstruction_with_acellular.10.aspx

Implant Based Breast Reconstruction With Acellular Dermal... To evaluate clinical outcomes of using acellular dermal matrix (ADM) with implant based breast reconstructions (IBBRs) in a randomized controlled trial.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30308615/

Implant Based Breast Reconstruction With Acellular ... In view of reports concerning harm, we present 6-months safety data of ADM-assisted IBBR in the setting of breast cancer treatment. Methods: An open-label ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12308944/

Comparative outcomes of human acellular dermal matrices in ... Outcome data will include Red Breast Syndrome, capsular contracture, implant failure, skin flap necrosis, wound dehiscence, delayed healing, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06555614

Evaluation of Safety of Acellular Dermal Matrix(ADM) in ... The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other ...

9. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13359-3

A comparison of acellular dermal matrices (ADM) efficacy and ... Current reports point to relatively high complication rates, including an elevated risk of seroma, infection, skin necrosis and the need for ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2352587824000226

Acellular dermal matrix in breast augmentation surgery The aim of our study is to review the published literature to date to evaluate efficacy and safety of ADM in cosmetic breast surgery. Materials and Methods.