ADMs for Breast Reconstruction

(Breast_ADM Trial)

Recruiting at 3 trial locations

Overseen By Raveena Gowda

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Gentamicin, Vancomycin

Disqualifiers: Previous reconstruction, Radiation, Allergies, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

328 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of four types of acellular dermal matrices (ADMs) in breast reconstruction after a mastectomy. ADMs, used with implants, help create a new breast shape. The study will compare AlloDerm, DermaCell, AlloMax, and Flex HD to determine which one results in better surgical outcomes and fewer complications over two years. Women who have had a mastectomy and plan to undergo breast reconstruction with implants may be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to contribute to research that could enhance breast reconstruction outcomes for many women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these acellular dermal matrixes are safe for breast reconstruction?

Research has shown that the safety of acellular dermal matrices (ADMs) used in breast reconstruction can vary by product. AlloDerm has not presented any unexpected safety issues, whether used short-term or for up to five years. Approximately 68.1% of patients using AlloDerm did not experience complications during follow-up.

However, concerns exist with AlloMax and Flex HD. The FDA has reported higher complication rates with these products, including implant removal, additional surgeries, and infections. Specifically, Flex HD and AlloMax have been associated with increased risks of fluid buildup and skin problems after surgery.

DermACELL appears to have a complication rate similar to AlloDerm, with no significant increase in risks. Overall, while some ADMs are generally safe, others may pose a higher risk of complications. These findings are important to consider when evaluating participation in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for breast reconstruction—AlloDerm, AlloMax, DermACELL, and Flex HD—because they use acellular dermal matrices (ADMs), which provide a supportive scaffold for the body’s own cells to grow and integrate. Unlike traditional methods that might rely heavily on autologous tissue transfer, these ADMs offer the potential for less invasive surgeries and quicker recovery times. Each product, like AlloDerm and DermACELL, is derived from human or porcine tissues and processed to remove cells, reducing the risk of rejection while maintaining the structure needed for effective tissue integration. This innovative approach offers a promising alternative to existing reconstruction techniques, potentially improving outcomes for patients seeking breast reconstruction.

What evidence suggests that these ADMs are effective for breast reconstruction?

This trial will compare different acellular dermal matrices (ADMs) used in breast reconstruction to support implants. Participants will be assigned to one of the following groups: AlloDerm, AlloMax, DermACELL, or Flex HD. Research has shown that AlloDerm effectively reduces complications, with many patients experiencing low infection rates. Studies comparing DermACELL and AlloDerm found no major differences in results, suggesting both work similarly well. AlloMax has been linked to good outcomes, but some studies reported higher complication rates with Flex HD, such as implant removal and infections. Overall, these ADMs provide support and can help lower the risk of some complications, although results can vary. ^{2 3 6 7 8}

Who Is on the Research Team?

Dr. Nancy Van Laeken

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

Women aged 21-65 who are undergoing breast reconstruction with tissue expanders and ADMs after a mastectomy can join. They must be having the procedure in two stages and have not had previous breast reconstructions, radiation to the chest, or axillary node dissection. Those allergic to certain antibiotics (Gentamicin, Vancomycin) or Polysporin's ingredients cannot participate.

Inclusion Criteria

I am a woman aged 21-65 planning to have breast reconstruction with synthetic materials.

My breast reconstruction will be in two stages, starting with tissue expanders.

Exclusion Criteria

My surgeon might consider me ineligible for breast reconstruction if they find poor blood flow in the breast area during surgery.

I have had radiation treatment to my breast or upper chest before.

I am having surgery to remove lymph nodes under my arm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo alloplastic breast reconstruction using one of four acellular dermal matrixes (ADMs) with two-stage tissue expander reconstruction

6 months

Multiple visits for stage I and stage II surgeries

Follow-up

Participants are monitored for surgical outcomes, including seroma incidence, capsular contracture, and other complications

2 years

Regular follow-up visits for outcome assessments

Post-operative assessment

Evaluation of post-operative satisfaction and aesthetic outcomes using BREAST-Q and other assessments

2 years

What Are the Treatments Tested in This Trial?

Interventions

• AlloDerm
• AlloMax
• DermACELL
• Flex HD

Trial Overview

The trial is testing four different acellular dermal matrices (ADMs): AlloDerm, DermaCell, Allomax, and Flex HD used during breast reconstruction surgery. It aims to find out which one has fewer complications by tracking patients' recovery over two years.

How Is the Trial Designed?

Group I: Flex HD group Active Control 1 Intervention

Device for immediate implant based breast reconstruction.

Group II: DermACELL group Active Control 1 Intervention

Device for immediate implant based breast reconstruction.

Group III: AlloDerm group Active Control 1 Intervention

Device for immediate implant based breast reconstruction.

Group IV: AlloMax group Active Control 1 Intervention

Device for immediate implant based breast reconstruction.

AlloDerm is already approved in United States, European Union, Canada for the following indications:

Approved in United States as AlloDerm for:

• Breast reconstruction
• Hernia repair
• Abdominal wall reconstruction

Approved in European Union as AlloDerm for:

• Breast reconstruction
• Soft tissue repair

Approved in Canada as AlloDerm for:

• Breast reconstruction
• Hernia repair

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

In a study of 74 patients undergoing immediate breast reconstruction, there were no significant differences in postoperative outcomes between the use of DermACELL and AlloDerm acellular dermal matrices (ADMs).

A systematic review of 12 studies involving 518 patients showed that DermACELL has a consistent safety profile and similar complication rates compared to AlloDerm, indicating it is a safe option for breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DermACELL Acellular Dermal Matrix in Oncologic Breast Reconstruction: A Cohort Study and Systematic Review. Swisher, AR., Landau, MJ., Kadakia, N., et al.[2022]

In a study comparing two leading acellular dermal matrices for breast reconstruction, no significant differences in postoperative complications were found between Alloderm-RTU and DermACELL, indicating both are safe options.

The overall complication rates were low, with implant loss and infection occurring in less than 2% of the 249 cases studied, supporting the continued use of acellular dermal matrices in breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Direct Comparison of Alloderm-Ready to Use (RTU) and DermACELL in Immediate Breast Implant Reconstruction. Zenn, MR., Salzberg, CA.[2022]

A meta-analysis of 5 studies involving 225 patients found no significant differences in complication rates between ready-to-use (RTU) and freeze-dried (FD) forms of AlloDerm in implant-based breast reconstruction.

Complications such as cellulitis, seroma, and explantation occurred at similar rates in both RTU and FD groups, indicating that both forms are equally safe for use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-analysis Assessing Postsurgical Outcomes between Aseptic and Sterile AlloDerm Regenerative Tissue Matrix. Macarios, D., Griffin, L., Chatterjee, A., et al.[2020]

Acellular dermal matrices (ADMs) play a significant role in breast reconstruction surgery, but there is limited data directly comparing the effectiveness of various products like AlloDerm® and Strattice™ specifically for this purpose.

The review highlights key features of different ADMs, such as their biological sources and costs, which can aid surgeons in making informed decisions, although an ideal ADM product for breast reconstruction has yet to be established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of different ADM materials in breast surgery. Cheng, A., Saint-Cyr, M.[2022]

In a study involving 302 patients, Cortiva 1-mm Allograft Dermis showed similar rates of reconstructive failure compared to AlloDerm RTU, indicating that both acellular dermal matrices are equally effective for immediate prosthetic breast reconstruction.

Cortiva was associated with a lower risk of seroma formation (7.6% vs. 12% for AlloDerm) and was also less expensive, suggesting it may be a preferable option without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortiva vs AlloDerm in Prepectoral and Partial Submuscular Implant-Based Breast Reconstruction: A Randomized Clinical Trial. Keane, AM., Chiang, SN., Tao, Y., et al.[2023]

In a study of 30 patients undergoing implant-based breast reconstruction, both AlloDerm RTU and AlloMax showed similar complication rates and patient satisfaction, indicating that both acellular dermal matrices are effective options for this procedure.

Histologically, AlloMax demonstrated significantly higher vessel density compared to AlloDerm, suggesting that it may promote better vascular in-growth, although overall patient outcomes were comparable between the two ADMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two cadaveric acellular dermal matrices for immediate breast reconstruction: A prospective randomized trial. Hinchcliff, KM., Orbay, H., Busse, BK., et al.[2022]

In a randomized controlled trial involving 62 patients undergoing immediate breast reconstruction, those using Alloderm reported significantly higher satisfaction scores at 3 months post-surgery compared to those using Dermacell, particularly in areas like satisfaction with breasts and overall results.

However, by 12 months post-surgery, there were no significant differences in patient-reported outcomes between the two groups, suggesting that while Alloderm may offer short-term benefits, both products yield similar long-term satisfaction levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of patient-reported outcomes between Alloderm and Dermacell in immediate alloplastic breast reconstruction: A randomized control trial. Stein, MJ., Arnaout, A., Lichtenstein, JB., et al.[2021]

In a multicenter randomized controlled trial involving 230 patients, there was no significant difference in matrix-related complications between the two commonly used human acellular dermal matrices, FlexHD Pliable and AlloDerm RTU, indicating both are safe options for implant-based breast reconstruction.

The study found that obesity and prepectoral placement of the matrix were associated with higher risks of complications, suggesting that patient factors should be considered when planning breast reconstruction procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular Dermal Matrix-Associated Complications in Implant-Based Breast Reconstruction: A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Two Human Tissues. Broyles, JM., Liao, EC., Kim, J., et al.[2023]

In a study of 547 breast reconstructions involving 382 women, there was no significant difference in postoperative complication rates between the two types of human acellular dermis (AlloDerm and FlexHD) used for immediate reconstruction.

However, multivariate analysis indicated that using FlexHD, along with factors like smoking and higher initial implant fill, may increase the risk of implant loss, suggesting careful consideration when choosing between these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. Liu, DZ., Mathes, DW., Neligan, PC., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4993036/

A Direct Comparison of Alloderm-Ready to Use (RTU) and ...

The data show that both products were equally effective for use in implant-based reconstruction. Both Alloderm-RTU and DermACELL had low rates of infection and ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0960977618300559

Breast reconstruction with Alloderm Ready to Use: A meta ...

The present meta-analysis was designed to compare the effectiveness of Alloderm-RTU with other earlier HADM products in reducing complications after breast ...

3.

cureus.com

cureus.com/articles/85517-clinical-outcomes-of-acellular-dermal-matrix-simpliderm-and-alloderm-ready-to-use-in-immediate-breast-reconstruction

Clinical Outcomes of Acellular Dermal Matrix (SimpliDerm ...

Throughout the follow-up period, 60.5% of the SimpliDerm group and 68.1% of the AlloDerm RTU group remained free of complications (P=.430).

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7816190/

A Randomized Controlled Trial Comparing Alloderm-RTU ...

Secondary outcomes included: post drain removal seroma aspiration, infection, redbreast syndrome, wound dehiscence, loss of the implant, and ...

5.

journals.lww.com

journals.lww.com/prsgo/fulltext/2018/05000/alloderm_rtu_integration_and_clinical_outcomes.1.aspx

AlloDerm RTU Integration and Clinical Outcomes When ...

This study was undertaken to report on the clinical performance of AlloDerm RTU in 2-stage, tissue expander/implant breast reconstruction, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5999421/

AlloDerm RTU Integration and Clinical Outcomes When ...

There were no unexpected safety concerns with its use at short-term or at long-term, at least up to 5 years of follow-up. INTRODUCTION.

7.

journals.lww.com

journals.lww.com/prsgo/fulltext/2014/03000/comparison_between_freeze_dried_and_ready_to_use.2.aspx

Comparison between Freeze-dried and Ready- ...

Our study demonstrates a clinically higher postoperative complication rate in immediate breast reconstruction with RTU AlloDerm compared with FD AlloDerm and ...

8.

jprasopen.com

jprasopen.com/article/S2352-5878(19)30031-2/fulltext

A retrospective review of breast reconstruction outcomes ...

The most important finding was no difference in complication rates between the AlloDerm and DermACELL groups. The DermACELL cohort had larger breasts, increased ...