Acellular Dermal Matrix for Breast Reconstruction

(ADMIRE Trial)

Recruiting at 11 trial locations

Overseen By Ana Villagomez

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: RTI Surgical

Must not be taking: Systemic steroids

Disqualifiers: Pregnancy, Infection, High BMI, Diabetes, 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

467 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist women undergoing breast reconstruction after a mastectomy. It examines whether using a special material called Acellular Dermal Matrix (ADM) improves reconstruction results when placed over the chest muscle. The study includes two groups: one with ADM and one without, to compare outcomes. Women who have had a nipple or skin-sparing mastectomy and are scheduled for a two-stage breast reconstruction might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance breast reconstruction outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who are currently taking systemic steroids. It's best to discuss your specific medications with the trial team.

What prior data suggests that Acellular Dermal Matrix is safe for breast reconstruction?

Research has shown that special materials called acellular dermal matrices (ADM) are often used in breast reconstruction, but they can sometimes cause problems. Some studies have reported issues like fluid build-up, infection, and skin tissue death. One study found that Cortiva, a type of ADM, had fewer cases of fluid build-up compared to another type called AlloDerm. This suggests that Cortiva might be a safer choice among these materials. These findings highlight the importance of considering potential risks when using ADMs in breast reconstruction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Acellular Dermal Matrix (ADM) is unique because it offers a scaffold that supports tissue regeneration, which is not typically provided by standard implant-only breast reconstruction methods. Unlike traditional options, ADM integrates with the body's own tissues, potentially leading to improved outcomes in terms of contour and support. Researchers are excited about ADM because it could reduce complications like implant exposure and improve the overall aesthetic results of breast reconstruction.

What evidence suggests that Acellular Dermal Matrix is effective for breast reconstruction?

Research has shown that using Acellular Dermal Matrix (ADM) in breast reconstruction can enhance the final appearance by providing better support and coverage for the implant. In this trial, one group will receive breast reconstruction with ADM, which has proven especially helpful in the lower part of the breast, where extra support is needed. ADM often accompanies implants to create a more natural look and may reduce the risk of complications compared to reconstruction without it. While results can vary, many patients report satisfaction with their appearance when ADM is used. Overall, ADM serves as a valuable tool in breast reconstruction for improving cosmetic results. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for genetic females aged 22 or older who are planning to have immediate breast reconstruction using a two-stage, pre-pectoral technique after nipple or skin sparing mastectomy. Participants must be willing and able to give informed consent and follow the study's requirements.

Inclusion Criteria

I am willing and able to agree to the study's procedures.

I can follow the study's requirements.

I am genetically female.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Stage 1

Participants undergo the first stage of breast reconstruction using a pre-pectoral technique

3 months

Treatment Stage 2

Participants undergo the second stage of breast reconstruction, including histopathology assessment

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Acellular Dermal Matrix

Trial Overview The study is testing Acellular Dermal Matrix (Cortiva Tissue Matrix) in women undergoing breast reconstruction. It's a prospective, multi-center clinical study with two non-randomized groups comparing outcomes of this specific surgical technique.

How Is the Trial Designed?

Group I: Acellular Dermal Matrix Experimental Treatment 1 Intervention

Breast reconstruction with Cortiva Tissue Matrix

Group II: no Acellular Dermal Matrix Active Control 1 Intervention

Breast reconstruction only with no ADM

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?

RTI Surgical

Lead Sponsor

Trials

18

Recruited

6,500+

Bright Research Partners

Industry Sponsor

Trials

18

Recruited

2,700+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Published Research Related to This Trial

In a study of 17 patients undergoing breast reconstruction with acellular dermal matrices (ADMs), Cortiva showed significantly lower levels of TGF-1 activation compared to Alloderm, suggesting a potentially safer profile for reducing fibrosis.

Both ADM products resulted in similar clinical outcomes and complication rates, but Cortiva demonstrated equal vascularity to natural capsules, indicating it may support better integration in breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Histological Comparison of Two Human Acellular Dermal Matrix Products in Prosthetic-Based Breast Reconstruction. Moyer, HR., Hart, AM., Yeager, J., et al.[2022]

In a study involving 90 patients undergoing immediate tissue expander breast reconstruction, there were no significant differences in overall complication rates between human acellular dermal matrix (HADM) and bovine acellular dermal matrix (BADM), with rates of 25% and 27% respectively.

Tissue expander loss occurred in 7% of patients using HADM compared to 17% using BADM, although this difference was not statistically significant, indicating that both materials can be used safely in breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allograft vs Xenograft Bioprosthetic Mesh in Tissue Expander Breast Reconstruction: A Blinded Prospective Randomized Controlled Trial. Asaad, M., Selber, JC., Adelman, DM., et al.[2021]

In a study of 62 patients undergoing acellular dermal matrix (ADM) based breast reconstruction, the complication rates were low, with skin necrosis occurring in 10.4% of cases and infection in 1.3%, leading to a total explantation rate of 5.2%.

Patient-reported outcomes were positive, with a mean satisfaction score of 83.1% and good scores for psychosocial (70.7%) and physical well-being (77.9%), indicating that patients generally felt satisfied with their reconstruction results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and patient reported outcomes in breast reconstruction using acellular dermal matrix. Powell-Brett, S., Goh, S.[2022]

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]

In a study of 726 patients undergoing prepectoral breast reconstruction using different types of acellular dermal matrix (ADM), no significant differences in complication rates were found among the ADM types (AlloDerm, FlexHD, and SurgiMend).

Despite variations in ADM characteristics and mastectomy types, the study concluded that the choice of ADM did not impact the risk of complications such as seroma, infection, or tissue expander loss, suggesting that ADM type may not be a critical factor in surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cohort Analysis of Early Outcomes After AlloDerm, FlexHD, and SurgiMend Use in Two-Stage Prepectoral Breast Reconstruction. Chu, JJ., Nelson, JA., Kokosis, G., et al.[2023]

A study comparing breast reconstructions with and without acellular dermal matrices (ADM) found that ADM-assisted reconstructions had significantly better esthetic outcomes, particularly in breast mound volume, placement, and inframammary fold definition.

The research involved a chart review of consecutive expander-implant reconstructions, with photographic assessments scored by independent reviewers, indicating that ADM can enhance the overall appearance of breast reconstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esthetic Outcomes of ADM-Assisted Expander-Implant Breast Reconstruction. Nguyen, KT., Mioton, LM., Smetona, JT., et al.[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]

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]

In a study of 179 implant-based breast reconstructions using acellular dermal matrix (ADM), specific modifications in surgical technique led to a significant reduction in seroma rates from 18.6% to 4.7%.

The major infection rate also decreased from 7% to 1.9% after implementing these modifications, demonstrating that targeted clinical practices can enhance safety and reduce complications in ADM-assisted breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimizing complications with the use of acellular dermal matrix for immediate implant-based breast reconstruction. Ganske, I., Verma, K., Rosen, H., 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 ... The reported advantages of using ADM-based breast reconstruction are enhanced soft tissue coverage of the lower pole, increased intraoperative ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681524007290

The use of Cortiva® Allograft Dermis in two-staged breast ... Acellular dermal matrices (ADM) are an adjunct in implant-based breast reconstruction. While clinical outcomes have generally been equivocal between brands, ...

3. journals.lww.com journals.lww.com/plasreconsurg/fulltext/2024/10001/cortiva_versus_alloderm_in_prepectoral_and_partial.3.aspx

Cortiva versus AlloDerm in Prepectoral and Partial... These reconstructions used a tissue expander (TE) in 83,487 cases and an acellular dermal matrix (ADM) 59,247 times, with bilateral reconstructions outpacing ...

4. 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 ...

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

Does the use of Acellular Dermal Matrices (ADM) in women ... Studies have suggested that ADM use improves aesthetic outcomes via improved implant coverage and additional tissue support [40], however claims ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12523482/

Effect of Acellular Dermal Matrix in Postoperative ... However, their use has also been associated with higher costs and a potential increase in postoperative complications, which remains a matter of ...

7. 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 ...

8. 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 ...