Acellular Dermal Matrix for Breast Reconstruction

(ADMIRE Trial)

Recruiting at 5 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

Trial Summary

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 data supports the effectiveness of the treatment Acellular Dermal Matrix (ADM) for breast reconstruction?

Some studies suggest that using acellular dermal matrix (ADM) in breast reconstruction may improve aesthetic outcomes, but there is also evidence of higher complication rates, such as infections. The effectiveness of ADM in improving overall outcomes remains uncertain due to limited high-quality data. ^{1 2 3 4 5}

Is acellular dermal matrix (ADM) safe for use in breast reconstruction?

Some studies suggest that using acellular dermal matrix (ADM) in breast reconstruction might lead to higher complication rates, such as early complications and implant loss, compared to not using ADM. ^{1 2 6 7 8}

How is the treatment Acellular Dermal Matrix (ADM) unique for breast reconstruction?

Acellular Dermal Matrix (ADM) is unique because it is a type of graft made from human, bovine, or porcine skin that supports or reconstructs soft tissue, particularly in breast reconstruction after mastectomy. Unlike other treatments, ADMs are used to cover breast implants and can also serve as a filling material for volume replacement in breast-conserving surgeries. ^{1 3 6 7 9}

What is the purpose of this trial?

Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

Eligibility Criteria

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 am genetically female.

I am having a 2-stage breast reconstruction above the chest muscle.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Allograft vs Xenograft Bioprosthetic Mesh in Tissue Expander Breast Reconstruction: A Blinded Prospective Randomized Controlled Trial. [2021]

2. England 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A controlled cost and outcomes analysis of acellular dermal matrix and implant-based reconstruction. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Minimizing complications with the use of acellular dermal matrix for immediate implant-based breast reconstruction. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Esthetic Outcomes of ADM-Assisted Expander-Implant Breast Reconstruction. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A Cohort Analysis of Early Outcomes After AlloDerm, FlexHD, and SurgiMend Use in Two-Stage Prepectoral Breast Reconstruction. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Histological Comparison of Two Human Acellular Dermal Matrix Products in Prosthetic-Based Breast Reconstruction. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical and patient reported outcomes in breast reconstruction using acellular dermal matrix. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Imaging features of volume replacement using an acellular dermal matrix in oncoplastic breast conserving surgery: A case report. [2022]