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

Trial Summary

What is the purpose of this trial?

This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.

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 data supports the effectiveness of the treatment AlloDerm and similar acellular dermal matrices for breast reconstruction?

Studies show that AlloDerm RTU and AlloMax, both acellular dermal matrices, are effective for implant-based breast reconstruction with similar complication rates and patient satisfaction. Additionally, a comparison between AlloDerm RTU and DermACELL found low complication rates, supporting the continued use of these materials in breast reconstruction. ^{1 2 3 4 5}

Is the use of acellular dermal matrices (ADMs) like AlloDerm and DermACELL safe for breast reconstruction?

Studies show that acellular dermal matrices (ADMs) like AlloDerm and DermACELL are generally safe for use in breast reconstruction, with low rates of complications such as infection and implant loss, both being less than 2% in a study of 249 cases. ^{1 2 3 5 6}

How does the treatment using ADMs like AlloDerm, AlloMax, DermACELL, and Flex HD differ from other breast reconstruction treatments?

The use of acellular dermal matrices (ADMs) like AlloDerm, AlloMax, DermACELL, and Flex HD in breast reconstruction is unique because they provide a scaffold that supports tissue integration and healing, which can enhance the outcomes of implant-based reconstruction. These ADMs differ in their processing methods, sterility, and thickness, which may influence their performance, but studies show they generally offer similar patient satisfaction and complication rates. ^{1 6 7 8 9}

Research Team

Dr. Nancy Van Laeken

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of two cadaveric acellular dermal matrices for immediate breast reconstruction: A prospective randomized trial. [2022]

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

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

3. United States 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. [2023]

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

Comparison of different ADM materials in breast surgery. [2022]

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

A Meta-analysis Assessing Postsurgical Outcomes between Aseptic and Sterile AlloDerm Regenerative Tissue Matrix. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A comparison of patient-reported outcomes between Alloderm and Dermacell in immediate alloplastic breast reconstruction: A randomized control trial. [2021]

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

DermACELL Acellular Dermal Matrix in Oncologic Breast Reconstruction: A Cohort Study and Systematic Review. [2022]

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

Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. [2022]

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

Cortiva vs AlloDerm in Prepectoral and Partial Submuscular Implant-Based Breast Reconstruction: A Randomized Clinical Trial. [2023]