Acellular Dermal Matrix in Breast Reconstruction Post-Cancer

Not currently recruiting at 1 trial location

Overseen By Evan Matros, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Radiotherapy, Smoker, Non-English, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using Acellular Dermal Matrix (ADM), a type of supportive tissue, in breast reconstruction after cancer surgery enhances safety and reduces complications. Researchers compare two groups: one undergoing breast reconstruction with ADM and one without. They focus on how ADM affects infection rates and the likelihood of additional surgery. Women planning breast reconstruction after a mastectomy for breast cancer or as a preventive measure may be suitable candidates, especially if they meet specific surgical criteria. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that prepectoral breast reconstruction using Acellular Dermal Matrix (ADM) is generally safe. A multi-center study found that patients undergoing this reconstruction had safety outcomes similar to those not using ADM. Some patients noticed rippling, but it was not a major concern. Another study confirmed that ADM is processed safely with specific technology.

For prepectoral breast reconstruction without ADM, research indicates it is also safe. It is cost-effective and does not increase cancer risk. Although some minor issues, such as skin infections and wound openings, were reported, these were uncommon.

Overall, current evidence suggests both treatments are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about prepectoral breast reconstruction using Acellular Dermal Matrix (ADM) because it offers a unique approach to post-cancer breast reconstruction. Unlike traditional methods that place the implant under the chest muscle, prepectoral reconstruction positions the implant above the muscle, which can lead to a more natural look and feel, and potentially reduce pain and recovery time. The inclusion of ADM provides additional support and integration with the patient’s tissue, potentially enhancing the structural integrity and aesthetic outcomes. This method could represent a significant advancement in comfort and cosmetic results for patients undergoing breast reconstruction after cancer.

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

This trial will compare Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) to Prepectoral Breast Reconstruction without ADM. Research has shown that using ADM in breast reconstruction surgery can lead to good results. One study found that patients experienced fewer issues, such as infections and the need to remove implants, when ADM was used. However, no randomized trial data directly compare these outcomes. Another study examined many cases and also reported positive outcomes with ADM. Conversely, some research suggests that results might be similar with or without ADM, indicating it might not always be necessary. Overall, ADM is considered helpful, but it may not be essential for successful reconstruction. ^{1 6 7 8 9}

Who Is on the Research Team?

Evan Matros, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for women aged 21-60 who are planning nipple-sparing or skin-sparing mastectomies, either as a preventive measure or to treat breast cancer. They must be able to undergo immediate two-stage prosthetic breast reconstruction with tissue expander placement first. Women can't join if they've had chest radiation, currently smoke, don't speak English, or plan direct-to-implant reconstruction.

Inclusion Criteria

I plan to have a two-stage breast reconstruction with an initial tissue expander.

The skin around my mastectomy area has good blood flow or can be treated by removing a small part.

I am a woman aged between 21 and 60.

Exclusion Criteria

I have had radiation therapy on the breast where surgery was performed.

I have had open-heart surgery before.

You are currently smoking cigarettes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo prepectoral breast reconstruction with or without Acellular Dermal Matrix (ADM)

Immediate post-surgery period

Follow-up

Participants are monitored for major and minor complications, including infections, explantation, reoperation, and seroma

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)
• Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)

Trial Overview The study compares the outcomes of prepectoral breast reconstruction using Acellular Dermal Matrix (ADM) versus without ADM. It focuses on immediate postoperative complications like infections and issues that might require additional surgery or removal of implants.

How Is the Trial Designed?

Group I: Prepectoral Breast Reconstruction without ADM Experimental Treatment 1 Intervention

Group II: Prepectoral Breast Reconstruction with ADM Experimental Treatment 1 Intervention

Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) is already approved in United States, European Union for the following indications:

Approved in United States as Acellular Dermal Matrix for:

• Breast reconstruction following mastectomy

Approved in European Union as Acellular Dermal Matrix for:

• Breast reconstruction following mastectomy

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

The Plastic Surgery Foundation

Collaborator

Trials

11

Recruited

1,300+

Published Research Related to This Trial

In a study of 124 patients undergoing prepectoral breast reconstruction, the use of acellular dermal matrix (ADM) did not lead to a significant difference in postoperative complications or explantation rates compared to procedures without ADM.

Both groups experienced similar rates of issues like seroma, hematoma, and infection, suggesting that ADM may not be necessary for reducing complications in this type of breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of Early Complications after Prepectoral Tissue Expander Placement in First-Stage Breast Reconstruction with and without Acellular Dermal Matrix. Pires, G., Marquez, JL., Memmott, S., et al.[2023]

A study of 63 patients undergoing immediate prepectoral tissue expander breast reconstruction without acellular dermal matrix (ADM) showed a major complication rate of 17%, which is comparable to traditional methods using ADM.

The explant rate for tissue expanders in this group was 13%, similar to rates seen in subpectoral reconstructions with ADM, suggesting that this approach is a viable alternative in breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prepectoral Breast Reconstruction Without the Use of Acellular Dermal Matrix: A 3-Year Review. Poveromo, LP., Franck, P., Ellison, A., et al.[2023]

A study of 76 cases of immediate prepectoral breast reconstruction found that using acellular dermal matrix (ADM) did not significantly reduce short-term complications compared to cases without ADM support.

Both groups had similar final implant sizes and complication rates, suggesting that ADM may not be necessary for all patients undergoing this type of reconstruction, potentially allowing for more selective use of ADM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do We Need Support in Prepectoral Breast Reconstruction? Comparing Outcomes with and without ADM. Salibian, AA., Bekisz, JM., Kussie, HC., et al.[2022]

The use of acellular dermal matrix (ADM) in one-stage prepectoral breast reconstruction allows for immediate reconstruction with reduced need for ADM and increased support from vascularized tissue.

This technique not only minimizes postoperative pain but also reduces anatomical disruption, enhancing the overall recovery experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Pectoral One-Stage Breast Reconstruction with Anterior Coverage Using Superior Anterior Biological Acellular Dermal Matrix (ADM) and Inferior Anterior Dermal Sling Support. Sisti, A., Sadeghi, P., Cuomo, R., et al.[2022]

Prepectoral acellular dermal matrix (ADM)-assisted breast reconstruction shows a safety profile comparable to partially submuscular reconstruction, with similar postoperative complications and improved recovery metrics like pain and range of motion.

Aesthetic outcomes are influenced by factors such as body mass index, fat grafting, and implant cohesiveness, with higher BMI and fat grafting reducing visible rippling, while radiation treatment increases the risk of capsular contracture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile and Predictors of Aesthetic Outcomes After Prepectoral Breast Reconstruction With Meshed Acellular Dermal Matrix. Belmonte, BM., Campbell, CA.[2023]

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]

Prepectoral direct-to-implant breast reconstruction using acellular dermal matrix (ADM) is safe for thin patients, showing no significant difference in early complications compared to women with an ideal body mass index (BMI).

However, thin women (BMI ≤ 22.0) have a nearly threefold increased risk of late complications, specifically rippling or wrinkling of the implant, which can be corrected with lipo-grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prepectoral Direct-To-Implant One-Stage Reconstruction With ADMs: Safety and Outcome in "Thin Patients". Scarabosio, A., Contessi Negrini, F., Pisano, G., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6996627/

Multicentre study of prepectoral breast reconstruction using ... This multicentre audit examined surgical outcomes following prepectoral reconstruction using acellular dermal matrix (ADM).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798312013510

Acellular dermal matrix (ADM) assisted breast ... Randomised trial data for breast reconstruction using ADM does not exist. Other non-dermal, natural prosthetic materials are being used in breast reconstruction ...

3. gs.amegroups.org gs.amegroups.org/article/view/33010/html

Prepectoral breast reconstruction with complete implant ... Here, we examined the records of 23 breast cancer patients followed up for 1 year after breast reconstruction surgery wherein two double-crossed ADMs were used ...

4. scientificarchives.com scientificarchives.com/article/acellular-dermal-matrix-in-prosthetic-breast-reconstructive-surgery-with-prepectoral-technique-a-literature-review

Acellular Dermal Matrix in Prosthetic Breast Reconstructive ... We performed a brief review of the literature about the use of ADMs in prepectoral direct-to-implant breast reconstruction, also discussing about the costs and ...

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

A comparison of acellular dermal matrices (ADM) efficacy and ... This study compares outcomes of different ADMs that are commonly used in women undergoing IBR, this was short and long-term complications.

6. 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 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820923002148

Prepectoral Direct-To-Implant One-Stage Reconstruction ... Prepectoral reconstruction with ADM in thin patients may be considered as safe as in standard BMI patients. Rippling may be more frequent, but, whenever needed, ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38601291/

Pre-pectoral breast reconstruction with tissue expander ... The purpose of this retrospective cohort study is to evaluate the feasibility and safety of two-step reconstruction with TE in pre-pectoral position covered by ...

9. journals.lww.com journals.lww.com/annalsplasticsurgery/Fulltext/2021/06005/Safety_Profile_and_Predictors_of_Aesthetic.25.aspx?context=LatestArticles&generateEpub=Article%7Cannalsplasticsurgery:2021:06005:00025%7C10.1097/sap.0000000000002764%7C

Safety Profile and Predictors of Aesthetic Outcomes After ... Safety Profile and Predictors of Aesthetic Outcomes After Prepectoral Breast Reconstruction With Meshed Acellular Dermal Matrix. Belmonte Briana M. MD ...