Acellular Dermal Matrix in Breast Reconstruction Post-Cancer

Recruiting at1 trial location

Overseen by Evan Matros, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is studying whether using a special material in breast reconstruction reduces problems like infections and the need for more surgeries. This material helps support new tissue growth. The goal is to see if patients have fewer issues after surgery when this material is used. This material has been increasingly used in breast reconstruction surgeries to support tissue growth and improve how the breast looks, though its impact on problems remains debated.

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.

What data supports the idea that Acellular Dermal Matrix in Breast Reconstruction Post-Cancer is an effective treatment?

The available research shows that using Acellular Dermal Matrix (ADM) in breast reconstruction can lead to positive outcomes. For example, one study highlights that ADM can enhance breast reconstruction by providing better support and reducing pain after surgery. Another study compares the use of ADM with cases where it wasn't used and suggests that ADM might help in reducing early complications. Overall, these studies suggest that ADM can be an effective part of breast reconstruction treatment, offering benefits like less pain and better support for the implant. ^{1 2 3 4 5}

What safety data is available for acellular dermal matrix in breast reconstruction?

The safety data for acellular dermal matrix (ADM) in breast reconstruction indicates that ADM-assisted prepectoral breast reconstruction has an appropriate postoperative safety profile, with improved pain scores and faster return to full range of motion compared to submuscular implant placement. Studies have examined early complication rates and explantation rates for prepectoral breast reconstruction with and without ADM, showing that ADM can be a safe option. However, there is limited data on aesthetic outcomes and the role of different ADM types in complication risk. Overall, ADM-assisted reconstruction is considered safe, especially in selected patient cohorts. ^{1 2 4 6 7}

Is Prepectoral Breast Reconstruction with or without Acellular Dermal Matrix (ADM) a promising treatment?

Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) is promising because it can enhance breast reconstruction by providing better support and reducing pain after surgery. It also allows for immediate reconstruction in one stage, which can be more convenient for patients. On the other hand, Prepectoral Breast Reconstruction without ADM is also being explored, but there are fewer studies comparing its outcomes directly with ADM use. ^{1 2 3 4 5}

Research Team

Evan Matros, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Treatment Details

Interventions

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

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.

Participant Groups

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

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

The Plastic Surgery Foundation

Collaborator

Trials

11

Recruited

1,300+

Findings from Research

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]

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]

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]

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 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]

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]

References

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

Do We Need Support in Prepectoral Breast Reconstruction? Comparing Outcomes with and without ADM. [2022]

2. United States 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. [2023]

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

Prepectoral Breast Reconstruction Without the Use of Acellular Dermal Matrix: A 3-Year Review. [2023]

4. 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]

5. Switzerland 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. [2022]

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

Prepectoral Direct-To-Implant One-Stage Reconstruction With ADMs: Safety and Outcome in "Thin Patients". [2023]

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

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