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Acellular Dermal Matrix in Breast Reconstruction Post-Cancer

Phase 3
Recruiting
Led By Evan Matros, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage
Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial is comparing the rate of complications after prepectoral breast reconstruction using Acellular Dermal Matrix (ADM) versus not using ADM.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include infection risks at the surgical site, possible reactions to the Acellular Dermal Matrix material used in some patients, and complications leading to further surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I plan to have a two-stage breast reconstruction with an initial tissue expander.
Select...
The skin around my mastectomy area has good blood flow or can be treated by removing a small part.
Select...
I plan to have a mastectomy that preserves the nipple or skin.
Select...
My surgeon confirmed the area in front of my chest muscles is suitable for surgery.
Select...
I am a woman aged between 21 and 60.
Select...
I am planning to have one or both breasts removed as a preventive measure or to treat breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients who experience major complications
Secondary outcome measures
Estimate rates of minor complications (specifically seroma)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Prepectoral Breast Reconstruction without ADMExperimental Treatment1 Intervention
Group II: Prepectoral Breast Reconstruction with ADMExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,546 Total Patients Enrolled
202 Trials studying Breast Cancer
80,751 Patients Enrolled for Breast Cancer
The Plastic Surgery FoundationOTHER
8 Previous Clinical Trials
795 Total Patients Enrolled
1 Trials studying Breast Cancer
200 Patients Enrolled for Breast Cancer
Evan Matros, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05316324 — Phase 3
Breast Cancer Research Study Groups: Prepectoral Breast Reconstruction with ADM, Prepectoral Breast Reconstruction without ADM
Breast Cancer Clinical Trial 2023: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) Highlights & Side Effects. Trial Name: NCT05316324 — Phase 3
Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05316324 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots in this research project for participants?

"Yes, this study is still looking for participants and is regularly updating their information as seen on clinicaltrials.gov. The trial was first posted on March 23rd, 2020 and the most recent update was on July 6th, 2020."

Answered by AI

Do I fit the requirements to become a subject in this experiment?

"For this study, we are seeking 352 individuals who: A) are 21-60 years old, B) have breast cancer, C) are female, D) are planning to undergo a mastectomy (unilateral or bilateral), E) are planning on immediate two-stage prosthetic breast reconstruction with TE placement as the first stage, F) are planning to undergo nipple-sparing or skin-sparing mastectomy, G) have adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion, and H"

Answered by AI

Are elderly patients above the age of retirement eligible for this experimental treatment?

"The ideal candidate for this trial would be someone who is under 60 years old and above the age of 21."

Answered by AI

Is the use of acellular dermal matrix for prepectoral breast reconstruction an accepted medical practice?

"Given that this is a Phase 3 trial with both efficacy and safety data, our team has given Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) a safety rating of 3."

Answered by AI

How many people are receiving therapy in this experiment?

"That is accurate. The information available on clinicaltrials.gov indicates that this particular trial is still enrolling patients. The trial was originally posted on March 23rd, 2022 and was last updated on July 6th, 2022. They are hoping to enroll 352 patients from 1 site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
2022. "A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05316324.
~165 spots leftby Mar 2026
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