A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction

February 13, 2026 updated by: Memorial Sloan Kettering Cancer Center

A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix

The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

353

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Rockville Centre, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Females aged 21-60 years
  • Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer
  • Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage
  • Planning to undergo nipple-sparing or skin-sparing mastectomy
  • 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
  • Intraoperative confirmation of prepectoral plane viability by operating physician

Exclusion Criteria:

  • History of radiotherapy to the operative breast
  • Current smoker
  • Non-English speaking patients
  • Planning to undergo direct-to-implant reconstruction
  • Prior sternotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prepectoral Breast Reconstruction with ADM
Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)
Prepectoral Breast Reconstruction with (ADM)
Experimental: Prepectoral Breast Reconstruction without ADM
Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)
Prepectoral Breast Reconstruction without ADM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients who experience major complications
Time Frame: 90 days

Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis):

  • Infection defined as:
  • Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics
  • Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics
  • Purulent drainage from the surgical site or incision
  • Explantation defined as the need for removal of a TE for any cause
  • Reoperation defined as skin excision performed in either the clinic or the operating room for mastectomy skin flap necrosis, surgical incision dehiscence, pending skin breakdown or another surgical complication
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate rates of minor complications (specifically seroma)
Time Frame: 90 days

Minor complication for (Tissue Expanders) TEs are defined as:

o Seroma: Clinically significant noninfected fluid collection requiring either needle aspiration or drain replacement
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

The Plastic Surgery Foundation

Investigators

  • Principal Investigator: Evan Matros, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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